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HUSM FORMULARY 6TH EDITION 2010/2011
PHARMACOLOGIC CATEGORY
1. CENTRAL NERVOUS SYSTEM PRODUCTS
1.1. Anticonvulsants
CARBAMAZEPINE
Dosage Form: Tablet 200 mg, SR 200 mg, CR 400 mg; Syrup 100 mg/5 ml (II)
Recommended Dose: 100-200 mg once or twice daily gradually increasing to 400
mg bd or tds; Child: Up to 1 year 100-200 mg daily; 1-5 yrs 200-400 mg daily; 5-10 yrs 400600 mg daily; 10-15 yrs 600 mg-1g daily; For trigeminal neuralgia: Usually 100 mg once or
twice daily on 1st day increasing gradually to 200 mg tds or qid, up to 1.6 gram daily.
Indications: As anticonvulsant in grand mal and partial seizures, (psychomotor
seizures), and trigeminal neuralgia, prophylaxis of bipolar disorder unresponsive to
lithium
Contra-Indications: Hypersensitivity to Carbamazepine, concurrent administration with
MAOI or within 2 weeks of its cessation, history of previous bone marrow suppression, AV
block.
Special Precautions: History of cardiac, hepatic or renal disease, pregnancy, lactation,
elderly, raised intraocular pressure. Caution in concurrent administration with oral
anticoagulant and oral contraceptive.
CLOBAZAM
Dosage Form: Tablet 10 mg [PSYCHOTROPIC] (II)
Recommended Dose: Treatment of anxiety states Adult & adolescents >15 yr Initially 20
mg/day. Max: 30 mg/day. Elderly Maintenance: 10-15 mg/day. Childn 3-15 yr 5-10
mg/day. Treatment of epilepsy as adjunctive therapy w/ other medicines to prevent or arrest
convulsions Adult & adolescents >15 yr Initially 5-15 mg/day; may be increased to max 80
mg/day. Childn 3-15 yr Initially 5 mg daily. Maintenance: 0.3-1 mg/kg/day.
Indications: Acute or chronic anxiety states w/ mental & somatic symptoms (organic
causes must be excluded). Adjuvant in treatment of epilepsy.
Contra-Indications: Myasthenia gravis.
Special Precautions: Monitor resp function in patients w/ chronic or acute respiratory
insufficiency. Preexisting muscle weakness; renal or hepatic impairment; history of alcohol
or drug abuse. Avoid abrupt w/drawal. Pregnancy & lactation. Investigate possible organic
cause in psychovegetative & psychosomatic disorders. May impair ability to drive or operate
machinery. Risk of habituation & dependence.
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HUSM FORMULARY 6TH EDITION 2010/2011
PHARMACOLOGIC CATEGORY
CLONAZEPAM
Dosage Form: Tablet 0.5 mg, 2 mg [PSYCHOTROPIC] (II)
Recommended Dose: Initial dose 1 mg (500 mcg for elderly) at night for 4 night,
maintenance dose 4-8 mg in 3 to 4 divided doses over 2 to 4 weeks according to response;
Max. 20 mg daily; Child: Up to 1 year: Initially 250 mcg, increased as above to maintenance
dose of 0.5-1 mg daily; 1-5 years: Initially 250 mcg, increased as above to 1-3 mg; 5-12
years: Initially 500 mcg, increased as above to 3-6 mg in 3-4 divided doses.
Indications: Myoclonic epilepsy, petite mal seizures, status epilepticus.
Contra-Indications: Respiratory
depression;
acute
pulmonary
insufficiency;
sleep apnoea syndrome; marked neuromuscular respiratory weakness including unstable
myasthenia gravis.
Special Precautions: Prolong use may lead to barbiturate-alcohol type dependence.
Hypersecreton may cause respiratory problems in children.
DIAZEPAM
Dosage Form: Tablet 2 mg, 5 mg, 10 mg; Injection 10 mg/2 ml ampoule; Rectal Tube 5
mg/tube [PSYCHOTROPIC] (II)
Recommended Dose: Status epilepticus & severe recurrent convulsive seizures: Child
>5yr 1 mg every 2-5 mins. Max: 10 mg; Child 1 month – 5 yr, 0.2 –0.5 mg, IV every 2-5
mins. Max: 5 mg. May repeat 2-4 hrly; By IM/ slow IV (into a large vein, at a rate of not more
than 5 mg/minute), for severe acute anxiety, control of acute panic attacks, and acute
alcohol withdrawal, 10 mg, repeated if necessary after not less than 4 hours. By mouth,
anxiety, 2 mg 3 times daily increased if necessary to 15–30 mg daily in divided doses;
ELDERLY (or debilitated) half adult dose.Insomnia associated with anxiety, 5–15 mg at
bedtime.CHILD night terrors and somnambulism, 1–5 mg at bedtime.By rectum,usual dose
0.25-0.5mg/kg.ADULT 20mg, CHILD >15kg 10mg, 10-15kg 5mg.Dose can be repeated
after 10mins.
Indications: Status epilepticus, muscle spasm of central and peripheral origin, short-term
use in anxiety or insomnia, adjunct in acute alcohol withdrawal, febrile convulsions, peri
operative use.
Contra-Indications: Acute narrow-angle glaucoma, respiratory depression; marked
neuromuscular respiratory weakness including unstable myasthenia gravis; acute
pulmonary insufficiency; sleep apnoea syndrome; severe hepatic impairment; not for chronic
psychosis; should not be used alone in depression or in anxiety with depression; avoid
injections containing benzyl alcohol in neonates.
Special Precautions: When given intravenously, facilities for reversing respiratory
depression with mechanical ventilation should be at hand. Caution in elderly, pregnancy,
lactation, arteriosclerosis, renal and hepatic dysfunction, and concurrent administration with
other CNS drugs and alcohol.
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HUSM FORMULARY 6TH EDITION 2010/2011
PHARMACOLOGIC CATEGORY
GABAPENTIN
Dosage Form: Capsule 300 mg, 400 mg (I* - Neurologist)
Recommended Dose: 300 mg on first day, then 300 mg twice daily on second day, then
300 mg 3 times daily on third day, then increased according to response to 1.2g daily in 3
equally divided doses; if necessary may be further increased in steps of 300 mg daily range
in 3 divided doses to max 2.4 g daily, usual range 0.9-1.2g daily; max period between doses
should not exceed 12 hours; CHILD 6–12 years (specialist use only) 10 mg/kg on day 1, then
20 mg/kg on day 2, then 25–35 mg/kg daily (in 3 divided doses approx. every 8 hours),
maintenance 900 mg daily (body-weight 26–36 kg) or 1.2 g daily (body-weight 37–50 kg)
Neuropathic pain, 300 mg on day 1, then 300 mg twice daily on day 2, then 300 mg 3 times
daily on day 3, then increased according to response in steps of 300 mg daily (in 3 divided
doses) to max. 1.8 g daily.
Indications: Adjunctive treatment of partial seizures with or without secondary
generalization not satisfactory controlled with other antiepileptics; neuropathic pain.
Contra-Indications: Hypersensitivity to gabapentin
Special Precautions: Elderly, renal impairment, haemodialysis, absence seizures,
pregnancy and lactation. Discontinuation of gabapentin &/or substitution of alternative
therapy should be gradual, over a min of 1 week. History of psychotic illness. May affect
ability to drive or operate machinery. Diabetes mellitus, false positive readings with some
urinary protein tests.
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HUSM FORMULARY 6TH EDITION 2010/2011
PHARMACOLOGIC CATEGORY
LAMOTRIGINE
Dosage Form: Tablet 5 mg (dispersable/chewable) (paediatric), 50 mg, 100 mg (noncrushable) (I*)
Recommended Dose: Adult & childn > 12 yr without Na valproate initially 50 mg once
a day for 2 week then 100 mg/day in 2 divided doses for 2 week. Maintenance 200-400 mg
in 2 divided doses. With Na valproate, initially 25 mg every alternate day for 2 weeks then
25mg once a day for 2 weeks. Maintenance 100 – 200 mg/day once a day or 2 divided
doses. Childn > 2 yr without Navalproate initially 2mg/kg/day in 2 divided doses. With
Na valproate, initially 0.2 mg/kg/day as a single dose for 2 weeks. Maintenance 1-5
mg/kg/day as a single dose or 2 divided doses.
Indications: Monotherapy and adjunctive treatment of partial seizures and primary and
secondarily generalised tonic-clonic seizures; Lennox-Gastaut syndrome, Seizure;
Management of psychotic condition (bipolar disorder), tranquilisation and emergency control
in behavioural disturbances.
Contra-Indications: Hypersensitivity to lamotrigine products
Special Precautions: Avoid abrupt withdrawal (reduce dosage stepwise over a period of 2
weeks) 4 unless serious skin reaction occurs. Closely monitor (including hepatic, renal and
clotting parameters) and consider withdrawal if rash, fever, influenza-like symptoms,
drowsiness, or worsening of seizure control develops (although causal relationship not
established, lamotrigine given with other antiepileptics has been associated with rapidly
progressive illness with status epilepticus, multi-organ dysfunction, disseminated
intravascular coagulation and death); Significant hepatic or renal impairment. Pregnancy,
lactation.
Serious skin reactions including Stevens-Johnson syndrome and toxic epidermal
necrolysis (rarely with fatalities) have developed especially in children; most rashes occur in
the first 8 weeks. Factors associated with increased risk of serious skin reactions include
concomitant use of valproate, initial lamotrigine dosing higher than recommended and more
rapid dose escalation than recommended.
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HUSM FORMULARY 6TH EDITION 2010/2011
PHARMACOLOGIC CATEGORY
LEVETIRACETAM
Dosage Form: Tablet 500 mg, 1 gm; Syrup 100 mg/ml (300 ml); Injection 500 mg/5 ml
(I* - Neuroscience)
Criteria of use: Restricted for adult patients from Neuroscience Unit
Recommended Dose: Adult and adolescent body-weight over 50 kg: Initially 1 g daily in 2
divided doses, adjusted in increments of 1 g every 2 to 4 weeks; max: 3 g daily in 2 divided
doses, Child and adolescent body-weight under 50 kg: Initially 20 mg/kg daily in 2 divided
doses, adjusted in steps not exceeding 20 mg/kg every 2 weeks; max. 60 mg/kg in 2 divided
doses.
Indications: Epilepsy; a new anti epileptic drug for the treatment of partial seizures with or
without secondary generalization in adult. It is effective as amonotherapy and as adjunctive
therapy. It may also be useful in the treatment of photosensitive epilepsy, and in the
management of post-hypoxic and post-encephalitic myoclonus.
Contra-Indications: Hypersensitivity to levetiracetam or any of the inactive ingredients.
Special Precautions: Renal impairment, pregnancy, severe hepatic impairment, lactation
and elderly.
PHENOBARBITONE
Dosage Form: Tablet 30 mg; Injection (as Sodium) 200 mg [PSYCHOTROPIC] (II)
Recommended Dose: Orally: Hypnotic 100 mg at night. Sedative 15 – 30 mg 3 –4 times
daily. Anticonvulsant 30 – 60 mg bd. Child: 5-8 mg/kg daily.
Emergency control of convulsions: Adult 200 mg IM/SC, repeat after 6 hours if
necessary. Child 15 mg/kg IM as a loading dose followed by 5 mg/kg daily by mouth. Max:
600 mg daily. Child: 3-5 mg/kg IM
Indications: All form of epilepsy except absence seizures, status epilepticus.
Contra-Indications: In patient with acute intermittent porphyria and in hyperkinetic children.
Special Precautions: In elderly, children, impaired renal/hepatic function, severe
respiratory depression, pregnancy and breast feeding. Avoid sudden withdrawal of
drug. Enhanced by concurrent administration of other sedatives, MAOI, some tranquilizers,
sodium valproate, anticholinestarase, etc.
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HUSM FORMULARY 6TH EDITION 2010/2011
PHARMACOLOGIC CATEGORY
PHENYTOIN SODIUM
Dosage Form: Capsule 30 mg, 100 mg; Suspension 30 mg/5 ml, 125 mg/5 ml; Injection 50
mg, 100 mg/2 ml, 250 mg/5 ml (II)
Recommended Dose: By mouth, initially 3–4 mg/kg daily or 150–300 mg daily (as a single
dose or in 2 divided doses) increased gradually as necessary (with plasmaphenytoin concentration monitoring); usual dose 200–500 mg daily (exceptionally, higher
doses may be used); child initially 5 mg/kg daily in 2 divided doses, usual dose range 4–
8 mg/kg daily (max. 300 mg).
By slow intravenous injection or infusion (with blood pressure and ECG monitoring),
status epilepticus, 15 mg/kg at a rate not exceeding 50 mg per minute, as a loading dose;
maintenance doses of about 100 mg should be given thereafter at intervals of every 6–8
hours, monitored by measurement of plasma concentrations; rate and dose reduced
according to weight; child15 mg/kg as a loading dose (neonate 15–20 mg/kg at rate of 1–
3 mg/kg/minute). ¹Prevention of seizures of during or following neurosurgery 250mg IV 6-12
hourly until oral dosage is possible. 4 Ventricular arrhythmias (but use now obsolete), by
intravenous injection via caval catheter, 3.5–5 mg/kg at a rate not exceeding 50 mg/minute,
with blood pressure and ECG monitoring; repeat once if necessary.
Indications: all forms of epilepsy except absence seizures; trigeminal neuralgia
if carbamazepine inappropriate, status epilepticus; seizures in neurosurgery; arrhythmias,
but now obsolete.
Contra-Indications: sinus bradycardia, sino-atrial block, and second- and third-degree
heart block; Stokes-Adams syndrome; porphyria. Do not give with lignocaine hydrochloride.
Special Precautions: In patients with hepatic impairments, hypotension, and severe
myocardial insufficiency. IV phenytoin should be given slowly andextravasation should be
avoided. Incompatible with amikacin, slindamycin, and many others, so it should not be
mixed with other drugs or infusion solution. Interact with many drugs such
as chloramphenicol, chlorpromazine, diazepam, estrogens, isoniazid, phenobarbital,
coumarin anticoagulant, prochlorperazine which may increase phenytoin level, drugs that
may decrease phenytoin level arecarbamazepine, ethyl alcohol, and phenobarbital drugs
like salicylic acid andphenylbutazone may alter plasma protein bindings of phenytoin.
Blood or skin disorders: Patients or their carers should be told how to recognise signs of
blood or skin disorders, and advised to seek immediate medical attention if symptoms such
as fever, sore throat, rash, mouth ulcers, bruising, or bleeding develop. Leucopenia which is
severe, progressive or associated with clinical symptoms requires withdrawal (if necessary
under cover of suitable alternative).
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HUSM FORMULARY 6TH EDITION 2010/2011
PHARMACOLOGIC CATEGORY
PRIMIDONE
Dosage Form: Tablet 250 mg (I)
Recommended Dose: Generalised Tonic-Clonic Seizures Adult: Initially, 125 mg daily at
bedtime, increased by 125 mg every 3 hrs if necessary up to 500 mg daily in 2 divided
doses, then further 250 mg every 3 days if needed. Maintenance: 0.75-1.5 g daily. Child: <9
yrs: Same as adult dose, except increased by increments of 125 mg. Maintenance: >9 yrs:
Same as adult dose; 6-9 yrs: 0.75-1 g daily; 2-5 yrs: 500-750 mg daily; less than or equal to
2 yrs: 250-500 mg daily. Max Dosage: Adult: 1.5 g daily in divided doses. Partial
Seizures Adult: Initially, 125 mg daily at bedtime, increased by 125 mg every 3 hrs if
necessary up to 500 mg daily in 2 divided doses, then further 250 mg every 3 days if
needed. Maintenance: 0.75-1.5 g daily. Child: <9 yrs: Same as adult dose, except
increased by increments of 125 mg. Maintenance: >9 yrs: Same as adult dose; 6-9 yrs:
0.75-1 g daily; 2-5 yrs: 500-750 mg daily; less than or equal to 2 yrs: 250-500 mg daily.Max
Dosage: Adult: 1.5 g daily in divided doses. Essential Tremor Adult: Initially, 50 mg daily
gradually increased over 2-3 weeks if necessary. Max Dosage: 750 mg daily.
Indications: Generalised tonic-clonic seizures, partial seizures, essential tremor
Contra-Indications: Hypersensitivity. Acute intermittent porphyria; pregnancy and lactation.
Special Precautions: Impaired hepatic, renal, respiratory function; abrupt withdrawal;
elderly, debilitated and paediatric patients; hypoadrenalism. May impair ability to drive or
operate machinery.
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HUSM FORMULARY 6TH EDITION 2010/2011
PHARMACOLOGIC CATEGORY
SODIUM VALPROATE
Dosage Form: Tablet 200 mg; *SR 500 mg; Syrup 200 mg/5 ml; Injection 400 mg (II)
Criteria of use: For non-compliance patients who previously on Sodium Valproate (TDS
dose)
Recommended Dose: Initially 600 mg daily in divided dose preferably after food increasing
by 200 mg/day for 3 days interval to a maximum of 2.5 g daily in divided doses. Usual
maintenance; 1 – 2 g daily (20-30 mg/kg daily). Children > 20 kg: Initially 400 mg daily in
divided doses, gradually increase 20-30 mg/kg until control. Children < 20 kg: Initially
20mg/kg daily in divided doses, may be increased to a max of 35 mg/kg daily. Withdrawal
to/from other type of anticonvulsants should be made gradually.
Injection monotherapy: adult 400-800 mg slow IV depending on body wt (up to 10 mg/kg)
over 3-5 mins then continuous or repeated infusion up to max of 2.5 g/day. Childn 20-30
mg/kg/day. Combined therapy; may be necessary to raise the dose by 5-10 mg/kg/day
when use with anticonvulsants. Dosage of barbiturates should be reduced if sedation is
observed 4.
Indications: Multiple seizures especially in absence seizures, also in a wide variety of
partial and generalised seizures. Much less effective for focal or complex partial seizures.
Contra-Indications: Severe hepatic dysfunction. Hypersensitivity to valproic acid.
Pregnancy has produced dysmorphogenic effects in animals. Should only be used in severe
cases of epilepsy and when resistant to other modes of therapy.
Special Precautions: Concurrent administration of barbiturates, MAO inhibitors, analgesic
agents that affect platelet function; monitor platelet and liver function before and during
therapy. Extensively bound to plasma protein and susceptible to interaction with drugs
competing for similar binding sites. Breast feeding.
SODIUM VALPROATE SR
Dosage Form: Tablet 500 mg
Criteria of use: For patient non-compliance with multiple daily dose Sodium Valproate.
Recommended Dose: 20 – 30 mg/kg/day in 1 or 2 divided doses.
Indications: Generalised, focal or other epilepsy. (For those who are not comply to tds
doses)
Contra-Indications: Active liver disease.
Special Precautions: Pregnancy
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HUSM FORMULARY 6TH EDITION 2010/2011
PHARMACOLOGIC CATEGORY
i.
ii.
iii.
TOPIRAMATE
Dosage Form: Tablet 25 mg, 50 mg, 100 mg (I*)
Recommended Dose: Monotherapy: Initially 25 mg/day at night for 1 week. Subsequently,
at 1-2 week intervals, the dose can be increased by 25 – 50 mg/day to 100 mg/day taken in
2 divided doses. Usual dose: 100 mg/day in 2 divided doses. Max: 400 mg/day. CHILD: 6–
16 years, initially 0.5–1 mg/kg daily at night for 1 week then increased in steps of 0.5–
1 mg/kg daily at intervals of 1–2 weeks taken in 2 divided doses; usual dose 3–6 mg/kg
daily in 2 divided doses; max.16 mg/kg daily.
Adjunctive therapy: Initially 25 mg/day at night for 1 week then increased 25-50 mg/day at
intervals of 1-2 weeks and taken in 2 divided doses. Usual dose 200-400 mg/day in 2
divided doses. Max: 800 mg/day. CHILD 2–16 years, initially 25 mg/day nightly for one
week then increased 1–3 mg/kg/day at intervals of 1–2 weeks taken in 2 divided doses;
recommended dose range 5–9 mg/kg/day in 2 divided doses; max. 30 mg/kg daily.
Migraine prophylaxis ADULT and CHILD over 16 years, initially 25 mg daily at night for 1
week then increased in steps of 25 mg daily at intervals of 1 week; usual dose 50–100 mg
daily in 2 divided doses.
Indications: Monotherapy and adjunctive treatment of generalisedtonic-clonic seizures or
partial seizures with or without secondarygeneralisation; adjunctive treatment of seizures in
Lennox-Gastaut syndrome; migraine prophylaxis (under specialist supervision).
Contra-Indication: Breast feeding
Special Precautions: Gradual withdrawal. Renal or liver impairment. Pregnancy,
lactation. May impair ability to drive or operate machinery. Ensure adequate hydration (if
predisposition to nephrolithiasis or strenuous activity or warm environment), avoid
in porphyria.
Topiramate has been associated with acute myopia with secondary angle-closure
glaucoma, typically occurring within 1 month of starting treatment.Choroidal effusions
resulting in anterior displacement of the lens and iris have also been reported. It is advises
that if raised intra-ocular pressure occurs:
seek specialist ophthalmological advice;
use appropriate measures to reduce intra-ocular pressure;
stop topiramate as rapidly as feasible
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HUSM FORMULARY 6TH EDITION 2010/2011
PHARMACOLOGIC CATEGORY
1.2. Antidepressants
AMITRIPTYLINE HCL
Dosage Form: Tablet 10 mg, Tablet 25 mg (II)
Recommended Dose: Depression: Initially 75 mg (elderly and adolescents 30-75 mg) daily
in divided doses or as a single dose at bedtime, increased gradually as necessary to a max
of 150-200 mg; child under 16 years not recommended for depression. For nocturnal
enuresis: Children: 7-10 years: 10-20 mg, 11-16 years: 25-50 mg at bedtime; Maximum
period of treatment (including gradual withdrawal) 3 months- full physical examination
before further course. Neuropathic pain [unlicensed], initially 10–25 mg daily at night,
increased if necessary to 75 mg daily; higher doses under specialist supervision.
Indications: Depressive illness including that accompanied by anxiety, nocturnal enuresis
in children, neurophatic pain and migraine prophylaxis.
Contra-Indications: Concomitant treatment with MAO inhibitors, recent myocardial
infarction, arrythmias (heart block), mania and severe liver disease.
Special Precautions: Impaired hepatic function, cardiovascular disease, hyperthyroidism,
epilepsy, glaucoma, urinary retention, prostatic hypertrophy, constipation, pregnancy, breast
feeding and in anaesthesia. Period of treatment should not exceed 3 months.
CLOMIPRAMINE HCL
Dosage Form: Tablet 25 mg (I* - Psychiatrist)
Recommended Dose: Initiate treatment with 10 mg daily, increased gradually as necessary
to 30-150 mg daily in divided doses or as a single dose at bedtime; maximum of 250
mg/day. ELDERLY initially 10 mg daily increased carefully over approx. 10 days to 30–75 mg
daily; CHILD not recommended. Phobic and obsessional states, initially 25 mg /day (elderly
10 mg daily) increased over 2 weeks to 100-150 mg daily; max: 250 mg/day; children: not
recommended.
Indications: Depression, Obsessive Compulsive Disorder and Phobia.
Contra-indications: Concomitant treatment with MAO inhibitors, recent myocardial
infarction, arrythmias (heart block), mania and severe liver disease.
Special Precautions: Dosage should be determined individually and adapted to the
patient's condition. Keep doses as low as possible while maintaining optimal effect. Elderly
and adolescents generally show a more remarked response. Monitor cardiovascular
function and ECG in patients with cardiovascular disorders, especially those with a history of
conduction disorders.
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PHARMACOLOGIC CATEGORY
DOTHIEPIN HCL
Dosage Form: Capsule 25 mg, Tablet 75 mg (I)
Recommended Dose: Adults Initially 75 mg in divided dose or as a single dose at
night. Increase gradually if necessary to 150 mg/day; up to 225 mg/day in hospital
use. Children: not recommended. Elderly: 50-75 mg daily. Half the normal adult dose may
be sufficient to produce a satisfactory response clinically.
Indications: Depression and anxiety associated with depression.
Contra-Indications: Epilepsy, MAOIs, recent myocardial infarction, any degree of heart
block or other cardiac arrhythmias, severe liver disease.
Special Precautions: The elderly are more prone to experience adverse reactions
especially agitation, confusion and postural hypotension. Close supervision in patients with
high suicidal risk or paranoia. Caution is required in epileptic patients and those with
cardiovascular disorders. If possible in history of epilepsy, narrow-angle or hyperthyroidism
glaucoma and symptoms suggestive of prostatic hypertrophy/urinary retention, latent
schizophrenia, abrupt withdrawal, pregnancy and lactation, surgery (anaesthetist should be
informed since anaesthetics may increase risk of arrhythmias and hypotension).
DULOXETINE
Dosage Form: Capsule 30 mg, 60 mg (I* - Psychiatrist)
Criteria of use: Restricted for liason services including psycho-oncology (Dr. Azhar,
Dr. Zarina, Dr. Asreene and PM Dr. Hasanah)
Recommended Dose: Major depression or diabetic neuropathy, 60 mg once daily; CHILD
and ADOLESCENT under 18 years not recommended.
Indications: Major depressive disorder; diabetic neuropathy; stress urinary incontinence
Contra-Indications: Hepatic impairment; renal impairment (avoid if creatinineclearance
less than 30 mL/minute); pregnancy; breast-feeding.
Special Precautions: Elderly; cardiac disease; hypertension (avoid if uncontrolled); history
of mania; history of seizures; raised intra-ocular pressure, susceptibility to angle-closure
glaucoma; bleeding disorders or concomitant use of drugs that increase risk of bleeding.
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ESCITALOPRAM
Dosage Form: Tablet 10 mg (I* - Psychiatrist)
Recommended Dose: Major depressive episodes 10 mg once daily; may be increased to
max 20 mg/day. Panic disorder w/ or w/o agoraphobia Initially 5 mg for the 1st wk, thereafter
increased to 10 mg/day. May be further increased up to max 20 mg/day, dependent on
individual patient response. Elderly initially half adult dose. Child and adolescent under 18
years not recommended.
Indications: Major depressive episodes. Treatment of panic disorder with or without
agoraphobia.
Contra-Indications: Concomitant use of MAO Inhibitors, hypersensitivity to
escitalopram products, pregnancy, lactation.
Special Precautions: Paradoxical anxiety, seizures, mania, diabetes, suicidal
tendencies, hyponatraemia, haemorrhage, ECT, reversible selective MAO-A inhibitors,
serotonin syndrome, St John's Wort, w/drawal reactions, not to be recommended for those
<18 yr.
FLUOXETINE HCL
Dosage Form: Capsule 20 mg, Dispersible 20 mg (I)
Recommended Dose: Depression with/without anxiety: Initial and maintenance treatment;
20 mg/day. Obsessive-compulsive disorder: start with 20 mg/day may be increased if
necessary after several weeks. Max: 60 mg/day. Children: not recommended.
Indications: Listed in dosage
Contra-Indications: Concomitant use with MAOIs
Special Precautions: History of seizure. Elderly. Volume-depletion. Diabetes.Pregnancy.
Lactation. May impair alertness.
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FLUVOXAMINE
Dosage Form: Tablet 50 mg, 100 mg (II)
Recommended Dose: Depression, 50 - 100 mg daily in the evening, gradually adjusted
according to individual response until the effective dose is reached. Maximum: 300 mg.
Doses >150 mg should be given in 2-3 divided doses. Children: not recommended.
Obsessive-compulsive disorder, initially 50 mg in the evening increased gradually if
necessary after some weeks to max. 300 mg daily (over 150 mg in divided doses); usual
maintenance dose 100–300 mg daily; CHILD over 8 years initially 25 mg daily increased if
necessary in steps of 25 mg every 4–7 days to max. 200 mg daily (over 50 mg in divided
doses).
Note: If no improvement in obsessive-compulsive disorder within 10 weeks, treatment
should be reconsidered.
Indications: Treatment of depressive illness, symptoms of depressive disorder and
obsessive compulsive disorder.
Contra-Indications: Hypersensitivity to the drug or excipients, lactation, MAOIs. At least 2
weeks should elapse between discontinuation of an irreversible MAOI and initiation
of fluvoxamine therapy. For a reversible MAOI, treatment with fluvoxamine can be initiated
the following day after MAOI discontinuation.
At least 1 week should elapse between discontinuation of fluvoxamine and initiation
with MAOIs.
Special Precautions: Patients with history of convulsive disorders, pregnancy, lactation,
hepatic or renal insufficiency, diabetes and bleeding diatheses. Concomitant administration
w/ drugs known to affect platelet function. Slower upward dose titration is warranted in the
elderly. Fluvoxamine may cause an insignificant decrease in heartbeat (2-6 beats/min).
Avoid alcohol. May affect ability to drive or operate machinery.
IMIPRAMINE HCL
Dosage Form: Tablet 25 mg (II)
Recommended Dose: Initially up to 75 mg tds gradually increased to 150-200 mg
(maximum of 300 mg daily in hospital patients); up to 150 mg may be given as a single dose
at bedtime; ELDERLY initially 10 mg daily, increased gradually to 30–50 mg daily, maximum
100mg/day; CHILD not recommended for depression. For nocturnal enuresis: children 7
years: 25 mg at bedtime, 8-11 years: 25-50 mg, over 11 years: 50-75 mg at bedtime.
Max. period of treatment (including gradual withdrawal) 3 months- full physical examination
before further course.
Indications: depressive illness, nocturnal enuresis in children.
Contra-Indications: See Amitriptylline HCl.
Special Precautions: See Amitriptylline HCl.
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MAPROTILINE
Dosage Form: Tablet 25 mg (I)
Recommended Dose: 25-75 mg (elderly 30 mg) daily in a single or 3 divided doses at
bedtime. Max: 150 mg/day. Children: not recommended.
Indications: Depressive episodes, recurrent depressive disorder or major depression.
Contra-Indications: Hypersensitivity to maprotiline or cross-allergy to tricyclic
antidepressants. Convulsive disorder or a lowered seizure threshold (eg. brain damage of
varying aetiology, alcoholism). Acute stage of myocardial infarction and cardiac conduction
defects. Narrow-angle glaucoma or urinary retention (eg. due to prostatic disease). Acute
poisoning with alcohol, analgesics, hypnotics or psychotropic drugs.
Special Precautions: Risk of suicide. Cardiovascular disease. Postural hypotension.
Schizophrenia, cyclic affective disorders. History of increased intraocular pressure, chronic
constipation, or urinary retention. Abrupt withdrawal or dose reduction. Concomitant
treatment with antihypertensives, sympathomimetics, anticholinergic agents, CNS drugs,
anticonvulsants, anticoagulants, antidiabetics. Alcohol. Contact lens wearers.
Electrocunvulsive therapy. Local or general anaesthesia, Hyperthyroidism.Monitor blood
count, hepatic and renal function. Pregnancy and lactation. Caution in road/machinery
users.
MIRTAZAPINE
Dosage Form: Tablet 30 mg, Soluble Tablet 15 mg (I* - Psychiatrist)
Recommended Dose: 15-45 mg daily.
Indications: Episode of major depression.
Contra-Indications: Hypersensitivity to mirtazapine, MAOI therapy within 14 days.
Special Precautions: Epilepsy, organic brain syndrome, hepatic or renal insufficiency,
cardiac diseases, low BP, micturition disturbances, acute narrow-angle glaucoma, increased
intraocular pressure, diabetes mellitus; pregnancy, lactation. Patients w/ schizophrenia or
other psychotic disturbances. Avoid abrupt w/drawal. Elderly. May impair ability to drive or
operate machinery.
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SERTRALINE
Dosage Form: Tablet 50 mg (I)
Recommended Dose: Treatment Of Depression Adult: Initially, 50 mg daily increased by
50-mg increments if necessary at intervals of at least 1 week. Max Dosage: 200 mg
daily. Management Of Obsessive-Compulsive Disorders Adult: Initially, 50 mg
daily. Child: >12 yrs: 50 mg once daily; 6-12 yrs: Initially, 25 mg once daily. Treatment Of
Panic Disorder With Or Without Agoraphobia Adult:Initially, 25 mg daily increased to 50 mg
daily after 1 week, further increased if necessary by 50-mg increments at intervals of at
greater than or equal to 1 week.Max Dosage: 200 mg daily. Posttraumatic Stress Disorder
Adult: Initially, 25 mg daily increased to 50 mg daily after 1 week, further increased if
necessary by 50-mg increments at intervals of at greater than or equal to 1 week. Max
Dosage: 200 mg daily. Hepatic/Renal impairment: Either lower dose or less frequent
dosage is preferred.
Indications: Treatment of depression, management of obsessive-compulsive disorders,
treatment of panic disorder with or without agoraphobia, posttraumatic stress disorder
Contra-Indications: Hypersensitivity; concomitant use with monoamine oxidaseinhibitor
(MAOIs). Childn <18 yrs.
Special Precautions: History of hypomania and seizure disorders; lower doses are to be
preferred (to avoid overdose); patients with diseases or condition that could affect
metabolism or haemodynamic responses; hepatic and renal impairment; cardiac disease,
recent MI; patients on diuretics or volume depletion. Pregnancy and lactation.
TIANEPTINE
Dosage Form: Tablet 12.5 mg (I)
Criteria of use: For patients who not responds to other alternatives.
Recommended Dose: 12.5 mg tds. Dose adjustments indicated in renal failure and in the
elderly. Administration: Should be taken on an empty stomach.
Indications: Major depressive episode (characterized).
Contra-Indications: Hypersensitivity to Tianeptine. Childn <15 yr. Association w/MAOIs. A
washout period of 2 wk is necessary between treatment w/ MAOIs & treatment w/
tianeptine. A washout period of only 24 hr is required when replacing tianeptine w/ a MAOI.
Special Precautions: Cardiovascular disease, gastrointestinal disorders, psychosis, elderly
patients. Pregnancy, lactation. Keep patient under medical supervision during the initial
phase of treatment as a risk of suicide exists in depressive patients. May affect ability to
drive or operate machinery. If treatment is to be interrupted, the dosage should be gradually
reduced. Stop 24-48 hr prior to surgery w/ general anesth.
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VENLAFAXINE HCL
Dosage form: Tablet 75 mg, 150 mg (II)
Recommended dosage: Initial dose is 75 mg/day in 2 divided doses increased if necessary
after several weeks to 150 mg daily in 2 divided doses. Severely depressed or hospitalized
patients, start with 150 mg/ day in 2 divided doses increased if necessary in steps of up to
75 mg every 2-3 days to max. 375 mg daily then gradually reduced. Child and adolescent
under 18 years are not recommended.
Indications: It is used in the treatment of major depressive disorder andgeneralised anxiety
disorder.
Contra-Indications: Conditions associated with high risk of cardiac arrhythmia,
uncontrolled hypertension; pregnancy; breast-feeding.Hypersensitivity, concurrent used of
MAOI drug, do not use Venlafaxine within 2 weeks of discontinuing an MAOI, do not use
MAOI for at least 7 days after stopping Venlafaxine.
Special Precautions: History of seizure, activation of mania/hypomania, changesin
appetite or weight. Due to the risk of suicide in depressed patients, careful monitoring is
recommended. Sustained increases in blood pressure associated with venlafaxine, routine
BP monitoring at doses > 200mg/day, anxiety and insomnia. Patients with recent myocardial
infection or unstable heartdisease, renal impairment or cirrhosis of the liver, reduction in
dose may be necessary). Medical disease or conditions which affect hemodynamic
response or metabolism. To minimize the risk of discontinuation symptoms, the dose
ofvenlafaxine should be gradually tapered over 2 weeks.
Raised intraocular pressure or patients at risk of acute narrow angle glaucoma.History of
bleeding disorders, predisposition to skin & mucous membrane bleeding, conditions that
may affect haemodynamic response to metabolism, concomitant use of drugs that increase
bleeding risk. Elderly patients taking diuretics, vol depletion or dehydration. May impair
ability to drive or operate machinery. Avoid abrupt w/drawal.
1.3. Antiemetics / Antinauseants/ Antivertigo
BETAHISTINE DHCL
Dosage Form: Tablet 16 mg, 24 mg (I*)
Recommended Dose: Usual adult dose starts with 16 mg tds after meals. Maintenance:
24-48 mg in divided doses (the dosage should be individually adapted according to
response)
Indications: Meniere's disease, symptomatic treatment of vestibular vertigo.
Contra-Indications: Phaeochromocytoma
Special Precautions: History of digestive ulcer or an active digestive ulcer, bronchial
asthma, phaeochromocytoma. Use in pregnancy only when expected therapeutic benefit
outweighs the risk.
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CHLORPROMAZINE HCL
Dosage Form: Tablet 25 mg, 50 mg, 100 mg (II)
Recommended Dose: Schizophrenia and other psychoses, mania, adjunct in short term
anxiety, psychomotor agitation, orally: 25 mg bd or tds (or 75 mg at night), usual
maintenance dose of 75–300 mg daily (but up to 1 g daily may be required in psychoses);
ELDERLY (or debilitated) third to half adult dose; CHILD (childhood schizophrenia and autism)
1–5 years 500 micrograms/kg every 4–6 hours (max. 40 mg daily); 6–12 years third to half
adult dose (max. 75 mg daily)
Intractable hiccup, 25–50 mg 3-4 times daily
By deep IM injection start with 25 mg then 25-50 mg every 6-8 hours until vomiting stops;
children: 0.5 mg/kg every 6-8 hours (1-5 years max. 40 mg/ day, 6-12 years max. 75 mg/
day).
Induction of hypothermia (to prevent shivering), 25–50 mg every 6–8 hours; CHILD 1–12
years, initially 0.5–1 mg/kg, followed by maintenance 500 micrograms/kg every 4–6 hours.
Indication: Severe nausea and vomiting of a variety of diseases and that caused by various
drugs. Schizophrenia and other psychoses, mania. Adjunct in short term anxiety,
psychomotor agitation and others see under dose.
Contra-Indications: Patients with bone marrow depression, coma especially under CNS
depressants, narrow angle glaucoma, subcutaneous injection.
Special Precautions: In patients with cardiovascular or respiratory disease,
pheochoromocytoma, Parkinsonism, epilepsy, acute infection, pregnancy, breast feeding,
renal/hepatic impairment, leucopenia, Myasthaenia Gravis. Avoid direct contact, may cause
severe dermatitis in sensitized person. Elderly, debilitated, diabetes, glaucoma. May impair
temp regulatory mechanism.
CINNARIZINE
Dosage Form: Tablet 25 mg (II)
Recommended Dose: Cerebral circulatory disorders & disorders of balance 1
tab tds. Peripheral circulatory disorders 2-3 tab tds. Motion sickness Adult 1tab ½ hr
before travelling, to be repeated 6 hrly. Childn ½ adult dose.
Indications: Vestibular disorders, tinnitus, nausea, vertigo, prophylaxis against motion
sickness and migraine. Maintenance therapy for symptoms of cerebrovascular origins,
labyrinthine & peripheral-circulatory disorders; prophylaxis against motion sickness &
migraine.
Special Precautions: May cause drowsiness, caution in epileptic patients, liver disease
and pregnancy. Avoid in porphyria. Pregnancy. Parkinson's disease.
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DOMPERIDONE
Dosage Form: Tablet 10 mg; Suspension 5 mg/5 ml (II)
Recommended Dose: Chronic dyspepsia Adult 10 mg tds. Childn 2.5 mL/10 kg body
wt tds & once more in the evening if necessary. Dosage may be doubled in adults
&childn >1 yr. Acute & subacute conditions (particularly nausea & vomiting) Adult 20
mg. Childn 5 mL/10 kg body wt. All to be taken tds-qds. Administration: Should be taken
on an empty stomach (Take 15-30 mins before meals)
Indications: Nausea and vomiting especially in GI disorder or treatment with cytotoxic
drugs, epigastric or retrosternal burning sensation. Dyspeptic symptom complex associated
w/ delayed gastric emptying, gastro-oesophageal reflux & oesophagitis.
Contra-Indications: GI haemorrhage, mechanical obstruction or perforation. Prolactinreleasing pituitary tumour.
Special
Precautions: Renal
impairment,
pregnancy
and
breast
feeding. Anticholinergic may inhibit anti-dyspeptic effect.
GRANISETRON HCL
Dosage Form: Tablet 1 mg; Injection 3 mg/3 ml (II)
Recommended Dose: Adult; Oral: 1-2 mg within 1 hour before chemotherapy, then 2 mg
daily in 1-2 divided doses during treatment. IV injection: (diluted in 15 ml sodium chloride
0.9% and given over not less than 30 seconds) or by intravenous infusion (over 5
minutes), prevention, 3 mg before start of cytotoxic therapy (up to 2 additional 3-mg doses
may be given within 24 hours); treatment, as for prevention (the two additional doses must
not be given less than 10 minutes apart); when tablet and intravenous also used, max.
combined total 9 mg in 24 hours; children, by IV infusion, (over 5 min), prevention, 0.04
mg/ kg (max. 3 mg) before start of cytotoxic therapy; treatment, as for prevention one
additional dose of 0.04 mg/ kg (max. 3 mg) may be given within 24 hours (not less than 10
minutes after initial dose) Post- operative nausea & vomiting: IV injection (diluted to 5 ml
and given over 30 seconds), prevention, 1 mg before induction of anaesthesia; treatment,
1 mg, given as for prevention; max. 2 mg in one day; Children not recommended.
Indications: Nausea & vomiting induced by cytotoxic chemotherapy & radiotherapy.
Prevention & treatment of post-operative nausea & vomiting.
Contra-Indications: Hypersensitivity to granisetron products.
Special Precautions: Pregnancy & lactation.
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HYOSCINE HYDROBROMIDE
Dosage Form: Injection 0.4 mg/ml (II)
Recommended Dose: Adult 300-650 mcg IM, IV or SC, may be repeated tdsqds. Childn 6 mcg/kg or 200 mcg/m2 IM, IV or SC. Antiemetic 200-1000 mcg. Inhibition of
salivation 200-600 mcg. Amnestic effect 320-650 mcg. Sedation or tranquillisation 600
mcg. Premedicant 400 mcg w/ papaveretum 20 mg, or morphine or pethidine about ½-1 hr
before induction of general anaesth. Control of secretions in cancer patients 1.2-1.8
mg/24 hr as continuous SC infusion.
Indications: As a premedicant, usually in association w/ papaveretum, morphine or
pethidine. Palliative treatment of cancer patients. Used in obstetrics, in conjunction w/
morphine or pethidine, to produce tranquillisation, amnesia & a state of "twilight sleep".
Sedative in acute mania & delirium, particularly delirium tremens. Parenterally as an
antiemetic & for the prevention of motion sickness.
Contra-Indications: Closed-angle glaucoma, pyloric obstruction, or urinary bladder neck
obstruction.
Special Precautions: Do not drive or operate machinery. Impaired liver or renal function,
geriatric patients.
ITOPRIDE HCL
Dosage Form: Tablet 50 mg (II)
Recommended Dose: Adult 50 mg tds.
Indications: Treatment of GI symptoms of functional, non-ulcer dyspepsia (chronic
gastritis) ie sensation of bloating, early satiety, upper abdominal pain or discomfort,
anorexia, heartburn, nausea & vomiting.
Contra-Indications: GI haemorrhage, mechanical obstruction or perforation.
Special Precautions: Enhances the action of acetylcholine & may produce cholinergic side
effects. Pregnancy & lactation, elderly.
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METOCLOPRAMIDE
Dosage Form: Tablet 10 mg; Injection 10 mg/2 ml ampoule (II)
Recommended Dose: by mouth, slow IV or IM. Above 20 years (>60 kg): 10 mg tds; 15-19
years (< 60 kg) 5 mg tds; Child: < 1 year (up to 10 kg) 1 mg bd; 1-3 years (10-14 kg) 1
mg bd-tds; 3-5 years (15-19 kg) 2 mg bd- tds; 5-9 years (20-29 kg) 2 mg tds, 9-14 years (30
kg and over) 5 mg tds. Daily dose should not normally exceed 0.5 mg/kg, particularly for
children and young adults.
For diagnostic procedures, as a single dose 5–10 minutes before examination, 10–20 mg
(10 mg in young adults 15–19 years); CHILD under 3 years 1 mg, 3–5 years 2 mg, 5–9 years
2.5 mg, 9–14 years 5 mg.
Indications: Dyspepsia, flatulence, nausea and vomiting due to gastrointestinal disorders,
during treatment with cytotoxic drugs or radiotherapy and postoperative condition.In those
<20 yr: Use restricted for severe intractable vomiting of known cause, or associated w/
radiotherapy & intolerance to cytotoxic drugs, as an aid to GI intubation.
Contra-Indications: Intestinal obstruction, perforation or haemorrhage; 3–4 days after
gastro-intestinal surgery, patients with phaeochromocytoma, breast feeding.
Special Precautions: In children and elderly patients, patients taking other drugs that can
also
cause
extrapyramidal
reaction
e.g
Phenothiazines,
renal
and
hepaticimpairment.Neuroleptics, anticholinergics, pyloroplasty, gut anastomoses,
pregnancy, abnormal renal or liver function.
Q & A: Has Metoclopramide been used for induction of lactation?
Metoclopramide has been used for its dopamine antagonist properties to stimulate lactation
in women who wish to breast feed and in whom mechanical stimulation of the nipple alone
is inadequate. Doses of 10 mg three times daily have been used for this purpose, but should
be viewed as adjunctive to mechanical methods and the duration of therapy should probably
be limited to 7 to 14 days [Martindale, The Extra Pharmacopoeia, 31st Edition, 1996].
ONDANSETRON
Dosage Form: Tablet 4 mg, 8 mg; Injection 4 mg/2 ml, 8 mg/4 ml (I*)
Recommended Dose: Adult; Emetogenic chemotherapy & radiotherapy 8 mg by IM or
slow IV immediately before treatment, severely emetogenic chemotherapy 8 mg IM or slow
IV immediately before chemotherapy as single dose or plus 2 further IV doses of 8 mg 24 hrly or by constant infusion of 1 mg/hr for up to 24 hr. Children, 5 mg/m2 single IV dose
over 15 minutes immediately before chemotherapy then, 4 mg by mouth every 12 hours for
up to 5 days. Postoperative nausea & vomiting: adult prevention 4 mg by IM or slow IV at
induction of anaesthesia as single dose; treatment, 4 mg by IM or slow IV as single dose.
Indications: Nausea & vomiting induced by cytotoxic chemotherapy & radiotherapy.
Prevention & treatment of post-operative nausea & vomiting.
Special Precautions: Pregnancy & lactation.
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PERPHENAZINE
Dosage Form: Tablet 4 mg (II)
Recommended Dose: Psychotic disorders Adult & children >12 yr 2-4 mg tds. Max: 24
mg daily unless hospitalised. Severe nausea & vomiting 8-16 mg daily not exceeding 24
mg.
Indications: Nausea, vomiting, intractable hiccups in adults, psychotic disorders.
Contra-Indications: Bone marrow depression, comatose states. Depressed states, liver
damage.
Special Precautions: Pregnancy, lactation; elderly, debilitated. Hepatic or renal
impairment, CV or resp disorders, parkinsonism, diabetes, phaeochromocytoma, epilepsy
and glaucoma. May impair temp regulatory mechanism.
PROCHLORPERAZINE MALEATE/MESYLATE
Dosage Form: Tablet 5 mg; Injection 12.5 mg/ml (II)
Recommended Dose: by mouth for nausea and vomiting; acute attack: Initially 20 mg,
then 10 mg after 2 hours. Prevention: 5-10 mg bd-tds. Child (over 10 kg only): For severe
nausea and vomiting 0.25 mcg/kg ORALLY OR RECTALLY 2-3 times a day. Labyrinthine
disorder: 5 mg tds, gradually increased if necessary to 30 mg/ day in divided
doses, then reduced after several weeks to 5-10 mg daily. By deep IM 12.5 mg when
required followed if necessary after 6 hours by an oral dose. By rectum: 25 mg followed if
necessary after 6 hours by oral dose.
Indications: Nausea, vomiting, vertigo and labyrinthine disorders.
Contra-Indications: Cardiovascular disease, hepatic impairment, CNS Depression,
comatose states.
Special Precautions: Caution in children, avoid alcohol, skin irritation, tardive dyskinesia.
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PROMETHAZINE HCL
Dosage Form: Syrup 5 mg/5 ml, 10 mg/5 ml; Injection 50 mg/2 ml (II)
Recommended Dose: prevention of motion sickness, By mouth, 25 mg at night
increased to 25 mg twice daily if necessary or 10–20 mg 2–3 times daily; CHILD under 2
years not recommended, 2–5 years 5–15 mg daily in 1–2 divided doses, 5–10 years 10–
25 mg daily in 1–2 divided doses.Premedication, CHILD under 2 years not recommended, 2–
5 years 15–20 mg, 5–10 years 20–25 mg
By deep intramuscular injection, 25–50 mg; max. 100 mg; CHILD 5–10 years 6.25–
12.5 mg.Premedication, 25–50 mg 1 hour before operation; CHILD 5–10 years, 6.25–
12.5 mg.By slow intravenous injection in emergencies, 25–50 mg as a solution containing
2.5 mg/mL in water for injections; max. 100 mg.
Indications: Hypersensitivity reactions, including urticaria and angioedema, rhinitis and
conjunctivitis, and pruritis; nausea and vomiting, vertigo due to Meniere's disease and other
vestibular disorders; sedation in pre- and post- surgery, for relief of apprehension,
symptomatic treatment of coughs and the common cold. Emergency treatment of
anaphylactic reactions; sedation; motion sickness.
Contra-Indications: Do not administer by SC.
Special Precautions: Avoid in premature infants and neonates as this gropu has increased
susceptibility tothe antimuscarinic effects of antihistamines. It has been recommended
that phenothiazine antihistamines be avoided in children under 1 to 2 years of age. Elderly
patients.
PROMETHAZINE THEOCLATE
Dosage Form: Tablet 25 mg (II)
Recommended Dose: 25-75 mg, maximum 100 mg, daily; CHILD 5-10 yrs, 12.5-37.5 mg
daily. Motion sickness prevention, 25 mg at bedtime on night before travel or 25 mg 1-2
hours before travel; CHILD 5-10 yrs, half adult dose. Hyperemesis: 25 mg at bedtime,
increased if necessary to a maximum of 100 mg daily.
Indications: Nausea, vertigo, labyrinthine disorders, motion sickness (acts longer than the
HCL).
Contra-Indications: As for the HCL.
Special Precautions: As for the HCL.
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1.4. Antimigraine Products
CARBAMAZEPINE
Dosage Form: Tablet 200 mg, SR 200 mg, CR 400 mg; Syrup 100 mg/5 ml (II)
Recommended Dose: 100 mg bd increased by 200 mg daily to maximum of 1.2 g
daily. Maintenance dose: 400-800 daily in divided doses, to be taken with or after food.
Indications: Trigeminal neuralgia, as an antiepileptic, anticonvulsive and in alcohol
withdrawal symptoms.
Contra-Indications: History of bone marrow depression, hypersensitivity to
Carbamazepine, AV block.
Special Precautions: Breast feeding, patients on MAO inhibitors, increased intracranial
pressure.
ERGOTAMINE TARTRATE + CAFFEINE HYDRATE (CAFERGOT)
Dosage Form: Tablet 1 mg + 100 mg (I)
Recommended Dose: 1-2 tablet at once, followed after 30 minutes by 1/2-1 tablet,
repeated every 30 minutes if necessary. Max : 6 tablets per attack and 10 tablets weekly.
Indications: Acute migraine attack, and related types of vascular headache.
Contra-Indications: Peripheral vascular disease, pregnancy, breast feeding, sepsis,
coronary heart disease, severe hypertension, hepatic and renal insufficiency.
Special Precautions: Unsuitable for prophylaxis, alcohol should not be taken with it. If
tingling in finger or toes occurs discontinue drug. May impair ability to drive vehicles or
operate machinery. Elderly, occlusive vascular disease.
PHENYTOIN SODIUM
Dosage Form: Capsule 30 mg, 100 mg; Suspension 30 mg/5 ml, 125 mg/5 ml; Injection 50
mg, 100 mg/2 ml, 250 mg/5 ml (II)
Recommended Dose: 100 mg bd or tds, increased up to 80 mg daily if required, to be
taken with or after food. Children: under 6 years: 5-8 mg/kg daily in two or four divided
doses.Status epilepticus, loading doses of 15 to 20 mg/kg intraveously at a rate not
exceeding 1-3 mg/kg/min are recommended.
Indications: Status epilepticus, trigeminal neuralgia, pain of diabetic neuropathy. All forms
of epilepsy, absence seizures.
Contra-Indications: Do not give with Lignocaine HCl. Cardiac functions impairment, SA
block, second and third degree AV block and Adams-Stokes Syndrome.
Special Precautions: In patients with hepatic impairment, hypotension and severe
myocardial insufficiency. IV Phenytoin should be given slowly and avoid extravasation.
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PIZOTIFEN
Dosage Form: Tablet 500 mcg (II)
Recommended Dose: 0.5 mg in the evening for the first 2 days, then 0.5 mg midday and
evening, then 0.5 mg tds adjusted according to response. Maximum single dose 3 mg,
maximum daily dose 4.5 mg. child over 2 years, up to 1.5 mg daily in divided doses;
max. Single dose at night 1 mg.
Indications: Prevention of concurrent migraine, vascular headache, including classical
migraine, common migraine and cluster headache.
Contra-Indications: Urinary retention, closed angle glaucoma.
Special Precautions: Concurrent administration of anticholinergics, phenothiazines and
butyrophenones. Increased appetite and weight gain may occur. Prostatichypertrophy. May
affect ability to drive vehicles or operate machinery, increase effect of alcohol.
PROPRANOLOL HCL
Dosage Form: Tablet 10 mg, 40 mg (II)
Recommended Dose: Initially 40 mg bd or tds. Maintenance 80-160 mg daily.
Indications: Prophylaxis of migraine, essential tremor.
Contra-Indications: Peripheral vascular disease, asthma, heart failure, heart block.
Special Precautions: Late pregnancy, breast feeding. Reduce dose in liver and renal
impairment, diabetes mellitus, Wolfe-Parkinson White syndrome.
SUMATRIPTAN
Dosage Form: Tablet 50 mg (I*- Neurologist)
Criteria of use: For patients not responding to cafergot only (5 to 10 patients per year)
Recommended Dose: ADULT: Initially 25 mg (may repeat after 2 hours). Usual dose: 25
mg – 100 mg OD. Maximum dose: 200 mg once daily. Elderly (>65 years old): not
recommended.
Indications: Migraine.
Contra-Indications: Previous hypersensitivity to sumatriptan, cerebrovascular
syndromessuch as stroke or transient ischemic attack, hemiplegic or basilar migraine,
concurrent administration of MAO inhibitors or 2 weeks within discontinuation of MAO
therapy, ischemic heart disease, uncontrolled hypertension, peripheral vascular disease
including ischemic bowel disease, concomitant administration or within 24 hours of
treatment with another serotonin agonist, ergotamine-containing or ergot-type medication.
Special Precautions: Pregnancy, breast feeding, hepatic and renal impairment, patient
with ischemic or vasospastic coronary artery disease.
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1.5. Antiparkinson Agents
AMANTADINE HCL
Dosage Form: Tablet 100 mg (I)
Recommended Dose: Initially, 1 tab/day for the 1st 3 days. May be increased to 2 tab/day
as a regular dosage. In special cases, may be increased to 5-6 tab/day. Max: 6 tab/day.
Indications: Parkinson's disease of varying origins.
Contra-Indications: Severe non-compensated cardiac non-compensated insufficiency
(NYHA IV), cardiomyopathy, myocarditis, grade II or III AV block, existing bradycardia (<55
beats/min), congenital QT syndrome in personal or family history, history of serious
ventricular arrhythmias including torsades de pointes, simultaneous treatment w/ budipine or
other drugs that prolong the QT interval, prostate hypertrophy, narrow angle glaucoma,
renal impairment, states of agitation or confusion, delirious syndromes or exogenous
psychosis in personal or family history. Simultaneous treatment w/ memantine.
Special Precautions: Perform baseline & periodic ECG. Monitor electrolyte balance in
patients at risk of electrolyte imbalances. Patients w/ cardiac pacemakers. Avoid abrupt
discontinuation in patients treated simultaneously w/ neuroleptic drugs & amantadine.
Seizure-prone patients or those w/ organic brain lesions. Pregnancy & lactation.Elderly.
BENZHEXOL HCL
Dosage Form: Tablet 2 mg (II)
Recommended Dose: Initially 1 mg on the first day, 2 mg od second day, then increase by
2 mg daily up to 6 – 10 mg per day in 3 to 4 divided doses before or with food. For drug
induced extrapyramidal symptoms 5-15mg daily. Advisable to initiate therapy with single
1mg dose. Elderly (>65 yr) smaller dose required. Max. 20mg daily.
Maintenance: 5 – 15 mg daily in 3 or 4 divided doses.
Indications: Parkinsonism, drug-induced extrapyramidal disorders (but not tardive
dyskinesia).
Contra-Indications: Untreated urinary retention, angle closure glaucoma, gastro intestinal
obstruction, prostatic hypertrophy. Tardive dyskinesia
Special Precautions: In patients with cardiovascular disease, renal/hepatic impairment,
hypertension, tachycardia and paralytic ileus, pregnancy, breast feeding. Avoid abrupt
discontinuation of treatment.
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BROMOCRIPTINE MESYLATE
Dosage Form: Tablet 2.5 mg (I)
Recommended Dose: 1st week: 1.25 mg at night, 2nd week: 2.5 mg at night, 3rd week: 2.5
mg twice daily, 4th week: 2.5mg tds then increased by 2.5 mg every 3 to 14 days according
to response to a usual range of 10 – 40 mg daily in 3 divided doses, taken with food.
Indications: Parkinsonism
Contra-Indications: No absolute contra-indications.
Special Precautions: To perform liver function tests for patients on long term therapy,
pregnancy. Severe cardiovascular disease, psychotic disorders, peptic ulcer, GI
bleeding. Hypotensive reactions in some patients may be disturbing during the first few days
of treatment and particular care should be exercised when driving or operating machinery;
tolerance may be reduced by alcohol.
LEVODOPA + BENSERAZIDE (MADOPAR)
Dosage Form: Tablet 100 mg + 25 mg, 200 mg + 50 mg (II)
Recommended Dose: The dosages are expressed as levodopa dosages: Initially 100 mg
twice daily adjusted according to response.
Mantenance: 400 – 800 mg daily in divided doses after food.
Indications: Parkinsonism except drug-induced Parkinson syndrome.
Contra-Indications: Closed-angle glaucoma, severe psychosis, concurrent administration
of MAO-Inhibitor or within 2 weeks of its therapy.
Special Precautions: In patients with cardiovascular, hepatic, pulmonary and renal
diseases, pregnancy, history of gastric ulceration. Use with caution in patients with history of
osteoporosis.
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LEVODOPA + CARBIDOPA (SINEMET)
Dosage Form: Tablet 100 + 25 mg, 250 mg + 25 mg, CR 200 mg + 50 mg (I)
Recommended Dose: The optimum daily dosage must be determined by careful titration in
each patient. Standard antiparkinson drugs, other than levodopa alone, may be continued
while Sinemet is being administered, although their dosage may have to be adjusted. Initial
therapy: 1 tab of Sinemet 25/100 tds providing 75 mg of carbidopa/day. Dosage may
be increased by 1 tab daily or every other day, as necessary, until a dosage equiv of 8 tab
of Sinemet 25/100 a day is reached.
Transfer patients from Levodopa: monitor closely during the dose adjustment
period. Levodopa should be discontinued at least 12 hr before therapy is started (24 hr for
slow-release prep of levodopa). A daily dosage of Sinemet should be chosen that will
provide approx 20% of the previous levodopa daily dosage. Patients taking <1500 mg of
levodopa/day: start on 1 tab of Sinemet 25/100 tds-qds. Patients taking >1500 mg
of levodopa: 1 tab of Sinemet 25/250 tds-qds.
Maintenance Therapy should be individualized & adjusted according to the desired
therapeutic response. At least 70-100 mg of carbidopa/day should be provided for optimal
inhibition of extracerebral decarboxylation of levodopa. When a greater proportion
of carbidopa is required, 1 tab of Sinemet 25/100 or 12.5/50 may be substituted for 1 tab
of Sinemet 10/100. When more levodopa is required, Sinemet 25/250 should be substituted.
If necessary, the dosage of Sinemet 25/250 may be increased by 1/2-1 tab daily or every
other day to a max of 8 tab a day.
Experience w/ total daily dosages of carbidopa >200 mg is limited. Max: 8 tab
of Sinemet 25/250 per day (200 mg of carbidopa & 2 g of levodopa). This is about 3 mg/kg
of carbidopa, & 30 mg/kg of levodopa in a patient weighing 70 kg. Sinemet CR 1 tab bd-tds.
Max initial dose: 600 mg of levodopa/day & not given at interval of <6 hr.
Indications: Treatment of Parkinson's disease & syndrome. Patients w/ Parkinsonism
taking vit B6 prep.
Contra-Indications: MAOIs must be discontinued at least 2 wk prior to initiating
therapy. May be administered concomitantly w/ an MAOI w/ selectivity for MAO type B (eg:
selegiline HCl). Hypersensitivity. Narrow-angle glaucoma. Should not be used in patients w/
suspicious undiagnosed skin lesions or a history of melanoma.
Special Precautions: Not recommended for treatment of drug-induced extrapyramidal
reactions. The occurrence of dyskinesias in patients previously treated w/ levodopa alone
may require dosage reduction. Dosage reduction may be required when involuntary
movements & mental disturbances occur. All patients should be observed carefully for the
development of depression w/ concomitant suicidal tendencies. Caution in patients w/ past
or current psychoses. Use cautiously w/ psychoactive drugs. Severe CV or pulmonary
disease, bronchial asthma, renal, hepatic or endocrine disease, or a history of peptic ulcer
disease or of convulsions, history of MI & residual atrial, nodal, or ventricular arrhythmia,
chronic wide-angle glaucoma. Observe carefully when the dosage is reduced abruptly or
discontinued, esp if the patient is receiving neuroleptics. Patients should be informed of
sudden onset of sleep during daily activities & advised to exercise caution while driving or
operating machines during treatment w/levodopa. Periodic evaluations of hepatic,
hematopoietic, CV & renal function are recommended during extended therapy. Pregnancy,
women of childbearing potential, lactation. Not recommended in patients <18 yr.
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LEVODOPA + CARBIDOPA + ENTACAPONE (STALEVO)
Dosage Form: Tablet 50 mg + 12.5 mg + 200 mg, 100 mg + 25 mg + 200 mg, 150 mg +
37.5mg + 200 mg (II)
Recommended Dose: Only 1 tablet of Stalevo to be taken for each dose; max. 10 tablets
daily. May be taken with or without food. Adjust dose of other antiparkinsonian drugs when
administered in patient not receiving entacapone: Patients receiving standard-release cocareldopa or co-beneldopa alone, initiate Stalevo at a dose that provides similar (or slightly
lower) amount of levodopa; Patients with dyskinesia or receiving more than
800 mg levodopa daily, introduce entacapone before transferring toStalevo (levodopa dose
may need to be reduced by 10–30% initially); Patients receiving entacapone and standardrelease co-careldopa or co-beneldopa, initiate Stalevo at a dose that provides similar (or
slightly higher) amount of levodopa
Indications: Idiopathic parkinson's disease: As a substitute therapy for patients receiving
previously administered individual drugs; treatment of patients experiencing symptoms of
end-of-dose phenomenon who are previously treated w/ carbidopa/levodopa therapy only.
Contra-Indications: Concomitant use of MAOIs. Severe hepatic impairment, narrow-angle
glaucoma, pheochromocytoma. History of neuroleptic maglinant syndrome and/or nontraumatic rhadomyolysis.
Special Precautions: Not for drug-induced extrapyramidal symptoms. Severe CV or
pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, chronic wideangle glaucoma, history of peptic ulcer disease, convulsions, MI, ventricular arrythmias,
psychosis, during general anesth, extended therapy or when discontinuing treatment.
Development of mental changes, depression w/ suicidal tendencies, & other serious
antisocial behaviour should be monitored. Pregnancy & lactation. May impair ability to drive
or operate machinery. Not recommended in patient <18 yr.
PIRIBEDIL
Dosage Form: Tablet 50 mg (I* - Neurologist)
Criteria of use: Restricted to neurologist for Parkinson patients not responding to
monotherapy
Recommended Dose: 1 tab/day to be taken at the end of the main meal, increasing to tabs
daily in 2 doses in severe cases. The dosage may be increased in Parkinson`s Disease.
Parkinson`s Disease; As monotherapy: 3-5 tab as 3-5 divided doses daily. In combination
with L-Dopa therapy: 1-3 tabs daily (1 tab per 250 mg of L-Dopa)
Indications: Parkinson’s disease, minor neurological disturbances related to aging, visual
disorder of circulatory origin, adjunctive treatment of arteriopathy of the lower limbs.
Treatment of Parkinson`s Disease either as monotherapy (treatment of all forms essentially
involving tremor) or in combination with Dopa therapy from the outset or secondarily in
particular in forms involving tremor.
Contra-Indications: Circulatory collapse; acute myocardial infarction. Cardiogenic shock.
Special Precautions: When in doubt, do not hesitate to seek the advice of the doctor and
pharmacist. To avoid possible interaction between several drugs, inform the doctor of any
other treatment being taken.
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PRAMIPEXOLE DHCL
Dosage Form: Tablet 0.125 mg, 1 mg, ER 0.375 mg, ER 1.5 mg (I* - Neurologist)
Recommended Dose: Dose escalation: 0.125 mg tds on wk 1, 0.25 mg tds on wk
2, 0.5 mg tds on wk 3. Increase by 0.75 mg at wkly intervals if needed up to a max of 4.5
mg/day. Patient on levodopa Reduce dose. Renal impairment: CrCl 20-50 mL/min
Initially 0.125 mg bd, <20 mL/min Initially 0.125 mg daily as a single dose.
Indications: Treatment of signs & symptoms of advanced idiopathic Parkinson's disease
as monotherapy or in combination w/ levodopa.
Contra-Indications: Hypersensitivity to pramipexole products. Lactation.
Special Precautions: Renal impairment, severe CV disease. Avoid abrupt w/drawal.
Pregnancy & lactation. May impair ability to drive or operate machinery.
PROCYCLIDINE HCL
Dosage Form: Injection 10 mg/2 ml (I)
Recommended Dose: IM: 5-10 mg repeated if necessary after 20 minutes; max. 20 mg
daily. IV: 5 mg (usually effective within 5 minutes). Occasionally 10 mg or more may be
required and may required up to half an hour to obtain relief.
Indications: Acute symptoms of Parkinson. (As for benzhexol HCl)
Contra-Indications: Untreated urinary retention, angle closure glaucoma, gastro intestinal
obstruction, prostatic hypertrophy. Tardive dyskinesia
Special Precautions: In patients with cardiovascular disease, renal/hepatic impairment,
hypertension, tachycardia and paralytic ileus, pregnancy, breast feeding. Avoid abrupt
discontinuation of treatment.
ROPINIROLE
Dosage Form: Tablet 2mg (prolonged release tablet) (as hydrochloride) (I* - Neurologist)
Recommended Dose: Individualised dosage. Initially 0.25 mg tds, increase by 0.25
mg tds wkly for 1st 4 wk. Thereafter, may further increase by up to 3 mg/day wkly. Max: 24
mg/day. In combination w/ L-dopa: the dose of L-dopa may be reduced gradually by 20% in
total.
Indications: Treatment of idiopathic Parkinson's disease. May be used alone or in
combination w/ L-dopa to control "on-off" fluctuations & reduce the daily total dose of Ldopa.
Contra-Indications: Pregnancy.
Special Precautions: Severe CV disease, major psychotic disorders. Co-administration w/
antihypertensive & antiarrhythmic agents. May affect ability to drive or operate machinery.
Lactation.
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SELEGILINE HCL
Dosage Form: Tablet 5 mg (I* - Neurologist)
Recommended Dose: 5mg bd
Indications: Management of Parkinson's disease or symptomatic parkinsonism either used
alone or as an adjunct to l-dopa therapy.
Contra-Indications: Extrapyrimidal syndrome unrelated to dopamine deficiency (essential
tremor, Huntington’s chorea), pregnancy.
Special Precautions: History of peptic ulcer disease. Lactation. Use in children.
1.6. Antipsychotics
ARIPIPRAZOLE
Dosage Form: Tablet 10 mg, 15 mg (I* - Psychiatrist)
Recommended Dose: Schizophrenia 10 or 15 mg/day. Maintenance dose: 15
mg/day. Bipolar mania Starting dose: 15 or 30 mg/day. Dose adjustment should occur at
intervals of not <24 hr.
Indications: Treatment of acute episodes of schizophrenia & for maintenance of clinical
improvement during continuation therapy. Treatment of acute manic episodes associated w/
bipolar I disorder.
Contra-Indications: Hypersensitivity to aripiprazole or any component of the product
Special Precautions: Suicide, tardive dyskinesia, neuroleptic malignant syndrome, seizure
disorder. Diabetes mellitus, CV disease, cerebrovascular disease. Dementia-related
psychosis & CV adverse events in elderly. May disrupt body's ability to increase/reduce core
body temp. Dysphagia. Pregnancy, lactation, childn. May impair ability to drive or operate
machinery.
CHLORPROMAZINE HCL
Dosage Form: Tablet 25 mg, 50 mg, 100 mg (II)
Recommended Dose: Psychoses and severe anxiety: Orally initially 25 mg tds or 75 mg at
bedtime, adjust according to the response to usual maintenance dose of 75-300 mg daily
(up to 1 g daily). Elderly (or debilitated): third to half adult dose. Children: 1-5 years: 0.5
mg/kg every 4-6 hours (max. 40 mg daily), 6-12 years: 1/3 -1/2 adult dose (max. 75 mg
daily).
Indications: Management of psychotic condition, tranquilisation and emergency control
in behavioural disturbances.
Contra-Indications: Patients with bone marrow depression, narrow angle glaucoma, coma
caused by CN depressants. Subcutaneous injection.
Special Precautions: Cardiovascular, cerebrovascular and respiratory disease,
phaeochromocytoma, parkinsonism, epilepsy, acute infection, pregnancy, breast feeding,
renal and hepatic impairment, history of jaundice, hypothyroidism, Myasthaenia Gravis,
prostatic hypertrophy and elderly. On prolonged use, examination on eye defect and
abnormal skin pigmentation is required. Avoid abrupt withdrawal. Patients should remain
supine for at least 30 minutes after IM injection.
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CLOZAPINE
Dosage Form: Tablet 25 mg, 100 mg (I*)
Recommended Dose: 12.5 mg once or twice on first day then 25-50 mg on second day
then increased gradually (if well tolerated) in steps of 25-50 mg daily over 14-21 days up to
300 mg daily in divided doses (larger dose at night, up to 200 mg daily may be taken as a
single dose at bedtime); if necessary may be further increased in steps of 50-100 mg once
(preferably) or twice weekly; usual dose 200-450 mg daily (max. 900 mg daily).
Indications: Schizopherenia in patients unresponsive to, or intolerant of, conventional
antipsychotic drugs.
Contra-Indications: Severe cardiac failure; hepatic impairment, severe renal impairment;
history of drug induced neutropenia or agranulocytosis; bone marrow disorders; alcoholic
and toxic psychoses; history of circulatory collapse or paralytic ileus; drug intoxication; coma
or severe CNS depression; uncontrolled epilepsy; pregnancy and breast-feeding.
Special Precautions: Use should be limited to classical neuroleptic treatment-resistant
schizophrenic patients who initially have normal leukocyte findings & whom the mandatory
WBC counts can be performed. Concurrent use of drugs w/a substantial potential to
depress bone marrow function & of long-acting depot antipsychotics should be avoided.
Caution when Patients drive vehicle or operate machinery. History of seizurea; presence of
CV, renal, or hepatic disorders, prostatic enlargement, narrow angle glaucoma. Lactation,
pregnancy, elderly, childn.
FLUPENTHIXOL DECANOATE (FLUPENTIXOL DECANOATE)
Dosage Form: Injection 20 mg/ml (I)
Recommended Dose: By deep IM injection: Test dose 20 mg, then after at least 7 days 2040 mg, repeated at 2-4 weeks intervals adjusted according to response; max. 400 mg
weekly; usual maintenance dose 50 mg every 4 weeks to 300 mg every 2 weeks; Elderly:
1/4-1/2 adult dose. Children: not recommended.
Indications: Maintenance in schizophrenia and related psychoses.
Contra-Indications: Porphyria, children.
Special Precautions: See Chlorpromazine HCl.
FLUPHENAZINE DECANOATE
Dosage Form: Injection 25 mg/ml (II)
Recommended Dose: By deep IM injection: Test dose 12.5 mg (6.25 mg in children and
elderly patients) then after 4-7 days 12.5-100 mg repeated at intervals of 14-35 days
adjusted according to the response. Maximum 100 mg/dose.
Indications: Maintenance in schizophrenia, related psychoses, mania and organic
disorders.
Contra-Indications: Children under 12 years old. See Chlorpromazine HCl.
Special Precautions: When used in depression, see Chlorpromazine HCl.
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HALOPERIDOL
Dosage Form: Tablet 1.5 mg, 5 mg; Injection 5 mg/ml (II)
Recommended Dose: For psychoses: Adult: Initially 0.5-5 mg 2-3 times daily adjusted
according to response. Maximum 200 mg daily. Children: Initially 50-150 mcg/kg daily
divided into 2 doses. By IM/IV injection: 2-10 mg (increasing to 30 mg for emergency
control) every 6 hours, or 5 mg every hour if necessary.
Indications: Control of psychotic manifestation, mania, schizophrenia, emergency control
in behaviour disturbances.
Contra-Indications: Lesions of basal ganglia, Parkinsonism, hypersensitivity, lactation.
Special Precautions: In patients with cardiovascular or respiratory disorders, pregnancy,
epilepsy, thyrotoxicosis, elderly, concomitant use with antihypertensives, arteriosclerosis
and depression.
LITHIUM CARBONATE
Dosage Form: Tablet 300 mg (I)
Recommended Dose: Initially dose of 250 mg daily after food gradually increased to 750
mg in divided doses. Manic-Depressive disease: Up to 1.6 g daily may be used .For acute
mania and hypermania up to 1.5-2 g daily for first 5-7 days. Reduce dose rapidly once the
acute phase has passed.
Indications: Prophylaxis and treatment of mania prophylaxis of manic depression and
recurrent depression. Agressive and self mutilating behaviour.
Contra-Indications: In patients with severe renal failure, dehydration, sodium depletion,
Addison's disease.
Special Precautions: Plasma concentration must be measured regularly and thyroid
function monitored. Maintain adequate sodium and fluid intake. Lithium has low margin of
safety and unsuitable for children. Pregnancy, lactation, hypothyroidism, concurrent
administration with diuretic, cardiac diseases, elderly, Myasthenia Gravis.
OLANZAPINE
Dosage Form: Tablet 5 mg, 10 mg; Zydis Orodispersible Tablet 5 mg, 10 mg (I* Psychiatrist)
Recommended Dose: 5 – 20 mg/day
Indications: Acute and maintenance treatment of schizophrenia and other psychoses.
Contra-Indications: Narrow angle glaucoma. Lactation
Special Precautions: Elevated ALT and/or AST, hepatic impairment, limited hepatic
functional reserve, seizure, low leucocyte/neutrophil counts, history of bone marrow
depression, hypereosinophilic condition, myeloproliperative disease, prostatic hypertrophy,
paralytic ileus. Pregnancy. May impair ability to drive or operate machine.
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PERPHENAZINE
Dosage Form: Tablet 4 mg (II)
Recommended Dose: Intially 4-8 mg tds adjusted to the response. Maximum 24 mg
daily. Elderly 1/4 adult dose.
Indications: Schizophrenia and related psychoses, tranquilisations, and emergency control
in behavioural disturbances, short term adjunctive treatment. Violent or dangerous
impulsive behaviour.
Contra-Indications: See Chlorpromazine.
Special Precautions: Avoid in children below 14 years. See Chlorpromazine HCl.
QUETIAPINE
Dosage Form: Tablet, XR 50 mg, XR 200 mg, XR 300 mg, XR 400 mg (I*-Psychiatrist)
Criteria of use:
1. Replacing Olanzapine for treatment of manic episode associated with bipolar disorder
2. As 2nd line drug in treatment of schizophrenia
Recommended Dose: Schizophrenia 25 mg twice daily on day 1, 50 mg twice daily on day
2, 100 mg twice daily on day 3, 150 mg twice daily on day 4, then adjusted according to
response, usual range 300-450 mg daily in 2 divided doses; max. 750 mg daily. ELDERLY
initially 25 mg daily as a single dose, increased in steps of 25-50 mg daily in 2 divided
doses.
Mania, 50 mg twice daily on day 1, 100 mg twice daily on day 2, 150 mg twice daily on day
3, 200 mg twice daily on day 4, then adjusted according to response in steps of up to 200
mg daily to max. 800 mg daily; usual range 400-800 mg daily in 2 divided doses; ELDERLY
initially 25 mg daily as a single dose, increased in steps of 25-50 mg daily in 2 divided
doses. CHILD and ADOLESCENT under 18 years, not recommended.
Indications: Schizophrenia; treatment of episodes of mania either alone or with mood
stabilizers.
Contra-Indications: Breast-feeding
Special Precautions: Should be used with caution in patients with cardiovascular disease,
or a history of epilepsy; elderly; pregnancy, hepatic impairment; renal impairment;
cerebrovascular disease.
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RISPERIDONE
Dosage Form: Tablet 1 mg, 2 mg; Syrup 1 mg/ml (I* - Psychiatrist)
Prescribing Criteria: Restricted to 30 patients a year for duration of 1 year only (for each
patient).
Only for patients who comply to their medication
Recommended Dose: Adults- Start with 1 mg bd (regardless of acute or chronic) in all
patients. Increase to 2 mg bd on the second day and to 3 mg bd on the third day. Thereon,
dosage can be maintained or further individualised as needed. Usual optimal dosage is 2 - 4
mg bd. Doses above 5 mg bd have not been shown to be superior in efficacy to lower doses
and may cause extrapyramidal symptoms. Do not use doses of >8 mg bd. ChildrenExperience is lacking in children <15 years of age. Elderly- Start with 0.5 mg bd. Adjust
individually by increments of 0.5 mg bd to 1-2 mg bd. Caution should be exercised in this
group until further experience is gained.
Indications: Treatment of acute and chronic schizophrenic psychoses and other psychotic
conditions in which positive and/or negative symptoms are prominent. Alleviates affective
symptoms associated with schizophrenia.
Contra-Indications: Known hypersensitivity to the drug.
Special Precautions: Patients with known cardiovascular disease since risperdal may
induce orthostatic hypotension. Reduce dose should hypotension occur. Discontinue all
antipsychotic drugs should signs and symptoms of tardive dyskinesia and/or the Neuroleptic
Malignant Syndrome (characterized by hyperthermia, muscle rigidity,autonomicin stability,
altered consciousness and elevated CPK levels) appear. Geriatrics and patients with renal
or liver insufficiency require dosage adjustments (halving the usual adult starting dose and
subsequent dose increments). Parkinsonism, epilepsy, pregnancy, lactation,
driving/operating machinery.
SULPIRIDE
Dosage Form: Capsule 50 mg; Tablet 200 mg (I*- Psychiatrists)
Criteria of use: For patients not responding or experiencing adverse effects to other
standard alternatives
Recommended Dose: Predominantly positive symptoms-Initially 800-1200 mg which
can be increased to a maximum daily dose of 2400 mg , in 2-3 divided doses for 1-3 weeks.
Predominantly negative symptoms-100-400 mg daily in 2-3 divided doses. Mixed
symptoms-300-800 mg daily in 2-3 divided doses.
Indications: Acute and chronic psychoses. At disinhibitory doses, sulpiride 200 mg is
indicated for psychoses with prominent retirement states, apragmatism and aboulia. At
antiproductive doses, 200 mg is indicated for psychoses with prominent delusion or
confusion and schizophrenia.
Contra-Indications: Phaeochromocytoma.
Special Precautions: Reduce dosage in geriatrics and renal insufficiency. Caution in
epileptic patients. The Malignant Neuroleptic Syndrome may occur at high doses of
sulpiride. Discontinue if hyperthermia occurs. Limit duration of use during pregnancy.
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THIORIDAZINE
Dosage Form: Tablet 25 mg, 100 mg (II)
Recommended Dose: Psychoses: 150-600 mg daily in divided doses. Max 800 mg daily
for up to 4 weeks. Moderate to severe non-psychotic emotional disturbances: 75-200 mg
daily. Anxiety, agitation and restlessness in elderly: 30-100 mg daily. Children: Severe
mental or behavioural problems only. Under 5 years: 1 mg/kg daily, 5-12 years: 75-150 mg
daily in severe cases up to 300 mg daily.
Indications: Schizophrenia and related related psychoses, tranquilisations in behavioural
disturbances, short term adjunctive treatment of severe anxiety.
Contra- Indications: See Chlorpromazine HCl.
Special Precautions: See Chlorpromazine HCl. History of Myasthaenia Gravis.
TRIFLUOPERAZINE HCL
Dosage Form: Tablet 5 mg (II)
Recommended Dose: Psychoses: Initially 5 mg bd, gradually increased according to
response to usual range of 15-20 mg daily in divided doses. Severe anxiety: 2-4 mg daily in
divided doses.
Indications: Schizpophrenia and related psychoses, tranquilisations in behavioural
disturbances, short term adjunctive treatment of severe anxiety.
Contra-Indications: See Chlorpromazine HCl.
Special Precautions: See Chlorpromazine HCl. Caution in children.
ZUCLOPENTHIXOL
Dosage Form: Oral drops 20 mg/ml (20 ml), Injection Accuphase 50 mg/ ml (I* Psychiatrist)
Recommended Dose: Initially 20 -30 mg daily in divided doses, increasing to a max. 150
mg daily if necessary; usual maintenance dose 20 - 50 mg daily; Elderly (or
debilitated) initially quarter to half adult dose. Child not recommended.
Indications: Schizophrenia and other psychoses, particularly when associated with
agitated, aggressive, or hostile behaviour.
Contra-Indications: See Chlorpromazine HCl.
Special Precautions: See Chlorpromazine HCl.
1.7. Drugs for Cerebral Oedema
MANNITOL
Dosage Form: Injection 10% (10 gm/100 ml) (500 ml), 20% (20 gm/100 ml) (500 ml) (II)
Recommended Dose: Forced diuresis: By IV infusion 50-200 g over 24
hours, preceeded by a test dose of 200 mg/kg by a slow IV injection. Cerebral Oedema: By
rapid infusion 1.5-2 g/kg as 15-25% solution over 30-60 minutes.
Indications: Cerebral Oedema, forced diuresis.
Contra-Indications: Congestive heart failure, pulmonary oedema, intracranial bleeding.
Special Precautions: Extravasation causes inflammation and thrombophlebitis. Observe
patient for signs of fluid and electrolyte imbalance.
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METHYLPREDNISOLONE ACETATE
Dosage Form: Injection 0.2 gm/5 ml (I)
Recommended Dose RA & osteoarthritis Large joint: 20-80 mg. Medium joint: 10-40 mg.
Small joint: 4-10 mg. Doses given by IA route may be repeated at intervals of 1-5 or more
wk. Ganglion, tendinitis, epicondylitis 4-30 mg. Dermatologic condition 20-60 mg
injected into the lesion. Adrenogenital syndrome 40 mg IM every 2 wk.Ulcerative
colitis 40-120 mg intrarectally (as retention enema or by continuous drip 3-7 times/wk) for 2
or more wk.
Indications: Endocrine, rheumatic & hematologic disorders; collagen, dermatologic, ophth,
GI, resp & neoplastic disease; allergic & edematous states; acute exacerbation of multiple
sclerosis; TB meningitis w/ subarachnoid block; trichinosis w/ neurologic or myocardial
involvement.
Contra-Indications: See Methyl Prednisolone Sodium Succinate.
Special Precautions: Unusual stress, intercurrent infection; immunization (defer); active or
latent TB; ocular herpes simplex; renal insufficiency, hypertension; osteoporosis;
myasthenia gravis; pregnancy. Non-specific ulcerative colitis. Not for intrathecal
administration.
METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form: Injection 0.5 gm/vial, 1 gm/vial (I)
Recommended Dose: By IM/slow IV injection or infusion: 10-40 mg repeated as required.
For IV injection, dissolve in appropriate volume of dextrose, or/and in NaCl injection.
Children: Not less than 500 mcg/kg daily. BY deep IM injection: 40-120 mg repeated every
2-3 week if required.
Indications: Treatment of inflammatory disorders.
Contra-Indications: Systemic fungal infection.
Special Precautions: Ocular herpes simplex; psychic derangements; non-specific
ulcerative colitis; active or latent peptic ulcer, renal insufficiency, hypertension, osteoporosis,
myasthenia gravis; immunisation (defer); active or latent TB; unusual stress; pregnancy,
lactation. May mask signs of infection & new infection may appear. Posterior subcapsular
cataracts & glaucoma w/ possible damage to optic nerves may occur. Reduce dose
gradually.
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1.8. Anxiolytics/ Hypnotics/Sedatives
ALPRAZOLAM
Dosage Form: Tablet 0.5 mg [PSYCHOTROPIC] (I)
Recommended Dose: Adults: Initially 0.25-0.5 mg tds. Usual dosage range: 0.5-3 mg daily
4. Max: 3mg/day. For geriatric patients or in debilitating disease; usual starting dose: 0.25
mg bd - tds. Panic related disorder: 0.5-1 mg at bedtime or 0.5 mg tds.
Indications: Treatment of anxiety states (anxiety neuroses) with or without associated
symptoms of depression (short term use only). Panic related disorders.
Contra-Indications: Known sensitivity to benzodiazepines, myasthenia gravis, acute
narrow-angle glaucoma.
Special Precautions: Avoid operating vehicles or machinery; abuse-prone individuals;
pregnancy; lactation; renal or hepatic dysfunction. Patients whose primary diagnosis is
schizophrenia. Avoid abrupt discontinuation. Childn <18 yr. Depressed or suicidal patients.
CHLORAL HYDRATE
Dosage Form: Mixture [P] 500 mg/5 ml (II)
Recommended Dose: Hypnotic: 0.5-2 g at night. Sedative: 250 mg tds. Insomnia: 500-2 g
daily. Max 2 g daily. Children: 1-5 years 2.5-5 ml, 6-12 years: 5-10 ml. Taken well diluted
with water or milk 5-30 minutes before before bedtime unless indicated otherwise.
Indications: Insomnia, sedation, hypnotics.
Contra-Indications: In severe cardiac disease, gastritis. Marked hepatic or renal
impairment. Lactation.
Special Precautions: May affect patient's ability to drive or operate machinery. Caution
in porphyria, vasodilation reaction with alcohol.
DEXMEDETOMIDINE
Dosage Form: Injection 100 mcg/ml (0.1 mg/ml) (I)
Recommended Dose: Not to be infused for > 24 hr. Adult Loading dose 1 mcg/kg IV over
10 mins, followed by maintenance infusion of 0.2-0.7 mcg/kg/hr. Adjust rate of infusion to
achieve desired clinical effect.
Indications: Sedation of intubated/mechanically ventilated ICU patients
Contra-Indications: Hypersensitivity to dexmedetomidine
Special Precautions: Elderly patients, hypovolemic patients, patients receiving vasodilators
or negative chronotropic agents, patients with arrhythmias or cardiovascular disease,
patients with diabetes mellitus or chronic hypertension, renal or hepatic insufficiency, signs
of light anesthesia (movement, sweating, lacrimation) may be blunted by alpha-2 agonists
such as dexmedetomidine; blunting of hemodynamic response to stress during surgery may
not adequately reflect the depth of anesthetic depth.
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DIAZEPAM
Dosage Form: Tablet 2 mg, 5 mg, 10 mg; Injection 10 mg/2 ml ampoule; Rectal Tube 5
mg/tube [PSYCHOTROPIC] (II)
Recommended Dose: 2 mg tds, increased in severe anxiety to 15-30 mg daily in divided
doses. Children: 1-2.5 mg tds or qid. Over 6 months: Insomnia: 5-15 mg at bedtime. By
deep IM/Slow IV injection: (at a rate not more than 5 mg/min) 10 mg repeated if necessary
after 4 hours.
Indications: Anxiety, insomnia, adjunctive treatment of acute alcohol, withdrawal other
mental and emotional symptoms.
Contra-Indications: Acute narrow angle glaucoma, Myasthaenia Gravis, hypersensitisity to
benzodiazepine.
LORAZEPAM
Dosage Form: Tablet 1 mg [PSYCHOTROPIC] (II)
Recommended Dose: Anxiety: 1-4 mg increased to 10 mg (if necessary) daily in divided
doses. Insomnia: 1-4 mg at bedtime.
Indications: Anxiety, insomnia, adjunctive treatment of acute alcohol, withdrawal other
mental and emotional symptoms.
Contra-Indications: Acute narrow angle glaucoma, Myasthaenia Gravis, hypersensitivity to
benzodiazepine.
MIDAZOLAM
Dosage Form: Tablet 7.5 mg, 15 mg; Injection 15 mg/3 ml, 5 mg/ml [PYSCHOTROPIC] (I)
Recommended Dose: Adult: 15 mg at night, if required second dose 7.5-15 mg can be
given later on same night. For premedication: 5 mg 30-60 minutes before operation. IM:
Adult 10-15 mg 20-30 minutes before induction of anaesthesia. Children: (over 8 years old):
0.15-0.20 mg/kg. Premedication before diagnostic or surgical intervention: 2.5-5 mg IV 5-10
minutes before operation.
Indications: Disturbances of sleep rythm and all forms of insomnia, premedication before
surgical or diagnostic procedure.
Contra-Indications: Myasthaenia Gravis, hypersensitivity to benzodiazepine, acute narrow
glaucoma, premature infants.
Special Precautions: In cases of insomnia, psychoses and severe depression, treat the
underlying disorder first. Caution in organic brain damage, severe respiratory insufficiency
and concomitant administration with centrally sedative drugs. Pulmonary diseases,
prolonged respiratory depression, hepatic/renal dysfunction.
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PHENOBARBITONE
Dosage Form: Tablet 30 mg; Injection (as Sodium) 200 mg [PSYCHOTROPIC] (II)
Recommended Dose: Hypnotic: 60-100 mg at night. Children: 3-6 mg/kg body weight.
Sedative: 15-30 mg tds to qid. Anticonvulsant: Adult: 60-180 mg ON, Children: 5-8 mg/kg
daily.
Emergency control of convulsions: Adult 200 mg IM/SC, repeat after 6 hours if necessary.
Child 15mg/kg IM as a loading dose followed by 5mg/kg daily by mouth. Max: 600 mg daily.
Child: 3-5 mg/kg IM
Indications: As hypnotics, sedative and anti convulsant. All form of epilepsy except
absence seizures, status epilepticus.
Contra-Indications: Porphyria, hyperkinetic children.
Special Precautions: In elderly, children, impaired renal/hepatic function, severe
respiratory depression, pregnancy and breast feeding. Avoid sudden withdrawal of drug.
Enhanced by concurrent administration of other sedatives, MAOI, some tranquilizers,
sodium valproate, anticholinestarase, etc. Suggest to establish Therapeutic Drug Monitoring
on drug serum level.
ZOLPIDEM
Dosage Form: Tablet 10 mg [PSYCHOTROPIC] (I* - Psychiatrist)
Criteria of use: For patients who face potential risk with benzodiazepines
Recommended Dose: 10 mg at bedtime; Elderly (or debilitated) 5 mg; Child not
recommended.
Indications: Insomnia (short-term use)
Contra-Indications: Obstructive sleep apnoea, acute pulmonary insufficiency, respiratory
depression, myasthenia gravis, severe hepatic impairment, psychotic illness, pregnancy and
breast-feeding.
Special Precautions: Depression, history of drug or alcohol abuse, hepatic impairment
(requires dosage reduction), renal impairment, elderly; avoid prolonged use ( and abrupt
withdrawal thereafter)
1.9. Cholinergic Agents
DISTIGMINE BROMIDE
Dosage Form: Tablet 5 mg (I)
Recommended Dose: Initially 5 mg daily half an hour before breakfast, increased at
intervals of 3-4 days if necessary to a max of 20 mg daily; child up to 10 mg daily according
to age.
Indications: myasthenia gravis (but rarely used); urinary retention and other indications
Contra-Indications: Intestinal or urinary obstruction and hypersensitivity to Neostigmine.
Special Precautions: In patients with bronchial asthma, bradycardia, hypotension,
myocardial infarction, epilepsy, Parkinsonism, peptic ulcer, pregnancy. When given by
injection, syringe of atropine sulphate should always be available to counter severe
cholinergic reaction.
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EDROPHONIUM CHLORIDE
Dosage Form: Injection 10 mg/ml (II)
Recommended Dose: Diagnosis of Myasthaenia Gravis: By IV injection: 2 mg followed
after 30 seconds, (if no adverse reaction has occurred) by 8 mg. Children: 20 mcg/kg IV.
Detection of over or under dosage of cholinergic drugs: By IV injection 2 mg one hour after
last dose of cholinergic drug. For paroxysmal tachycardia: 10-20 mg.
Indications: Diagnosis of Myasthaenia Gravis, detection of under or overdosage with
cholinergic drugs.
Contra-Indications: Intestinal or urinary obstruction and hypersensitivity to edrophonium.
Special Precautions: In patients with bronchial asthma.
NEOSTIGMINE
Dosage Form: Injection 0.5 mg/ml, 2.5 mg/ml (II)
Recommended Dose: Orally 7.5-300 mg or more, daily in divided doses at suitable
intervals. Children: Neonate 1-5 mg every 4 hours. Older children 15-60 mg daily in divided
dosed. By SC, IM/slow IV injection: 1-2.5 mg daily in divided dosed at suitable intervals.
Children: Neonate: 0.05-0.25 mg every 4 hours. Older children 0.2-0.5 mg daily in divided
doses. Max dose: Adult: 5 mg, Children: 2.5 mg.
Indications: Treatment and diagnosis of Myasthaenia Gravis, as curare antagonist,
paralytic ileus, post-operative distension, urinary retention, paroxysmal supraventricular
tachycardia.
Contra-Indications: Intestinal or urinary obstruction and hypersensitivity to Neostigmine.
Special Precautions: In patients with bronchial asthma, bradycardia, hypotension,
myocardial infarction, epilepsy, Parkinsonism, peptic ulcer, pregnancy. When given by
injection, syringe of atropine sulphate should always be available to counter severe
cholinergic reaction.
PYRIDOSTIGMINE BROMIDE
Dosage Form: Tablet 10 mg, 60 mg (II)
Recommended Dose: Myasthaenia Gravis: 0.3-1.2 g daily in divided doses at suitable
intervals. Children: Neonates: 5-10 mg every 4 hours. Older children: 10 mg initially
increased by 5 mg amount according to response. Intestinal atony and atonic constipation:
60 mg every 4 hours.
Indications: Myasthaenia Gravis, intestinal atony, atonic constipation.
Contra-Indications: See Neostigmine, hypersentivity to Bromide Ion.
Special Precautions: See Neostigmine.
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1.10. Muscle Relaxants
BACLOFEN
Dosage Form: Tablet 10 mg (II)
Recommended Dose: Initially 5 mg tds after meals increased by 15 mg daily every fourth
day to 20 mg tds or when therapeutic effect obtained. Maximum: 80 mg daily. Children: 1-2
years: 10-20 mg in 4 divided doses. 2-10 years: 30-60 mg in 4 divided doses. Maximum: 60
mg daily.
Indications: Muscle spasm in multiple sclerosis and lesions of spinal cord.
Contra-Indications: Patients with history of epilepsy or convulsive disorders. Patients with
a history of hypersensitivity to the drug.
Special Precautions: In patients with cerebrovascular disease, psychiatric illness, ulcers,
impaired pulmonary and renal function and patients receiving anti hypertensive therapy.
Avoid abrupt withdrawal of drug.
BOTULINUM A TOXIN
Dosage Form: Injection 100 U, 500 U (I)
Recommended Dose: Strabismus 0.05-0.15 mL/muscle. Blepharospasm 1.25-2.5 u into
the medial & lateral pre-tarsal orbicularis oculi of the upper lid & into lateral pretarsal orbicularis oculi of the lower lid.
Indications: Peripherally-acting muscle relaxants. Strabismus & blepharospasm associated
w/ dystonia.
Contra-Indications: Hypersensitivity to botulinum A toxin products. Infection at the
proposed injection site(s)
Special Precautions: Anaphylaxis, corneal exposure.
EPERISONE
Dosage Form: Tablet 50 mg (I*)
Criteria of use:
1. For muscular contraction headache where conventional alternatives are ineffective or
patients are intolerant to the adverse reactions.
2. To be prescribed for a duration of 6 - 12 months only.
Recommended Dose: Usual initial dose is 50 mg tds, after meals. Dosage may be
adjusted according to age and severity of symptoms.
Indications: Improvement of myotonic symptoms associated with cervical syndrome,
periarthritis of the shoulder, and lumbago; spastic paralysis associated
withcerebrovasculardiseases, spinal, cervical spondylosis, postoperative sequelae
(including cerebrospinal tumor), sequelae to trauma (spinal trauma, head injury),
amyotrophic lateral sclerosis, cerebral palsy, spinocerebellar degeneration, spinal vascular
diseases, and other encephalomyelopathies.
Contra-Indications: Breastfeeding.
Special Precautions: Do not drive or operate machinery, hepatic disorders, pregnancy
(only if benefit outweighs risk), safety in children not established.
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1.11. Neurotonics/Nootropics
PIRACETAM
Dosage Form: Tablet 800 mg, 1200 mg; Injection 1 gm, 12 gm/60 ml; Solution 20%
(Drinkable) (I*)
Recommended Dose: Adult oral 1 tab tds. Childn 30-50 mg/kg body wt/day. Learning
difficulties 3.3 g daily or 8ml syr 20%. Infusion/inj CVA 12 g IV bolus over 20 minsfollowed
by 12 g/day (IV or oral soln) including 1st day, for 2-4 wk, then 4.8g/day (tab) for 6-12 weeks.
Indications: Involutional syndrome related to ageing: memory deficits, asthenia, adaptation
disorders, disturb psychomotor reactions. CVA & cerebral circulatory insufficiency: ischemic
or even hemorrhagic acute accidents; chronic manifestations of the above accidents or
cerebral atherosclerosis. Chronic alcoholism & addiction. Post traumatic syndrome; cerebral
dysfunction related to post traumatic sequelae. Severe obnubilation vascular coma of a
traumatic or toxic origin: rapid recovery of consciousness. Pead therapy: Dyslexia, learning
difficulties.
Contra-Indications: Severe renal insufficiency.
Special Precautions: Renal insufficiency. Creatinine clearance < 60 mL/minute or
serum creatinine > 1.25 mg/100 Ml.
1.12. Cerebrovascular Agents
CINNARIZINE
Dosage Form: Tablet 25 mg (II)
Recommended Dose: Initially: 75 mg tds, maintenance 75 mg bd-tds.
Indications: Vestibular vascular disease.
Contra-Indications: In patient with known hypersensitivity to the drug.
Special Precautions: In patients with hypotension.
PENTOXIFYLLINE
Dosage Form: Tablet 400 mg (I)
Recommended Dose: Initially: 200 mg tds, maintenance: 100 mg tds. By slow IV: 100 mg
over 10 minutes. IV infusion: 100 mg in 250-500 ml of NaCl, dextrose or leavulose 5% given
over 90-180 minutes. Maximum 400 mg daily.
Indications: Peripheral vascular disease.
Contra-Indications: Severe haemorrhage and recent myocardial infarction.
Special Precautions: Patients with chronic occlusive arterial disease of the limbs show
other manifestations of artherosclerotic disease. They have been occasional reports of
angina, hypotension and arrythmia. Diabetes mellitus, hypotensive states, coronary artery
or cerebrovascular disease.
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1.13. Anti- obesity Agents
ORLISTAT
Dosage Form: Capsule 120 mg (I* - Endocrine)
Recommended Dose: 120 mg taken immediately before, during, or up to 1 hour after each
main meal (up to max 360 mg daily); max. period of treatment 2 years; CHILD not
recommended.
Indications: Use in conjunction weigth a mildly hypocaloric diet in those with a body mass
index (BMI) of 30 kg/m2 or greater; it may also be considered in those with a BMI of 28
kg/m2 or greater and associated risk factor. Treatment with orlistat should be started only if
diet alone has previously produced a weight loss of 2.5 kg over a period of 4 consecutive
weeks.
Contra-Indications: Chronic malabsorption syndrome; cholestasis; pregnancy and breast
feeding.
Special Precautions: Patients should be advised to adhere to dietary guidelines;
gastrointestinal adverse events may increase if taken with a diet high in fat (>30% total daily
calories from fat). The daily intake of fat should be distributed over three main meals. If
taken with any one meal very high in fat, the possibility of gastrointestinal effects increase.
Patients should be counseled to take a multivitamin supplement that contains fat soluble
vitamins to ensure adequate nutrition because orlistat has been shown to reduce the
absorption of some fat-soluble vitamins and beta carotene. The supplement should be taken
once daily at least two hours before or after the administration of orlistat (i.e. bedtime).
Some patients may develop increased levels of urinary oxalate following treatment; caution
should be exercised when prescribing it to patients with a history of hyperoxaluria or calcium
oxalate nephrolithiasis. As with any weight-loss agent, the potential exist for misuse
inappropriate patient population (e.g. patients with anorexia nervosa or bulimia).
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1.14. Neurodegenerative Disease
DONEPEZIL HCL
Dosage Form: Tablet 5 mg, 10 mg (I)
Recommended Dose: 5 mg daily at bedtime, increased if necessary after 1 month to 10
mg daily; max. 10 mg daily
Indication: Mild to moderate dementia in Alzheimer’s disease
Contra-Indications: Pregnancy and breastfeeding
Special Precaution: Sick sinus syndrome or other supraventricular conduction
abnormalities; patients at risk of developing peptic ulcers; asthma; obstructive airways
disease
MEMANTINE HCL
Dosage Form: Tablet 10 mg (1* - Neurologist, Pyschiatrist)
Recommended Dose: Adult 5 mg/day on the 1st wk, 10 mg/day on the 2nd wk, then 15
mg/day on the 3rd wk. From the 4th wk on, treatment can be continued w/ the
recommended maintenance dose of 20 mg/day. Max: 20 mg/day. Elderly >65 yr 20 mg/day
(1 tab bd).
Indication: Monotherapy or adjunct w/ cholinesterase inhibitors for symptomatic treatment
of patients w/ moderate to severe Alzheimer's dementia.
Contra-Indications: Renal impairment (CrCl <50 mL/min); current seizure disorder or with
history of seizure.
Special Precaution: Severe renal impairment, epilepsy. Co-administration w/ N-methyl-Daspartate (NMDA)-antagonists (eg amantadine, ketamine or dextromethorphan).Careful
monitoring of patients w/ factors that may raise urine pH. Recent MI, uncompensated CHF,
uncontrolled HTN. Pregnancy & lactation.
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RIVASTIGMINE
Dosage Form: Cap 1.5 mg, 3.0 mg, 4.5 mg; Oral solution 2 mg/ml (120 ml); Patch 4.6
mg/24 hr, 9.5 mg/24 hr (I* - Psychiatrist, Neuroscience)
Recommended Dose: Initially 1.5 mg twice daily, increased in steps of 1.5 mg twice daily at
intervals of at least 2 weeks according to response and tolerance; usual range 3–6 mg twice
daily; max. 6 mg twice daily. Patch: Adult -switch from oral to patch, for total daily doses of
less than 6 mg of ORAL rivastigmine switch to 4.6 mg/24 hr patch; for a total daily dose
between 6 to 12 mg of ORAL rivastigmine switch to 9.5 mg/24 hr patch; apply the first patch
on the day following the last oral dose. 1) Alzheimer's disease - Dementia (Mild to
Moderate)- initial, 4.6 mg/24 hr patch TOPICALLY once daily; after a minimum of 4 weeks
and good tolerability, increase to 9.5 mg/24 hr patch once daily. 2) Dementia (Mild to
Moderate) - Parkinson's disease- initial, 4.6 mg/24 hr patch TOPICALLY once daily; after a
minimum of 4 weeks and good tolerability, increase the dose to 9.5 mg/24 hr patch once
daily. Pediatric -safety and efficacy in children have not been established.
Indications: mild to moderate dementia in Alzheimer's disease or in Parkinson's disease
Contra-Indications: breast-feeding
Special Precautions: gastric or duodenal ulcers (or susceptibility to ulcers); monitor bodyweight; sick sinus syndrome, conduction abnormalities; history of asthma or chronic
obstructive pulmonary disease; history of seizures; bladder outflow obstruction; hepatic
impairment (avoid if severe); renal impairment; pregnancy
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1.15. CNS Stimulants
ATOMOXETINE
Dosage Form: Capsule 10 mg, 18 mg, 25 mg, 40 mg, 60 mg (I*- Psychiatrist, Peadiatric,
Neurologist)
Recommended Dose: ADOLESCENT body-weight over 70 kg, initially 40 mg daily for 7 days
then increased according to response to usual maintenance dose 80 mg daily; max. 100 mg
daily; CHILD over 6 years and ADOLESCENT body-weight up to 70 kg, initially
500 micrograms/kg daily for 7 days then increased according to response to usual
maintenance dose 1.2 mg/kg daily (higher dose unlikely to be beneficial)
Note: Total daily dose may be given either as a single dose in the morning or in 2 divided
doses with last dose no later than early evening
Indication: Attention deficit hyperactivity disorder (initiated by a specialist physician
experienced in managing the condition)
Contra-Indication: Angle-closure glaucoma
Special Precautions: cardiovascular disease including hypertension and tachycardia;
monitor growth in children; QT interval prolongation (avoid concomitant administration of
drugs that prolong QT interval); history of seizures; susceptibility to angle-closure glaucoma;
hepatic impairment; pregnancy; breast-feeding.
METHYLPHENIDATE HCL
Dosage Form: Tablet 10 mg, LA 20 mg, LA 30 mg, ER 18 mg, ER 36 mg
[PSYCHOTROPIC] (I* - Neurologist, Psychiatrist)
Recommended Dose: Narcolepsy Adult: 20-30 mg daily in divided doses. Effective dose
may be 10-60 mg daily. Hyperactivity disorders Child: Conventional forms: ≥6 yr: Initially,
5 mg once or bid before breakfast or lunch. Increase, as necessary, by 5-10 mg at wkly
intervals to a max of 60 mg daily in divided doses. Consider a later dose in the evening if the
effect wears off. Discontinue periodically to re-evaluate or if there is no improvement within
1 mnth. Modified-release forms: Dose depends on brand.
Indications: Attention
Deficit/Hyperactivity
Disorder
(ADHD,
DSM-IV)
and
narcolepsy.
Contra-Indications: Hypersensitive to methylphenidate or to any of of the excipient in
Ritalin. Anxiety, tension, agitation, hyperthyroidism, cardiac arrhythmias,severe angina
pectoris and glaucoma. Patients with motor tics or siblings with tics or with diagnosis or
family history of Tourette’s syndrome.
Special Precaution: Avoid in children under 6 years of age; Should not be used to treat
severe exogenous or endogenous depression; Used with caution in patients with epilepsy;
During prolonged therapy periodic CBC, differential and platelet counts are recommended;
History of drug or alcohol dependence; Monitor blood pressure at appropriate intervals
especially in patients with hypertension.
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2. OPTHALMIC PRODUCTS
2.1. Antiinfectives
CHLORAMPHENICOL
Dosage Form: Eye drop 0.5%; Eye ointment 1% (II)
Recommended Dose: 1-2 drops qid. Apply into the conjunctival a thin strip (1 cm) tds or
more frequently, continue for 48 hours after healing.
Indications: Local treatment of conjunctivitis blepharitis, keratitis, trachoma. Prophylaxis of
ophthalmia neonatorum, dacryocystitis, corneal ulceration due to bacterial infections.
Contra-Indications: Pregnancy & infancy, patient with epithelial herpes simplex keratitis,
raccinia, varicella & other viral disease of the cornea & conjunctiva.
Special Precautions: Prolonged use may cause over-growth of non-susceptible organisms,
posterior subcapsular cataract formation and glaucoma.
CIPROFLOXACIN HCL
Dosage Form: Eye drop 0.3% (I)
Recommended Dose: Corneal ulcer: apply throughout day and night, day 1 apply every 15
min for 6 hours, then 30 min, day 2 apply every hour, day 3-14 apply every 4 hours (max
duration of treatment 21 days). Bacterial conjunctivitis: 1-2 drops every 2 hours into
conjunctival sac while awake for 2 days, 1-2 drops every 4 hours while awake for next 5
days.
Indications: Corneal ulcer and Bacterial conjunctivitis.
Contra-Indications: Hypersensitivity to ciprofloxacin/other quinolones.
Special Precautions: Prolonged used may result overgrowth of non-susceptible organism,
discontinue at first appearance of skin rash, children < 1 year, pregnancy, breast-feeding.
FUSIDIC ACID
Dosage Form: Eye drop 1% in gel basis (liquifies on contact with eye) (II)
Recommended Dose: 1 drop in conjunctival sac 12 hrly to be continued for 2 days after the
eye appears normal. On the 1st day, treatment may be applied more frequently (1 drop 4
hrly). Surgical prophylaxis: 1 drop 12 hrly, 24-48 hr before operation.
Indications: Bacterial eye infection. Prophylaxis in ophth surgery, removal of foreign
bodies.
Contra-Indications: Allergy to any of the constituents.
Special Precautions: Fucithalmic should not be applied while patients are wearing contact
lenses. Such patients should be advised to wear glasses during the treatment.
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GENTAMICIN
Dosage Form: Eye drop 0.3% (as sulphate); Eye ointment 0.3% (as sulphate) (I)
Recommended Dose: 1-2 drops qid. Apply into conjunctival sac tds-qid.
Indications: Local treatment of conjunctivitis, keratitis, blepharitis, corneal ulcers and
infected eye sockets, blepharoconjunctivitis, acute meibomianiatis and dacryocystitis.
Contra-Indications: Known hypersensitivity to gentamicin or other aminoglycosides,
patients with disrupted tympanic membranes.
Special Precautions: Prolonged use may cause over growth on non susceptible
organisms. May cause sensitization renal problems and may retard corneal healing.
MOXIFLOXACIN
Dosage Form: Eye drop 0.5% (as hydrochloride) (I* - Ophthalmologist)
Criteria of use: For bacterial conjunctivitis, bacterial keratitis, and pre and post cataract
surgery antibiotic prophylaxis according to:
A. Flowchart of Patients Diagnosed with Bacterial Conjunctivitis,
B. Flowchart of Patients Diagnosed with Bacterial Keratitis, and
C. Flowchart of Patients Requiring Pre and Post Cataract Surgery Antibiotic Prophylaxis
Recommended Dose: 1 drop in the affected eye tds for 7 days.
Indications: Treatment of bacterial conjunctivitis caused by susceptible organisms.
Contra-Indications: Hypersensitivity to quinolones.
Special Precautions: Not to be injected subconjunctivally or introduced directly to the
anterior chamber of the eye. Prolonged use. Pregnancy & lactation. Infant <1 yr
2.2. Antiinfectives with Corticosteroids
GENTAMICIN + BETAMETHASONE
Dosage Form: Eye drop 0.3% + 0.1% (II)
Recommended Dose: 2 drops tds-qid. Apply thin coating of ointment tds-qid.
Indications: Inflammatory and allergic conditions involving superficial eye structure and
when bacterial infection is either present or suspected.
Contra-Indications: Acute herpes simplex, vaccinia, varicella. Acute untreated purulent
bacterial or fungal infections of the eye.
Special Precautions: Avoid prolonged use and monitor intra-ocular pressure. Rebound
may occur following sudden withdrawal. Avoid using in infants & children up to 4 years old.
NEOMYCIN SULPHATE + DEXAMETHASONE
Dosage Form: Eye drop 0.5% + 0.1% (II)
Recommended Dose: 1-2 drops into the conjunctival sac tds-qid.
Indications: Inflammatory and allergic conditions of the eye.
Contra-Indications: In viral and fungal infections.
Special Precautions: Avoided prolonged use, extensive use may lead to systemic side
effects. Rebound may occur following sudden withdrawal. Infants & children up to 4 years
old should not be treated with topical steroids for > 3 weeks.
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2.3. Corticosteroids
EMEDASTINE DIFUMARATE
Dosage Form: Eye drop 0.05% (II)
Recommended Dose: Adult dose: 1 drops twice daily. If needed up to 4 times
daily, Pediatric dose: Allergic conjunctivitis: (3 yrs and 1 drop ophthalmic solution in
affected EYE(s) up to four times daily; safety and efficacy not established in children less
than 3 years of age
Indications: Allergic conjunctivitis
Contra-Indications: Hypersensitivity to Emedastine product
Special Precautions: Ophthalmic solution contains benzalkonium chloride which may be
absorbed by soft contact lenses, prevent contamination of dropper tip and solution, wait at
least 10 minutes after instillation of emedastine drops to insert contact lenses
PREDNISOLONE ACETATE
Dosage Form: Eye drop 0.12%, 1.0% (II)
Recommended Dose: 1-2 drops into conjunctival sac bd-qid.
Indications: Mild allergies, inflammatory disorders, chemical and thermal burns. Fortesevere inflammation tritis scleritis.
Contra-Indications: Acute herpes simplex and fungal infections. Tuberculosis of the eye.
Special Precautions: Avoid prolonged use, extensive use may lead to systemic side
effects.
2.4. Antivirals
ACYCLOVIR
Dosage Form: Eye ointment 3% (I)
Recommended Dose: Apply one cm of ointment into the lower conjunctival sac at 4 hourly
intervals. Continue treatment for at least 3 days after healing is complete.
Indications: Herpes simplex infections
Special Precautions: Pregnancy
2.5. Miotics/Mydriatics
ATROPINE SULPHATE
Dosage Form: Eye drop 1% (II)
Recommended Dose: 1-4 drops daily.
Indications: Mydriatic, cycloplegic, refraction procedures in young children.
Contra-Indication: Glaucoma.
Special Precautions: May cause blurred vision and increase sensitivity of the eye to light.
Risk of systemic effects with eye drops in infant under 3 months.
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CARBACHOL
Dosage Form: Injection 0.01% (1.5 ml/vial) (I)
Recommended Dose: Instill no more than ½ ml gently into the anterior chamber
Indications: Intraocular use for miosis during surgery.
Contra-Indication: Situations where pupillary constriction is undesireable.
Special Precautions: Patients w/ acute cardiac failure, bronchial asthma, peptic ulcer,
hyperthyroidism, GI spasm, urinary tract obstruction & Parkinson's disease.
HOMATROPINE HYDROBROMIDE
Dosage Form: Eye drop 2% (II)
Recommended Dose: Adult dose Mydriasis: 1-2 drops of 2% solution TOPICALLY in
eye(s), repeat in 5-10 min if needed; Uveitis: 1-2 drops of 2% solution TOPICALLY in eye(s)
every 3-4 hr. Pediatric dose Mydriasis: 1-2 drops of 2% solution TOPICALLY in eye(s)
every 10 min for 2-3 doses prior to refraction; Uveitis: 1-2 drops of 2% solution TOPICALLY
in eye(s) 2 or 3 times per day
Indications: Treatment of anterior segment inflammation
Contra-Indications: Primary glaucoma, narrow anterior chamber angle.
Special Precaution: Infant and small children.
PHENYLEPHRINE HCL
Dosage Form: Eye drop 2.5% (II)
Recommended Dose: A drop of suitable topical anaesthetic may be applied, followed in a
few minutes by 1 drop of the solution. If necessary repeat after 1 hour.
Indication: Mydriatic.
Contra-Indications: Narrow angle glaucoma, premature infant and elderly with severe
cardiovascular or cerebrovascular disease, in intraocular procedures when corneal barrier
has been disturbed.
Special Precaution: Tachycardia, hyperthyroidism, diabetes.
PILOCARPINE
Dosage Form: Eye drop 2%, 4% (II)
Recommended Dose: 1 drop 1-4 times daily.
Indications: As miotic in chronic open angel glaucoma.
Contra-Indications: Hypersensitivity, narrow angel glaucoma, or where constriction is
undesirable such as acute iritis, anterior uveitis and some forms of secondary glaucoma.
Special Precautions: Sensitization may occur with prolonged use.
TROPICAMIDE
Dosage Form: Eye drops 1% (I)
Recommended Dose: 1-2 drops several times a day.
Indications: Myadtric and Cycloplegia.
Contra-Indication: Glaucoma.
Special Precautions: May cause CNS disturbances.
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2.6. Diagnostic Agents
FLUORESCEIN SODIUM
Dosage Form: Injection 10% (100 mg/ ml) (5 ml); Sterile Ophthalmic Strip 1 mg (II)
Recommended Dose: IV As 10 or 25% soln: 500 mg; Moisten tip with tear fluid from lower
fornic, sterile water or ophtalmic solution and gently stroke accross the conjunctiva.
Indications: Angioscopy of the retinal and iris vasculature, detection of lesions and foreign
bodies, corneal staining in diagnostic examination including Goldman tonometry and contact
lens fitting.
Special Precautions: Allergic, thrombocyctopenia reaction.
METHYLENE BLUE
Dosage Form: Injection 1% (I)
Recommended Dose: 0.1 to 0.2 mL per kilogram of body weight (0.045 to 0.09 mL per
pound of body weight). Inject Methylene Blue intravenously very slowly over a period of
several minutes.
Indications: Drug-induced methemoglobinemia, antidote for cyanide poisoning, indicator
dye.
Contraindications: Intraspinal injection is contraindicated.
Special Precautions: Methylene Blue must be injected intravenously very slowly over a
period of several minutes to prevent local high concentration of the compound from
producing additional methemoglobin. Do not exceed recommended dosage.
2.7. Eye Miscellaneous
AMETHOCAINE HCL
Dosage Form: Eye drop 1% (I)
Recommended Dose: 1 drop as required.
Indications: Local anaesthetic
Special Precautions: Cornea may be damaged with prolonged application.
BETAXOLOL HCL
Dosage Form: Eye drop 0.5% (I* - Ophthalmologist)
Criteria of Use: To reduce intraocular pressure in glaucoma patients with underlying asthma,
IHD and heart block
Recommended Dose: Apply eye drops twice daily.
Indications: Chronic open-angle glaucoma, ocular hypertension.
Contraindications: Sinus bradycardia, >1st degree AV block, cardiogenic shock, overt
cardiac failure.
Special Precautions: Though betaxolol has a lower incidence of systemic effects
compared to other beta-blockers and has been found useful in patients with asthma,
bronchitis, and cardiovascular disorders, caution is still advised, especially in treating
patients with severe reactive airway disease or history of asthma.
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DORZOLAMIDE
Dosage Form: Eye drop 2% (as hydrochloride) (I* - Ophthalmologist)
Recommended Dose: Monotherapy:1 drop in affected eye(s) 3 times daily. Adjunctive
therapy with ß-Blocker: 1 drop in the affected eye(s) twice daily.
Indications: Treatment of elevated intraocular pressure in patients with occular
hypertension, open-angle glaucoma, pseudoexfoliative glaucoma and other secondary
glaucoma.
Contra-Indications: Hypersensitivity to any components, severe renal impairment or
hyperchloraemic acidosis, pregnancy, breast feeding.
Special Precautions: Renal impairment.Pregnancy: Require anticipated benefits >
risks. Lactation: A decision should be made whether to discontinue the drug or to
discontinue nursing, hepatic impairment, systemic absorption follows topical application,
chronic corneal defects, intra-occullar history.
HYDROXYPROPYL METHYLCELLULOSE
Dosage Form: Eye drop 0.3% (II)
Recomended Dose: 1-2 drops on to concave part of contact glass.
Indications: As contact fluid for examination of fundus of the eye with contact glass at slit
lamp, gonioscopy, and goniotomy.
Special Precautions: Check with physician if eye pain, changes in vision, continued
redness, irritation, if present symptons continue or become worse.
HYDROXYPROPYL METHYLCELLULOSE + DEXTRAN 70
Dosage Form: Eye drop 0.3 % + 0.1 % (II)
Recommended Dose: Instill 1-2 drops as & when required.
Indications: Symptomatic relief of ocular dryness due to the use of contact lenses, dust &
pollution.
Contra-Indication: Hypersensitivity to the components.
Special Precautions: Check with physician if eye pain, changes in vision, continued
redness, irritation, if present symptons continue or become worse.
HYDROXYPROPYL METHYLCELLULOSE + DEXTRAN 70 (PRESERVATIVE FREE)
Dosage Form: Eye drop 0.3 % + 0 0.1 % (preservative free) (II)
Recommended Dose: 1 drop 3 to 4 times daily
Indications: Relief in both mucin and aqueos deficient dry eye syndromes and symptoms of
severe keratoconjunctivitis sicca with associated ocular pain, disturbance in visual acuity,
stickiness discomfort and dryness
Contra-Indication: Hypersensitivity to the components.
Special Precautions: Do not self-prescribe use as ocular lubricant for more than 3 days,
Remove viscoelastic solutions from the anterior chamber at the end of the surgical, Treat
emergent elevations of intraocular pressure
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HYPROMELLOSE + CARBOMER (GEN TEAL GEL®)
Dosage Form: Gel 0.3% + 0.22% (I)
Recommended Dose: Adult & elderly 1 drop in each eye as needed
Indications: Lubricant eye gel for wearers of all types of contact lenses
Contraindications: Special Precautions: Not to be used during surgery.
LATANOPROST
Dosage Form: Eye drop 0.005% (I* - Ophthalmologist)
Recommended Dose: Adults & elderly: 1 drop in the affected eye(s) once daily. Optimal
effect if administered in the evening.
Indications: Reduction of elevated intraocular pressure in patients with open-angle
glaucoma.
Contra-Indication: Hypersensitivity to the components. Not recommended to the children.
Special Precautions: Transient blurring of vision (effect on ability to drive or operate
machine). Pregnancy: Require anticipated benefits > risks. Lactation: A decision should be
made whether to discontinue the drug or to discontinue nursing.
LATANOPROST + TIMOLOL
Dosage form: Eye drop 0.005% + 0.05% (II)
Recommended dose: Once daily in the morning
Indication: For raised intra-ocular pressure in patients with open-angle glaucoma and
ocular hypertension when beta-blocker alone not adequate.
Contra indication: Patients with bradycardia, heart block, uncontrolled heart failure,
asthma
Special precaution: Before initiating treatment, advise patients of possible change in eye
color, monitor for eye color change; aphakia, or pseudophakia wih torn posterior lens
capsule or anterior chamber lenses; risk factors for cystoid macular oedema; brittle or
severe asthma; not to be used within 5 minutes of used of thiomersal-containing
preparations; manufacturer advises avoid in pregnancy and in breast-feeding. History of
severe cardiac disease, spontaneous hypoglycemia, may mask sign of hyperthyroidism and
worsen Prinzmetal’s angina.
OLOPATADINE
Dosage Form: Eye drop (as hydrochloride) 0.1% (II)
Criteria of use: For allergic conjunctivitis
Recommended Dose: ADULT and CHILD over 3 years, apply twice daily; max. duration of
treatment 4 months
Indications: allergic conjunctivitis
Special Precautions: Pregnancy, lactation
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OXYBUPROCAINE HCL
Dosage Form: Eye drop 0.4% (4 mg/ml) (I)
Recommended Dose: 2, 3 or 5 instillations as required.
Indications: Local anaesthetic for diagnostic eye procedures, eye surgery, removal of
foreign bodies and contact lens fitting.
Special Precautions: Cornea may be damaged with prolonged application.
PROPARACAINE
Dosage Form: Eye drop 0.5% (I)
Recommended Dose: 1-2 drops up to 3 doses.
Indications: For procedures in which a rapid & short-acting topical ophth anaesth is
indicated eg suture removal from the cornea, tonometry, removal of foreign bodies & other
short procedures.
Contra-Indications: Hypersensitivity to proparacaine products
Special Precautions: Prolonged use may result in corneal infection &/or opacification w/
permanent visual loss or corneal perforation. Do not instill repeatedly.
SODIUM CHLORIDE
Dosage Form: Eye drops 0.9% (II)
Recommended Dose: 1-2 drops every 3-4 hours
Indications: Soothe irritated eyes and refreshes tired eyes
Contra-Indications: Hypersensitivity
Special Precautions: Contains Benzalkonium Chloride which is incompatible with soft
lenses and must not be used with them. A minimum of 20minutes should elapse before
inserting contact lenses after using this product.
SODIUM CROMOGLYCATE
Dosage Form: Eye drops 2% (I)
Recommended Dose: 1-2 drops into each eye 4 times daily.
Indications: Allergic conjunctivitis.
Contra-Indications: Hypersensitivity to benzalkonium chloride.
Special Precautions: Soft contact lenses should not be worn during treatment period.
SODIUM HYALURONATE
Dosage Form: Solution 0.25% (2 ml) (II)
Recommended Dose: Apply onto corneal surface or stroma before & alternating w/ laser
treatment.
Indications: Viscous masking & wetting soln in excimer laser surgery & other ocular
surgical procedures.
Contra-Indications: Hypersensitivity to hyaluronan (hyaluronate) preparations
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TETRAHYDROZOLINE
Dosage Form: Eye drops 0.05% (II)
Recommended Dose: 1-2 drops at intervals. Up to 4 times daily.
Indications: Relief of burning, itching, excessive lacrimation and redness due to
conjunctival hyperemia.
Contra-Indications: Narrow-angel glaucoma.
TIMOLOL MALEATE
Dosage Form: Eye drops 0.5% (I* - Ophthalmologist)
Recommended Dose: 1 drop in the affected eye(s) twice daily
Indications: Reduction of elevated intraocular.
Contra-Indications: Hypersensitivity to timolol, bronchiol asthma or with history of bronchiol
asthma or chronic obstructive pulmonary disease, sinus bradycardia, 2nd & 3rd degree
atrioventricular block, overt cardiac failure, cardiogenic shock
Special Precautions: Ophtalmic use in patient with narrow-angle or angle-closure
glaucoma. Pregnancy: Require anticipated benefits > risks. Lactation: A decision should
be made whether to discontinue the drug or to discontinue nursing. History of cardiac
disease, elderly patients, diabetes mellitus.
TIMOLOL MALEATE-XE
Dosage Form: Eye drops 0.5% (I* - Ophthalmologist)
Recommended Dose: 1 drop in the affected eye(s) once daily
Indications: Reduction of elevated intraocular pressure in patients with ocular
hypertension, chronic open-angle glaucoma, aphakia and glaucoma, secondary glaucoma,
narrow angle amd history of spontaneous or iatrogenially anduced narrow angle closure in
the opposite eye in whom reduction of intraoclar pressure is necessary.
Contra-Indications: bronchiol asthma or with history of bronchiol asthma or chronic
obstructive pulmonary disease, sinus bbradycardia, 2nd & 3rd degree atrioventricular block,
overt cardiac failure, cardiogenic shock, hypersensitivity to any component of timolol XE.
Severe allergic rhinitis or nutritional disorders involving the cornea.
Special Precautions: Pregnancy: Require anticipated benefits > risks. Lactation: A
decision should be made whether to discontinue the drug or to discontinue nursing.
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TRAVOPROST
Dosage Form: Eye drops 0.004% (II)
Recommended Dose: Open-angle glaucoma: 1 drop in the affected eye(s)once daily in the
evening. Ocular hypertension: 1 drop in the affected eye(s) once daily in the evening.
Indications: Open-angle glaucoma, ocular hypertension.
Contra-Indications: Hypersensitivity to travoprost, benzalkonium chloride or any other
ingredient of the product; women who are pregnant or attempting to become pregnant.
Special Precautions:
- Active intraocular inflammation (iritis/uveitis), Angle-closure, inflammatory, or neovascular
glaucoma (clinical experience with travoprost lacking);
- Aphakia, pseudophakia, or other risk factors for macular edema (enhanced risk of cystoid
macular edema),
- Contact lenses (should be removed before instillation and not reinserted until at least 15
minutes postinstillation),
- Eyelid skin darkening has been reported in association with the use of travoprost,
- Hepatic or renal impairment, May gradually change eye color in the treated eye (increased
brown pigmentation of the iris), May gradually change eyelashes in the treated eye
(increased length, thickness, pigmentation, and/or number of lashes),
- Travoprost has been reported to cause changes, which may be permanent, to pigmented
tissues; the most frequently reported changes have been increased pigmentation of the
iris and periorbital tissue (eyelid) and increased pigmentation and growth of eyelashes,
- Women who are pregnant or attempting to become pregnant should avoid direct exposure
to the contents of the bottle
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3. ANALGESIC PRODUCTS
3.1. Non-Narcotic Analgesics
ACETYLSALICYLIC ACID
Dosage Form: Tablet 300 mg (II)
Recommended Dose: As analgesic and anti pyretic; Adult: 300-900 mg every 4-6 hours
when required. Maximum up to 4 g daily. Children: 1-2 years: 75 mg, 3-6 years: 225 mg, >6
years: 300 mg. Not more than 3-4 times daily. For acute rheumatic disorders: 4-8 g daily in
divided doses. Children: 60-80 mg/kg up to 125 mg/kg daily.
Indications: Anti-inflammatory agent in rheumatoid arthritis, rheumatic fever, antipyretic
agent, analgesic for mild to moderate pain.
Contra-Indications: Haemophiliac, intolerance to aspirin, peptic ulcer or dyspepsia.
Concomitant use with Probenecid or other uricosuric agent, bleeding ulcers, haemorrhage
state, anaemia, compromised cardiac funtion, hypoprothrombinaemia or Vitamin K
deficiency.
Special Precautions: In patients prone to dyspepsia, impaired renal or hepatic function,
dehydration, bronchial asthma, patients on anticoagulants or hypoglycaemic agents. Not
recommended for infants under one year of age. Pregnancy, lactation, allergis diseases,
G6PD deficiency.
CELECOXIB
Dosage Form: Capsule 200 mg, 400 mg (I)
Criteria of use:
1. For rheumatoid arthritis and osteoarthritis only
2. Follow The Chronic Pain Management Protocol
Recommended Dose: Adult Acute pain: initial dose, 400 mg ORALLY once plus 1
additional 200 mg dose ORALLY as needed on the first day. Acute pain: maintenance, 200
mg ORALLY twice a day as needed. Familial adenomatous polyposis: 400 mg ORALLY
twice a day. Primary dysmenorrhea: initial dose, 400 mg ORALLY once plus 1 additional
200 mg dose ORALLY as needed on the first day. Primary dysmenorrhea: maintenance,
200 mg ORALLY twice a day as needed. Osteoarthritis: 100 mg ORALLY twice a day or 200
mg ORALLY once a day. Rheumatoid arthritis: 100-200 mg ORALLY twice a day. Pediatric,
(usual) Safety and efficacy in children under 18 years of age have not been established
Indications: Relief of signs and symptoms of osteoarthritis; relief of signs and symptoms of
rheumatoid arthritis in adults; reduce the number of adenomatous colorectal polyps in
familial adenomatous polyposis as adjunct to usual care.
Contra-Indications: Hypersensitivity to celecoxib or any component, sulfonamides, aspirin,
or other nonsteroidal anti-inflammatory drugs (NSAIDs)
SPECIAL Precautions: Gastrointestinal irritation, ulceration, bleeding, and perforation may
occur with NSAIDs. Patient with history of GI disease (bleeding or ulcers), decreased renal
function, hepatic disease, congestive heart failure, hypertension or asthma.
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DICLOFENAC SODIUM
Dosage Form: Tablet 50 mg; Injection 75 mg/3ml ampoule; Suppository 12.5 mg, 100 mg
(II)
Recommended Dose: 75-150 mg daily in 2-3 divided doses preferably after food.
Ostheoarthritis: 100-150 mg daily in divided doses. Rheumatoid arthritis: 150-200 mg daily
in divided doses. Ankylosing Spondylitis: 100-125 mg daily, give as 25 mg every 6 hours
with an extra 25 mg dose at bedtime if necessary. Post operative pain, initially after surgery:
25-50 mg IV infusion over 15-60 min then 5 mg/hr for maximum 2 days. Child: 1-2 yrs
juvenile arthritis, by mouth or rectum 1-3 mg/kg daily in divided doses.
Indications: Treatment of acute and chronic signs and symptoms of Rheumatoid Arthritis,
osteoarthritis, ankylosing spondylitis. Acute gout. Post operative pain.
Contra-Indications: See Mefenamic Acid.
Special Precautions: See Mefenamic Acid.
ETORICOXIB
Dosage Form: Tablet 90 mg, 120 mg (I)
Criteria of use: Follow the Chronic Pain Management Protocol
Recommended Dose: Osteoarthritis, adult and adolescent over 16 years, 60 mg once daily
Rheumatoid arthritis, adult and adolescent over 16 years, 90 mg once daily; Acute
gout, adult and adolescent over 16 years, 120 mg once daily
Indications: pain and inflammation in osteoarthritis and in rheumatoid arthritis; acute gout
Contra-Indications: inflammatory bowel disease; uncontrolled hypertension
Special Precautions: monitor blood pressure; breast-feeding
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IBUPROFEN
Dosage Form: Tablet 200 mg (I)
Recommended Dose: Adult (usual) Fever, self-medication of: 200-400 mg ORALLY every
4-6 hours as needed; MAX 1200 mg/day. Osteoarthritis: 1200-3200 mg/day ORALLY
divided in 3-4 doses. Pain, mild to moderate: 400 mg ORALLY every 4 hours as needed.
Pain, self-medication of minor: 200-400 mg ORALLY every 4-6 hours as needed, MAX 1200
mg/day. Primary dysmenorrhea: 400 mg ORALLY every 4 hours as needed. Rheumatoid
arthritis: 1200-3200 mg/day ORALLY divided in 3-4 doses. Pediatric, (usual) Fever, selfmedication of: 6 months-12 years old, 5-10 mg/kg ORALLY every 6-8 hours as needed,
MAX 4 doses/day; 12 years and older, 200-400 mg ORALLY every 4-6 hours as needed,
MAX 1200 mg/day. Juvenile Rheumatoid Arthritis: 30-50 mg/kg/day ORALLY in 3-4 divided
doses; MAX: 2.4 g/day. Pain, self-medication of minor: 6 months-12 years old, 5-10 mg/kg
ORALLY every 6-8 hours as needed, MAX 4 doses/day; 12 years and older, 200-400 mg
ORALLY every 4-6 hours as needed, MAX 1200 mg/day
Indications: Pain and inflammation in rheumatic disease (including juvenile arthritis) and
other musculoskeletal disorder; mild to moderate pain including dysmenorrhoea;
postoperative analgesia; migraine; fever and pain in children.
Contra-Indications: Pregnancy, children under 14 years, syndromes of nasal polyps,
angioedema, bronchospasm induced by aspirin or other NSAIDs.
Special Precautions: Patients with bleeding disorders, peptic ulceration and those
receiving coumarin and anti-coagulants and cardiovascular disease.
INDOMETHACIN
Dosage Form: Capsule 25 mg (II)
Recommended Dose: 25-50 mg bd or tds with food, up to 200 mg daily. Child not
recommended. Rheumatic disease 50-200 mg daily in divided doses. Acute gout, 150 –
200mg daily in divided doses. Dysmenorrhoea, up to 75mg daily.
Indications: Treatment of moderate to severe rheumatoid arthritis, ankylosing spondylitis,
osteoarthritis, dysmenorrhoea and acute gout.
Contra-Indications: Peptic ulceration, salicylate hypersensitivity, pregnancy, lactation and
children under 14 years old.
Cari maklumat untuk injection
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MEFENAMIC ACID
Dosage Form: Capsule 250 mg (II)
Recommended Dose: Adult For dysmenorrhea, the initial dose is 500 milligrams followed
by 250 milligrams every 6 hours, as needed, with food. Therapy should begin with the onset
of bleeding and associated symptoms; therapy is usually not necessary for more than 2 to 3
days.
PAIN The usual oral dose of MEFENAMIC ACID for acute pain is 500 milligrams initially,
followed by 250 milligrams every 6 hours, as needed, with food. MEFENAMIC ACID therapy
is not usually recommended for more than 1 week.
Paediatric dose: The recommended dose of MEFENAMIC ACID for treatment of acute
pain in children over 14 years of age is 500 milligrams initially, followed by 250 milligrams
every 6 hours as needed; therapy should usually not continue for more than one week.
Safety and efficacy in children under 14 years of age has not been adequately evaluated
Indications: Treatment of primary dysmenorrhoea and menorrhaegia, rheumatois arthritis
(including juvenile arthritis), osteoarthritis, analgesic for mild to moderate pain, antipyretic
agent.
Contra-Indications: GI Inflammation/ ulceration.
Special Precautions: Impaired hepatic function, bronchial asthma may enhance effects of
coumarin anticoagulants, pregnancy, dehydration, epilepsy.
MELOXICAM
Dosage Form: Tablet 7.5 mg (I)
Criteria of use: Follow the Chronic Pain Management Protocol
Recommended Dose: Osteoarthritis 7.5 mg/day. May be increased to 15
mg/day. RA Initially 15 mg/day. May be reduced to 7.5 mg/day. Ankylosing spondylitis 15
mg/day. Max: 15 mg/day.
Indications: Osteoarthritis, RA, Ankylosing spondylitis
Contra-Indications: Hypersensitivity to NSAIDs or aspirin. Active peptic ulceration, severe
hepatic insufficiency, non-dialysed severe renal insufficiency. Childn <15 yr. Pregnancy &
lactation.
Special Precautions: History of GI disease, dehydration, CHF, liver cirrhosis, nephrotic
syndrome, overt renal disease, recent major surgical procedures. W/draw if peptic ulceration
or GI bleeding occurs. Concomitant anticoagulant or diuretic treatment. Elderly.
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NAPROXEN
Dosage Form: Tablet 250 mg (II)
Recommended Dose: 0.5 – 1 g daily in 1 – 2 divided doses; CHILD (over 5 years), juvenile
arthritis, 10 mg/kg daily in two divided doses. Acute musculoskeletal disorder and
dysmenorrhoea, 500 mg initiallly, then 250 mg every 6 – 8 hours as required; max dose
after first day 1.25g daily; CHILD under 16 not recommended. Acute gout, 750 mg initiallly,
then 250 mg every 8 hours until attack has passed; CHILD under 16 years not
recommended.
Indications: Acute and chronic pain and inflammation of musculoskeletal origin, postoperative pain, dysmenorrhoea pain following IUD insertion, acute gout.
Contra-Indications: See Mefenamic Acid.
Special Precautions: See Mefenamic Acid.
PARACETAMOL
Dosage Form: Tablet 500 mg; Oral Suspension 120 mg/5 ml, 250 mg/5 ml; Suppository
125 mg, 250 mg; Injection 150 mg/ml (2 ml amp) (II)
Recommended Dose: 500 mg-1 g every 4-6 hours up to maximum of 4 g daily. Children: 2
months 60 mg for post immunisation pyrexia. Under 3 months 10 mg/kg (5 mg/kg if
jaundice). 3 months-1 year: 60-120 mg, 1-6 years 120-250 mg, 7-12 years up to 500 mg
repeated every 4-6 hours as required. Suppository: Adult: 1-2 supp in the rectum up to 4
times daily. Injection IM only as required.
Indications: For relief of mild to moderate pain and fever.
Contra-Indications: Nephropathy, anaemia, cardiac and pulmonary disease. Concomitant
use with phenothiazines, zidovudine.
Special Precautions: Impaired renal or hepatic function, daily use may potentiate effects of
oral anti-coagulants, G6PD deficiency, may potentiate hepatotoxicity in patients who are
chronic alcohol abusers or under hepatic enzyme inducing medication eg. barbiturates.
Avoid long-term usage.
PARECOXIB
Dosage Form: Injection 40 mg (I* - Anaesthesiologist)
Criteria of use: Restricted for ICU/ HDU and OT only
Recommended Dose: By deep intramuscular injection or by intravenous injection, initially
40 mg, then 20–40 mg every 6–12 hours when required; max. 80 mg daily; elderly weighing
less than 50 kg, initially 20 mg, then max. 40 mg daily; child and adolescent under 18 years,
not recommended
Indications: short-term management of acute postoperative pain
Contra-Indications: history of allergic drug reactions including sulphonamide
hypersensitivity; inflammatory bowel disease
Special Precautions: dehydration; following coronary artery bypass graft surgery
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PIROXICAM
Dosage Form: Tablet 10 mg (II)
Recommended Dose: 10-30 mg daily in single or in divided doses. Acute gout: Initially 40
mg then 40 mg daily for 4-6 days. Acute musculoskeletal disorder: 40 mg daily for 2 days
then 20 mg daily for 7-14 days. Children: Over 6 years: <15: 5 mg daily. 16-25 kg: 10 mg
daily. 26-45 kg: 15 mg daily. >46 kg: 20 mg daily.
Indications: Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout and
acute musculoskeletal disorders.
Special Precautions: In impaired renal and hepatic function. Patietns with history of
gastrointestinal haemorrhage or ulcers or aspirin sensitivity.
3.2. Narcotic Analgesics
ALFENTANIL
Dosage Form: Injection 0.5 mg [PSYCHOTROPIC] (I)
Recommended Dose: Administration of analgesic; Adjunct - Surgical procedure: surgery
duration 30 min or less; 8-20 mcg/kg IV, then continuous IV infusion of 0.5-1 mcg/kg/min;
total dose 8-40 mcg/kg; Administration of analgesic; Adjunct - Surgical procedure: surgery
duration 30-60 min; 20-50 mcg/kg IV, then maintenance IV injections of 5-15 mcg/kg every
5-20 min; total dose up to 75 mcg/kg; Administration of analgesic; Adjunct - Surgical
procedure: surgery duration longer than 45 min; 50-75 mcg/kg IV, then continuous IV
infusion of 0.5-3 mcg/kg/min
Indications: Administration of analgesic; Adjunct - Surgical procedure
Contra-Indications: Intolerance to alfentanil or to morphinomimetics. In labor or before
clamping of the cord during caesarean section. Respiratory depression and obstructive
airways disease; acute alcoholism, convulsive disorders; head injuries, and conditions in
which intracranial pressure is raised.
Special Precautions: Decreased respiratory reserve and pulmonary disease; prostatic
hyperplasia; hypotension; shock; inflammatory or obstructive bowel disorders; myasthenia
gravis; hypovolaemia; uncontrolled hypothyroidism; renal or hepatic impairment; alcoholism;
chronic opioid therapy and history of opioid abuse. Avoid rapid bolus injection in
compromised intracerebral compliance. Do not administer during the last 10 min of
surgery. Elderly, debilitated patients, pregnancy and lactation. May affect ability to drive and
operate machinery.
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DIHYDROCODEINE TARTRATE
Dosage Form: Tablet 30 mg [PSYCHOTROPIC] (II)
Recommended Dose: 30mg every 4-6 hours with or after meals when necessary. Children
over 4 years: 0.5-1 mg/kg/daily every 4 – 6 hours.
Indications: Moderate to severe pain.
Contra-Indications: Respiratory depression, concomitant use with MAO inhibiotrs,
bronchial asthma, increased intracranial pressure. Patients known to be hypersensitive to
the drug.
Special Precautions: Renal impairment, late pregnancy, Children under 1 year. May
potentiate the effect of tricyclic antidepressants, sedatives and hypnotics, general
anaesthetics and alcohol.
FENTANYL
Dosage Form: Injection (as citrate) 50 mcg/ml (2 ml ampoule); Patch (as citrate) 12 mcg/hr,
25 mcg/hr [PSYCHOTROPIC] (I)
Recommended Dose: Premedication by IM 50-100 mcg 30-60 min prior to surgery. By IV
inj. as an adjunct to general anaesthesia, with spontaneous respiration 50-200 mcg then 50
mcg every 20-30 min as required. Child: 3-5 mcg/kg then 1 mcg/kg as required. With
assisted ventilation: 300-3500 mcg (up to 50 mcg/kg) then 100 – 200 mcg as required.
Child: 10-15 mcg/kg then 1 – 3 mcg/kg as required. Post operatively IM 50-100 mcg.
Repeat dose in 1-2 hrs as needed. Treatment of intractable chronic pain in adults,
transdermal patches 25-100 mcg/hour. Max dose adults/children regardless of weight is 400
mcg.
Indications: Analgesic in anaesthesia for all types of surgical intervention,
neuroleptanalgesia. It is also used as a respiratory depressant in the management of
mechanically ventilated patient under intensive care.
Contra-Indications: Children 2 yrs and under, bronchial asthma patients susceptible to
respiratory depression.
Special Precautions: Patients with myasthenia gravis. Reduced doses are used in the
elderly or debilitated patients.
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MORPHINE SULPHATE
Dosage Form: Tablet SR 10 mg [PSYCHOTROPIC]; Injection 10 mg/ml
[PSYCHOTROPIC]; Mixture [P] 2 mg/ml [DANGEROUS DRUG] (II)
Recommended Dose: Acute pain and Post operative pain, – By SC (not suitable for
oedematous patients) or by IM injection, 10 mg every 4 hours if necessary (15 mg for
heavier well-muscled patients); CHILD up to 1 month 150 mcg/kg, 1 – 12 months 200
mcg/kg, 1 – 5 years 2.5 – 5.0 mg, 6 – 12 years 5 – 10mg. By slow invenous injection,
quarter to half corresponding IM dose. Premedication, by SC or IM injection, up to 10 mg
60 – 90 min before operation; CHILD, by IM injection, 150 mcg/kg. Myocardial infarction,
by slow IV injection (2 mg/min), 10 mg followed by a further 5 – 10 mg if necessary; elderly
or frail patients reduce dose by half. Acute pulmonary oedema, by slow IV injection (2
mg/min) 5 – 10 mg. Chronic pain,by mouth or by IM injection, 5 – 20 mg regularly every 4
hours; dose may be increased according to needs. Oral dose should be approx. double
corresponding IM dose and approximately triple corresponding IM diamorphine dose.
Indications: Relief pain especially that is associated with neoplastic disease and for postoperative pain, relieves dyspnoea of left ventricular failure and of pulmonary oedema. Used
post-operatively as an adjunct to anaesthesia for pain relief and to allay anxiety.
Contra-Indications: Respiratory depression, acute alcoholism, head injuries and conditions
in which intracranial pressure is raised during an attack of bronchial asthma, in heart failure
secondary to lung disease, renal impairment. Avoid injection in phaeochromocytoma-risk of
pressor response to histamine release.
Special Precautions: Reduce dose in elderly and delibitated patients. Should not be given
pre-operatively to children under 1 year old and in patients with inflammatory or obstructive
bowel disorders. May cause respiratory depression in the new born infant if administered
during labour.Caution in hypothyroidism, adrenocortical insufficiency , impaired liver
function, prostatic hypertrophy and shock, MAOI therapy or within 14 days of stopping
treatment.
OXYCODONE HCL
Dosage Form: Controlled Release Tablet 10 mg, 20 mg [PSYCHOTROPIC] (I)
Criteria of use: Follow The Chronic Pain Management Protocol
Recommended Dose: total daily dose as determined for conventional product; give half
total daily dose every 12 hours. Do not use controlled release tablet for initial
stabilisation.Titrate dose depending on response.
Indications: Moderate-to-severe acute or chronic pain
Contra-Indications:
Significant
respiratory
disease,
Comatose
patients,
phaeochromocytoma
Special Precautions: Reduced dose may be required in moderate and severe renal
impairment.
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PHARMACOLOGIC CATEGORY
PETHIDINE HCL
Dosage Form: Injection 50 mg/ml, 100 mg/2 ml amp [PSYCHOTROPIC] (II)
Recommended Dose: Acute and Post operative pain by IM/SC: 25-100 mg up to 150 mg
repeated every 3-4 hours. By slow IV injection: 25-50 mg repeated after 4 hours.Child: 0.5 –
2.0 mg/kg IM injection. Premedication: by IM injection 25-100 mg 1 hour before operation.
Children: 0.5 - 2 mg/kg. Adjunct to Nitrous Oxide oxygen by slow IV injection: 10-25 mg
repeated when required. Obstetric analgaesia by SC/IM: 50-100 mg repeated 1-3 hours
later if necessary. Max: 400 mg daily.
Indications: Relief of moderate to severe pain including post-operative pain, obstetric
analgesic. Pre-operative medication and as an adjunct in anaesthesia.
Contra-Indications: Increased intracranial pressure, patients in MAO inhibitors or within 10
days of stopping treatment severe liver disease alcoholism.
Special Precautions: Concomitant administration of phenothiazaines, phenobarbitones
may enhance respiratory depression in the newborn infant if administered during labour.
Caution in renal impairment and supraventricular tachycardia.
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TRAMADOL HCL
Dosage form: Tablet 50 mg; Injection 50 mg/ ml, 100 mg/ 2 ml (II)
Criteria of use: For patients at high risk to develop post-operative respiratory depression.
Tablet form: as adjunctive to NSAIDs. Restricted to pain clinic only.
Injection forms: Not to be used in all types of acute and chronic pain case (First choice is
Inj. Morphine).
Recommended dosage: IV (over 2-3 min) and oral; Adults: 50-100 mg every 46 hours(maximal dose is 400mg), Childn 12-18 yr: 0.7 mg/kg/dose(maximal dose is 5.6
mg/kg). Post operative pain, 100 mg initially then 50 mg every 10-20 min if necessary during
first hour to total maximum 250 mg (including initial dose) then 50-100 mg every 4-6 hour,
maximum 600 mg daily.
Indications: Treatment of a variety of pain syndrome.
Contra-Indications: Hypersensitivity and acute intoxication with alcohol, centrally acting
analgesics, hypnotics, opiods or psychotropic drugs.
Special Precautions: History of seizure, concomitant administration of MAOI, TCA, SSRI,
neuroleptic agents and other drugs that lower the seizure threshold, respiratory depression,
previous sensitivity to other opiod, increased intracranial pressure or head trauma,
pregnancy and lactation, capacity to drive or operatye machines may be impaired especially
if taken with alcohol and in renal impairment,dose reduction may be required.
3.3. Narcotic Antagonists
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NALOXONE HCL
Dosage Form: Injection 20 mcg/ml, 400 mcg/ml (I)
Recommended Dose: Post-operative opiate depression: Initally 100-200 mcg (1.53 mcg/kg) by IV injection. If response inadequate, increments of 100 mcg every 2
minutes. Further doses by IM injection after 1-2 hours if required. Neonatal respiratory
depression: 10 mcg/kg by SC/IM or IV injection repeated every 2-3 minutes or 200 mcg (60
mcg/kg) by IM injection as a single dose at birth. Known or suspected opiate overdosage:
Initially 0.4-2.0 mg IV administered at 2-3 minutes intervals if necessary. If no response
observed after a total of 10 mg, condition may be due to other causes. Children: Initially
0.01 mg/kg IV. If no response obtained, subsequent dose of 0.1 mg/kg may be
administered. For continous IV infusion: Loading dose: 0.005 mg/kg followed by infusion of
0.0025 mg/kg/hour diluted in normal saline or dextrose 5% to produce concentration of 4
mcg/ml .
Indications: For complete or partial reversal of narcotic depression including respiratory
depression induced by natural or synthetic narcotics propoxyphene and pentazocine, for
diagnosis of suspected acute opiate overdosage.
Contra-Indications: Hypersensitivity.
Special Precautions: In patients with cardiac irritability, patients physically dependent on
narcotics, (including neonates of dependent mothers) and pregnancy. Excessive
overdosage should be avoided since it may result in an increase in blood pressure,
excitement.
4. GENITO-URINARY PRODUCTS
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4.1. Diuretics (Refer 9.1)
4.2. Drugs Used in Obstetrics
4.2.1. Prostaglandins and Oxytocics/Drugs Acting on Uterus
CARBOPROST TROMETHAMINE
Dosage Form: Injection 250 mcg/ml (as tromethamine salt) (1 ml ampoule) (I* - Obstetrics
& Gynaecology)
Recommended Dose: By deep IM injection 250mg repeated if necessary at interval of 1.5
hour (in severe cases the interval may be reduced but should not be less than 15 minutes).
Total dose should not exceed 2mg (8 doses).
Indications: Post-partum haemorrhage due to uterine atony in patients unresponsive
to ergometrine and oxytocin.
Contra-Indications: Acute pelvic inflammatory disease, cardiac, renal, pulmonary, or
hepatic disease.
Special Precautions: History of glaucoma or raised intraocular pressure, asthma,
hypertension, hypotension, anemia, jaundice, diabetes, epilepsy, uterine scars; excessive
dosage may cause uterine rupture.
DINOPROSTONE
Dosage Form: Vaginal tablet 3 mg (I)
Recommended Dose: Inserted high into posterior formix 3 mg, followed after 6-8 hours by
3 mg if labour is not established. Maximum 6 mg (2 consecutive pessaries).
Indications: Induction of labour.
Contra-Indications: Hypertonic uterine inertia, mechanical obstruction of delivery,
placenta praevia, predisposition to uterine rupture, severe toxaemia, untreated pelvic
infection,foetal distress, multiple pregnancy, prior history of difficult or traumatic delirium.
Special Precautions: Asthma, glaucome, and raised intraocular pressure, exercise dosage
may cause uterine rupture; continued administration for more than 2 days not
recommended.
ERGOMETRINE MALEATE
Dosage Form: Injection 0.5 mg/ml (II)
Recommended Dose: Post-partum haemorrhage: 200-500 mcg IM. Haemorrhage during
ceasatian section: 250-500 mcg into uterine muscle. Emergency: 200 mcg IV.
Indications: Management of 3rd stage labour, treatment of post-partum haemorrhage.
Contra-Indications: 1st and 2nd stage of labour, impaired renal and hepatic function
(severe), vascular disease, cardiac disease, sepsis, severe hypertension, eclampsia.
Special Precautions: In patients with toxaemia, cardiac disease and hypertension, hepatic
and renal impairment, multiple pregnancy, porphyria.
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ERGOMETRINE MALEATE + OXYTOCIN (SYNTOMETRINE)
Dosage Form: Injection 0.5 mg + 5 units per ml (II)
Recommended Dose: By IM injection: 1ml, by IV injection: 0.5 - 1 ml.
Indications: Management of 3rd stage labour, treatment of post-partum haemorrhage.
Contra-Indications: 1st and 2nd stages of labour, impaired renal and hepatic function
(severe), vascular disease, cardiac disease, sepsis, severe hypertension, eclampsia.
Special Precautions: In patients with toxaemia, cardiac disease, hypertension, hepatic and
renal impairment, multiple pregnancy, porphyria.
GEMEPROST
Dosage Form: Pessary 1 mg (I*- Obstetrics & Gynaecology)
Recommended Dose: 1 mg inserted into posterior formix 3 hours before surgery
for transcervical operative procedures in first trimester. 2nd trimester abortion: 1 mg every 3
hours for maximum of 5 administrations. 2nd course may begin 24 hours after start of
treatment. 2nd trimester intra-uterine death: 1 mg every 3 hours for maximum 5
administrations only.
Indications: Softening and dilatation of the cervix to facilitate transcervical operative
procedures in first trimester. Second trimester abortion, 2nd trimester intra-uterine death.
Contra-Indications: Unexplained vaginal bleeding.
Special Precautions: Obstructive airway disease, cardiovascular insufficiency, raised intraoccular pressure, cervicitiss or vaginitis. Monitor for coagulopathy.
OXYTOCIN
Dosage Form: Injection 10 units/ml (II)
Recommended Dose: Missed abortion: 10-20 iu in 500 ml Dextrose 5% infused at rate of
10-30 drops/minute and increased by 1-20 milli unit/minute every hour to maximum of
100milliunit/minute. Induction of labour: By IV infusion of 1 iu/100 ml in glucose or dextrose
5% at the rate of 10-20 drops perminute. Post-partum haemorrhage: By IV/IM/SC injection:
2-10iu.
Indications: Induction and maintenance of labour, to control post-partum bleeding,
inadequate uterine action, promote lactation and in missed abortion.
Contra-Indications: Hypertonic
uterine
dysfunction,
severe toxaemia,
placenta praevia, cephalopelvic disproportion. Malposition or tactal distress.
Special
Precautions: Hypertension
treated
with pressor drugs,
multiple
pregnancy, abnormal presentation.
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4.2.1.1. Ductus Arteriosus
ALPROSTADIL
Dosage Form: Injection 500 mcg/ml; Urethral suppository 1 mg (I)
Recommended Dose: By IV infusion initially 50 – 100 nanogram/kg/min, then decrease to
lowest effective dose. Urethral Initially 250 mcg, may increase to 500 or 1000 mcg or reduce
to 125 mcg depending on erectile response. The optimal dose should not be given >2
times/day or 7 times/wk.
Indications: Congenital heart defects in neonates prior to corrective surgery, erectile
dysfunction.
Special Precautions: History of haemorrhage, avoid in hyaline membrane disease, monitor
arterial pressure. Alprostadil is used to maintain patent ductus arteriosus in centers where
intensive care unit is available.
INDOMETHACIN
Dosage Form: Injection 1 mg (II)
Recommended Dose: By IV injection over 20 – 30 minutes, 3 doses at interval of 12 – 24
hrs. Neonate under 48 hrs, 200 mcg/kg then 100 mcg/kg then 100 mcg/kg. Neonates 2 – 7
days, 200 mcg/kg then 200 mcg/kg then 200 mcg/kg. Neonates over 7 days, 200 mcg/kg
then 250 mcg/kg then 250 mcg/kg.
Indications: Patent ductus arteriosus in premature babies.
Contra-Indications: Peptic ulceration, salicylate hypersensitivity, pregnancy, lactation and
children under 14 years old, untreated infection, bleeding thrombocytopenia, coagulation
defect, necrotizing enterocolitis.
4.2.2. Myometrial Relaxant
SALBUTAMOL SULPHATE
Dosage Form: Tablet 2 mg, 4 mg; Syrup 2 mg/5 ml; Injection 0.5 mg/ml (II)
Recommended Dose: IV infusion: 10 mcg/minute gradually increased (according to
response at 10 minutes interval) to 45 mcg/minute until contractions have ceased, and
then gradually reduced. IM/IV injection: 100-25 mcg repeated according to patient response.
Oral: 4 mg every 6-8 hours. Children: 2 years: 100 mcg/kg every 6 hours. 2-6 years: 1-2 mg
every 6-8 hours, 6-12 years: 2 mg every 6-8 hours.
Indications: Uncomplicated premature labour, foetal asphyxia.
Contra-Indications: Threateaned abortion of 1st and 2nd trimester, antepartum
haemorrhage, cardiac disorders, haemorrhage, hypertension, eclampsia and pre-eclampsia,
cordcompression,intrauterine infection thyrotoxicosis, treatment with monoamine-oxidase
inhibitors, tricyclic anti-depressants, beta-adrenoceptor blocking drugs, antihypertensive.
Special Precautions: Diabetes mellitus, treatment with corticosteroids, anaesthetics,
potassium depleting diuretics, aminophylline, pulmonary oedema.
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4.3. Drugs for Urinary Retention / Anti-spasmodics
DUTASTERIDE
Dosage Form: Capsule 0.5 mg (I*)
Recommended Dose: Adult males (including elderly) 0.5 mg once daily.
Indications: Treatment & control of symptomatic benign prostatic hyperplasia (BPH) in men
w/ an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention &
the need for BPH-related surgery.
Contra-Indications: Severe hepatic impairment. Women, children.
Special Precautions: Mild to moderate hepatic impairment. Avoid donating blood until min
6 mth after last dose.
FINASTERIDE
Dosage Form: Tablet 5 mg (I*)
Recommended Dose: 5 mg daily.
Indications: Treatment & control of benign prostatic hyperplasia (BPH) to cause regression
of the enlarged prostate, improve urinary flow, & improve the symptoms associated w/ BPH.
Contra-Indications: Women or childn. Hypersensitivity. Pregnancy or women may
potentially be pregnant.
Special Precautions: Large residual urine vol &/or severely diminished urinary flow
(monitor for obstructive uropathy); Prostate cancer: digital rectal exam (& other evaluations
for prostate cancer) & serum prostate-specific antigen (PSA) level. Women should not
handle crushed or broken tab when they are or may potentially be pregnant. Lactation.
Urethral stricture, infection, cancer, hypotonic bladder & other neurogenic disorders should
be excluded before treatment w/ finasteride is started. Hepatic dysfunction.
OXYBUTYNIN HCL
Dosage Form: Tablet 5 mg (I)
Recommended Dose: Adult 5 mg bd-tds, or up to max of qds. Childn >5 yr 5 mg bd.
Indications: Urinary frequency, urgency and incontinence, neurogenic bladder instability
and nocturnal enuresis associated with overactive bladder.
Contraindications: Obstruction of bladder or bowel, intestinal atony, severe ulcerative
colitis, toxic megacolon, myasthenia gravis, glaucoma, lactation.
Special Precautions: Autonomic neuropathy, hepatic or renal disease, frail elderly.
Hyperthyroidism, coronary artery disease, congestive heart failure, cardiac arrhythmias,
tachycardia, prostatic pregnancy.
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PRAZOSIN HCL
Dosage Form: Tablet 1 mg, 2 mg (II)
Recommended Dose: Hypertension Initially 0.5 mg bd-tds. Adjust according to response
after
4-7
days.
Maintenance:
3-20
mg
daily
in
divided
doses.
Benign prostatic hyperplasia Initially0.5 mg bd for 3-7 days, then adjust according to clinical
response. Maintenance: 2 mg bd. This dose should not be exceeded. CHF 0.5 mg tdsqds. Maintenance: 4-20 mg in divided doses.
Indications: Hypertension, CHF, Benign prostatic hyperplasia
Contra-Indications: Left
ventricular
failure
due
to
mechanical
obstruction. Hypersensitivity. Childn <12 yr.
Special Precautions: Ischemic heart disease, pregnancy & lactation.
TOLTERODINE TARTRATE
Dosage Form: Tablet 2 mg, SR 4 mg (I)
Recommended Dose: 2 mg bd. In case of troublesome side-effects, the dose may be
reduced to 1 mg bd.
Contra-Indications: Urinary retention, uncontrolled narrow angle glaucoma, severe
ulcerative colitis, toxic megacolon, myasthenia gravis. Pregnancy, lactation.
Indications: Urinary frequency, urgency and incontinence, suppress of lactation,
acromegaly. As an adjunct to treatment by surgery or radiotherapy. Hypogonadism and
galactorrohoeasyndrome. Infertility. Cyclical benign breast disease and menstrual disorder
and Parkinson's disease.
Special Precautions: Significant bladder outlet obstruction at risk of urinary retention, GI
obstructive disorder eg pyloric stenosis, renal disease, hepatic disease, autonomic
neuropathy, hiatus hernia with reflux oesofagitis, hyperthyroidism, coronary artery
disease, prostatic hypertrophy, congestive heart failure, arrhythmias, tachycardia.
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4.4. Drugs Used in Urological Pain
4.4.1. Alkalinisation of Urine
POTASSIUM CITRATE
Dosage Form: Mixture [P] 3 gm/10 ml (II); Tablet 1080 mg (10 mEq) (I* - Medical)
Recommended Dose: Mixture: Cystitis: Adults and children over 6 years: 3g well diluted
with water tds. Children 1-6 years: half above dose. Alkalinisation of urine: 3-6 g with water
every 6 hours. Tablet: Hypocitraturia; mild: Initiate with 30meq/day severe: initiate with
50meq/day.
Indications: Mixture: Alkalinisation of urine, relief of discomfort in mild urinary tract
infections. Tablet: Management of tubular acidosis (RTA) with calcium stones.
Hypocitraturic Ca-oxalate nephrolithasis of any etiology and uric acid lithlasis with/without
Ca stones.
Contra-Indication: Hyperkalemia: patient with delay gastric emptying, esophageal
compression, intestinal obstruction or structure or those taking anticholinergic drugs; peptic
ulser, active UTI, renal insufficiency.
Special Precautions: Mixture: In renal impairment and cardiac disease. Tablet: Chronic
renal failure, severe myocardial damage or heart failure. Pregnancy and lactation.
POTASSIUM CITRATE + SODIUM CITRATE + CITRIC ACID (POLYCITRA)
Dosage form: Syrup [P] 11% + 11% + 6.67% (II)
Recommended dosage: Adults: 15-30 ml, Childn: 5-10 ml. Diluted with 1 glass of water
and taken after meal and at bedtime.
Indications: Used to correct acidosis of certain renal tubulardisorder, to treat metabolic
acidosis, for long term urine alkalinization, for prevention and treatment of uric acid and
calcium kidney stones and as nonparticulate neutralizing buffer.
Contra-Indications: Severe renal impairment with oliguria, azotemia or anuria, acute
dehydration, severe myocardial damage, Sodium citrate for patients on sodium restricted
diets/hyperkalaemia,Potassium citrate in patients with peptic ulcer, impaired potassium
excretion, taking potassium sparing diuretics and using salt substitutes
and adynamia apisodehereditaria.
Special Precautions: Sodium citrate in patients with CHD, HTN, pulmonary or peripheral
edema and toxemia of pregnancy. Potassium citrate in patients with decreased urinary
output, especially in the presence of hypocalcemia. Concurrent administration with
aluminium based gels. Concurrent administration of potassium containing medications,
potassium-sparing diuretics, angiotensin-converting enzyme (ACE) Inhibitor or cardiac
glycosides.
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SODIUM BICARBONATE 8.4%
Dosage Form: Injection 1 mmol/ ml (10 ml, 50 ml) (II)
Recommended Dose: 3 g in water every 2 hours until urinary pH >7; maintenance of
alkaline urine 5-10 g daily.
Indications: relief of discomfort in mild urinary tract infections; alkalinisation of urine.
Contra-Indications: Respiratory alkalosis, Hypocalcemia, Hypochloremia, Do not use
Neutralizing Additive Solution 4.2% (LyphoMed) as a systemic alkalinizer
Special Precautions: hepatic impairment, renal impairment, cardiac disease, pregnancy;
patients on sodium-restricted diet; elderly; avoid prolonged use
SODIUM CITRATE + CITRIC ACID
Dosage Form: Syrup [P] 1.5 gm + 0.25 gm in 5 ml (II)
Recommended Dose: 10-15 tds diluted in a glass of water for maximum of 3 days.
Indications: Relief of discomfort in mild UTI
Special Precautions: Renal impairment, cardiac disease, pregnancy, patients in sodium
restricted diet and elderly.
4.4.2. Acidification of Urine
ASCORBIC ACID
Dosage Form: Tablet 50 mg, 100 mg (II)
Recommended Dose: 4-12 g daily in divided doses.
Indications: Acidification of urine.
Special Precautions: Hyperoxaluria, the formation of renal calcium oxalate calculi and
ascorbic acid.
4.4.3. Irrigation Solutions
AMINO ACETIC ACID (GLYCINE)
Dosage Form: Solution 1.5% (Irrigation 3 L) (I)
Recommended Dose: Used as irrigating solution. Dosage depends on capacity or surface
area and nature of the procedure.
Indications: Irrigating fluid in transurethral prostatic resection & other surgical procedures,
urologic irrigation during electrosurgery.
Contra-Indications: Anuric patients.
Special Precautions: Avoid freezing. Should not be heated to temperature >66 Celsius.
Store at 40 Celsius or less. Systemic absorption may result in fluid and electrolytes
disturbances.
SODIUM CHLORIDE
Dosage Form: Solution 0.9% (Bladder irrigation 500 ml, 1L, 3L) (II)
Recommended Dose: Used as irrigating solution. Dosage depends on capacity or surface
area and nature of the procedure.
Indications: Mechanical irrigation
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SODIUM CITRATE
Dosage Form: Solution 3.8% (Irrigation 3 L) (II)
Recommended Dose: Used as bladder washout.
Indications: As bladder irrigation to dissolve blood clot.
Special Precautions: Renal impairment, cardiac disease, pregnancy, patients in sodium
restricted diet and elderly.
WATER FOR IRRIGATION
Dosage Form: Irrigation solution 500 ml (II)
Recommended Dose: Used as irrigating solution. Dosage depends on capacity or surface
area and nature of the procedure.
Indications: Bladder irrigation
4.4.4. Urinary Tract Infection
NITROFURANTOIN
Dosage Form: Tablet 100 mg (I)
Recommended Dose: 50-100 mg every 6 hours taken with or immediately after food or at
bedtime with food or milk. Continued up to 14 days. For prophylaxis: 50-100 mg at bedtime.
Not recommended for infants under 1 month. Children: over 3 months; 1.25-1.75 mg/kg qid.
Reduce dose if continue beyond 10-14 days, 1 mg/kg at night if used for prophylaxis.
Indications: UTI
Contra-Indications: Infants under one month of age, G6PD deficiency patient, impaired
renal function.
Special Precautions: Should be avoided in 1st trimester of pregnancy, may produce a
brown discolouration in urine and ineffective in alkaline urine. Check the patients for early
sign of polyneuritis and changes in pulmonary function. Electrolyte imbalance,
hepatic impairment (long therapy), false positive urinary glucose.
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4.5. Vaginal and Vulval Preparations
4.5.1. Topical Hormones
OESTROGEN CONJUGATED (PREMARIN)
Dosage Form: Tablet 0.3 mg, 0.625 mg; Cream 0.625 mg/gm (Vaginal) (I)
Recommended Dose: Tablet: The lowest effective dose administered. Vasomotor
symptoms, atrophic vaginitis & atrophic urethritis associated w/ oestrogen deficiency
Usual dosage range: 0.3-1.25 mg daily. Osteoporosis 0.625 mg daily. Female
hypoestrogenism 0.3-1.25 mg daily, adjusted depending on severity of symptoms &
endometrial responsiveness.Vaginal Cream: Intravag or topically 2-4 g daily depending on
severity of condition. Cyclic administration (3 wks on & 1 wk off) should be used.
Indications: Tablet: Moderate to severe vasomotor symptoms associated w/ oestrogen
deficiency, prevention & management of osteoporosis associated w/ oestrogen deficiency,
atrophic vaginitis & atrophic urethritis, female hypoestrogenism. Vaginal cream: Atrophic
vaginitis, dyspareunia & kraurosis vulvae.
Contra-Indications: Tablet & Vaginal Cream: Known or suspected estrogen-dependent
neoplasia. Active thrombophlebitis/thromboembolic disorders, known or suspected breast
cancer. Undiagnosed abnormal genital bleeding; pregnancy. Active or recent
arterial thromboembolic disease.
Special Precautions: Tablet: Cardiac/renal dysfunction, increased BP, history
of thromboembolic disease, epilepsy, migraine, asthma, gallbladder disease, liver disorders,
pancreatitis, risk of endometrial hyperplasia or cancer, breast or ovarian cancer, increase in
size of pre-existing uterine leiomyomata, vag bleeding, metabolic bone disease associated
w/hypercalcemia, surgery & lactation. Fluid retention, retinal vascular thrombosis, venous
thromboembolism, hypertriglyceridemia, hepatic impairment, history of cholestatic jaundice,
elevated BP, epilepsy, migraine, porphyria, asthma, diabetes mellitus, hypocalcemia,
hypothyroidism. Pregnancy & lactation. Premarin is not a contraceptive. Pre-treatment
physical exam advised. Vaginal Cream: Systemic absorption may occur. Warnings &
precautions associated w/ oral Premarin should be considered.
4.5.2. Anti-Infectives
CLOTRIMAZOLE
Dosage Form: Pessary 100 mg (II)
Recommended Dose: Insert 2 tabs into the vagina daily for 3 days. Recurrent cases: 1 tab
daily for 6 days.
Indications: Candidal and trichomonal vaginitis.
Contra-Indications: Hypersentivity reactions.
Special Precautions: First trimester of pregnancy.
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METRONIDAZOLE
Dosage Form: Tablet 200 mg; Suspension 200 mg/5 ml (II)
Recommended Dose: 200-250 mfg tds for 7-10 days after food, 2nd course may be given
for 7 days after an interval of 4-6 weeks. Children up to 3 years: 50 mg/kg/daily in 3 divided
doses for 7 to 10 days.
Indications: Bacterial vaginosis. Vulval and vaginal candidiasis.
Contra-Indications: Hypersensitivity reactions, 1st trimester with trichomoniasis.
Special Precautions: Dose should be reduced in patients with severe hepatic impairment.
NYSTATIN
Dosage Form: Pessary 100,000 units. (II)
Recommended Dose: insert 1-2 pessaries into vaginal at night for at least 14 nights.
Indications: Vulval and vaginal candidiasis.
4.6. Oral Contraceptives
LEVONORGESTREL + ETHINYLOESTRADIOL
Dosage Form: Tablet 150 mcg + 30 mcg (21 tablets) (II)
Recommended Dose: 1 tablet daily from 5-25th day of menstrual cycle. Then tablet free
interval of 7 days before starting subsequent therapy.
Indications: Oral contraception endometriosis, dyemenorrhoea, and cycle disturbances
without organic cause.
Contra-Indications: Pregnancy. severe disturbances of liver function, jaundice, DubinJohnson syndrome, Rotor syndrome, thromboembolism, sickle cell anaemia, cancer of
breast andendometrium, severe diabetes, disturbances of lipid metabolism.
Special Precautions: Diabetes, hypotension, varicose veins, porphyria otosclerosis,
multiple scelrosis, epilepsy, tetany, chorea minor, women with tendency to diabetes or
history of phlebitis, heavy smoking, increasing age, and use of combines oral
contraceptives. Interact with hydantoins, barbiturates, rifampicin, phenylbutazone, ampicillin.
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MEDROXYPROGESTERONE ACETATE
Dosage Form: Tablet: 5 mg, Injection 150 mg/3 ml (I)
Recommended Dose: Tablet: Secondary amenorrhoea 5-10 mg daily for 5-10 days. To
produce optimum secretory transformation 10 mg daily for 10 days. Abnormal uterine
bleeding due to hormonal imbalance 5-10 mg daily for 5-10 days on day 16 or 21 of
menstrual cycle. Optimum secretory transformation 10 mg daily for 10 days from day 16.
Injection: 150 mg at beginning of cycle or early puerperium, effective for 3 months, or 300450 every 6 months.
Indications: Tablet: Secondary amenorrhoea, Abnormal uterine bleeding due to hormonal
imbalance. Injection: Long acting contraceptive, endometriosis.
Contra-Indications: Tablet: Thrombophlebitis, thromboembolic disorders, cerebral
apoplexy; liver dysfunction or disease; known or suspected malignancy of breast or genital
organs; undiagnosed vag bleeding; pregnancy, missed abortion. Injection: Pregnancy,
thromphlebitis, liver dysfunction, missed or incomplete abortion, undiagnosed vaginal
bleeding, and breast pathology.
Special Precautions: Epilepsy, migraine, asthma, cardiac or renal dysfunction; history of
mental depression; diabetes.
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5. GASTROINTESTINAL PRODUCTS
5.1. Antacids
ALUMINIUM HYDROXIDE GEL
Dosage Form: Tablet 600 mg (Dried gel) (II)
Recommended Dose: 1 tablets qid and at bedtime. Children: not recommended for antacid
therapy.
Indications: Hyperacidity, phosphate binding in renal dysfunction. Uncomplicated peptic
ulcer.
Contra-Indications: Hypophosphatemia, porphyria
MAGNESIUM CARBONATE
Dosage Form: Mixture (aromatic) [P] (II)
Recommended Dose: 10 ml 3 times daily in water
Indications: Dyspepsia
Contra-Indications: Hypophosphataemia
Special Precautions: Renal impairment
MAGNESIUM TRISILICATE CPD.
Dosage Form: Tablet; Mixture (II)
Recommended Dose: 1-2 tablet chewed after meals or PRN . Children over 6 years: Half
adult dose. Not recommended for children under 6 years. Mixture: 10-20 mls PRN / 3 times
daily.
Indications: Hyperacidity, dyspepsia, peptic ulcer condition.
Contra-Indications: Should be given with caution in renal insufficiency.
Special Precautions: May alter absorption of other drugs, therefore antacids, tetracyclines
or iron salts should be given 1-2 hours apart. At high dosage, magnesium salts not only
cause diarrhoea but also possible CNS depression.
5.2. Antidiarrhoeals
DIPHENOXYLATE HYDROCHLORIDE + ATROPINE SULPHATE
Dosage Form: Tablet 2.5 mg + 25 mcg (II)
Recommended Dose: 2 tablets tds-qid. Children 2-5 years: 2 mg tds, 5-8 years: 2 mg qid,
8-12 years: 2 mg qid.
Indications: As an adjunctive therapy to proper rehydration in acute and chronic diarrhoea,
after colostomy or ileostomy for control of stool formation and for relief of symptoms in
ulcerative colitis.
Contra-Indications: Intestinal obstruction, diarrhoea associated with pseudomembraneous
enterocolitis which may follow treatment with certain antibiotics.
Special Precautions: In patients with liver disease and those receiving narcotic or sedative
drugs. Not recommended for use in children under 2 years old.
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KAOLIN INFANT MIXTURE BPC 73 (KAOPECTATE)
Dosage Form: Mixture [P] (II)
Recommended Dose: Up to 1 year- 5 mls , 1-5 years- 10 mls every 3-4 hours as required.
Indications: Diarrhoea.
Special Precautions: Mixture should not be used for longer than a few days without
medical advice.
KAOLIN MIXTURE (ADULT)
Dosage Form: Mixture [P] (II)
Recommended Dose: 10 - 20 mls after each loose stool.
Indications: Diarrhoea.
Special Precautions: Mixture should not be used for longer than a few days without
medical advice.
LOPERAMIDE HCL
Dosage Form: Capsule 2 mg (II)
Recommended Dose: Acute diarrhoea, 4 mg initially followed by 2 mg after each loose
stool for up to 5 days. Usual dose 6 – 8mg daily. maximum 16 g daily. Children under 4
years not recommended, 4 – 8 years 1mg 3 – 4 times daily for up to 3 days only, 9 – 12
years 2mg 4 times daily for up to 5 days. Chronic diarrhoea in adults, initially 4 – 8mg daily
in divided doses. Subsequently adjusted according to response and given in 2 divided
doses for maintenance; max 16mg daily.
Indications: Diverticular disease, infective diarrhoea.
Special Precautions: Discontinue if improvement not apparent in 48 hours. Pregnancy,
lactation, young children. In treating inflammatory bowel disease patient, observe carefully
for signs of toxic megacolon.
5.3. Antispasmodics/Anticholinergics/Anti- flatulants
ATROPINE SULPHATE
Dosage Form: Injection 1 mg/ml (II)
Recommended Dose: Recommended dose for spastic conditions of the gastrointestinal
tract ranges from 0.3 milligram to 1.2 milligrams every 4 to 6 hours, subcutaneously,
intramuscularly or intravenously. The usual dosage is 0.4 to 0.6 milligram every 4 to 6 hours
if needed
Indications: Pylorospasm, hypertrophis, non-ulcerative dyspepsia, irritable bowel
syndrome.
Contra-Indications: Glaucoma (acute angle closure) GI tract obstruction.
Special Precautions: Elderly, fever, urinary retetnion, prostatic enlargement. tarchycardia,
cardiac insufficiency, paralytic ileus, thyrotoxicosis.
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CHARCOAL ACTIVATED
Dosage Form: Tablet 250 mg (II)
Recommended Dose: 2-3 tablets several times daily.
Indications: Absorb gases in the treatment of flatulence and intestinal distension,
diarrhoea.
Special Precautions: Causes black discolouration of faeces. Should not be given with
emetics.
HYOSCINE-N-BUTYLBROMIDE
Dosage Form: Tablet 10 mg; Syrup 1 mg/ml; Injection 20 mg/ml (II).
Recommended Dose: Orally (adults)-20 mg tds - qid.; (children)-10 mg tds, Injection
(adults)-20 mg IM or slow IV tds - qid; (Infants/child)- 5 mg tds.
Indications: Gastrointestinal spasm and pylorospasm in infants, spasmodic
dysmenorrhoea, biliary spastic constipation and spasm of the urinary tract.
Contra-Indications: Glaucoma, hypertrophy of the prostate, functional stenosis in the
region of gastrointestinal tract, tachycardia.
Special Precautions: Caution in thyrotoxicosis, cardiac insufficiency or failure, and in
cardiac surgery.
MEBEVERINE HCL
Dosage Form: Tab 135 mg (I)
Recommended Dose: Adult & Children >10yrs; 135 mg tds taken 20 minutes before meal.
The dosage may be reduced gradually after a few week of treatment, if the desired effect
has been achieved.
Indications: Gastrointestinal spasm secondary to organic diseases, irritable bowel
syndrome.
Contra-Indications: Bowel obstruction, paralytic ileus, intestine atony, pyloric obstruction,
urinary tract obstructive uropathy/genitourinary and tachicardia.
Special Precautions: Pregnancy, lactation, hepatic impairment, renal impairment, cardiac
disorder.
SIMETHICONE (DIMETHY POLYSILOXANE)
Dosage Form: Syrup 40 mg/ml; Drops 40 mg/ml (I)
Recommended Dose: Adult: 10 mls qid. Children above 6 months: 1 ml diluted with equal
volume of water for 2-3 days before meals to establish tolerance. If satisfactory, increase to
2-5 ml 6 times per day. Up to 4 years: 5 mls qid. 4-12 years: 5-10 mls qid.
Indications: Infant colic, gastrointestinal spasm, flatulence and discomfort due to entrapped
gas.
Contra-Indications: Children <6 months of age.
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5.4. Antiulcerants
CIMETIDINE
Dosage Form: Tablet 400 mg (II)
Recommended Dose: 400 mg bd (with breakfast and at night) or 800 mg at night (benign
gastric and duodenal ulceration) for at least 4 weeks (6 weeks in gastric ulceration, 8 weeks
in NSAIDs – associate ulceration); when necessary dose may be increased to 400 mg qid or
rarely (as in stress ulceration) to max 2.4 g daily in divided doses; INFANT under 1 year
20mg/kg OD in divided doses has been used.Children over 1 year 25-30 mg/kg daily in
divided doses. Maintenance, 400mg ON or 400mg OM and ON. Reflux oesophagitis 400 mg
4 times daily for 4 – 8 weeks. Zollinger-Ellison syndrome : 400 mg qid.Gastric acid reduction
( prophylaxis of acid aspiration; do not use syrup), obstetrics 400mg at start of labour , then
up to 400mg every 4 hours if required ( max of 2.4g OD); surgical procedures 400mg 90 –
120 min before induction of general anaesthasia. Short bowel syndrome, 400mg BD
adjusted accrding to response. To reduce degradation of pancreatic enzyme su[pplements,
0.8 – 1.6 g daily in 4 divided dose according to response 1 hours before meals. By IM or
slow IV injection: 200 mg every 4-6 hours up to maximum of 2 g daily. By IV infusion: 100150 mg/hr (or 2mg/kg/hour) for 2 hours repeated after an interval of 4-6 hours or by
continous infusion up to 75 mg/hr over 24 hours, max 2.4 g daily. Children: by slow IV
injection/infusion- 20-30 mg/kg daily in divided doses.
Indications: Benign gastric and duodenal ulcer, post-operative ulcer, reflex Oesophagitis,
Zollinger-Ellison syndrome. Other conditions where reduction of gastric acidity is beneficial.
Contra-Indications: Hypersensitivity to Cimetidine
Special Precautions: Reduce dose in impaired renal and hepatic function, IV injections
should be given slowly. Caution in concurrent administration with warfarin, benzodiazepines.
May induce early recurrence of duodenal or gastric ulcer on discontinuation of the drug.
Pseudohypoparathyroidism increases sensitivity to neurotoxic effects of Cimetidine skin
tests (supress response to immediate skin tests).
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ESOMEPRAZOLE
Dosage Form: Tablet 40 mg; Injection 40 mg (II)
Criteria of use: Follow the Protocol For Management of Acute Bleeding, Protocol for
Management of Chronic Bleeding and Prophylaxis Against Stress Ulcer
Recommended Dose: By mouth duodenal ulcer associated with Helicobacter pylori, Oral,
20 mg twice daily for 1 week, with 2 antibiotics; NSAID-associated gastric ulcer, 20 mg once
daily for 4–8 weeks; prophylaxis in patients with an increased risk of gastroduodenal
complications who require continued NSAID treatment, 20 mg daily; Gastro-oesophageal
reflux disease, 40 mg once daily for 4 weeks, continued for further 4 weeks if not fully
healed or symptoms persist; maintenance 20 mg daily; symptomatic treatment in the
absence of oesophagitis, 20 mg daily for up to 4 weeks, then 20 mg daily when required;
child not recommended
By intravenous injection over at least 3 minutes or by intravenous infusion, gastrooesophageal reflux disease, 40 mg once daily; symptomatic reflux disease without
oesophagitis, treatment of NSAID-associated gastric ulcer, prevention of NSAID-associated
gastric or duodenal ulcer, 20 mg daily; continue until oral administration possible; child not
recommended
Indications: see under Dose
Contra-Indications: No known contraindications.
Special Precautions: liver disease, pregnancy, breast-feeding, Gastric carcinoma—
exclude before starting treatment for gastric ulcers; PPIs may mask symptoms and delay
diagnosis, renal impairment
LANSOPRAZOLE
Dosage Form: Capsule 30 mg (II)
Criteria of use: Follow the Protocol For Management of Acute Bleeding, Protocol For
Management of Chronic Bleeding and Prophylaxis Against Stress Ulcer
Recommended Dose: Benign gastric ulcer, 30 mg daily in the morning for 8 weeks;
Duodenal ulcer, 30 mg daily in the morning for 4 weeks; maintenance 15 mg daily; NSAIDassociated duodenal or gastric ulcer, 15–30 mg once daily for 4 weeks, continued for further
4 weeks if not fully healed; prophylaxis, 15–30 mg once daily; Eradication of Helicobacter
pylori associated with duodenal ulcer or ulcer-like dyspepsia, 30 mg twice daily for 1 week,
with 2 antibiotics; Zollinger-Ellison syndrome (and other hypersecretory conditions), initially
60 mg once daily adjusted according to response; daily doses of 120 mg or more given in
two divided doses; Gastro-oesophageal reflux disease, 30 mg daily in the morning for 4
weeks, continued for further 4 weeks if not fully healed; maintenance 15–30 mg daily; Acidrelated dyspepsia, 15–30 mg daily in the morning for 2–4 weeks; child under 18 years not
recommended
Indications: see under Dose
Contra-Indications: No known contrindications.
Special Precautions: liver disease, pregnancy, breast-feeding, Gastric carcinoma—
exclude before starting treatment for gastric ulcers; PPIs may mask symptoms and delay
diagnosis.
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OMEPRAZOLE
Dosage Form: Tablet 20 mg (II)
Recommended Dose: 20 mg daily for 4 weeks in duodenal ulceration or 8 weeks in gastric
ulceration. Zollinger-Ellison syndrome: Initially 60 mg once daily, usual range 20-120 mg
daily. Reflux Oesophagitis: 20 mg daily for 4 weeks followed by a further 4-8 weeks if not
fully healed. 40 mg daily has been given for 8 weeks in reflus oesophagitis refractory to
other treatment may be continued at 20 mg daily.
Indications: Benign gastric and duodenal ulcers. Zollinger-Ellison syndrome, Reflux
oesophagitis.
Contra-Indications: No known contrindications.
Special Precautions: When gastric ulcer is suspected, the possibility of malignancy should
be excluded before treatment with omeprazole is instituted, as treatment may alleviate
symptoms and delay diagnosis.
PANTOPRAZOLE
Dosage Form: Tablet 40 mg; Injection 40 mg/vial (I)
Recommended Dose: Tablet; Symptomatic treatment of mild reflux oesphagitis 20 mg daily
for 4-8 wk. Long-term management & prevention of relapse of reflux oesophagitis 20 mg
daily, may increase to 40 mg/day. Reduce to 20 mg daily once relapse is controlled.
Treatment duration: 1 yr. Eradication of H pylori in gastric or duodenal ulcers 40 mg bd w/
combination of 1000 mg amoxicillin bd & 500 mg clarithromycin bd or 500 mg metronidazole
bd & 500 mg clarithromycin bd or 1000 mg amoxicillin bd & 500 mg metronidazole bd.
Duodenal ulcer, gastric ulcer, reflux oesophagitis 40 mg daily. Max: 80 mg daily for 2 wk.
May be prolonged to 4 wk (duodenal ulcer) or 8 wk (gastric ulcer, reflux oesophagitis). Vial;
If oral therapy is inappropriate, use 1 vial IV daily.
Indications: see under Dose
Contra-Indications: Pregnancy, lactation. Combination therapy for eradication of H pylori in
patients w/ moderate to severe hepatic or renal impairment.
Special Precautions: Exclude gastric & oesophageal malignancy. Childn. Severe liver
impairment.
RANITIDINE
Dosage Form: Tablet 150 mg; Injection 50 mg/2 ml (II)
Recommended Dose: 150 mg bd for 4 weeks in benign gastric ulcer and duodenal ulcer up
to 8 weeks. Reflux Oesophagitis: 150 mg tds and increase if necessary to 6 g daily in
Zollinger-Ellison syndrome. Maintenance: 150 mg at bedtime. By slow IV injection: 50 mg
repeated every 6-8 hours. By IV infusion: 25mg/hr for 2 hours repeated every 6-8 hours.
Indications: See Cimetidine.
Contra-Indications: Hypersensitivity to Ranitidine.
Special Precautions: Reduce dose in impaired renal function and hepatic insufficiency.
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SUCRALFATE
Dosage Form: Tablet 1 gm (I* - Medical, Surgical, ICU)
Criteria of use: For treatment and prevention of stress ulcer
Recommended Dose: Adult; Duodenal ulcer Acute: 1g qid or 2g bd on an empty stomach,
1 hour before meal & at bedtime. Maintenance: 1g qid. Treatment should be continued for a
max of 8-12wk unless healing has been demonstrated. Gastric ulcer 1g qid for 6 wk. May
require a further 6 wk for large gastric ulcers. Prophylaxis of duodenal ulcer recurrence 1g
bd for up to 1 yr.
Indications: Sucralfate is an oral anti-ulcer agent which acts by forming a protective barrier
over the ulcer site, thus promoting ulcer healing. Part of the activity of sucralfate may be
related to enhance mucosal defence or cytoprotection.
Contra-Indications: There are no known contra indications for sucralfate.
Special Precautions: a) Symptomatic response to sucralfate does not preclude the
possibility of gastric malignancy. b) Chronic failure and dialysis patients, increased risk of
aluminium accumulation and toxicity.
5.5. Inflammatory Bowel Disease Drugs
MESALAZINE
Dosage Form: Tablet 500 mg (II)
Recommended Dose: 6 tablets daily in divided doses. Maintenance dose: 3-6 tablets daily
individed doses. Children: Not recommended.
Indications: Treatment of mild to moderate ulcerative colitis and maintenance remission.
Contra-Indications: Severe hepatic impairment, blood clotting abnormalities,
hypersensitivity to salicylates and moderate renal impairment.
Special Precautions: Pregnancy, breast-feeding and elderly patients.
SULPHASALAZINE
Dosage Form: Tablet 500 mg (enteric coated) (II)
Recommended Dose: Acute attack: 1-2 g qid daily up to 12 g until remission occurs.
Maintenance dose: 500 mg qid. Children over 2 years, acute attack 40-60 mg/kg daily.
Maintenance: 20-30 mg/kg daily.
Indications: Maintenance therapy in ulcerative colitis and colonic Crohn's disease;
rheumatoid arthritis.
Contra-Indications: Hypersensitivity to Sulphonamides and Salicylates, late pregnancy,
premature and newborn babies, porphyria, Intestinal tract obstruction.
Special Precautions: Maintain adequate fluid intake to prevent crystalluria. Patients with
G6PD deficiency, hepatic and renal disease.
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5.6. Haemorrhoidal Agents, Phlebitis and Varicose Preparations
ANUSOL (ZINC OXIDE + PERUVIAN BALSAM + BENZYL BENZOATE)
Dosage Form: Suppository 300 mg + 50 mg+ 33 mg (II)
Recommended Dose: Supp Insert morning & night after each bowel movement.
Indications: Uncomplicated haemorrhoids, simple anorectal inflammation & irritations
caused by, or associated w/ proctitis or cryptitis. May be used pre- & post- op in
haemorrhoidectomy & repair of anal fistula as well as after incision of thrombosed or
sclerosed anorectal veins.
DIOSMINE
Dosage Form: Tablet 500 mg (I)
Recommended Dose: Chronic Venous Insufficiency - 2 tablet daily. Acute Haemorhhoid
Attacks - 6 tablet for the first 4 days, then 4 tabs/day for 3 days, 2 tabs thereafter. Chronic
Haemorrhoids - 2 tabs daily.
Indications: Organic and functional chronic venous insufficiency of the lower limbs; heavy
legs, pain, nocturnal cramps. Haemorrhoidal disease, acute haemorrhoidal attacks.
Special Precautions: Lactation.
SODIUM TETRADECYL SULPHATE
Dosage Form: Injection 3% in 1 ml ampule (I)
Recommended Dose: 0.5-2 ml by IV injection at up to 4 sites.
Indications: Sclerotherapy of varicose veins.
Contra-Indications: Inability to walk, acute phlebitis, oral contraceptivae use, obese legs,
thrombosis of deep veins of legs.
Special Precautions: Extravasation may cause necrosis of tissues.
XYLOPROCT (LIDOCAINE + HYDROCORTISONE ACETATE + ALUMINIUM ACETATE +
ZINC OXIDE)
Dosage Form: Suppository (60 mg + 5 mg + 50 mg + 400 mg) (I)
Recommended Dose: Intrarectal use: Supp Insert 1 supp morning & night after each
defecation. If defecation is painful, insert a few mins before. Max: 5/day.
Indications: for the treatment of proctitis or internal haemorrhoids.
Special Precautions: Monitoring should be considered w/ amiodarone. Debilitated or
elderly & childn < 12 yr; allergy to amide-type anesth; traumatised mucosa or sepsis in
anorectal region.
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5.7. Laxative
BISACODYL
Dosage Form: Tablet 5 mg; Suppository 10 mg, 5 mg (Paediatric) (II)
Recommended Dose: 5-10 mg after melas at night. Avoid taking with milk or antacids. One
suppository inserted 20-60 minutes before evacuation is required. Before radiological
procedures: 10 mg orally at bedtime for 2 days before examination & one suppository 1 hour
before examination. Children: Up to 10 years: One 5 mg suppository inserted 20-60 minutes
before evacuation is required.
Indications: Constipation, pre and post-operative evacuation, bowel evacuation before
radiological procedures and endoscopy.
Contra-Indications: Intestinal obstruction.
Special Precautions: Prolonged use should be avoided. may cause harmless pink
discolouration of urine.
ISPHAGHULA HUSK
Dosage Form: Powder 3.5 gm (I)
Recommended Dose: One teaspoonful (5ml) 1-3 times daily in 150 ml water. Children 6-12
years: 2.5-5ml.
Indications: Chronic constipation as bulk laxative.
Contra-Indications: Intestinal obstruction, colonic atony, faecal impaction.
Special Precautions: Ulcerative colitis. Maintain adequate fluid intkae to avoid intestinal
obstruction.
LACTULOSE
Dosage Form: Syrup 3.35 gm/5 ml (I)
Recommended Dose: Chronic constipation: 30 mls daily for 3 days. Maintenance dose: 20
mls daily,. Hepatic encephalopathy: 30-50 mls tds, subsequently adjusted to produce 2-3
soft stools daily. Doses should be taken with liquids or food.
Indications: Chronic constipation, hepatic encephalopathy.
Contra-Indications: Intestinal obstruction, cramps, amdominal pain of unknown aetiololgy,
nausea and vomiting.
Special Precautions: Prolonged use may result in serious loss of water and electrolytes.
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LIQUID PARAFFIN
Dosage Form: Liquid (II)
Recommended Dose: Adult; 7.5 – 15 ml, children, 3-6 yrs old; 2.5-5 ml, more than 6 years
old;5-10 ml. To be taken before bedtime.
Indications: Constipation and to promote regularity.
Contra-Indications: Intestinal obstruction, cramps, amdominal pain of unknown aetiololgy,
nausea and vomiting or other symptoms of acute appendicitis, acute hepatitis or late
pregnancy.
Special Precautions: Prolonged use may result in serious loss of water and eletrolyte,
muscular weakness and weight loss. Do not use products with potassium or Magnesium salt
or Phosphate in patients with renal dysfunction.
MONOBASIC SODIUM PHOSPHATE + DIBASIC SODIUM PHOSPHATE
Dosage Form: Solution 48% + 18% (Colclean, 90 ml); Enema 16% + 6% (66.6 ml
(Paediatric), 133 ml (Adult))
Recommended Dose:
Enema: Adult: 1 bottle (133 ml) administered rectally, children less than 2 yr, 66.6 ml.
Colclean:
Adults and children 12 years and older
20 to 45 ml* (4 to 9 teaspoons*)
Children 10 and 11 years
10 to 20 ml* (2 to 4 teaspoons*)
Children 5 to 9 years
5 to 10 ml* (1 to 2 teaspoons*)
Children under 5 years
DO NOT USE
*Do not use more than this amount in a 24-hour period.
Single Daily Dosage: Do not take more unless directed by a doctor.
Administration : Dilute recommended dose with at least one-half glass(4 fl. oz.) of cold water
or other clear liquid. Drink, then follow with at least two additional glasses (8 fl. oz. each) of
water or other clear liquid.
Indications: Relief constipation and as bowel evacuant for a variety of diagnostic, surgical
and therapeutic indications.
Contra-Indications: Congenital megacolon, imperforate anus, CHF or when nausea,
vomiting or abdominal pain is present
Special Precautions: Impaired renal function, heart disease or pre-existing electrolyte
disturbances or in patient on Ca-channel blockers, diuretics or other medications which may
affect electrolyte levels or where colostomy exist.
SODIUM ACID PHOSPHATE + DISODIUM PHOSPHATE + GLYCERIN
Dosage Form: Enema 7.69% + 3.175% + 25% (II)
Recommended Dose: Adult & Children: 1 tube to be administered rectally
Indications: For short-term relief of rectal constipation.
Special Precautions: For rectal use only
5.8. Mouth and Throat Preparations
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CHLORHEXIDINE MOUTHWASH
Dosage Form: Liquid 0.2 % (II)
Recommended Dose: Rinse mouth with 10 ml for 1 minute bd-tds. Can be diuted with 10
ml water if prefered.
Indications: Mouth ulcers, control of dental plague, post-periodental surgery, oral
conditions and other minor oral infections.
Contra-Indications: Hypersensitivity to chlorhexidine.
Special Precautions: Superficial discolourarion may occur and can be reduced by brushing
with conventional toothpaste before using the rinse.
CHOLINE SALICYLATE + CETALKONIUM CHLORIDE
Dosage Form: Dental Gel, 8.7% + 0.01% (II)
Recommended Dose: Apply to affected area every 3 hours.
Indications: Relief of pain and discomfort in mouth ulcers, cold sores, irritations of the
gums; infant teething disorders.
Contra-Indications: History of salicylate sensitivity; infants under 4 months.
Special Precautions: Aspirin preparation should not be given to infants concomitantly.
SALIVA REPLACEMENT SOLUTION
Dosage Form: Syrup [P] (I)
Recommended Dose: Apply locally to the lips when necessary.
Indications: For relief of dry mouth
SODIUM BICARBONATE
Dosage Form: Mouthwash [P] 2% (dilute from 8.4%) (II)
Recommended Dose: Rinse mouth with 10 ml for 1 minute bd-tds. Can be diuted with 10
ml water if prefered.
Indications: Mouth ulcers, control of dental plague, post-periodental surgery, oral
conditions and other minor oral infections.
Contra-Indications: Hypersensitivity to sodium bicarbonate.
TRIAMCINOLONE ACETONIDE
Dosage Form: Dental Paste 0.1 % in Orabase (I)
Recommended Dose: Apply a thin fils over lesions 2-3 times daily, preferably after meals
and at bedtime.
Indications: For oral and perioral lesions.
Contra-Indications: Herpetic lesions of known viral origin.
5.9. Bile and Liver Therapy
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BETAINE GLUCURONATE + DIETHANOLAMINE GLUCURONATE + NICOTINAMIDE
ASCORBATE (JETEPAR)
Dosage Form: Capsule 150 mg + 30 mg + 20 mg (I)
Recommended Dose: Cap 4-6 caps daily. Syr Adult & childn >12 yr 1-2 tsp, 6-12 yr 1 tsp,
3-6 yr ½ tsp. To be taken 3 times daily. Amp 1-2 x 10 mL IV or infusion daily.
Indications: Endogenous & exogenous intoxications, acute & chronic liver diseases,
hepatic cirrhosis, physical & mental overwork, fatty liver degeneration, alcoholism.
6. ANTIINFLAMMATORY/ANTIRHEUMATICS/ GOUT PREPARATIONS
6.1. Steroidal Antiinflammatory Agents
DEXAMETHASONE
Dosage Form: Injection 4 mg/2 ml (as phosphate) (II)
Recommended Dose: By IM/IV injection or infusion: Initially 0.5-20 mg. Children: 200-500
mcg/kg daily. Shock: by IV injection or infusion 2-6 mg/kg repeated if necessary after 2-6
hours. Cerebral oedema: IV injection 10 mg initially then 4 mg IM every 6 hours as required
for 2-10 days.
Indications: Adjunctive treatment of severe shock of haemorrhage, traumatic, surgical of
septic origin, cerebral oedema.
Contra-Indications: In systemic viral and fungal infections; peptic ulcer, psychosis,
congestive heart failure, chronic renal failure.
Special Precautions: In hypertension, epilepsy, elderly person. Long term treatment should
not be abruptly discontinued. Rapid, large doses of IV injection may cause cardiovascular
collapse.
HYDROCORTISONE
Dosage Form: Tablet 10 mg (II)
Recommended Dose: The initial dosage varies from 20 to 240 mg/day depending on the
disease being treated.
Indication: Replacement therapy in chronic adrenocortical insufficiency, salt-losing forms of
congenital adrenal hyperplasia syndromes, antiinflammatory agent.
Contra-Indications: See Dexamethasone
Special Precautions: See Dexamethasone
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METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form: Injection 0.5 gm/vial, 1 gm/vial (I)
Recommended Dose: By IM/slow IV injection or infusion: 10-40 mg repeated as required.
For IV injection, dissolve in approriate volume of dextrose, or/and in NaCl injection.
Children: Not less than 500 mcg/kg daily. BY deep IM injeection: 40-120 mg repeated every
2-3 week if required.
Indications: Suppression of inflammatory and allergic disorders; cerebral oedema
associated with malignancy, rheumatic disease, skin.
Contra-Indications: See Dexamethasone.
Special Precautions: See Dexamethasone.
METHYLPREDNISOLONE ACETATE
Dosage Form: Injection 0.2 gm/5 ml (I)
Recommended Dose: See Methyl Prednisolone Sodium Succinate.
Indications: See Methyl Prednisolone Sodium Succinate.
Contra-Indications: See Dexamethasone.
Special Precautions: See Dexamethasone.
PREDNISOLONE
Dosage Form: Tablet 5 mg; Syrup 2.5 mg/5 ml, 3 mg/5 ml (II)
Recommended Dose: Initially 20-40 mg daily or up to 60-80 mg if necessary for 4-5 days.
Maintenance dose: 5-20 mg daily. Children: Initially 2 mg/kg daily then gradually reduced.
Indications: Severe bronchial asthma and status asthmaticus, allergic and inflammatory
disorders, acute leukaemia, nephrotic syndrome and either corticosteroid indicated
conditions.
Contra-Indications: See Dexamethasone.
Special Precautions: See Dexamethasone.
6.2. Antirheumatics
D-PENICILLAMINE
Dosage Form: Capsule 250 mg (I)
Recommended Dose: Initially 125-250 mg daily. Increase at interval of 1-3 months to
maximum 1.5g/day. Maintenance: 500-750 mg daily. Children: Under 20 kg; 25 mg bd up to
150 mg tds. Over 20 kg; 50 mg bd uo to 200 mg tds, increased slowly over several weeks.
Indications: Severe rheumatoid arthritis not responsive to other anti-inflammatory agents.
Contra-Indications: In patients receiving gold therapy, antimalarial drugs, or other drugs
capable of causing blood disorders.
Special Precautions: In renal and hepatic impairment.
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HYDROXYCHLOROQUINE SULPHATE
Dosage Form: Tablet, 200 mg (I*)
Criteria of use: 1. Restricted for Skin Clinic and Medical Specialist Clinic 2. For Systemic
Lupus Erythematosus (SLE) cases only
Recommended Dose: Administered on expert advice, initially 400 mg daily in divided
doses; maintenance 200-400 mg daily; max. 6.5 mg/kg daily (but not exceeding 400 mg
daily), CHILD, the minimum effective doses should be employed and should not exceed 6.5
mg/kg daily (max. 400 mg daily).
Indications: Active rheumatoid arthritis (including juvenile idiopathic arthritis), systemic and
discoid lupus erythematosus; dermatological conditions caused or aggravated by sunlight.
Contra-Indications: Patients with preexisting maculopathy. Patients sensitive to 4aminoquinoline compounds.
Special Precautions: Used with caution in hepatic impairment and in renal impairment. All
patients should have an ophthalmological examination before treatment with
hydroxychloroquine is initiated. Thereafter, ophthalmological examination must be repeated
at least every 6 months. Used with caution in neurological disorders (especially in those with
a history of epilepsy), in severe gastro-intestinal disorders, in G6PD deficiency, in porphyria,
and in the elderly.
SEE ALSO NON-STEROIDAL ANTIINFLAMMATORY AGENTS
6.3. Anti-Gout Preparations
ALLOPURINOL
Dosage Form: Tablet 100 mg (II)
Recommended Dose: Initially 100 mg daily. Maintenance: 200-600 mg daily in divided
doses. Maximum of 800 mg daily. Children: 8mg/kg/day up to 20 mg/kg/day. Take with food.
Indications: Treatment of chronic gout, hyperuricaemia, uric acid nephropathy and
recurrent uric acid stone formation.
Contra-Indications: Acute gout attack. Nursing mothers.
Special Precautions: Reduce dose in renal and hepatic impairment. Pregnancy. Increase
fluid intake.
6.4. Non-Steroidal Antiinflammatory Agents
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ACETYLSALICYLIC ACID
Dosage Form: Tablet 300 mg (II)
Recommended Dose: 0.3–1 g every 4 hours after food; max. in acute conditions 8 g daily;
child, juvenile arthritis, up to 80 mg/kg daily in 5–6 divided doses after food, increased in
acute exacerbations to 130 mg/kg
Indications: Rheumatoid arthritis, plaelet aggregration (Transient ischaemic attacks,
secondary prevention of MI, prophylaxis against stroke, vascular occlusion & deep vein
thrombosis), myocardial infarction, mild to moderate pain, pyrexia.
Contra-Indications: Gastro-intestinal ulceration, haemophilia, concurretn anti-coagulants
therapy. Asthmatic patients.
Special Precautions: In impaired renal and hepatic function dehydration, pregnancy,
allergic disease, G6PD deficiency.
CELECOXIB
Dosage Form: Capsule 200 mg, 400 mg
Recommended Dose: Osteoarthritis: 200 mg per day administered as a single dose or as
100 mg twice daily. Rheumatoid arthritis: 100 to 200 mg twice daily. Familial adenomatous
polyposis (FAP): 400 mg twice daily.
Indications: Relief of signs and symptoms of osteoarthritis; relief of signs and symptoms of
rheumatoid arthritisin adults; reduce the number of adenomatous colorectal polyps in
familial adenomatous polyposis as adjunct to usual care.
Contra-Indications: Hypersensitivity to celecoxib or any component, sulfonamides, aspirin,
or other nonsteroidal anti-inflammatory drugs (NSAIDs)
Special Precautions: Gastrointestinal irritation, ulceration, bleeding, and perforation may
occur with NSAIDs. Patient with history of GI disease (bleeding or ulcers), decreased renal
function, hepatic disease, congestive heart failure, hypertension or asthma.
DICLOFENAC SODIUM
Dosage Form: Injection 75 mg/3 ml ampoule (II)
Recommended Dose: By deep IM injection: 75 mg daily.
Indications: Rheumatoid arthritis and other rheumatoid disorder, acute gout.
Contra-Indications: Peptic ulcer, asthma or other allergic reaction induced by NSAIDs.
Special Precautions: GI symptoms, severe hepatic or renal damage, pregnancy, bleeding
ETORICOXIB
Dosage Form: Tab 90 mg, 120 mg (I)
Criteria of use: Follow the Chronic Pain Management Protocol
Recommended Dose: Osteoarthritis, adult and adolescent over 16 years, 60 mg once daily
Rheumatoid arthritis, adult and adolescent over 16 years, 90 mg once daily; Acute gout,
adult and adolescent over 16 years, 120 mg once daily
Indications: pain and inflammation in osteoarthritis and in rheumatoid arthritis; acute gout
Contra-Indications: inflammatory bowel disease; uncontrolled hypertension
Special Precautions: monitor blood pressure; breast-feeding
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IBUPROFEN
Dosage Form: Tablet 200 mg (I)
Recommended Dose: 200-400 mg tds with food up to 2.4g daily. Children: 20mg/kg daily
in divided doses. Maximum: 500 mg for those weighing less than 30 kg.
Indications: Rheumatoid arthritis, osteoarthritis, acute gout and musculoskeletal disorders.
Dysmenorrhoea.
Contra-Indications: Pregnancy, children under 14 years, syndromes of nasal polyps,
angioedema, bronchospasm induced by aspirin or other NSAIDs.
Special Precautions: Patients with bleeding disorders, peptic ulceration and those
receiving coumarin and anti-coagulants and cardiovascular disease.
INDOMETHACIN
Dosage Form: Capsule 25 mg (II)
Recommended Dose: 25-50 mg bd or tds with food, up to 200 mg daily.
Indications: Treatment of rehumatoid arthritis, ankylosing spondylitis, osteoarthritis and
gout.
Contra-Indications: Peptic ulceration, salicylate hypersensitivity, pregnancy, lactation and
children under 14 years old.
Cari maklumat untuk injection
MEFENAMIC ACID
Dosage Form: Capsule 250 mg (II)
Recommended Dose: 500 mg tds after food. Children: Over 6 months; 6.5 mg/kg tds-qid
for maximum of 7 days.
Indications: Relief of pain in rheumatoid arthritis, Still;s disease and osteoarthritis.
Contra-Indications: Patients with ulceration or inflammation of gastro-intestinal tract.
Special Precautions: In impaired renal and hepatic function; epilepsy, bronchial asthma;
may enhance effects of coumarin anti-coagulants.
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MELOXICAM
Dosage Form: Tablet 7.5 mg (I)
Criteria of use: Follow the Chronic Pain Management Protocol
Recommended Dose: Osteoathritis, 7.5 mg daily with food, increased if necessary to
max.15 mg once daily. Rheumatoid athritis and ankylosing spondylitis 15 mg once daily with
food. (7.5 mg daily in elderly)
Indications: Pain and inflamation in rheumatic disease; exacerbation of osteoathritis (shortterm); ankylosing spondylitis.
Contra-Indications: Treatment of peri-operative pain in setting of coronary artery bypass
graft (CABG) surgery , hypersensitivity to meloxicam , patients who have experienced
asthma, urticaria, or allergic-type reactions after taking aspirin or other nonsteroidal antiinflammatory agents; severe, even fatal, anaphylactic-like reactions have been reported.
Special Precautions:
 Increased risk of serious cardiovascular thrombotic events, myocardial infarction, and
stroke; risk may increase with duration of use and in patients at risk for cardiovascular
disease
 Increased risk of serious gastrointestinal adverse events (bleeding, ulceration,
perforation of stomach or intestines) that can occur at any time and without warning;
higher risk in elderly or debilitated patients
 Asthma
 Avoid in late pregnancy; may cause premature closure of the ductus arteriosus
 Dehydration
 Elderly
 History of coagulation defects
 History of GI ulceration, bleeding or perforation
 History of liver dysfunction
 History of renal disease
 Hypertension, fluid retention, or CHF
 Preexisting anemia
NAPROXEN
Dosage Form: Tablet 250 mg (II)
Recommended Dose: Rheumatoid disorders: Initially 250 mg bd adjusted to 500 mg-1 g
daily in 2 divided doses. Acute gout: Initially 750 mg followed by 250 mg every 8 hours.
Children: Over 5 years; 10 mg/kg/day in 2 divided doses.
Indications: Treatment of rehumatoid arthritis, osteoarthritis and acute gout.
Contra-Indications: Syndromes of nasal polyps, angiodema, bronchospasm induced by
aspirin or other NSAIDs, pregnancy.
Special Precautions: Pre-existing ulcer disease or history of GI bleeding.
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PARECOXIB
Dosage Form: Injection 40 mg (I* - Anaesthesiologist)
Criteria of use: Restricted for ICU/ HDU and OT only
Recommended Dose: By deep intramuscular injection or by intravenous injection, initially
40 mg, then 20–40 mg every 6–12 hours when required; max. 80 mg daily; elderly weighing
less than 50 kg, initially 20 mg, then max. 40 mg daily; child and adolescent under 18 years,
not recommended
Indications: short-term management of acute postoperative pain
Contra-Indications: history of allergic drug reactions including sulphonamide
hypersensitivity; inflammatory bowel disease
Special Precautions: dehydration; following coronary artery bypass graft surgery.
PIROXICAM
Dosage Form: Tablet 10 mg (II)
Recommended Dose: 10-30 mg daily in single or in divided doses. Acute gout: Initially 40
mg then 40 mg daily for 4-6 days. Acute musculoskeletal disorder: 40 mg daily for 2 days
then 20 mg daily for 7-14 days. Children: Over 6 years: <15 : 5 mg daily. 16-25 kg: 10 mg
daily. 26-45 kg: 15 mg daily. >46 kg : 20 mg daily.
Indications: Rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, acute gout and
acute musculoskeletal disorders.
Special Precautions: Patietns with history of gastrointestinal haemorrhage or ulcers or
aspirin sensitivity.
6.5. Antiinflammatory Enzymes
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HYALURONIDASE
Dosage Form: Injection 1,500 units amp (I)
Recommended Dose: Adult: Parenteral Adjunct in hypodermoclysis 1,500 u for every 5001,000 mL of fluid for SC administration. Facilitate SC/IM inj 1,500 u added directly into the
inj. Aid in dispersal of extravasated fluids or blood 1,500 u into the affected area. Aid in
diffusion of local anesth in ophthalmology 15 u/mL of local anesth soln.
Indications: Enhance permeation of subcutaneous or intramuscular injection, local
anaesthetics and subcutaneous infusion; promote resorption of excess fluids and blood.
Contra-Indications: Hypersensitivity, malignancy. Direct application to the cornea,
reduction of swelling of bites or stings. Inj into or around infected area. IV admin;
unexplained premature labour.
Special Precautions: Impaired renal function. Infants, elderly. Patients with infections.
Pregnancy, lactation.
PAPAIN
Dosage Form: Tablet 150,000 units (II)
Recommended Dose: Suck or chew 2 tablets qid for the first day then 1 tablet qid for 5
days.
Indications: In conjunction w/ other physical or chemotherapeutic measures for treatment
of oedema & inflammation.
Contra-Indications: Blood clotting disease, generalised or systemic infections.
Concomitant therapy w/ anticoagulant.
Special Precautions: Pregnancy. Renal or hepatic disease.
PROLASE
Dosage Form: Tablet 10,000 units (II)
Recommended Dose: 2 tablets sucked or chewed every 4 hours for 1st day, then 1 tablet
every 4 hours for at least 5 days.
Indications: Treatment / prevention of oedema, inflammatory disorders and induced
trauma, in conjunction with other physical/chemothrapeutic measureas.
Contra-Indications: Concomitant use with anti-coagulants, blood clotting disorders.
Special Precautions: In pregnancy.
7. NUTRITION AND ELECTROLYTES
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7.1. Hypolipidaemic Products (Refer 9.9)
7.2. Ion Exchange Resins
CALCIUM POLYSTYRENE SULFONATE (KALIMATE)
Dosage Form: Powder (II)
Recommended Dose: By mouth, 15 g 3–4 times daily in water (not fruit squash which has
a high potassium content) or as a paste; child 0.5–1 g/kg daily in divided doses
Indications: Hyperkalaemia associated with anuria or severe oliguria, and in dialysis
patients
Contra-Indications: Obstructive bowel disease; oral administration or reduced gut motility
in neonates; avoid calcium-containing resin in hyperparathyroidism, multiple myeloma,
sarcoidosis, or metastatic carcinoma
Special Precautions: Children (impaction of resin with excessive dosage or inadequate
dilution); monitor for electrolyte disturbances (stop if plasma-potassium concentration below
5 mmol/litre); pregnancy and breast-feeding; sodium-containing resin in congestive heart
failure, hypertension, renal impairment, and oedema.
7.3. Vitamin Products
ALFACALCIDOL
Dosage Form: Capsule 0.25 mcg (II)
Recommended Dose: Cap Adult & children >20 kg body wt Initial dose: 1 mcg daily. Drops
Children <20 kg body wt 0.05 mcg/kg/day. Neonate 0.1 mcg/kg/day. Inj Adult Initial dose: 1
mcg/dialysis. May be adjusted according to response.
Indications: Diseases caused by disturbances in the Ca metabolism in consequence of
reduced endogenous production of 1,25-dihydroxyvit D3. Osteoporosis. Renal
osteodystrophy. Post-op or idiopathic hypoparathyroidism, pseudohypoparathyroidism. As
an adjunct to the management of tertiary hyperparathyroidism. Vit D-resistant rickets or
osteomalacia. Vit D-dependent rickets. Neonatal hypocalcemia or rickets. Malabsorption of
Ca. Malabsorptive & nutritional rickets & osteomalacia.
Contra-Indications: Hypercalcemia.
Special Precautions: Infants. Lactation.
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ASCORBIC ACID
Dosage Form: Tablet 50 mg, 100 mg (II)
Recommended Dose: Vitamin deficiency: 100-500mg/day IM or oral. Urine acidification: 312g/day in 4 divided doses. Prophylactic for paediatrics: 30-60 mg/day (age dependent).
Scurvy (Paediatrics): 100 mg 8 hourly for one week followed by 100 mg daily until
symptoms abate.
Indications: Prevention and treatment of scurvy methaemoglobinaemia deficiency states.
Urine acidifier.
Special Precautions: Hyperoxaluria. Incompatible with ferric salts, oxidizing agents and
salts of heavy metals esp. copper. Tolerance may be induced in high doses. Avoid rapid IV
injections in kidney stone disease. G6PD deficiency, haemochromatosis, thalassemia or
sideroblastic anemia.
CALCITRIOL
Dosage Form: Capsule 0.25 mcg (II)
Recommended Dose: 0.5-2 mcg daily. Hypocalcaemia undergoing hemodialysis: initially
0.25 mcg daily, may increase at 2-4 weeks interval by 250 mcg daily until response
obtained. Hypoparathyroidism: Adult and child > 1 yr: initially 0.25 ncg daily, increased at 24 weeks interval. Maintenance: 0.5-2 mcg daily.
Indications: Neonatal hypocalcaemia, hypoparathyroidism, pseudohypoparathyroidism,
vitamin D dependent rickets. Management of hypocalcaemia in chronic hemodialysis for
renal failure.
Contra-Indications: Hypercalcaemia, evidence of Vitamin D toxicity.
Special Precautions: Monitor plasma calcium in patients receiving high doses, especially
in patients on digitalis. Phosphate-binding drugs should be used concomitantly to prevent
elevations in serum phosphates. Magnesium-containing products.
CYANOCOBALAMIN (VITAMIN B12)
Dosage Form: Injection 1 mg/ml (1 ml, 10 ml) (II)
Recommended Dose: By intramuscular injection, initially 1 mg repeated 10 times at
intervals of 2–3 days, maintenance 1 mg every month.
Indications: Treatment for megaloblastic anaemias
ESSENTIAL PHOSPHOLIPID 175mg + VITAMINS B1 3mg, B2 3 mg, B6 3mg, B12 3
mcg + VITAMIN E 3.3mg + NICOTINAMIDE 15mg
Dosage Form: Capsule (I)
Recommended Dose: 1-2 softgel daily with meals.
Indications: Dietary supplement to help restore phosphatidyl choline level in the body &
support vital functions of the liver.
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FERRIC AMMONIUM CITRATE
Dosage Form: Mixture [P] 400 mg/5 ml (Padiatric) (II)
Recommended Dose: 10 ml tds. Child up to 1 year: 5 ml up to 4 times daily. 1-5 years: 10
ml up to 4 times daily. To be taken well diluted with water. (2-3 mg/kg/day elemental iron).
Indications: Treatment of prophylactic treatment of iron deficiency anemia.
Contra-Indications: Hemachromatosis, hemosiderosis and hemolytic anemia and all
anaemias other than iron deficiency. Peptic ulcer, regional enteritis, ulcerative colitis.
Special Precautions: Iron-absorption disease, haemoglobinopathies, existing gastro
intestinal disease. Straw should be used to prevent discoloration of teeth.
MECOBALAMINE
Dosage Form: Tablet 0.5 mg (II)
Recommended Dose: 0.5 mg three times daily
Indications: Peripheral neuropathies
Special Precautions: Discontinue if there is no response after several months.
MULTIVITAMIN
Dosage Form: Tablet; Syrup; Injection 10 ml (Parentrovite), Vial (Cernevit) (II)
Recommended Dose: 1-2 tabs daily. Child: 5 ml up to 4 times orally daily or as required. 1
vial added to not less than 500 ml of IV infusion solution. Child 3 kg-11 years: 5 ml daily, 13k g: 65% of vial, < than 1 kg: 30% of vial.
Indications: Deficiency states, maintenance in TPN and when IV route is required.
Special Precautions: MVI Paed formulation contains vitamin K. Protect from light. Should
be administered within 48 hours. MVI Paed should be added to not less than 100ml of
infusion fluid.
PYRIDOXINE HYDROCHLORIDE (VITAMIN B6)
Dosage Form: Tablet 10 mg (II)
Recommended Dose: Pyridoxine-dependent convulsions in infants: 4 mg/kg daily for short
periods. Sideroblastic anaemia: 150 mg daily in divided doses. Megaloblastic anaemia: 100200 mg daily. Prophylactic against peripheral neuritis in isoniazid therapy: 150 mg daily in
divided doses. Child: 25-50 mg daily. For treatment of nausea and vomiting in pregnancy,
irradiation sickness: 20-100 mg daily. Treatment of seizures and/or coma from acute
isoniazid toxicity, a dose of pyridoxine HCl equal to the amount of INH ingested can be
given I.M./I.V. in divided doses together with other anticonvulsants; if the amount INH
ingested is not known, administer 5 g IV pyridoxine. Treatment of acute hydralazine toxicity,
a pyridoxine dose of 25 mg/kg in divided doses IM/IV has been used.
Indications: Treatment of deficiency states, sideroblastic, adjunct to treatment of acute
toxicity from isoniazid, cycloserine, or hydralazine overdose and megaloblastic anaemia.
Special Precautions: Pyridoxine reduces the effects of levodopa, and incompatible with
alkaline solution, iron salts and oxidizing solutions.
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SOLUVIT (MIXTURE OF ALL WATER SOLUBLE VITAMIN)
Dosage Form: Injection (I)
Recommended Dose: For adult patients and children weighing 10 kg or more; one vial. For
children weighing less than 10 kg should be given 1/10 of the content of one vial per kg
body weight per day.
Indications: In adult patients and childrens as a supplement in intravenous nutrition to meet
the daily requirements of water soluble vitamins.
Contra-Indications: Known hypersensitivity to any of the components, eg. Thiamine or
methyl parahydroxybenzoate.
Special Precautions: Must not be given undiluted. Once diluted with water based solutions,
the admixture should be protected from light.
THIAMINE (VITAMIN B1)
Dosage Form: Tablet 100 mg; Injection 100 mg/ml (II)
Recommended Dose: Recommended Daily Allowance: <6 months - 0.3 mg, 6 months to 1
year – 0.4 mg, 1 to 3 yrs – 0.7 mg, 4 to 6 yrs – 0.9 mg, 7 to 10 yrs – 1 mg, 11 to 14 yrs –
(1.1 – 1.3 mg), >14 yrs – (1 – 1.5 mg). Thiamine deficiency (beriberi): Childn ~ 10-25
mg/dose IM or IV dly (if critically ill), or 10-50 mg/dose orally every day for 2 week, then 5-10
mg/dose orally dly for 1 month. Adults ~ 5-30 mg/dose IM or IV tds (if critically ill), then orally
5-30 mg/day in single or divided doses tds for 1 month. Wernicke’s encephalopathy: Adults
~ initial 100 mg IV, then 50-100 mg/day IM or IV until consuming a regular, balanced diet.
Dietary supplement (depends on caloric or carbohydrate content of the diet): Infants ~ 0.30.5 mg/day. Childn ~ 0.5-1.0 mg/day. Adults ~ 1-2 mg/day. Metabolic disorders (Oral):
Adults ~ 10-20 mg/day (dosages up to 4g/day in divided doses have been used).
Indications: Treatment of thiamine deficiency including beriberi, Wernicke’s
encephalopathy syndrome, and peripheral neuritis associated with pellagra, alcoholic
patients with altered sensorium; various genetic metabolic disorders.
Special Precautions: Use with caution with parenteral route (especially IV) of
administration.
VITALIPID N
Dosage Form: Injection 10 ml amp (Adult, Pead) (II)
Recommended Dose: One ampoule (10 ml) of vitalipid is added to 500ml intralipid 10% or
20%.
Indications: As a supplement in complete intravenous nutrition to meet daily requirements
of the fat-soluble vitamins A, D2, E and K1.
Special Precautions: Patients known to be allergic to soy or egg proteins should be given
Vitalipid with caution. Vitalipid should not be given undiluted.
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VITAMIN B COMPLEX
Dosage Form: Tablet; Injection 1 mg/ml (1 ml, 10 ml) (II)
Recommended Dose: 1-2 tab daily. By IM injection: 1-2 ml daily.
Indications: Deficiency states, for better appetite and normal growth, physiological stress.
VITAMIN B COMPLEX + FOLIC ACID (0.4-1 MG) + FERROUS FUMARATE (5-100 MG)
Dosage Form: Tablet (I*)
Recommended Dose: 1 tab daily. May be taken with meals for better absorption or if
gastrointestinal discomfort occurs.
Indications: Vitamin and mineral supplement for pregnant and lactating women.
VITAMIN B1 + B6 + B12
Dosage Form: Tablet (II)
Recommended Dose: 1 tab tds swallowed unchewed.
Indications: Deficiency states, polyneuritis, neuralgias and convalescence.
VITAMIN B2 (RIBOFLAVIN)
Dosage Form: Tablet 3 mg (II)
Recommended Dose: 1-2 tab daily
Indications: Pernicious and macrocytic anaemias, neuropathies.
Contra-Indications: Optic neuritis, neuropathies associated with raised cyanocobalamine.
7.4. Electrolytes and Minerals
BALANCE SALT
Dosage Form: Solution 250 ml, 500 ml (II)
Recommended Dose: Single dose unit.
Indications: For irrigation during various surgical procedures at the eyes.
Contra-Indications: Not for injection/intravenous infusion
Special Precautions: Discard any unused portion. Check the solution is clear before use.
BIOZINC
Dosage Form: Tablet 75 mg (Zinc amino acid chelate 75 mg + Elemental zinc 15 mg +
Ascorbic acid 250 mg) (II)
Recommended Dose: Adult: 1 tablet daily. Children (6-12 yrs): 1 tablet every other day
with food.
Indications: As a nutritional supplement
Contra-Indications: None known
Special Precautions: None known
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CALCIUM CARBONATE
Dosage Form: Tablet 250 mg, 500 mg (II)
Recommended Dose: According to the requirement of the patient.
Indications: Hyperphosphatemia and hyperacidity.
Contra-Indications: Hypercalcaemia, severe renal failure, renal calculi.
CALCIUM LACTATE
Dosage Form: Tablet 300 mg (II)
Recommended Dose: 1-5g in divided doses according to patients needs.
Indications: Calcium deficiency.
Contra-Indications: Hypercalcaemia, severe renal impairment.
Special Precautions: Impaired renal function, history of renal stones.
ORAL REHYDRATION SALTS
Dosage Form: Powder (II)
Recommended Dose: Dissolve contents in cool boiled water.
POTASSIUM CHLORIDE
Dosage Form: Tablet 600 mg; Mixture [P] 1 gm/10 ml; Injection 10% (1 gm/10 ml) amp
(13.4 mmol) (II)
Recommended Dose: 1 tablet tds or as required, after food, begin with 40-80 mEq/day with
monitoring, mixture is given as needed. IV inf: up to 6g (80 mmol) daily. (at 10-15 mEq/h).
Indications: Potassium deficiency, cumulative digitalis poisoning.
Contra-Indications: Acute dehydration. Severe renal impairment with oliguria or azotemia,
untreated Addison's disease, heat cramps and hyprekalaemia. Solid dosage forms in
patients in whom there might be delay or arrest of the tablet through the GI tract with
resulting GI mucosal erosion or ulceration.
Special Precautions: Should not be administered with potassium sparing diuretic agent.
Digitalis induced AV conduction unless patient is hypokalaemic. Sickle cell disease.
Concurrent use of potassium-containing products.
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SODIUM CHLORIDE
Dosage Form: Injection 0.45% 500 ml, 0.9% (10 ml, 100 ml, 250 ml, 500 ml), 3% 500 ml,
20% 10 ml (II)
Recommended Dose: According to needs of patients. Adult, average daily requirements: 1
liter of 0.9% sodium chloride (154 mEq Na and 154 mEq Cl). To calculate sodium deficit:
(140 mEq/L - patient's serum Na) x (total body water in liters) = mEq Na. Hypertonic (3% or
5%) solutions for replacement: administer half of dose over 8 hours, <100 ml/Hr. Continue
treatment until serum sodium is 130 mEq/L or neurologic symptoms improve.
Indications: Electrolyte imbalance, dehydration/hyponatremia. nasal sinus irrigation,
induction of emesis, cutaneous leishmaniasis, flushing cannula, hypovolemic shock,
Induction of emesis, wound care. Hypochloremic alkalosis
Contra-Indications: Hypertension, hypernatremia, hyperchloremic acidosis, hypokalemia
Special Precautions: Young child, elderly, restrict intake in impaired renal function, cardiac
failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy.
ZINC SULPHATE
Dosage Form: Capsules 220 mg (I)
Recommended Dose: 1 capsule once daily
Indications: Zinc deficiency or supplementation in zinc-losing conditions
Contra-Indications: Acute renal failure
Special Precautions: Prolonged use of high doses of zinc supplements, by mouth or
parenterally, leads to copper deficiency with associated sideroblastic anaemia and
neutropenia; full blood counts and serum cholesterol should be monitored to detect early
signs of copper deficiency.
7.5. Iron and Haematopoetics
CYANOCOBALAMIN (VITAMIN B12)
Dosage Form: Injection 1 mg/ml (1 ml, 10 ml) (II)
Recommended Dose: By IM inj.: 250-1000mcg on alternate days for 1-2 weeks, followed
by 250mcg weekly until blood count is normal. Then maintain dose of 1000mcg monthly.
Pernicious anaemia: 300mcg daily.
Indications: Pernicious anaemia, macrocytic anaemia, vitamin B12 deficiency.
Contra-Indications: Cyanocobalamin is not a suitable form of Vit. B12 for the treatment of
optic neuropathies associated with raised plasma concentration of cyanocobalamin.
Special Precautions: Should not be given before diagnosis is fully established. Oral
therapy is markedly inferior to parenteral therapy and should be used only in treatment of
Vit. B12 deficiency with normal GI absorption.
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FERRIC AMMONIUM CITRATE
Dosage Form: Mixture [P] 400 mg/5 ml (Padiatric) (II)
Recommended Dose: Up to 6g daily taken well diluted with water.
Indications: Treatment of iron deficiency anaemia.
Contra-Indications: In patients receiving repeated blood transfusion, anaemia not due to
iron deficiency.
Special Precautions: Tetracyclines. Use straw to prevent discoloration of teeth. Care in
patients with iron storage or iron-absorption diseases, haemoglobinopathies or existing
disease.
FERROUS FUMARATE
Dosage Form: Tablet 200 mg (II)
Recommended Dose: Initially: 200 mg tds. Maintenance: 200 mg daily. Child: up to 1 yr: 35
mg tds., 1-5 yrs: 70 mg tds., 6-12 yrs: 140 mg tds.
Indications: Treatment of iron deficiency anaemia.
Contra-Indications: In patients receiving repeated blood transfusions or in anaemia not
due to iron deficiency. Peptic ulcer, regional enteritis and ulcerative colitis.
Special Precautions: Concomitant administration of tetracycline and antacids decrease
amount of iron absorbed.
FILGRASTIM (GRANULOCYTE - COLONY STIMULATING FACTOR)
Criteria of use: Standard for chemotheraphy patient only
Dosage Form: Injection 300 mg (30 mu/ml) (I*)
Recommended Dose: 0.5 MU/kg body wt once daily.
Indications: Reduction in the duration of neutropenia & its clinical sequelae in patients
undergoing myeloablative therapy followed by bone marrow transplantation. Reduction in
the duration & incidence of febrile neutropenia in patients treated with established cytotoxic
chemotherapy for non myeloid maglinancy. Treatment of severe chronic neutropenias.
Contra-Indications: Severe congenital neutropenia with abnormal cytogenetics. Do not use
drug to increase dose of cytotoxic chemotherapy beyond established dosage regimen.
Special Precautions: Malignancy with myeloid characteristic. Monitor bone density in
patients with underlaying osteoporotic bone disease who undergo continuous therapy for >
6 months. Lactation.
FOLIC ACID
Dosage Form: Tablet 5 mg (II)
Recommended Dose: Initially 10-20 mg daily for 14 days. Maintenance: 2.5-10 mg daily.
Prophylaxis of megaloblastic anaemia of pregnancy: 200-500 mcg daily.
Indications: Treatment of megaloblastic anaemia, anaemia of sprue, pregnancy and
pellagra.
Contra-Indications: Megaloblastic anaemia secondary to Vit. B12 deficiency.
Special Precautions: Should not be given before diagnosis is fully established. Large
continuous doses of folic acid may lower the blood concentration of Vit. B12.
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IRON SUCROSE
Dosage Form: Injection 100 mg (I)
Recommended Dose: By slow intravenous injection or by intravenous infusion, calculated
according to body-weight and iron deficit, consult product literature; child not recommended
Indications: iron-deficiency anaemia
Contra-Indications: history of allergic disorders including asthma, eczema and
anaphylaxis; liver disease; infection
Special Precautions: oral iron therapy should not be given until 5 days after last injection;
facilities for cardiopulmonary resuscitation must be at hand; pregnancy
PYRIDOXINE HYDROCHLORIDE (VITAMIN B6)
Dosage Form: Tablet 10 mg (II)
Recommended Dose: Pyridoxine-dependent convulsions in infants: 4 mg/kg daily for short
periods. Sideroblastic anaemia: 150 mg daily in divided doses. Megaloblastic anaemia: 100200 mg daily. Prophylactic against peripheral neuritis in isoniazid therapy: 150 mg daily in
divided doses. Child: 25-50 mg daily. For treatment of nausea and vomiting in pregnancy,
irradiation sickness: 20-100 mg daily. Treatment of seizures and/or coma from acute
isoniazid toxicity, a dose of pyridoxine HCl equal to the amount of INH ingested can be
given I.M./I.V. in divided doses together with other anticonvulsants; if the amount INH
ingested is not known, administer 5 g IV pyridoxine. Treatment of acute hydralazine toxicity,
a pyridoxine dose of 25 mg/kg in divided doses IM/IV has been used.
Indications: Treatment of deficiency states, sideroblastic, adjunct to treatment of acute
toxicity from isoniazid, cycloserine, or hydralazine overdose and megaloblastic anaemia.
Special Precautions: Pyridoxine reduces the effects of levodopa, and incompatible with
alkaline solution, iron salts and oxidizing solutions.
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THIAMINE (VITAMIN B1)
Dosage Form: Tablet 100 mg; Injection 100 mg/ml (II)
Recommended Dose: Recommended Daily Allowance: <6 months - 0.3 mg, 6 months to 1
year – 0.4 mg, 1 to 3 yrs – 0.7 mg, 4 to 6 yrs – 0.9 mg, 7 to 10 yrs – 1 mg, 11 to 14 yrs –
(1.1 – 1.3 mg), >14 yrs – (1 – 1.5 mg). Thiamine deficiency (beriberi): Childn ~ 10-25
mg/dose IM or IV dly (if critically ill), or 10-50 mg/dose orally every day for 2 week, then 5-10
mg/dose orally dly for 1 month. Adults ~ 5-30 mg/dose IM or IV tds (if critically ill), then orally
5-30 mg/day in single or divided doses tds for 1 month. Wernicke’s encephalopathy: Adults
~ initial 100 mg IV, then 50-100 mg/day IM or IV until consuming a regular, balanced diet.
Dietary supplement (depends on caloric or carbohydrate content of the diet): Infants ~ 0.30.5 mg/day. Childn ~ 0.5-1.0 mg/day. Adults ~ 1-2 mg/day. Metabolic disorders (Oral):
Adults ~ 10-20 mg/day (dosages up to 4g/day in divided doses have been used).
Indications: Treatment of thiamine deficiency including beriberi, Wernicke’s
encephalopathy syndrome, and peripheral neuritis associated with pellagra, alcoholic
patients with altered sensorium; various genetic metabolic disorders.
Special Precautions: Use with caution with parenteral route (especially IV) of
administration.
8. ENDOCRINE PRODUCTS AND SEX HORMONES
8.1. Corticosteroids
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DEXAMETHASONE
Dosage Form: Tablet 0.5 mg; Injection 4 mg/2 ml (as phosphate) (II)
Recommended Dose: Orally 0.5-2 mg daily in divided doses up to 15 mg daily in severe
disease. By IM/ slow IV infusion: Initially 0.5-20 mcg. Children: 200-500 mcg/kg daily.
Shock: 2-6 mg/kg by IV infusion repeated if necessary after 2-6 hours. Cerebral edema: 10
mg initially by IV, then 4 mg IM every 6 hours as required for 2-10 days.
Indications: Suppression of inflammatory and allergic disorders, adrenal hyperplasia
diagnosis of Cushing disease, adjunctive treatment of severe hemorrhagic shock, traumatic,
surgical or septic shock, cerebral edema.
Contra-Indications: In systemic viral and fungal infections, peptic ulcer, psychosis,
congestive heart failure, chronic renal failure.
Special Precautions: In hypertension, epilepsy, elderly person, long-term treatment should
not be abruptly discontinued.
FLUDROCORTISONE ACETATE
Dosage Form: Tablet 0.1 mg (II)
Recommended Dose: 50–300 micrograms daily; child 5 micrograms/kg daily.
Indications: Mineralocorticoid replacement in adrenocortical insufficiency.
Contra-Indications: Hypersensitivity to fludrocortisone and systemic fungal infection.
Special Precautions: Cirrhosis, diabetes mellitus, electrolite abnormalities, hypertension,
hypothyroidism, immunizations, infections, myasythenia gravis, ocular changes with
prolonged use, osteoporosis, peptic ulcer, severe ulcerative colitis, renal insufficiency, Na
and water retention.
HYDROCORTISONE
Dosage Form: Tablet 10 mg (II)
Recommended Dose: The initial dosage varies from 20 to 240 mg/day depending on the
disease being treated.
Indications: replacement therapy in chronic adrenocortical insufficiency, salt-losing forms of
congenital adrenal hyperplasia syndromes, antiinflammatory agent.
Contra-Indications: See Dexamethasone
Special Precautions: See Dexamethasone
HYDROCORTISONE SODIUM SUCCINATE
Dosage Form: Injection 100 mg/vial (II)
Recommended Dose: By IM/ slow IV injection or infusion: 100-500 mg repeated up to 4
times in 24 hours. Children: 2-8 mg/kg/24 hours. Shock in neonates: 25 mg/kg IV. For
severe shock: 50 mg/kg in 24 hours by slow IV injection over several minutes in divided
doses or by IV infusion.
Indications: Acute adrenocortical insufficiency, supression of inflammatory and allergic
disorders and shock.
Contra-Indications: See Dexamethasone.
Special Precautions: See Dexamethasone.
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METHYLPREDNISOLONE SODIUM SUCCINATE
Dosage Form: Injection 0.5 gm/vial, 1 gm/vial (I)
Recommended Dose: Severe shock: by IV injection up to 30 mg/kg repeated after 4-6
hours if necessary. Other conditions: 10-20 mg IM or IV. IM injection 40 mg every 2 weeks
to 80 mg weekly up to 120 mg weekly.
Indications: Severe shock and other conditions in which a rapid and intense hormonal
effect is required. (Principally for short-term emergency treatment).
Contra-Indications: See Dexamethasone
Special Precautions: See Dexamethasone. Rapid intravenous administration of large
doses associated with cardiovascular collapse.
PREDNISOLONE
Dosage Form: Tablet 5 mg; Syrup 2.5 mg/5 ml, 3 mg/5 ml (II)
Recommended Dose: Initially 20-40 mg daily up to 60-80 mg if necessary for 4-5 days then
tapering by 2.5-5 mg every 2-4 days. Maintenance 5-20 mg daily. Children: Initially 2mg/kg
daily then gradually reduce to lowest effective dose.
Indications: Severe bronchial asthma and status asthmaticus, allergic and inflammatory
disorders, acute leukaemia, nephrotic syndrome and other corticosteroid indicated
condition.
Contra-Indications: See Dexamethasone.
Special Precautions: See Dexamethasone.
TRIAMCINOLONE ACETONIDE
Dosage Form: Injection 10 mg/ml (5 ml) vial
Recommended Dose: 40 mg for depot effect by deep IM injection into gluteal muscle,
repeated at intervals according to patient's response. Maximum: 100 mg as single dose.
Indications: Inflammatory, allergic and rheumatic disorders. Hodgkin's disease.
Contra-Indications: See Dexamethasone.
Special Precautions: See Dexamethasone.
8.2. Pituitary and Hypothalamic Agents
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BROMOCRIPTINE MESYLATE
Dosage Form: Tablet 2.5 mg (I)
Recommended Dose: Prevention of lactation, 2.5mg on day 1, Supression of lactation: 2.5
mg daily for 2-3 days then 2.5 mg twice daily for 14 days. Hypogonadism/galactorrhoea and
infertility, initially 1–1.25 mg at bedtime, increased gradually; usual dose 7.5 mg daily in
divided doses, increased if necessary to max. 30 mg daily, usual dose in infertility without
hyperprolactinaemia, 2.5 mg twice daily. Cyclical benign breast disease& cyclical menstrual
disorders (particularly breast pain), 1–1.25 mg at bedtime, increased gradually; usual dose
2.5 mg twice daily. Acromegaly, initially 1–1.25 mg at bedtime, increase gradually to 5 mg
every 6 hours.Usual dose 20-60mg dly. Prolactinoma, initially 1–1.25 mg at bedtime;
increased gradually to 5 mg every 6 hours (occasional patients may require up to 30 mg
daily). Parkinson's disease: first week 1–1.25 mg at night, second week 2–2.5 mg at night,
third week 2.5 mg twice daily, fourth week 2.5 mg 3 times daily then increasing by 2.5 mg
every 3–14 days according to response to a usual range of 10–40 mg daily; taken with food.
CHILD under 15 years, not recommended.
Indications: Treatment of galactorrhoea, hypogonadism, infertility, cyclical benign breast
disease, cyclical menstrual disorders, acromegaly, prolactinoma, prevention or supression
of lactation and Parkinson's disease.
Contra-Indications: Hypersensitivity to bromocriptine or other ergot alkaloids; toxaemia of
pregnancy and hypertension in postpartum women or in puerperium.
Special Precautions: Monitor for pituitary enlargement, particularly during pregnancy,
annual gynaecological assessment (postmenopausal, every 6 months), monitor for peptic
ulceration in acromegalic patients; contraceptive advice if appropriate (oral contraceptives
may increase prolactin concentration); avoid breast-feeding for about 5 days if lactation
prevention fails; history of serious mental disorders (especially psychotic disorders) or
cardiovascular disease or Raynaud's syndrome; monitor for retroperitoneal fibrosis;
porphyria; hepatic impairment.
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CABERGOLINE
Dosage Form: Tablet 0.5 mg (I)
Recommended Dose: Prevention of lactation, 1 mg as a single dose, during first day
postpartum, suppression of established lactation, 250 micrograms every 12 hours for 2
days, Hyperprolactinaemic disorders, 500 micrograms weekly (as a single dose or as 2
divided doses on separate days) increased at monthly intervals in steps of 500 micrograms
until optimal therapeutic response (usually 1 mg weekly, range 0.25–2 mg weekly) with
monthly monitoring of serum prolactin levels; reduce initial dose and increase more
gradually if patient intolerant; over 1 mg weekly give as divided doses; up to 4.5 mg weekly
has been used in hyperprolactinaemic patients, Parkinsonism, initially 1 mg daily, increased
by increments of 0.5–1 mg at 7 or 14 day intervals; usual range 2–6 mg daily.child under 16
years, not recommended.
Indications: Treatment of galactorrhoea, hypogonadism, infertility, cyclical benign breast
disease, cyclical menstrual disorders, acromegaly, prolactinoma, prevention or supression
of lactation and Parkinson's disease. (Cabergoline has actions and uses similar to those of
bromocriptine, but its duration of action is longer).
Contra-Indications: Hypersensitivity to bromocriptine or other ergot alkaloids; toxaemia of
pregnancy and hypertension in postpartum women or in puerperium (patients intolerant of
bromocriptine may be able to tolerate cabergoline (and vice versa). Exclude pregnancy
before starting and discontinue 1 month before intended conception (ovulatory cycles
persist for 6 months)—discontinue if pregnancy occurs during treatment (specialist advice
needed); avoid breast-feeding if lactation prevention fails.
Special Precautions: Monitor for pituitary enlargement, particularly during pregnancy,
annual gynaecological assessment (postmenopausal, every 6 months, monthly pregnancy
tests during the amenorrhoeic period), advise non-hormonal contraception if pregnancy not
desired (oral contraceptives may increase prolactin concentration), monitor for peptic
ulceration in acromegalic patients, gastro-intestinal bleeding, avoid breast-feeding for about
5 days if lactation prevention fails, history of serious mental disorders (especially psychotic
disorders), cardiovascular disease , Raynaud's syndrome, fibrotic lung disease, monitor for
retroperitoneal fibrosis, porphyria, severe hepatic impairment.Hypotensive reactions may be
disturbing in some patients during the first few days of treatment.
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DESMOPRESSIN ACETATE
Dosage Form: Tablet 0.1 mg, 0.2 mg; Injection 4 mcg/ml, Nasal drop 0.1 mg/ml; Nasal
spray 10 mcg/metered spray (I)
Recommended Dose: Injection: 1-4 mcg daily. Children: 400 nanograms for Diabetes
insipidus.
Nasal drop/spray: Diabetes insipidus, diagnosis, adult and child 20 micrograms (limit fluid
intake to 500 mL from 1 hour before to 8 hours after administration). Diabetes insipidus,
treatment, adult 10–40 micrograms daily (in 1–2 divided doses); child 5–20 micrograms
daily; infants may require lower doses.
Primary nocturnal enuresis (if urine concentrating ability normal), adult (under 65 years) and
child over 5 years (preferably over 7 years) initially 20 micrograms at bedtime, only
increased to 40 micrograms if lower dose not effective; withdraw for at least 1 week for
reassessment after 3 months.
Nocturia associated with multiple sclerosis (when other treatments have failed), adult (under
65 years) 10–20 micrograms at bedtime, dose not to be repeated within 24 hours.
Renal function testing (empty bladder at time of administration and limit fluid intake to
500 mL from 1 hour before until 8 hours after administration), adult 40 micrograms;
infantunder 1 year 10 micrograms (restrict fluid intake to 50% at next 2 feeds to avoid fluid
overload), child 1–15 years 20 micrograms.
Tablet: Diabetes insipidus, treatment, adult and child initially 300 micrograms daily (in 3
divided doses); maintenance, 300–600 micrograms daily in 3 divided doses; range 0.2–
1.2 mg daily. Primary nocturnal enuresis (if urine concentrating ability normal), adult (under
65 years) and child over 5 years (preferably over 7 years) 200 micrograms at bedtime, only
increased to 400 micrograms if lower dose not effective; withdraw for at least 1 week for
reassessment after 3 months. Postoperative polyuria or polydipsia, adjust dose according to
urine osmolality
Indications: Injection: Pituitary diabetes insipidus. Boost concentrations of facator VII prior
to surgical procedures in patients with mild to moderate haemophilia. Nasal drop/spray:
Diagnosis and treatment of diabetes insipidus, Primary nocturnal enuresis, nocturia
associated with multiple sclerosis, renal function testing. Tablet: Treatment of diabetes
insipidus, primary nocturnal enuresis, postoperative polyuria or polydipsia.
Contra-Indications: Cardiac insufficiency and other conditions treated with diuretics;
psychogenic polydipsia and polydipsia in alcohol dependence.
Special Precautions: Cardiovascular disease, heart failure, hypertension, asthma,
epilepsy, elderly (avoid for nocturnal enuresis and nocturia in those over 65 years), cystic
fibrosis, migraine, nocturia and nocturnal enuresis (limit fluid intake to minimum from 1 hour
before dose until 8 hours afterwards) or other conditions which might be aggravated by
water retention,renal impairment , pregnancy, avoid fluid overload.
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HUMAN CHORIONIC GONADOTROPHIN ALFA
Dosage Form: Injection 0.25 mg (6500 units)/0.5 ml (I)
Recomended Dose: By subcutaneous injection, according to patient’s response
Indications: Induction of ovulation in fertility and assisted reproduction techniques
Contra-Indications: Ovarian enlargement or cyst (unless caused by polycystic ovarian
disease); ectopic pregnancy in previous 3 months; active thromboembolic disorders;
hypothalamus, pituitary, ovarian, uterine or mammary malignancy
Special Precautions: Rule out infertility caused by hypothyroidism, adrenocortical
deficiency, hyperprolactinaemia, tumours of the pituitary or hypothalamus
SOMATOSTATIN ACETATE
Dosage Form: Injection 3 mg/vial (I* - Gastroenterologist, Physician)
Recommended Dose: Initially 3.5 mcg/kg ie 250 mcg slow IV bolus over not <1 min,
followed immediately by a continuous IV infusion of 3.5 mcg/kg/hr (one 3 mg amp) over 12
hr. Continuous administration should last at least 48 hr for max 5 days.
Indications: Adjuvant treatment of intestinal & pancreatic fistulae. Treatment of acute,
severe GI haemorrhage, resulting from gastric or duodenal ulcers, haemorrhagic gastritis &
oesophageal varices, recognised at endoscopy.
Contra-Indications: Pregnancy, lactation, administration during pre- & post-natal periods.
Special Precautions: Avoid repeated administration. Arterial haemorrhage observed during
endoscopy should be treated surgically.
VASOPRESSIN
Dosage Form: Injection 20 units/ml (I*-ICU)
Recommended Dose: By subcutaneous or intramuscular injection for diabetes insipidus: 520 units every four hours. By intravenous infusion for initial control of variceal bleeding: 20
units over 15 minutes.
Indications: For prevention and treatment of postoperative abdominal distention, in
abdominal roentgenography to dispel interfering gas shadows. Diabetes insipidus. Bleeding
from oesophageal varices.
Contra-Indications: Anaphylaxis or hypersensitivity to the drug or its components.
Vascular disease (especially disease of coronary arteries) unless extreme caution, chronic
nephritis (until reasonable blood nitrogen concentration attained).
Special Precautions: Vasopressin should be used cautiously in the presence of epilepsy,
migraine, asthma, heart failure or any state in which a rapid addition to extracellular water
may produce hazard for an already overburdened system. Chronic nephritis with nitrogen
retention contraindicates the use of vasopressin until reasonable nitrogen blood levels have
been attained.
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8.3. Endocrine Pancreatic Agents
INSULIN ASPART (NOVORAPID®)
Dosage Form: Injection 100 units/ml (3 ml FlexPen, penfill) (I)
Recommended Dose: By SC injection, immediately before meals or when necessary,
shortly after according to requirements, by subcutaneous infusion, intravenous injection or
intravenous infusion, according to requirements.
Indications: Treatment of Diabetes mellitus.
Contra-Indications: Hypersensitivity to insulin, hypoglycaemia, insulinoma.
Special Precautions: Decreased insulin requirements due to hepatic or renal impairment,
malabsorption, diarrhea, nausea/vomiting & hypothyroidism, hypokalemia, stress due to
fever, infection, surgery, trauma, systemic allergic reactions (desensitization prior to use) &
children.
INSULIN BIPHASIC ASPART (NovoMix® 30/70)
Dosage Form: Injection 100 units/ml (3ml FlexPen) (recombinant human insulin analogue)
30% insulin aspart + 70% insulin aspart protamine (I)
Criteria of use: Criteria of use:
1. When OAD’s fail
2.Uncontrolled with Mixtard
Recommended Dose: By subcutaneous injection, up to 10 minutes before or soon after a
meal, according to requirements
Indications: Treatment of diabetic mellitus.
Contra-Indications: Hypoglycaemia, insulinoma
Special Precautions: See under Insulin Soluble and Insulin Aspart.
INSULIN BIPHASIC ISOPHANE (PRE-MIXED 30/70, MIXTARD® 30 HM)
Dosage Form: Injection 100 units/ml (10 ml vial, 3 ml penfill) (II)
Recommended Dose: By subcutaneous injection, according to individual needs.
Indications: Treatment of diabetic mellitus.
Contra-Indications: Hypoglycaemia, insulinoma
Special Precautions: Decreased insulin requirements--diarrhea, nausea/vomiting,
malabsorption, hypothyroidism, renal impairment & hepatic impairment, increased insulin
requirements--fever, hyperthyroidism, trauma, infection, surgery and systemic allergic
reaction to insulin (desensitize prior to use).
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INSULIN DETEMIR (LEVEMIR®)
Dosage Form: Injection 100 iu/ml (3ml penfill) (I)
Criteria of use: Restricted for specialist only according to Flowchart for Use of Insulin
Detemir
Recommended Dose: SC Once daily or bd.
Indications: Type 1 DM in adult & childn. Type 2 DM in adult requiring basal insulin for
hyperglycaemic control.
Contra-Indications: Hypersensitivity to insulin detemir or to any of the excipients.
Special Precautions: Monitor glucose levels in elderly & patients w/ renal or hepatic
impairment. Concomitant illness. Do not administer IV. Risk of hyper/hypoglycemia during
therapy. Pregnancy & lactation, childn.
INSULIN GLARGINE (LANTUS®)
Dosage Form: Injection 100 units/ml (3 ml penfill) (I* - Endocrinologist)
Criteria of use: Restricted for Endocrinologist from Diabetic Clinic in patients who at risk of
hypoglycaemia with Insulin NPH
Recommended Dose: Diabetes mellitus type 1: individualized SC dose administered once
daily at the same time every day, Diabetes mellitus type 2: insulin naïve, average starting
dose, 10 international units SC once daily at the same time every day; maintenance, 2-100
international units daily administered once daily at bedtime.
Indications: Diabetes mellitus (type 1 & type 2).
Contra-Indications: Hypersensitivity to any component of insulin glargine, intravenous
administration
Special Precautions: Do not dilute; do not mix with any other insulin product or solution,
insulin dose adjustment may be needed with renal or hepatic impairment, illness, stress,
emotional disturbances, or in elderly patients.
INSULIN ISOPHANE (NPH)
Dosage Form: Injection 100 units/ml (Insulatard® HM, 10 ml Vial, 3 ml Penfill), (Humulin N
10 ml Vial, 3 ml Penfill) (II)
Recommended Dose: By subcutaneous injection, according to individual needs.
Indications: Treatment of diabetes mellitus.
Contra-Indications: Hypoglycaemia, insulinoma
Special Precautions: Decreased insulin requirements--diarrhea, nausea/vomiting,
malabsorption, hypothyroidism, renal impairment & hepatic impairment, increased insulin
requirements--fever, hyperthyroidism, trauma, infection, surgery and systemic allergic
reaction to insulin (desensitize prior to use).
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INSULIN LISPRO
Dosage Form: Injection 100 units/ml (Humalog® 3 ml Penfill) (Humalog® Mix 25, 25% insulin lispro +
75% insulin lispro protamine (I1)
Recommended Dose: By subcutaneous injection, according to individual needs.
Indications: Treatment of diabetes mellitus.
Contra-Indications: Hypoglycaemia, insulinoma
Special Precautions: Decreased insulin requirements--diarrhea, nausea/vomiting,
malabsorption, hypothyroidism, renal impairment & hepatic impairment, increased insulin
requirements--fever, hyperthyroidism, trauma, infection, surgery and systemic allergic
reaction to insulin (desensitize prior to use).
INSULIN SOLUBLE (REGULAR, NEUTRAL)
Dosage Form: Injection 100 units/ml (Actrapid® HM 10 ml Vial, 3 ml Penfill), (Humulin R
10 ml Vial, 3 ml Penfill) (II)
Recommended Dose: By SC/IM/IV: Dosage prescribed acccording to individual needs.
Rapid acting: Onset 0.5 hour, peak: Humulin R 2-4 hr; Actrapid HM 1st-3rd hr, duration 6-8
hours.
Indications: Treatment of Diabetes mellitus, diabetic coma & diabetic ketoacidosis.
Contra-Indications: Hypersensitivity to insulin, hypoglycaemia, insulinoma. Usage in
insulin pump.
Special Precautions: Change in type or purity of insulin, accidental or surgical trauma,
emotional stress and pregnancy. Dosage requirements may vary during illness and
infection. Propranolol may mask symptoms of hypoglycaemia.
INSULIN ZINC SUSPENSION (MONOTARD®)
Dosage Form: Injection 100 units/ml (10 ml/vial) containing human monocomponent insulin
(30% amorphous and 70% crystalline) and zinc. Recombinant DNA origin. (II)
Recommended Dose: By SC only: Dosage prescribed according to individual needs.
Intermediate acting: Onset: 2.5 hours, peak: 7th-15th hr, duration: 24 hours.
Indications: Treatment of diabetic mellitus.
Contraindication: Hypoglycaemia, insulinoma
Special Precautions: See Insulin regular. Should not be given IV and not suitable for
emergency treatment of diabetic ketoacidosis.
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8.4. Oral Hypoglycaemic Agents
ACARBOSE
Dosage Form: Tablet 50 mg, 100 mg (II)
Criteria of use:
1. When diet therapy fails
2. Uncontrolled with other agents
Recommended Dose: Efficacy and tolerability varies between individuals. Thus dosage
needs to be adjusted accordingly. Unless otherwise prescribed, usual initial dosage is 50
mg (1 x 50 mg tablet or 1/2 x 100 mg tablet) three times a day. After an initial phase of 1 - 2
weeks (or longer), subsequent dosage may be increased to 100 mg three times daily up to a
maximum daily dose of 600 mg. Do not increase dose if distressing complaints develop in
spite of strict diet adherence. Reduce dose if necessary.
Indications: As an adjunct to diet in patients with diabetes mellitus.
Contra-Indications: Hypersensitivity to acarbose and/or inactive constituents, patients <18
years old, chronic intestinal disorders associated with distinct disturbances of digestion and
absorption, conditions which may deteriorate as a result of increased gas formation in the
intestine (eg, Roemheld's syndrome, major hernias, intestinal obstructions and intestinal
ulcers), pregnancy and breastfeeding (lack of information).
Special Precautions: Acarbose is not a substitute for dietary control and should only be
used under specialist direction. Use with caution in patients with chronic intestinal
conditions. Monitor liver enzyme values at regular intervals for 6 months in patients requiring
daily doses of 600 mg (200 mg tds). Information on long-term safety is lacking.
GLIBENCLAMIDE
Dosage Form: Tablet 5 mg (II)
Recommended Dose: Initially 5 mg daily (elderly patients 2.5 mg) adjusted every 7 days in
increment of 2.5 mg up to maximum of 15 mg daily. Dose taken with meals.
Indications: Treatment of diabetes mellitus type II.
Contra-Indications: Juvenile onset diabetes mellitus, diabetic coma, serious impaired
renal/hepatic/thyroid function.
Special Precautions: Hypoglycaemic effects may be enhanced by chloramphenicol, MAO
inhibitors, beta blockers, alcohol, sulphonamides.
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GLIBENCLAMIDE + METFORMIN
Dosage Form: Tablet 1.25 mg + 250 mg, 2.5 mg + 500 mg, 5 mg + 500 mg (II)
Recommended Dose: Initial therapy Recommended starting dose: 250/1.25 mg once- bd.
Second-line therapy Recommended starting dose: 500/2.5 mg or 500/5 mg bd, up to a max
daily dose of 2000 mg metformin/ 20 mg glibenclamide. Should be taken with food (Take w/
meals.).
Indications: As initial therapy, as an adjunct to diet & exercise, to improve glycaemic
control in patients w/ type 2 diabetes whose hyperglycaemia cannot be satisfactorily
managed w/ diet & exercise alone. As second-line therapy when diet, exercise, & initial
treatment w/ a sulphonylurea or metformin do not result in adequate control in patients w/
type 2 diabetes.
Contra-Indications: Renal disease or renal dysfunction, CHF requiring pharmacologic
treatment, acute or chronic metabolic acidosis, including diabetic ketoacidosis w/ or w/o
coma.
Special Precautions: Lactic acidosis is rare & may occur in significant renal insufficiency.
Regular renal monitoring, esp in the elderly, is needed. Avoid use in patients w/ clinical or
lab evidence of hepatic disease. Patients should be cautioned against excessive alcohol
intake. Concomitant medications that may affect renal function or result in significant
hemodynamic change or may interfere w/ the disposition of metformin. Suspend therapy
during surgery & clinical investigations using IV iodinated contrast media. Pregnancy, paed,
debilitated & malnourished patients.
GLICLAZIDE
Dosage Form: Tablet 80 mg (II)
Recommended Dose: Initially 40-80 mg daily. Maximum 320 mg daily. Up to 160 mg as a
single dose, taken at breakfast. Higher doses divided with the main meals.
Indications: Treatment of diabetes mellitus type II.
Contra-Indications: Juvenile diabetes, severe insulin dependant diabetes with ketosis.
Special Precautions: Reduce dosage in case of renal insufficiency.
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GLICLAZIDE MR
Dosage Form: Tablet MR 30 mg (II)
Criteria of use: For non-compliance patients who previously on Gliclazide (TDS dose) only
Recommended Dose: For adult use only. The initial recommended dose is 30 mg daily,
even in elderly patients (65 years old). The daily dose should not exceed 120 mg. Take with
meals.
Indications: Treatment of diabetes mellitus type II in association with dietary measures
when dietary measures alone are inadequate to control blood glucose, for patients which
poor compliance.
Contra-Indications: Type I diabetes, diabetic keto-acidosis, diabetic pre-coma, severe
renal @ hepatic insufficiency, treatment with miconazole, pregnancy and lactation,
hypersensitivity to gliclazide, other sulfonylureas, sulfonamides or to any of the excipients. It
is generally not recommended to use this agent in combination with phenylbutazone or
danazol.
Special Precautions: Hypo glycemia, renal and hepatic insufficiency, replacement of
diamicron with insulin may be necessary during fever, trauma, infection or surgery.
GLIMEPIRIDE
Dosage Form: Tablet 1 mg, 2 mg, 3 mg (II)
Criteria of use: For patients who at risk of hypoglycaemia, example elderly, renal or hepatic
impairment and fasting patient
Recommended Dose: Adult; Initially 1-2 mg once daily taken with breakfast or the first
meal. Dose increment should be based on blood glucose response; not more than 2 mg at 1
to 2 week intervals. Usual maintenance dose: 1-4 mg once daily. Maximum dose: 8 mg
daily.
Indications: Treatment of diabetes mellitus (NIDDM), may be used in combination with
insulin.
Contra-Indications: Diabetic ketoacidosis, hypersensitivity, breastfeeding, porphyria,
pregnancy, hepatic & renal insufficiency.
Special Precautions: a) Hypoglycemia, b) Replacement of glimepiride with insulin may be
necessary during stress; infection, fever, trauma, surgery, c) Loss of glycemic control due to
secondary failure, d) Milder or absent symptoms of hypoglycaemia eg.in patients with
autonomic neuropathy or taking beta-blockers, clonidine, reserpine, guanethidine or other
sympatholitic drugs.
GLIPIZIDE
Dosage Form: Tablet 5 mg (I)
Recommended Dose: Initially 5-15 mg daily adjusted according to response. Maximum 40
mg daily. Up to 15 mg may be given as single dose before breakfast. Higher doses in
divided doses.
Indications: Treatment of diabetes mellitus.
Contra-Indications: Juvenile diabetes, severe insulin dependant diabetes with ketosis.
Special Precautions: Reduce dosage in case of renal insufficiency.
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METFORMIN
Dosage Form: Tablet 500 mg (II)
Recommended Dose: 500 mg tds with meals or 850 mg bd. Maximum: 3 g daily.
Indications: Treatment of diabetes mellitus type II.
Contra-Indications: Diabetic coma, serious ketoacidosis, pregnancy, impaired
renal/hepatic function, congestive heart failure, diabetes mellitus complicated by infection,
surgery or gangrene.
Special Precautions: Patients on metformin should avoid taking alcohol.
METFORMIN SR
Dosage Form: Tablet SR 850 mg (II)
Recommended Dose: 850 mg once daily (give with the morning meal). Dosage increase
should be made in increment of 850 mg/day at intervals of every other week (daily dose
given in divided doses), up to maximum of 2550 mg/day. Usual maintanance dose; 850 mg
twice daily (with morning and evening meals). Some patients may be given 850 mg 3
times/day.
Indications: Treatment of diabetes mellitus type II.
Contra-Indications: Diabetic coma, serious ketoacidosis, pregnancy, impaired
renal/hepatic function, congestive heart failure, diabetes mellitus complicated by infection,
surgery or gangrene.
Special Precautions: Patients on metformin should avoid taking alcohol.
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METFORMIN XR
Dosage Form: Tablet XR 500 mg (II)
Criteria of use:
1. Restricted for specialist only
2. For patient who has GIT problems and non-compliance to immediate-release metformin
3. Use according to Flowchart for Use of Glucophage XR
Recommended Dose: Monotherapy & combination w/ other oral antidiabetic agents 1
tab once daily, adjust after 10-15 days. Max: 4 tab daily. In patients already treated w/
metformin, start w/ the same daily dose of metformin immediate-release tab. Transfer from
another OAD Discontinue the other agent & initiate at the dose indicated previously.
Combination w/ insulin 1 tab once daily, adjust insulin according to blood glucose
measurements. Childn Not to be used in childn.
Indications: Treatment of type 2 DM in adult when dietary management & exercise alone
does not result in adequate glycaemic control. May be used as monotherapy or in
combination w/ other oral antidiabetic agents or w/ insulin.
Contra-Indications: Diabetic ketoacidosis, diabetic pre-coma; renal failure or dysfunction
(CrCl <60 mL/min). Acute conditions w/ potential to alter renal function eg dehydration,
severe infection, shock, intravascular administration of iodinated contrast agents. Acute or
chronic disease which may cause tissue hypoxia eg cardiac or resp failure, recent MI,
shock, hepatic insufficiency, acute alcohol intoxication, alcoholism. Lactation.
Special Precautions: Lactic acidosis is rare & may occur in significant renal failure.
Regular renal monitoring is needed. Discontinue therapy prior to, during or 48 hr after use of
IV iodinated contrast media & surgery. Combination w/ insulin or sulfonylureas may increase
hypoglycemia. Elderly.
PIOGLITAZONE
Dosage Form: Tablet 15 mg, 30 mg (I)
Recommended Dose: Initially 15–30 mg once daily increased to 45 mg once daily
according to response.
Indications: type 2 diabetes mellitus (alone or combined with metformin or a
sulphonylurea).
Contra-Indications: hepatic impairment, history of heart failure, combination with insulin
(risk of heart failure), pregnancy, breast-feeding.
Special Precautions: Monitor liver function (see below); cardiovascular disease (risk of
heart failure); substitute insulin during peri-operative period (omit pioglitazone on morning of
surgery and recommence when eating and drinking normally).
REPAGLINIDE
Dosage Form: Tablet 0.5 mg, 1 mg, 2 mg (I* - Endocrinologist)
Recommended Does: 0.5 – 4 mg with meals. Give immediately to 30 minute before eating.
Indication: Diabetes mellitus.
Contra-Indications: Diabetes ketoacidosis, type I diabetes, hypersensitivity to repaglinide
products.
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ROSIGLITAZONE
Dosage Form: Tablet 4 mg, 8 mg (I* - Endocrinologist)
Recommended Dose: Initial: 4 mg daily as a single daily dose or in divided dose twice
daily. If response is inadequate after 12 week of treatment, the dosage may be increased to
8 mg daily as a single daily dose or in divided dose twice daily.
Indications: Type II diabetes, monotherapy or combination therapy.
Contra-Indications: Hypersensitivity to rosiglitazone or any component of the formulation;
active liver disease (transaminases > 2.5 times the upper limit of the normal baseline)
Special Precautions: Cardiovascular disease, particularly hypertension (rosiglitazone may
cause fluid retention/edema); New York Heart Association Class III and IV cardiac status
(due to possible increases in plasma volume); edema; hepatic dysfunction (potential
exacerbation); concurrent use of insulin; concurrent use of other hypoglycemic agents
(increased risk of hypoglycemia); in premenopausal, anovulatory women with insulin
resistance, ovulation may resume during treatment with rosiglitazone, and the patient may
be at risk for pregnancy; hemoglobin and the white blood count may decrease during the
first 4 to 8 weeks of therapy.
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ROSIGLITAZONE + MEFFORMIN
Dosage Form: Tablet 2 mg + 500 mg, 4 mg + 500 mg (I)
Recommended Dose:






Diabetes mellitus type 2; Adjunct: initial (drug-naive patients), rosiglitazone 2
mg/metformin 500 mg ORALLY once or twice daily
Diabetes mellitus type 2; Adjunct: maintenance/to achieve control (after initial therapy in
drug-naive patients), if not adequately controlled after 4 weeks, titrate in increments of
rosiglitazone 2 mg/metformin 500 mg per day, MAX 8 mg/2000 mg daily
Diabetes mellitus type 2; Adjunct: initial (previously receiving rosiglitazone 4 mg/day),
rosiglitazone 2 mg/metformin 500 mg ORALLY twice daily
Diabetes mellitus type 2; Adjunct: initial (previously receiving rosiglitazone 8 mg/day), 4
mg/500 mg ORALLY twice daily
Diabetes mellitus type 2; Adjunct: initial (previously receiving metformin 1000 mg/day), 2
mg/500 mg ORALLY twice daily
Diabetes mellitus type 2; Adjunct: initial (previously receiving metformin 2000 mg/day), 2
mg/1000 mg ORALLY twice daily

Diabetes mellitus type 2; Adjunct: maintenance/to achieve control, titrate in increments of
rosiglitazone 4 mg and/or metformin 500 mg ORALLY daily, MAX 8 mg/2000 mg daily
Indications: Adjunct to diet & exercise for glycaemic control in patients w/ type 2 diabetes
mellitus who are already treated w/ combination rosiglitazone & metformin or who are
inadequately controlled on metformin alone.
Contra-Indications: Diabetic ketoacidosis or pre-coma, renal failure.
Special Precautions: Type 1 diabetes mellitus; hepatic & renal impairment, oedema. May
result in ovulation in some premenopausal anovulatory women. Monitor patients at risk of
heart failure. Poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol
intake, conditions associated w/ tissue hypoxia; suspend therapy 48 hr before & after
surgery w/ general anaesth & in clinical investigations using iodinated contrast agents.
Pregnancy & lactation. Elderly.
8.5. Thyroid Hormones/ Antithyroid Agents
CARBIMAZOLE
Dosage Form: Tablet 5 mg (II)
Recommended Dose: Adult: Initially 30-60 mg daily in divided doses for 4-8 weeks
reduced to 5-20 mg daily. 7 year and above: 15 mg daily.
Indications: Thyrotoxicosis; Grave's disease.
Contra-Indications: Tracheal obstruction lactation.
Special Precautions: Smallest effective dose to be used in pregnancy and discontinued 34 weeks before delivery.
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POTASSIUM IODIDE
Dosage Form: Solution [P] 100 gm/100 ml (Saturated) (40-50 mg Iodide per drop) (II)
Recommended Dose: 1-2 drops three times a day. Doses of up to 250 mg three times
daily with food have been suggested. Management of thyroid storm (given one hour after
administration of an antithyroid agent): 50 to 100 mg (1-2 drops) have been given twice
daily; higher doses have been employed.
Indications: As an adjunct to antithyroid agents in the pre-operative management of
hyperthyroidism or thyrotoxicosis; management of thyroid storm.
Contra-Indications: Breast feeding.
Special Precautions: Not to be used regularly in children and during pregnancy except
when iodine supplementation is required.Reduce doses in patients over 45 years of age or
with nodular goitres. May interfere with thyroid function tests.
PROPYLTHIOURACIL
Dosage Form: Tablet 50 mg (II)
Recommended Dose: 100-150 mg every 8 hours with adjustment to 900-1200 mg/day if
necessary. Maintenance: 50-200 mg daily. Children: 6-10 years: 50-150 mg daily in 3
divided doses. Over 10 years: 150-300 mg daily.
Indications: Thyrotoxicosis.
Contra-Indications: Tracheal obstruction, lactation.
Special Precautions: Reduce dosage in renal failure, pregnancy, tendency to
haemorrhage and breast feeding.
THYROXINE SODIUM
Dosage Form: Tablet 25 mcg, 50 mcg, 100 mcg. (II)
Recommended Dose: Initially 50-200 mcg daily increased fortnightly by 50 mcg until
thyroid deficiency is corrected. In elderly/cardiac disease intially 12.5-25 mcg daily.
Maintenance dose 100-300 mcg daily. Infants: 25-50 mcg daily. Children: Over 1 year: 2.5-5
mcg/kg/day. Dose taken before breakfast.
Indications: Hypothyroidism, myxoedema, cretinism.
Special Precautions: In elderly patients, patients with cardiac disease or hypertension. I
pituitary myxoedema the adrenocortical deficiency should be treated first to prevent
addisonism crisis.
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8.6. Female Sex Hormones
CARBOPROST TROMETHAMINE
Dosage Form: Injection 250 mcg/ ml (as tromethamine salt) (1 ml ampoule) (I* - Obstetrics
&Gynaecology)
Recommended Dose: Deep IM inj. 250 mcg repeated if necessary at intervals of 1½ hours
(in severe cases the interval may be reduced but should not be less than 15 minutes); total
dose should not exceed 2 mg (8 doses).
Indications: Postpartum haemorrhage due to uterine atony in patients unresponsive to
ergometrine an oxytocin.
Contra-Indications: Acute pelvic inflammatory disease; cardiac, renal, pulmonary, or
hepatic disease.
Special Precautions: History of glaucoma or raised intra-ocular pressure, asthma,
hypertension, hypotension, anaemia, jaundice, diabetes, epilepsy, uterine scars; excessive
dosage may cause uterine rupture.
DYDROGESTERONE
Dosage Form: Tablet 10 mg (I* - Obstetrics & Gynaecology)
Criteria of use:
1) For O&G clinic
2) For cases of luteal phase defect
Recommended Dose: Dysmenorrhoea: 10 mg BD from day 5-25 of the cycle.
Endometriosis: 10 mg BD–TDS from day 5-25 of the cycle or continuously. Dysfunctional
bleeding (to arrest bleeding): 10 mg BD with an oestrogen OD for 5-7 days, (To prevent
bleeding): 10 mg BD with an oestrogen OD from day 11-25 of the cycle. Premenstrual
syndrome/Infertility due to Luteal insufficiency/irregular cycles: 10 mg BD from day 11 - 25
of the cycle. Threatened abortion: 40 mg at once then 10 mg TDS until symptoms remit.
Habitual abortion: 10 mg BD until 20th week of pregnancy. Post menopausal complaints
(HRT) in combination with continuous oestrogen therapy: 10-20 mg daily during the last 1214 days of each cycle. In combination with cyclical oestrogen therapy: 10-20 mg daily during
the last 12-14 days of oestrogen therapy.
Indications: Listed in Recommended Dose
Contra-Indications: Avoided in patients with history of liver tumours, severe liver
impairment, genital or breast cancer (unless progestogenes are being used in the
management of these conditions), severe arterial disease, undiagnosed vaginal bleeding
and porphyria, history during pregnancy of idiopathic jaundice, severe pruritus or
pemphigoid gestationis.
Special Precautions: Should be used with caution in conditions that may worsen with fluid
retention e.g. epilepsy, hypertension, migraine, asthma, cardiac or renal dysfunction, and in
those susceptible to thromboembolisme. Care is also required in liver impairment (avoid if
severe) and in those with history of depression. Pregestogenes can decrease glucose
tolerance and diabetes. Should be monitored closely.
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Levonorgestrel + Ethinyloestradiol
Dosage Form: Tablet 150 mcg + 30 mcg (21 tablets) (II)
Recommended Dose: Contraception: 1 tablet ORALLY daily for 21 consecutive days; then
discontinue for 7 days or take the 1 inert tablet ORALLY daily for 7 days; repeat cycle.
Contraception: Seasonale (R), 1 active tablet ORALLY daily for 84 consecutive days,
followed by 7 days of inactive tablets; repeat cycle
Indications: Contraception
Contra-Indications: A past history of deep-vein thrombophlebitis or thromboembolic
disorders, carcinoma of the endometrium or other known or suspected estrogen-dependent
neoplasia, cerebral-vascular or coronary artery disease, cholestatic jaundice of pregnancy
or jaundice with prior pill use, diabetes with vascular involvement, headaches with focal
neurological symptoms ,hepatic adenomas or carcinomas or active liver disease ,
hypersensitivity to any of the product components ,known or suspected carcinoma of the
breast ,known or suspected pregnancy, thrombogenic rhythm disorders, thrombogenic
valvulopathies, thrombophlebitis or thromboembolic disorders, uncontrolled hypertension,
undiagnosed abnormal genital bleeding.
Special Precautions: Cigarette smoking (15 or more cigarettes per day) and over age 35,
contact lens wearers who develop visual changes, depression, diabetes, does not protect
against HIV infection ,dose-related risk of vascular disease, family history of breast cancer,
fluid retention, hyperlipidemias, hypertension, inherited or acquired thrombophilias, obesity,
persistence of risk of vascular disease after discontinuation ,post-operative thromboembolic
complications.
MEDROXYPROGESTERONE ACETATE
Dosage Form: Tablet 5 mg (I)
Recommended Dose: 2.5-10 mg daily for 5-10 days beginning on 16th-21st day of cycle,
repeated for 2 cycles in dysfunctional uterine bleeding and 3 cycles in secondary
amenorrhoea. Mild to moderate endometriosis, 10 mg 3 times daily for 90 consecutive days,
beginning on 1st day of cycle.
Indications: See under Recommended Dose.
Contra-Indications: Pregnancy, undiagnosed vaginal bleeding, hepatic impairment or
active liver disease, severe arterial disease, breast or genital tract carcinoma; porphyria.
Special Precautions: Diabetes, hypertension, cardiac or renal disease.
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NORETHISTERONE
Dosage Form: Tablet 5 mg (II)
Recommended Dose: Endometriosis: 5-10 daily starting on 5th day of cycle, increased at
14-day interval and continue for 6-9 months. Increase if spotting occur to 25 mg daily in
divided doses to prevent breakthrough bleeding. Dysfunctional uterine bleeding
menorrhagia: 5 mg tds for 10 days to arrest bleedings. To prevent bleeding, 5 mg bd daily
from 19-25th day for 3-4 cycles. Premenstrual syndrome: 10-15 mg daily from 19-26th day
for several cycles. Postponement of menstruation: 5 mg tds starting 3 days before
anticipated onset.
Indications: Endometriosis, abnormal uterine bleeding, dysmenorrhea, premenstrual
syndrome, postponement of menstruation, in combination with oestrogen as oral
contraceptive.
Contra-Indications: Thromphlebitis, thromboembolic disorders, cerebral apoplexy,
undiagnosed vaginal bleeding, missed abortion, carcinoma of breast, test for pregnancy.
Special Precautions: Asthma, seizure disorders, migraine cardiac or renal dysfunction,
history of mental depression, impaired liver function and pregnancy.
OESTRADIOL
Dosage Form: Tablet 1 mg (I)
Recommended Dose: Oestrogen replacement therapy Either as a continuous daily
regimen or as a 21-day regimen w/ 1 wk of tab-free interval. Combined hormone
replacement therapy Either as a continuous daily regimen or as a 21-day regimen w/ 1 wk
of tab-free interval & combined w/ an appropriate progestogen. The progestogen may be
given continuously or as a sequential addition (to a continuous or 21-day regimen of
Progynova) given for at least 10-12 days/cycle.
Indications: Climacteric complaints in the postmenopause or deficiency symptoms after
oophorectomy or radiological castration for non-carcinomatous diseases, eg hot flushes,
outbreaks of sweat, sleep disturbances, depressive moods, irritability, headache, dizziness.
Contra-Indications: Pregnancy; severe liver dysfunction; jaundice or persistent itching
during a previous pregnancy; Dubin-Johnson syndrome, Rotor syndrome; previous or
existing liver tumours; existing or previous thromboembolic processes; sickle-cell anaemia;
existing or suspected hormone-dependent tumours of the uterus or mammae;
endometriosis; severe diabetes w/ vascular changes; congenital disturbances of
lipometabolism; otosclerosis w/ deterioration during pregnancy.
Special Precautions: Close supervision in diabetes, high BP, varicose veins, otosclerosis,
multiple sclerosis, epilepsy, porphyria, tetany, chorea minor, a history of phlebitis. Benign &
rarely, malignant liver tumours which may lead to life-threatening intra-abdominal
haemorrhage has been observed. If severe upper abdominal complaints, liver enlargement
or signs of intra-abdominal haemorrhage occur, a liver tumour should be taken into
consideration.
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OESTRADIOL AND OESTRADIOL + DYDROGESTERONE
Dosage Form: Tablet 2 mg + (2 mg + 10 mg), 1 mg + (1 mg + 10 mg), 1 mg oestradiol + 5
mg dydrogesteron (Femoston Conti) (I*- O&G)
Criteria of use: For O&G Clinic only.
Recommended Dose: One tablet containing 2 mg estradiol daily during 14 consecutive
days per cycle of 28 days and one tablet, containing 2 mg oestradiol and 10 mg
dydrogesterone, daily during the remaining 14 days has to be taken. Immediately after 28day cycle, the next treatment cycle is to be started.
Indications: Hormone replacement therapy for women with disorders due to natural or
surgically induced menopause with an intact uteri.
Contra-Indications: Known or suspected carcinoma of the breast, endometrial carcinoma
or other hormone dependent neoplasia. Acute or cronic liver disease. Acute venous
thromboembolic disorders. Abnormal genital bleeding of unknown aetiology. Pregnancy.
Special Precautions: Physical examination and a complete medical and family history
should be taken prior to the initiation of any HRT with special reference to blood pressure,
palpation of the breast and the abdomen, and a gynaecological examination. Mammography
is advisable.
OESTROGEN CONJUGATED (PREMARIN)
Dosage Form: Tablet 0.3 mg, 0.625 mg; Cream 0.625 mg/gm (Vaginal) (I)
Recommended Dose: Menopausal symptoms: 0.3-1.25 mg daily from 5th day of cycle for 3
weeks. Then repeat after 1 week in subsequent cycles. Amenorrhoea: 1.25-3.75 mg daily
for 21 days with a progestogen for the last 7 days. Prostatic caracinoma: 10 mg tds for at
least 3 months. Vaginal cream: 1/2-1 applicatorful (2-4 g) daily intravaginally.
Indications: Menopausal symptoms, menstrual disorders.
Contra-Indications: Pregnancy, oestrogen-dependant cancer, history of thromboembolism, hepatic impairment, endometriosis, porphyria, sickel-cell anaemia, undiagnosed
vaginal bleeding, deterioration of otosclerosis.
Special Precautions: Large doses may cause premature closure of epiphyses. Long-term
usage may increase frequency of carcinoma of breast, cervix, vagina and liver. Breastfeeding, diabetes, epilepsy, asthma, hypertension, migraine, cardiac or renal disease,
history of jaundice.
RALOXIFENE HCL
Dosage Form: Tablet 60 mg (I* - Family Medicine, O&G, Orthopedic)
Criteria of use: Restricted to family medicine, O&G and orthopedic patients for postmenopausal osteoporosis
Recomended Dose: 60 mg once daily
Indications: Treatment and prevention of postmenopausal osteoporosis
Contra-Indications: Women w/ childbearing potential. Active or past history of venous
thromboembolic events including deep vein thrombosis, pulmonary embolism & retinal vein
thrombosis. Hepatic impairment including cholestasis. Severe renal impairment.
Unexplained uterine bleeding. Endometrial or breast cancer.
Special Precautions: Co-administration w/ systemic oestrogens is not recommended.
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8.7. Male Sex Hormones
ALPROSTADIL
Dosage Form: Injection 500 mcg/ml; Urethral suppository 1 mg (I)
Recommended Dose: Erectile dysfunction of neurogenic etiology, starting dose: 1.25 ug,
2nd dose: 2.5 ug. Additional increments until optimal dose of 5 ug is achieved. Erectile
dysfunction of vasculogenic, psychogenic or mixed etiology, starting dose: 2.5 ug, 2 nd dose:
5 ug (partial response): 7.5 ug (no response). Additional increments until optimal dose of 510 ug is achieved. Maintenance therapy: not > once daily & not > 3 times weekly. Diagnose
of erectile dysfunction, a single dose that induces a film erection is used. Urethral Initially
250 mcg, may increase to 500 or 1000 mcg or reduce to 125 mcg depending on erectile
response. The optimal dose should not be given >2 times/day or 7 times/wk.
Indications: Erectile dysfunction.
Contra-Indications: Predisposition to priapism eg sickle cell anemia or trait, multiple
myeoloma or leukaemia. Anatomical deformation of the penis eg angulation, carvenosal
fibrosis or Peyronie’s disease. Patients with penile implants, men for whom sexual activity is
inadvisable or contraindicated.
Special Precautions: Regular follow-up to detect signs of penile fibrosis. Patients on
anticoagulants.
DUTASTERIDE
Dosage Form: Capsule 0.5 mg (I*)
Recommended Dose: Adult males (including elderly) 0.5 mg once daily.
Indications: Treatment & control of symptomatic benign prostatic hyperplasia (BPH) in men
w/ an enlarged prostate to improve symptoms, reduce the risk of acute urinary retention &
the need for BPH-related surgery.
Contra-Indications: Severe hepatic impairment. Women, children.
Special Precautions: Mild to moderate hepatic impairment. Avoid donating blood until min
6 mth after last dose.
FINASTERIDE
Dosage Form: Tablet 5 mg (I*)
Recommended Dose: 5 mg daily, review treatment after 6 months (may be require several
months treatment before benefit is obtained)
Indications: Benign prostatic hyperplasia, improve urinary flow & symptoms associated
with BPH.
Contra-Indications: Women and paediatric patients.
Special Precautions: Obstructive uropathy, prostate cancer (may decrease markers such
as prostate specific antigen); use of condoms recommended if sexual partner is pregnant or
is likely to become pregnant (finasteride excreted in semen); women of child-bearing
potential should avoid handling crushed or broken tablet.
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TESTOSTERONE ENANTHATE
Dosage Form: Injection 250 mg/ml (oily) (I)
Recommended Dose: Initially: 250 mg every 2-3 weeks. Maintenance: 250 mg every 3-6
weeks.
Indications: Hypogonodism, infertility, mammary carcinoma and endometrial carcinoma in
women.
Contra-Indications: Prostatic carcinoma, breast cancer in men, previous/existing liver
tumours, nephrosis, breast-feeding and pregnancy.
Special Precautions: Cardiac, renal or hepatic impairment, circulatory failure,
hypertension, epilepsy, migraine, thyroid disease and diabetes mellitus.
8.8. Antioestrogenic Agents
ANASTROZOLE
Dosage Form: Tablet 1 mg (I)
Criteria of use: Second choice drug after using Tamoxifen for breast cancer, except for
cases that are justified to be used as 1st line
Recommended Dose: 1 mg daily
Indications: Adjuvant treatment of oestrogen-receptor-positive early breast cancer in
postmenopausal women, either as sole therapy or following 2-3 years of tamoxifen therapy;
advanced breast cancer in postmenopausal women which is oestrogen-receptor positive or
responsive to tamoxifen.
Contra-Indications: Pregnancy and breast-feeding; moderate or severe hepatic disease;
moderate or severe renal impairment; not for premenopausal women.
Special Precautions: Laboratory test for menopause if doubt; susceptibility to osteoporosis
(assess bone mineral density before treatment and at regular intervals)
CLOMIPHENE CITRATE
Dosage Form: Tablet 50 mg (I)
Recommended Dose: 50 mg daily for 5 days starting on 5th day of menstrual cycle or at
any time if there is amenorrhoea. Maximum of 6 courses.
Indications: Anovulatory infertility, indicated only in ovarian dysfunction.
Contra-Indications: Liver disease, ovarian cyst, endometrial carcinoma, pregnancy,
abnormal uterine bleeding.
Special Precautions: Polycystic ovary syndrome & incidence of multiple births.
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DANAZOL
Dosage Form: Capsule 200 mg (I)
Recommended Dose: Endometriosis: Initially 400 mg daily in 2-4 in divided doses on first
day of menstrual cycle, adjusted to response, usually for 6 months. Menorrhagia: 100-400
mg daily in 2-4 divided doses, starting on first day of menstrual cycle. Hereditary angiooedema: 400 mg daily and reduced to 200 mg daily after 2 months attack-free period.
Indications: Treatment of endometriosisi, gynaecomastia, benign breast cancer,
menorrhagia, primary consatitutional precocious puberty, prophylaxis of hereditary angiooedema.
Contra-Indications: Pregnancy, lactation, severe hepatic, renal or cardiac impairment,
thromboembolic disease, undiagnosed abnormal uterine bleeding.
Special Precautions: Migraine, epilepsy, non-hormonal contraceptives methods should be
used.
LETROZOLE
Dosage Form: Tablet 2.5 mg (I)
Criteria of use: Second choice drug after using Tamoxifen for ‘hormonal advanced breast
cancer’ in post-menopausal patients
Recommended Dose: 2.5 mg daily
Indications: Adjuvant treatment of oestrogen-receptor-positive early breast cancer in
postmenopausal women; advanced breast cancer in postmenopausal women (including
those in whom other anti-oestrogen therapy has failed); early invasive breast cancer in
postmenopausal women after standard adjuvant tamoxifen therapy; pre-operative treatment
in postmenopausal women with localised hormone-receptor-positive breast cancer to allow
subsequent breast conserving surgery
Contra-Indications: Severe hepatic impairment; not indicated for premenopausal women;
pregnancy and breast-feeding
Special Precautions: Severe renal impairment
TAMOXIFEN CITRATE
Dosage Form: Tablet 20 mg (I)
Recommended Dose: For breast cancer: 10 mg bd increased to 20 mg bd if no response
within one month. For anovulatory infertility: 10 mg bd on days 2, 3, 4, 5 of menstrual cycle
increased if necessary in subsequent cycles to 40 mg bd.
Indications: Palliative treatment of advanced breast cancer & anovulatory infertlity,
idiopathic oligospermia in males.
Contra-Indications: Pregnancy.
Special Precautions: Functioning ovaries.
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8.9. Drugs Affecting Bone Metabolism
ALENDRONATE SODIUM
Dosage Form: Tablet 70 mg (I* - Medical, Orthopaedic, Obstetrics & Gynaecology)
Recommended Dose: 10 mg daily or 70 mg once weekly at least 30 minutes before
breakfast.
Indications: Postmenopausal osteoporosis treatment.
Contra-Indications: Abnormalities of eosophagus and other factors which delay emptying
(eg. Stricture or achalasis), hypocalcaemia, renal impairment, pregnancy, lactation, inability
to stand or sit upright for 30 minutes.
Special Precautions: Upper gastro-intestinal disorders, correct disturbances of calcium
and mineral metabolism (vit. D deficiency, hypocalcaemia) before starting exclude other
causes of osteoporosis. Alert at any signs/symptoms signaling possible esophageal
reaction. Discontinue if dysphagia, odynophagia or retrosterhal pain occurs, pregnancy,
lactation, paediactric use.
ALENDRONATE SODIUM + COLECALCIFEROL
Dosage Form: Tablet 70 mg + 2800 units (II)
Recommended Dose: Treatment of postmenopausal osteoporosis in women at risk of
vitamin D deficiency, 1 tablet once weekly.
Indications: Treatment of osteoporosis in postmenopausal women to increase bone mass,
prevent fractures, including those of the hip & spine. Treatment of osteoporosis in men to
prevent fractures.
Contra-Indications: Abnormalities of the esophagus (eg stricture or achalasia), inability to
stand or sit upright for at least 30 mins, hypocalcemia.
Special Precautions: Discontinue in case of dysphagia, odynophagia, retrosternal pain or
new or worsening heartburn. Active upper GI problems (dysphagia, esophageal diseases,
gastritis, duodenitis or ulcers). CrCl <35 mL/min. Correct hypocalcemia & other disorders
affecting mineral metabolism (eg vit D deficiency) before starting therapy. Monitor serum Ca
& urine. Childn, pregnancy & lactation.
PAMIDRONATE DISODIUM
Dosage Form: Injection 30 mg/10 ml (I* - Medical)
Recommended Dose: By slow IV infusion. Bone metastases & multiple myeloma 90 mg
single infusion every 4 week, or every 3 week if chemotherapy for bone metastases is at 3
weekly intervals. Tumout-induced hypercalcemia Total dose 30-90mg in single or multiple
infusions. Paget’s disease of bone 30mg weekly or 60mg every other week up to total dose
of 180-210mg.
Indications: Bone metastases, multiple myoloma, tumour induced hypercalcemia, Paget’s
disease of bone.
Contra-Indications: Hypersensitivity to other bisphosphonates.
Special Precautions: Do not administer as a bolus inj or with other bisphosphonates or Cacontaining IV infusions. Monitoring of serum electrolytes, Ca phosphate, renal function.
Renal impairment, cardiac disease. Road/machinery users. Pregnancy, lactation, Child.
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STRONTIUM RANELATE
Dosage Form: Granules 2 gm/sachet (I*- Orthopaedic, Obstetrics & Gynaecology and
Family Medicine)
Criteria of use: Use according to Algorithm for the Management of Postmenopausal
Osteoporosis
Recommended Dose: 2 g once daily.
Indications: Treatment of postmenopausal osteoporosis to reduce the risk of vertebral &
hip fractures.
Contra-Indications: Pregnancy, breast feeding
Special Precautions: Not recommended in severe renal impairment (CrCl <30 mL/min).
Monitor renal function periodically in chronic renal impairment. VTE, phenylketonuria.
Interferes w/ colorimetric methods. Discontinue treatment in case of hypersensitivity
reactions. Childn & adolescent.
ZOLEDRONIC ACID
Dosage Form: Injection 4 mg (II)
Recommended Dose: Reduction of bone damage in advanced malignancies involving
bone (with calcium and vitamin D supplement), by intravenous infusion, 4 mg every 3–4
weeks; Hypercalcaemia of malignancy, by intravenous infusion, 4 mg as a single dose; child
not recommended
Indications: see under Dose
Contra-Indications: pregnancy, breast-feeding
Special Precautions: monitor serum electrolytes, calcium, phosphate and magnesium;
assess renal function before each dose; ensure adequate hydration; renal impairment;
severe hepatic impairment; cardiac disease (avoid fluid overload); consider preventive
dental treatment before initiating bisphosphonate (risk of osteonecrosis of the jaw)
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9. CARDIOVASCULAR PRODUCTS
9.1. Diuretics
ACETAZOLAMIDE
Dosage Form: Tablet 250 mg; Injection 500 mg/vial (II)
Recommended Dose: 250-375 mg ORALLY once daily in morning for 1 or 2 days,
alternating with day of rest. By IM/IV injection: 250-500 mg. Drug induced oedema: 250-375
mg daily, 1 to 2 days.
Indications: CHF induced oedema, oedema due to adverse drug reaction
Contra-Indications: Arenal gland failure,cirrhosis, hyponatremia/hypokalemia,
hyperchloremic acidosis, hypersensitivity to acetazolamide, severe hepatic or renal disease.
Special Precautions: Avoid in renal impairment, first trimester of pregnancy, chronic
closed-angle glaucoma, care in acidosis, diabetes mellitus.
AMILORIDE HYDROCHLORIDE + HYDROCHLOROTHIAZIDE (MODURETIC)
Dosage Form: Tablet 5 mg + 50 mg (I)
Recommended Dose: Hpertension, initially ½ tablet daily, increased if necessary to max. 1
tablet daily. Congestive heart failure, initially ½ tablet daily, increased if necessary to max. 2
tablets daily. Oedema and ascites in cirrhosis of the liver, initially 1 tablet daily, increased if
necessary to max. 2 tablets daily; reduce for maintenance if possible.
Indications: Hypertension, congestive heart failure, oedema and ascites in cirrhosis of the
liver.
Contra-Indications: Hyperkalaemia, renal failure
Special Precautions: Pregnancy and breast feeding, renal impairment (avoid if moderate
to severe), diabetes mellitus, elderly
CHLOROTHIAZIDE
Dosage Form: Tablet 500 mg (II)
Recommended Dose: Oedema, Associated with congestive heart failure, hepatic cirrhosis,
renal dysfunction, corticosteroid and estrogen therapy; Adjunct: 0.5-1 g ORALLY once or
twice daily, may give every other day or 3-5 days each week. Hypertension: 0.5-1 g
ORALLY divided once or twice-daily.
Indications: Oedema, Oedema Associated with congestive heart failure, hepatic cirrhosis,
renal dysfunction, corticosteroid and estrogen therapy; Adjunct, Hypertension.
Contra-Indications: Anuria, hypersensitivity to chlorothiazide or sulfonamides.
Special Precautions: Avoid lithium, diabetes mellitus, electrolyte imbalance, geriatric
patients, hyperuricemia or gout, hypotension, liver disease, may aggravate digitalis toxicity,
post-sympathectomy patients, renal disease, sensitivity reactions may occur with or without
a history of allergy or asthma,systemic lupus erythematosus.
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FRUSEMIDE
Dosage Form: Tablet 40 mg; Injection 20 mg/2 ml (II)
Recommended Dose: By mouth, oedema, initially 40 mg in the morning; maintenance 20–
40 mg daily, increased in resistant oedema to 80 mg daily or more; child 1–3 mg/kg daily,
max. 40 mg daily. Oliguria, initially 250 mg daily; if necessary larger doses, increasing in
steps of 250 mg, may be given every 4–6 hours to a max. of a single dose of 2 g (rarely
used). By intramuscular injection or slow intravenous injection , initially 20–50 mg; child 0.5–
1.5 mg/kg to a max. daily dose of 20 mg. By intravenous infusion (by syringe pump if
necessary), in oliguria, initially 250 mg over 1 hour (rate not exceeding 4 mg/minute), if
satisfactory urine output not obtained in the subsequent hour further 500 mg over 2 hours,
then if no satisfactory response within subsequent hour, further 1 g over 4 hours, if no
response obtained dialysis probably required; effective dose (up to 1 g) can be repeated
every 24 hours.
Indications: Oedema, oliguria due to renal failure.
Contra-Indications: Precomatose states associated with liver cirrhosis; renal failure with
anuria.
Special Precautions: Hypotension; correct hypovolaemia before using in oliguria; prostatic
enlargement; although manufacturer advises that rate of intravenous administration should
not exceed 4 mg/minute, single doses of up to 80 mg may be administered more rapidly;
hepatic impairment, renal impairment, pregnancy.
INDAPAMIDE, INDAPAMIDE SR
Dosage Form: Tablet 2.5 mg, SR 1.5 mg (II)
Recommended Dose: Tablet 2.5 mg: 2.5 mg in the morning. Tablet 1.5 mg (sustainedrelease): 1.5 mg daily
Indications: Essential hypertension
Contra-Indications: Severe hepatic impairment
Special Precautions: Monitor plasma potassium and urate concentrations in elderly,
hyperaldosteronism, gout, or with concomitant cardiac glycosides; hyperparathyroidism
(discontinue if hypercalcaemia); porphyria; hepatic impairment); renal impairment—stop if
deterioration); pregnancy); breast-feeding).
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MANNITOL
Dosage Form: Injection 10% (10 gm/100 ml) (500 ml), 20% (20 gm/100 ml) (500 ml) (II)
Recommended Dose: Acute renal failure; Prophylaxis - Oliguria: (during cardiac and other
surgeries) 50-100 grams IV as a 5%-15% solution (concentration dependent on patient's
fluid requirements); Acute renal failure - Oliguria: use test dose; 300-400 mg/kg (21-28
grams for a 70-kg patient) or up to 100 grams of solution, given as a single dose (often in
addition to furosemide); Cerebral edema - Raised intracranial pressure: 0.25-1 gram/kg IV
over 20 to 30 minutes every 6-8 hr; MAX 6 grams/kg/24 hr;Cerebral edema - Raised
intracranial pressure: (to reduce brain mass before/after neurosurgery) 1.5-2 grams/kg IV
over 30-60 min; Raised intraocular pressure: 1.5-2 grams/kg IV infused over 30-60 min as a
15%-20% solution; MAX 6 grams/kg/24 hr; Toxicity of drug: continuous IV infusion as a 5%20% solution (concentration dependent on patient's fluid requirements and urinary output);
discontinue if no benefit is shown after infusion of 200 grams.
Indications: Acute renal failure; Prophylaxis – Oliguria, Acute renal failure – Oliguria,
Cerebral edema - Raised intracranial pressure, Raised intraocular pressure, Toxicity of
drug.
Contra-Indications: Anuria, dehydration (severe), heart failure or pulmonary congestion
(after initiation of mannitol), hypersensitivity to mannitol, intracranial bleeding (except during
craniotomy), pulmonary edema/congestion,renal damage/dysfunction (after initiation of
mannitol).
Special Precautions: Cardiopulmonary dysfunction, electrolyte imbalance, renal
impairment
SPIRONOLACTONE
Dosage Form: Tablet 25 mg (II)
Recommended Dose: 100–200 mg daily, increased to 400 mg if required; child initially
3 mg/kg daily in divided doses
Indications: Oedema and ascites in cirrhosis of the liver, malignant ascites, nephrotic
syndrome, congestive heart failure, primary hyperaldosteronism
Contra-Indications: Hyperkalaemia, hyponatraemia; Addison's disease
Special Precautions: Potential metabolic products carcinogenic in rodents; elderly; monitor
electrolytes (discontinue if hyperkalaemia); porphyria; hepatic impairment; renal impairment;
pregnancy; breast-feeding.
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9.2. Antianginal, Coronary Vasodilator
9.2.1. Nitrates
GLYCERYL TRINITRATE
Dosage Form: Tablet 0.5 mg (II)
Recommended Dose: Sublingually 0.3–1 mg, repeated as required
Indications: Prophylaxis and treatment of angina and left ventricular failure.
Contra-Indications: Hypersensitivity to nitrates; hypotensive conditions and hypovolaemia;
hypertrophic obstructive cardiomyopathy, aortic stenosis, cardiac tamponade, constrictive
pericarditis, mitral stenosis; marked anaemia, closed-angle glaucoma.
Special Precautions: Severe hepatic or renal impairment; hypothyroidism, malnutrition, or
hypothermia; head trauma, cerebral haemorrhage; recent history of myocardial infarction;
metal-containing transdermal systems should be removed before cardioversion or
diathermy; tolerance.
ISOSORBIDE DINITRATE
Dosage Form: Tablet 10 mg; Injection 10 mg/10 ml (II)
Recommended Dose: By mouth, daily in divided doses, angina 30–120 mg, left ventricular
failure 40–160 mg, up to 240 mg if required. By intravenous infusion, 2–10 mg/hour; higher
doses up to 20 mg/hour may be required
Indications: Prophylaxis and treatment of angina and left ventricular failure.
Contra-Indications: Hypersensitivity to nitrates; hypotensive conditions and hypovolaemia;
hypertrophic obstructive cardiomyopathy, aortic stenosis, cardiac tamponade, constrictive
pericarditis, mitral stenosis; marked anaemia, closed-angle glaucoma.
Special Precautions: Severe hepatic or renal impairment; hypothyroidism, malnutrition, or
hypothermia; head trauma, cerebral haemorrhage; recent history of myocardial infarction;
metal-containing transdermal systems should be removed before cardioversion or
diathermy; tolerance.
NITROGLYCERIN
Dosage Form: Transdermal Disc (TDD) 5 mg, 10 mg; Injection 10 mg/10 ml (l)
Recommended Dose: 5mg daily applied to healthy, non-hairy, clean and dry skin of chest
or on inner side of upper arm. If well tolerated, dose can be increased (stepwise) to 10-20
mg daily.
Indications: Treatment of angina pectoris and congestive heart failure
Contra-indications: Known intolerance of organic nitrate drugs and marked anaemia.
Special Precautions: Not intended for immediate relief of acute attacks. If these occur,
other preparation should be used. Apply new disc every 24 hours to different site.
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9.2.2. Calcium-Channel Blocker
AMLODIPINE BESYLATE
Dosage Form: Tablets 5 mg, 10 mg (II)
Recommended Dose: Hypertension or angina, initially 5 mg once daily; max. 10 mg once
daily.
Indications: Hypertension, prophylaxis of angina.
Contra-Indications: Cardiogenic shock, unstable angina,significant aortic stenosis;
pregancy and breastfeeding
Special Precautions: Hepatic impairment.
AMLODIPINE BESYLATE + ATORVASTATIN
Dosage Form: Tablet 5 mg +10 mg, 10 mg + 10 mg, 5 mg + 20 mg (II)
Recommended Dose: 5 mg/10 mg to a max dose of 10 mg/80 mg once daily.
Indications: For hypertension in patients stabilized on the individual components in the
same proportions.
Contra-Indications: Active liver disease or unexplained persistent elevations of serum
transaminases >3x the upper limit of normal. Pregnancy, lactation or women of childbearing
potential who are not using adequate contraceptive measures.
Special Precautions: Heart failure. Co-administration with drugs that may decrease the
levels or activity of endogenous steroid hormones (eg ketoconazole, spironolactone &
cimetidine). History of liver disease or heavy alcohol consumption. Perform liver fucntion
tests before treatment & periodically thereafter. Should an increase in ALT or AST of >3x
the upper limit of normal persist, reduce dose or withdraw drug. Patients should be advised
to report promptly any unexplained muscle pain, muscle tenderness or weakness especially
if accompanied by malaise or fever. Discontinue if markedly elevated CPK levels occur or
myopathy is diagnosed or suspected. Women of childbearing potential. Rarely, patients (esp
those w/ severe obstructive coronary artery disease) have developed increased frequency,
duration &/or severity of angina or acute MI on starting Ca-channel blocker therapy or at the
time of dosage increase.
AMLODIPINE BESYLATE + VALSARTAN
Dosage Form: Tablet 5 mg + 80 mg, 5 mg + 160 mg, 10 mg + 160 mg (I)
Recommended Dose: 1 tab/day
Indications: Essential hypertension where BP is not adequately controlled on
antihypertensive monotherapy
Contra-Indications: Pregnancy
Special Precautions: Risk of hypotension in Na- &/or vol-depleted patients. ß-blocker
w/drawal should be gradual. Severe renal impairment (CrCl <10 mL/min), dialysis.
Unilateral/bilateral renal artery stenosis, stenosis to a solitary kidney, after recent kidney
transplantation, hepatic impairment, biliary obstructive disorders. Aortic or mitral stenosis,
obstructive hypertrophic cardiomyopathy. May impair ability to drive or operate machinery.
Avoid in women planning a pregnancy, lactation. Childn <18 yr
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DILTIAZEM HCL
Dosage Form: Tablet 30 mg; Injection 10 mg (II)
Recommended Dose: Angina, 60 mg 3 times daily (elderly initially twice daily); increased if
necessary to 360 mg daily
Indications: Prophylaxis and treatment of angina; hypertension
Contra-Indications: Severe bradycardia, left ventricular failure with pulmonary congestion,
second- or third-degree AV block (unless pacemaker fitted), sick sinus syndrome;
pregnancy; breast-feeding.
Special Precautions: Reduce dose in hepatic and renal impairment; heart failure or
significantly impaired left ventricular function, bradycardia (avoid if severe), first degree AV
block, or prolonged PR interval.
FELODIPINE
Dosage Form: Tablet 2.5 mg, 5 mg, 10 mg (I)
Recommended Dose: Hypertension, initially 5 mg (elderly 2.5 mg) daily in the morning;
usual maintenance 5–10 mg once daily; doses above 20 mg daily rarely needed. Angina,
initially 5 mg daily in the morning, increased if necessary to 10 mg once daily.
Indications: Hypertension, prophylaxis of angina
Contra-Indications: Unstable angina, uncontrolled heart failure; significant aortic stenosis;
within 1 month of myocardial infarction; pregnancy.
pregnancy, including the early stages, hypertensitivity to felodipine
Special Precautions: Withdraw if ischaemic pain occurs or existing pain worsens shortly
after initiating treatment or if cardiogenic shock develops; severe left ventricular dysfunction;
avoid grapefruit juice (may affect metabolism); reduce dose in hepatic impairment; breastfeeding.
NIFEDIPINE
Dosage Form: Tablet 10 mg (II)
Recommended Dose: 10 mg tds up to 20 mg tds if necessary with or after food. Elderly: 5
mg tds. For immediate effect, bite the capsule and retain liquid in mouth (in angina): 10-20
mg. Maximum dose: 180 mg/day regular release preparation. Children: 0.25-0.5 mg/kg SL.
Indications: Prophylaxis of angina; hypertension; Raynaud's phenomenon
Contra-Indications: Cardiogenic shock; advanced aortic stenosis; within 1 month of
myocardial infarction; unstable or acute attacks of angina; porphyria.
Special Precautions: Withdraw if ischaemic pain occurs or existing pain worsens shortly
after initiating treatment; poor cardiac reserve; heart failure or significantly impaired left
ventricular function (heart failure deterioration observed); severe hypotension; reduce dose
in hepatic impairment; diabetes mellitus; may inhibit labour; pregnancy; breast-feeding;
avoid grapefruit juice (may affect metabolism).
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NIMODIPINE
Dosage Form: Tablet 30 mg; Injection 10 mg /50 ml (I)
Recommended Dose: Adult: PO Prophylaxis of neurological deficit following subarachnoid
haemorrhage 60 mg 4 hrly for 21 days beginning w/in 4 days of onset of haemorrhage. IV
Ischaemic neurological deficits following subarachnoid haemorrhage Initial: 1 mg/hr for 2 hr,
up to 2 mg/hr if no severe decrease in BP is observed. Start treatment at once and continue
for 5-14 days. Total duration should not exceed 21 days if patient has received oral
treatment. Treatment, by intravenous infusion via central catheter, initially 1 mg/hour (up to
500 micrograms/hour if body-weight less than 70 kg or if blood pressure unstable),
increased after 2 hours to 2 mg/hour if no severe fall in blood pressure; continue for at least
5 days (max. 14 days); if surgical intervention during treatment, continue for at least 5 days
after surgery; max. total duration of nimodipine use 21 days
Indications: Prevention and treatment of ischaemic neurological deficits following
aneurysmal subarachnoid haemorrhage.
Contra-Indications: Within 1 month of myocardial infarction; unstable angina.
Special Precautions: Cerebral oedema or severely raised intracranial pressure;
hypotension; avoid concomitant administration of nimodipine tablets and infusion, other
calcium-channel blockers, or beta-blockers; concomitant nephrotoxic drugs; avoid grapefruit
juice (may affect metabolism); hepatic impairment; renal impairment & pregnancy.
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9.2.3. Other
PAPAVERINE HCL
Dosage Form: Injection 60 mg/2 ml (I)
Recommended Dose: Papaverine hydrochloride may be administered intravenously or
intramuscularly. The intravenous route is recommended when an immediate effect is
desired, but the drug must be injected slowly over the course of 1 or 2 minutes to avoid
uncomfortable or alarming side effects. Parenteral administration of papaverine
hydrochloride in doses of 1 to 4 mL is repeated every 3 hours as indicated. In the treatment
of cardiac extrasystoles, 2 doses may be given 10 minutes apart.
Indications: Papaverine is recommended in various conditions accompanied by spasm of
smooth muscle, such as vascular spasm associated with acute myocardial infarction
(coronary occlusion), angina pectoris, peripheral and pulmonary embolism, peripheral
vascular disease in which there is a vasospastic element, or certain cerebral angiospastic
states; and visceral spasm, as in ureteral, biliary, or gastrointestinal colic.
Contraindications: Intravenous injection of papaverine is contraindicated in the presence
of complete atrioventricular heart block. When conduction is depressed, the drug may
produce transient ectopic rhythms of ventricular origin, either premature beats or
paroxysmal tachycardia.
Papaverine hydrochloride is not indicated for the treatment of impotence by intracorporeal
injection. The intracorporeal injection of papaverine hydrochloride has been reported to
have resulted in persistent priapism requiring medical and surgical intervention.
Special Precautions: Should not be added to Lactated Ringer's Injection, because
precipitation would result.
Papaverine hydrochloride should be used with caution in patients with glaucoma. The
medication should be discontinued if hepatic hypersensitivity with gastrointestinal
symptoms, jaundice or eosinophilia becomes evident or if liver function test values become
altered.
TRIMETAZIDINE DHCL (METABOLIC AGENT)
Dosage Form: MR tablet 35 mg (I* - Medical)
Recommended Dose: 1 tab morning & evening. Should be taken with food.
Indications: Prophylactic treatment of episodes of angina pectoris. Adjuvant symptomatic
treatment of vertigo & tinnitus. Adjuvant treatment of the decline in visual acuity & visual
field disturbances presumably of vascular origin.
Contra-Indications: Pregnancy & lactation.
Special Precautions: Not indicated for treatment of acute angina attacks, unstable angina
or MI.
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9.3. Vasoconstrictors
DOBUTAMINE HCL
Dosage Form: Injection 250 mg/20 ml (vial) (I)
Recommended Dose: 2.5-10 mcg/kg/min.
Indications: Short-term treatment of cardiac failure secondary to acute MI or cardiac
surgery.
Contra-Indications: Idiopathic hypertropic subaortic stenosis.
Special Precautions: Monitor ECG & BP continuously. Correct hypovolaemia before
treatment. Atrial fibrillation w/ rapid ventricular response, pre-existing hypertension.
EPHEDRINE
Dosage Form: Injection 30 mg/ml (II)
Recommended Dose: IM, SC or IV Severe, acute bronchospasm 12.5-25 mg. When used
as a pressor agent Adult 25-50 mg SC/IM. If necessary, a 2nd IM dose of 50 mg or an IV
dose of 25 mg may be given. Direct IV inj, 10-25 mg may be given slowly. Max parenteral
adult dose: 150 mg in 24 hr. Childn 3 mg/kg or 100 mg/m 2 SC or IV daily, in 4-6 divided
doses.
Indications: Treatment of bronchial spasm in asthma & to produce cardiac stimulation &
vasoconstriction in the treatment of shock. Adjunct to correct haemodynamic imbalances
which persist after adequate fluid vol replacement. Treat hypotension during spinal anaesth.
Contra-Indications: Closed-angle glaucoma. Patients being treated w/ MAOIs or w/in 10
days of ceasing such treatment. Coronary thrombosis, HTN & hyperthyroidism.
Special Precautions: Geriatric males (esp those w/ an enlarged prostate), diabetics, &
patients w/ CV disease. Patients receiving chloroform, cyclopropane, halothane or other
halogenated anaesth.
NORADRENALINE (NOREPINEPHRINE) BITARTRATE
Dosage Form: Injection 4 mg/4 ml amp (I)
Recommended Dose: Acute hypotension, by intravenous infusion, via central venous
catheter, of a solution containing noradrenaline acid tartrate 80 micrograms/mL (equivalent
to noradrenaline base 40 micrograms/mL) at an initial rate of 0.16–0.33 mL/minute, adjusted
according to response. Cardiac arrest, by rapid intravenous or intracardiac injection, 0.5–
0.75 mL of a solution containing noradrenaline acid tartrate 200 micrograms/mL (equivalent
to noradrenaline base 100 micrograms/mL)
Indications: Acute hypotension, Cardiac arrest
Contra-Indications: Hypertension (monitor blood pressure and rate of flow frequently);
pregnancy.
Special Precautions: Coronary, mesenteric, or peripheral vascular thrombosis; following
myocardial infarction, Prinzmetal's variant angina, hyperthyroidism, diabetes mellitus;
hypoxia or hypercapnia; uncorrected hypovolaemia; elderly; extravasation at injection site
may cause necrosis
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HAEMACCEL (MODIFIED POLYPEPTIDES - POLYGELINE)
Dosage Form: Injection 3.5% (II)
Recommended Dose: The usual dose is 500 to 1000 milliliters (mL), with total dosage not
to exceed 2500 mL daily (or approximately 20 mL/kg/day). Patients losing volumes of blood
greater 1500 mL will require blood transfusion other than polygeline and crystalloid
solutions.
Indications: Volume expander
Contra-Indications: Hypersensitivity to polygeline, Asthma, Histamine release
predisposition, Hemostatic defects, Cardiac failure, Hypercalcemia
Special Precautions Patients with impaired renal function, patients at risk of developing
pulmonary edema and/or congestive heart failure
PHENYLEPHRINE HCL
Dosage Form: Injection 1% (10 mg/ml) (I* - ICL & OT Cardiology)
Recommended Dose: SUBCUTANEOUSLY OR INTRAMUSCULAR: Usual dose, from
2mg to 5 mg. Range, from 1mg to 10mg. Initial dose should not exceed 5mg.
INTRAVENOUSLY: Usual dose, 0.2mg. Range, from 0.1mg to 0.5mg. Initial dose should
not exceed 0.5 mg. Injections should not be repeated more often than every 10 to 15
minutes. A 5 mg intramuscular dose should raise blood pressure for one to two hours. A 0.5
mg intravenously dose should elevate the blood pressure for about 15 minutes.
Indications: For the maintenance of an adequate level of blood pressure during spinal and
inhalation anesthesia. For the treatment of vascular failure in shock, shock–like states and
drug induced hypertension or hypersensitivity. To overcome paroxysmal supraventricular
tachycardia, to prolong spinal anesthesia and as a vasoconstrictor in regional analgesia.
Contra-Indications: Should not be used in patients with severe hypertension, ventricular
tachycardia or in patients who are hypersensitivity to it or to any of the components.
Special Precautions: Phenylephrine hydrochloride should be employed only with extreme
caution in elderly patients or in patients with hyperthyroidism, bradycardia, partial heart
block, myocardial disease or severe arteriosclerosis.
9.4. Antiarrhythmic Agents
ADENOSINE
Dosage Form: Injection 3 mg/ ml (2 ml vial) (I)
Recommended Dose: By rapid intravenous injection into central or large peripheral vein,
3 mg over 2 seconds with cardiac monitoring; if necessary followed by 6 mg after 1–2
minutes, and then by 12 mg after a further 1–2 minutes; increments should not be given if
high level AV block develops at any particular dose
Indications: Rapid conversion to a normal sinus rhythm of paroxysmal supraventricular
tachycardias, including those associated w/ accessory by-pass tract (Wolff-Parkinson-White
syndrome). Aid to diagnosis of broad or narrow complex supraventricular tachycardias.
Contra-Indications: second- or third-degree AV block and sick sinus syndrome (unless
pacemaker fitted); asthma
Special Precautions: atrial fibrillation or flutter with accessory pathway (conduction down
anomalous pathway may increase); heart transplant
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AMIODARONE HCL
Dosage Form: Tablet 200 mg; Injection 150 mg/3 ml (II)
Recommended Dose: By mouth, 200 mg 3 times daily for 1 week reduced to 200 mg twice
daily for a further week; maintenance, usually 200 mg daily or the minimum required to
control the arrhythmia.By intravenous infusion via central venous catheter, initially 5 mg/kg
over 20–120 minutes with ECG monitoring; subsequent infusion given if necessary
according to response up to max. 1.2 g in 24 hours.Ventricular fibrillation or pulseless
ventricular tachycardia, by intravenous injection over at least 3 minutes, 300 mg.
Indications: Treatment of tachyarrythmias associated with Wolff-Parkinson-White
syndrome, control of ventricular and supraventricular arrythmias, in management of angina
pectoris. Reserve for treatment of life-threatening arrythmias or which are unresponsive to
other drugs. Ventricular extra systoles, atrial or ventricular tachyarrythmias, flutter, atrial
fibrillation and ventricular fibrillation.
Contra-Indications: Sinus bradycardia, sino-atrial heart block; unless pacemaker fitted
avoid in severe conduction disturbances or sinus node disease; thyroid dysfunction; iodine
sensitivity; avoid intravenous use in severe respiratory failure, circulatory collapse (except in
cardiac arrest), severe arterial hypotension; avoid bolus injection in congestive heart failure
or cardiomyopathy; pregnancy; breast-feeding.
Special Precautions: Liver-function and thyroid-function tests required before treatment
and then every 6 months (see notes above for tests of thyroid function); serum potassium
concentration and chest x-ray required before treatment; heart failure; elderly; severe
bradycardia and conduction disturbances in excessive dosage; intravenous use may cause
moderate and transient fall in blood pressure (circulatory collapse precipitated by rapid
administration or overdosage) or severe hepatocellular toxicity (monitor transaminases
closely); porphyria.
b-Adrenoreceptor Blocking Agents (refer Antihypertensives)
Refer 9.7 Antihypertensive Agents.
LIGNOCAINE HCL
Dosage Form: Injection 100 mg/5 ml, 500 mg/5 ml (I)
Recommended Dose: By intravenous injection, in patients without gross circulatory
impairment, 100 mg as a bolus over a few minutes (50 mg in lighter patients or those whose
circulation is severely impaired), followed immediately by infusion of 4 mg/minute for 30
minutes, 2 mg/minute for 2 hours, then 1 mg/minute; reduce concentration further if infusion
continued beyond 24 hours (ECG monitoring and specialist advice for infusion.
Indications: Ventricular arrhythmias, especially after myocardial infarction
Contra-Indications: Sino-atrial disorders, all grades of atrioventricular block, severe
myocardial depression; porphyria.
Special Precautions: Lower doses in congestive cardiac failure, and following cardiac
surgery; elderly; hepatic impairment; renal impairment; pregnancy.
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PHENYTOIN SODIUM
Dosage Form: Capsule 30 mg, 100 mg; Suspension 30 mg/5 ml, 125 mg/5 ml; Injection 50
mg, 100 mg/2 ml, 250 mg/5 ml (II)
Recommended Dose: By slow IV inj: 3.5-5 mg/kg repeated if necessary at a rate not
exceeding 50 mg/min. Maintenance: orally 100-200 mg tds with or after food. ECG
monitoring recommended. For maximum benefit, dosage should be individualized.
Indications: Treatment of digitalis induced arrythmias of both the ventricular and
supraventricular types.
Contra-Indications: IV administration to patients with heart block, bradycardia, StokesAdams syndrome.
Special Precautions: Elderly, children, diabetes mellitus, impaired renal and hepatic
function, severe respiratory depression, hypotension, severe myocardial insufficiency. Avoid
extravasation, abrupt withdrawal, pregnancy. Discontinue if skin rash occurs.
VERAPAMIL HCL
Dosage Form: Tablet 40 mg; Injection 5 mg/2 ml (I)
Recommended Dose: By mouth, supraventricular arrhythmias (but see also Contraindications), 40–120 mg 3 times daily, Angina, 80–120 mg 3 times daily. Hypertension, 240–
480 mg daily in 2–3 divided doses. By slow intravenous injection over 2 minutes (3 minutes
in elderly), 5–10 mg (preferably with ECG monitoring); in paroxysmal tachyarrhythmias a
further 5 mg after 5–10 minutes if required.
Indications: Angina pectoris, hypertension, treatment of supraventricular arrythmias
(PSVT), atrial fibrillation, atrial flutter.
Contra-Indications: Hypotension, bradycardia, second- and third-degree AV block, sick
sinus syndrome, cardiogenic shock, sino-atrial block; history of heart failure or significantly
impaired left ventricular function, even if controlled by therapy; atrial flutter or fibrillation
complicating Wolff-Parkinson-White syndrome; porphyria.
Special Precautions: First-degree AV block; acute phase of myocardial infarction (avoid if
bradycardia, hypotension, left ventricular failure); patients taking beta-blockers; hepatic
impairment; children, specialist advice only; pregnancy and breast-feeding; avoid grapefruit
juice (may affect metabolism).
9.5. Vascular Sclerosants
SODIUM TETRADECYL SULPHATE
Dosage Form: Injection 3% in 1 ml ampule (I)
Recommended Dose: Slow injection into empty isolated segment of veins, 0.1-1ml
according to site and condition being treated
Indications: Sclerotherapy of vericose vein
Contra-Indications: Inability to walk, acute phlebitis, oral contraceptive use, obese legs
Special Precautions: Extravasation may cause necrosis of tissues.
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9.6. Cerebrovascular Agents
9.6.1. Peripheral Vasodilators
CINNARIZINE
Dosage Form: Tablet 25 mg (II)
Recommended Dose: Initially: 75 mg tds. Maintenance: 75 mg bd-tds.
Indications: Peripheral vascular disease, Raynaud's disease.
Special Precautions: In patients with hypotension, extra pyramidal symptoms, epilepsy,
prostatic hypertrophy, urinary retention, glaucoma and pyloroduodenal obstruction. Hepatic
disease and renal impairment.
PAPAVERINE HCL
Dosage Form: Injection 60 mg/2 ml (I)
Recommended Dose: Papaverine hydrochloride may be administered intravenously or
intramuscularly. The intravenous route is recommended when an immediate effect is
desired, but the drug must be injected slowly over the course of 1 or 2 minutes to avoid
uncomfortable or alarming side effects. Parenteral administration of papaverine
hydrochloride in doses of 1 to 4 mL is repeated every 3 hours as indicated. In the treatment
of cardiac extrasystoles, 2 doses may be given 10 minutes apart.
Indications: Papaverine is recommended in various conditions accompanied by spasm of
smooth muscle, such as vascular spasm associated with acute myocardial infarction
(coronary occlusion), angina pectoris, peripheral and pulmonary embolism, peripheral
vascular disease in which there is a vasospastic element, or certain cerebral angiospastic
states; and visceral spasm, as in ureteral, biliary, or gastrointestinal colic.
Contraindications: Intravenous injection of papaverine is contraindicated in the presence
of complete atrioventricular heart block. When conduction is depressed, the drug may
produce transient ectopic rhythms of ventricular origin, either premature beats or
paroxysmal tachycardia.
Papaverine hydrochloride is not indicated for the treatment of impotence by intracorporeal
injection. The intracorporeal injection of papaverine hydrochloride has been reported to
have resulted in persistent priapism requiring medical and surgical intervention.
Special Precautions: Should not be added to Lactated Ringer's Injection, because
precipitation would result.
Papaverine hydrochloride should be used with caution in patients with glaucoma. The
medication should be discontinued if hepatic hypersensitivity with gastrointestinal
symptoms, jaundice or eosinophilia becomes evident or if liver function test values become
altered.
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PENTOXIFYLLINE
Dosage Form: Tablet 400 mg (I)
Recommended Dose: 400 mg 2–3 times daily
Indications: Peripheral vascular disease.
Contra-Indications: Cerebral haemorrhage, extensive retinal haemorrhage, acute
myocardial infarction; pregnancy and breast-feeding.
Special Precautions: Hypotension, coronary artery disease; renal impairment, severe
hepatic impairment; avoid in porphyria.
9.7. Antihypertensive Agents
9.7.1. Centrally Acting Agents
METHYLDOPA
Dosage Form: Tablet 250 mg (II)
Recommended Dose: Initially 250 mg 2–3 times daily, increased gradually at intervals of 2
or more days, max. 3 g daily; elderly initially 125 mg twice daily, increased gradually, max.
2 g daily.
Indications: Hypertension.
Contra-Indications: Depression, active liver disease, phaeochromocytoma; porphyria
Special Precautions: History of liver impairment ; renal impairment; blood counts and liverfunction tests advised; history of depression; positive direct Coombs' test in up to 20% of
patients (may affect blood cross-matching); interference with laboratory tests.
9.7.2. Vasodilating Agents
HYDRALLAZINE HCL (@ DIHYDRALLAZINE)
Dosage Form: Injection 20 mg (II)
Recommended Dose: Hypertensive crisis; Adult: 5-10 mg via slow IV inj, repeated if
necessary after 20-30 min. Alternatively, as continuous IV, initial dose is 200-300 mcg/min.
Maintenance: 50-150 mcg/min.
Indications: Hypertensive crisis
Contra-Indications: Severe tachycardia, dissecting aortic aneurysm, heart failure with high
cardiac output, cor pulmonale, myocardial insufficiency due to mechanical obstruction,
coronary artery disease, idiopathic SLE. Patients with recent MI.
Special Precautions: Cerebrovascular disorders. Ischaemic heart disease. Hepatic or renal
impairment. May deplete pyridoxine in the body. May impair ability to drive or operate
machinery. Monitor for postural hypotension if given to patients with heart failure. Withdraw
gradually. CBC and antinuclear antibody tests should be carried out every 6 mth during
long-term therapy. Urine analysis is also recommended. Pregnancy and lactation. Daily
doses >100 mg may increase the risk of SLE especially in women and slow acetylators.
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SILDENAFIL
Dosage Form: Tablet 50 mg (II)
Criteria of use: For Pulmonary arterial hypertension only
Recommended Dose: Pulmonary arterial hypertension, Adult: 50-100 mg OD. 50 mg QID,
if developed nausea, headache, decreased dose; 12.5 mg QID for 1-2 week, then up to 12.5
mg 4 hourly. Peadiatric: 0.3–2 mg/kg/dose every 3-6 hour. Erectile Dysfunction: Adult: 50
mg OD taken approximately 1 hour before sexual activity. The dose may be increased to
100 mg/decreased to 25 mg. Max 100 mg OD. Elderly > 65 years old: initially 25 mg may
increase to 50-100 mg based on efficacy & toleration.
Indications: Pulmonary arterial hypertension &. Erectile Dysfunction
Contra-Indications: Patients receiving nitrates (in any form)/patients in whom
vasodilation/sexual activity are inadvisable (patients with severe cardiovascular disorders
e.g. unstable angina/ severe cardiac failure), severe hepatic impairment, hypotension (<
90/50mmHg), recent history of stroke/myocardial infarction, known hereditary degenerative
retinal disorders such as retinitis pigmentosa. Hypersensitivity to sildenafil.
Special Precautions: Anatomical deformation of the penis (angulation, cavernal fibrosis,
Peyronie's disease), Conditions predisposing patients to priapism (sickle cell anemia,
multiple myeloma, or leukemia), Bleeding disorders or active peptic ulceration/untreated
proliferative diabetic retinopathy, Retinitis pigmentosa or other retinal abnormality, Coronary
ischemia or congestive heart failure, Multi-drug antihypertensive regimens, Concurrent use
of erythromycin, cimetidine, or other drugs that could prolong the half-life of sildenafil,
coadministarion with ritonavir not advised,if necessary, max dose of sildenafil is 25mg/48
hours.
SODIUM NITROPRUSSIDE
Dosage Form: Injection 50 mg/ 5 ml ampule (I)
Recommended Dose: Adult Commence infusion at 0.5 mcg/kg/min & adjust in increments
of 0.5 mcg/kg/min every 5 mins until desired BP reduction is obtained. Patient not receiving
antihypertensive drugs 3 mcg/kg/min (range: 0.5-10 mcg/kg/min).
Indications: Immediate reduction of BP of patients in hypertensive crises. To produce
controlled hypotension during anesth to reduce bleeding.
Contra-Indications: Compensatory hypertension; physically poor-risk patients or w/
uncorrected anaemia or hypovolemia or those w/ known inadequate cerebral circulation.
Avoid sildenafil, tadalafil, vardenafil.
Special Precautions: Renal, hepatic or cerebrovascular impairment; low plasmacobalamin conc; Leber's optic atrophy; hypothyroidism, impaired cyanide metabolism,
hypothermia, stress.
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9.7.3. a,b-Adrenoreceptor Blocking Agents
ESMOLOL HCL
Dosage Form: Injection 100 mg/10ml (I)
Recommended Dose: SUPRAVENTRICULAR TACHYCARDIA
Dosage needs to be titrated, using ventricular rate as the guide. An initial loading dose of
0.5 milligrams/kg (500 micrograms/kg) infused over a minute duration followed by a
maintenance infusion of 0.05 milligrams/kg/min (50 micrograms/kg/min) for the next 4
minutes is recommended. This should give a rough guide with respect to the
responsiveness of ventricular rate. After the 4 minutes of initial maintenance infusion (total
treatment duration being 5 minutes), depending upon the desired ventricular response, the
maintenance infusion may be continued at 0.05 mg/kg/min or increased step-wise (e.g. 0.1
mg/kg/min, 0.15 mg/kg/min to a maximum of 0.2 mg/kg/min) with each step being
maintained for 4 or more minutes.
INTRAOPERATIVE AND POSTOPERATIVE TACHYCARDIA AND/OR HYPERTENSION
In the intraoperative and postoperative settings it is not always advisable to slowly titrate the
dose of BREVIBLOC (Esmolol Hydrochloride) to a therapeutic effect. Therefore, two dosing
options are presented: immediate control dosing and a gradual control when the physician
has time to titrate.
Immediate Control
For intraoperative treatment of tachycardia and/or hypertension give an 80 mg
(approximately 1 mg/kg) bolus dose over 30 seconds followed by a 150 mcg/kg/min
infusion, if necessary. Adjust the infusion rate as required up to 300 mcg/kg/min to maintain
desired heart rate and/or blood pressure.
Gradual Control
For postoperative tachycardia and hypertension, the dosing schedule is the same as that
used in supraventricular tachycardia. To initiate treatment, administer a loading dosage
infusion of 500 mcg/kg/min of BREVIBLOC for one minute followed by a four-minute
maintenance infusion of 50 mcg/kg/min. If an adequate therapeutic effect is not observed
within five minutes, repeat the same loading dosage and follow with a maintenance infusion
increased to 100 mcg/kg/min.
Indications: Supraventricular tachycardia, Intraoperative and postoperative tachycardia
and/or hypertension.
Contraindications: In patients with sinus bradycardia, heart block greater than first degree,
cardiogenic shock or overt heart failure.
Special Precautions: Because the acid metabolite of esmolol is primarily excreted
unchanged by the kidney, it should be administered with caution to patients with impaired
renal function. The elimination half-life of the acid metabolite was prolonged ten-fold and the
plasma level was considerably elevated in patients with end-stage renal disease.
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LABETALOL
Dosage form : Tablet 100 mg, Injection 25 mg/ 5 ml (II)
Recommended dose: By mouth, initially 100 mg (50 mg in elderly) twice daily with food,
increased at intervals of 14 days to usual dose of 200 mg twice daily; up to 800 mg daily in 2
divided doses (3–4 divided doses if higher); max. 2.4 g daily
By intravenous injection, 50 mg over at least 1 minute, repeated after 5 minutes if
necessary; max. total dose 200 mg
Indications: hypertension (including hypertension in pregnancy, hypertension with angina,
and hypertension following acute myocardial infarction); hypertensive crisis, controlled
hypotension in anaesthesia
Contra-Indications: asthma, uncontrolled heart failure, Prinzmetal's angina, marked
bradycardia, hypotension, sick sinus syndrome, second- or third- degree AV block,
cardiogenic shock, metabolic acidosis, severe peripheral arterial disease;
phaeochromocytoma (apart from specific use with alpha-blockers, see also notes above
Special Precautions: Severe hepatocellular damage reported after both short-term and
long-term treatment. Appropriate laboratory testing needed at first symptom of liver
dysfunction and if laboratory evidence of damage (or if jaundice) labetalol should be
stopped and not restarted
9.7.4. b-Adrenoreceptor Blocking Agents
ATENOLOL
Dosage Form: Tablet 50 mg, 100 mg (II)
Recommended Dose: For hypertension, 50 mg daily increase every week up to max of 200
mg. Maintenance: 100 mg daily. Angina: 100 mg daily. Arrythmias: 50-100 mg daily.
Indications: Hypertension, Angina, Arrhythmias
Contra-Indications: Asthma (important: see Bronchospasm below), uncontrolled heart
failure, Prinzmetal's angina, marked bradycardia, hypotension, sick sinus syndrome,
second- or third- degree AV block, cardiogenic shock, metabolic acidosis, severe peripheral
arterial disease; phaeochromocytoma (apart from specific use with alpha-blockers, see also
notes above)
Special Precautions: Avoid abrupt withdrawal especially in ischaemic heart disease; firstdegree AV block; portal hypertension (risk of deterioration in liver function); diabetes; history
of obstructive airways disease (introduce cautiously and monitor lung function—see also
Bronchospasm below); myasthenia gravis; history of hypersensitivity—may increase
sensitivity to allergens and result in more serious hypersensitivity response, also may
reduce response to adrenaline (epinephrine) see also notes above; reduce dose of oral
propranolol in hepatic impairment; renal impairment, pregnancy, breast-feeding.
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BISOPROLOL FUMARATE
Dosage Form: Tablet 2.5 mg, 5 mg (I)
Recommended Dose: For hypertension, 2.5 mg – 20 mg. Usual dose: 5 mg daily, increase
gradually to achieved an optimum effect by a few days for a several weeks. Angina: 5-20
mg daily.
Indications: Hypertension and angina
Contra-Indications: Cardiogenic shock, Hypersensitivity to bisoprolol, Overt cardiac
failure, Second and third degree AV block, Severe sinus bradycardia
Special Precautions: Anaesthesia / surgery (myocardial depression), Avoid abrupt
withdrawal, gradual withdrawal over a period of 1-2 weeks is recommended ( when
discontinued: decrease gradually to avoid rebound hypertension / angina and other severe
cardiovascular problem (myocardial infarction, arrhytemias, sudden death), Bronchospastic
disease, Congestive heart failure,Diabetes mellitus, Hepatic disease, Hyperthyroidism /
thyrotoxicosis, Peripheral vascular disease, Renal disease
CARVEDILOL
Dosage Form: Tablet 6.25 mg, 25 mg (I)
Recommended Dose: Hypertension, initially 12.5 mg once daily, increased after 2 days to
usual dose of 25 mg once daily; if necessary may be further increased at intervals of at least
2 weeks to max. 50 mg daily in single or divided doses; elderly initial dose of 12.5 mg daily
may provide satisfactory control. Angina, initially 12.5 mg twice daily, increased after 2 days
to 25 mg twice daily
Adjunct in heart failure (section 2.5.5) initially 3.125 mg twice daily (with food), dose
increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily,
then to 25 mg twice daily; increase to highest dose tolerated, max. 25 mg twice daily in
patients with severe heart failure or body-weight less than 85 kg and 50 mg twice daily in
patients over 85 kg
Indications: Hypertension; angina; adjunct to diuretics, digoxin, or ACE inhibitors in
symptomatic chronic heart failure
Contra-Indications: Asthma, uncontrolled heart failure, Prinzmetal’s angina, marked
bradycardia, hypotension, sick sinus syndrome, 2nd or 3rd degree AV block, cardiogenic
shock, metabolic acidosis, severe peripheral arterial disease, phaeochromocytoma, hepatic
impairment.
Special Precautions: Before increasing dose, ensure renal function and heart failure not
deteriorating. Avoid in acute or decompensated heart failure requiring intravenous inotropes.
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METOPROLOL TARTRATE
Dosage Form: Tablet 100 mg (II)
Recommended Dose: Oral: For hypertension: Initially 50-100 mg bd for 1 week.
Maintenance: 100-200 mg bd. Angina: 50-100 mg bd-tds. Hyperthyroidism: 50 mg qid.
Arrythmias: 50 mg bd-tds up to 300 mg daily if necessary, in divided doses. Injection: up to
5 mg at rate 1-2 mg/min, repeated after 5 min if necessary, toatal dose of 10-15 mg.
Surgery: 2-4 mg by slow IV inj. at induction or to control arrythmias developing during
anaesthesias; 2 mg doses may be repeated to a max of 10 mg. Early intervention within 12
hrs of infarction, 5 mg by IV inj. every 2 min to a max of 15 mg followed after 15 min by 15
mg p.o q 6 hourly for 48 hrs.
Indications: Hypertension, as monotherapy or in combination with diuretic. In angina
pectoris. Adjunct treatment of hyperthyroidism and arrythmias. Migraine prophylaxis.
Contra-Indications: AV block, severe bradycardia, cardiogenic shock, heart failure, acute
MI.
Special Precautions: Withdrawal of drug should be gradual, pregnancy, sinus bradycardia,
surgery, diabetes, thyrotoxicosis, CHF.
PROPRANOLOL HCL
Dosage Form: Tablet 10 mg, 40 mg; Injection 1 mg/ml (1 ml amp) (II)
Recommended Dose: For hypertension: initially 40 mg bd increase at weekly intervals,
when necessary; maintenance 160-320 mg daily. Angina: initially 10 mg bd-qid;
maintenance 120-240 mg daily. Migraine: tremor initially 40 mg bd-tds; maintenance 80-160
g daily. Cardiac arrythmias: 10-40 mg tds-qid. Pheochromocytoma (concurrent with alphaadrenoceptor blockade): 60 mg daily for 3 days; maintenance 30 mg daily. For emergency
treatment of cardiac arrythmias: slow IV 1mg over 1 min, repeated if necessary every 2 min
up to max of 10 mg (5 mg in anaesthesia). Atropine IV 1-2 mg should be given before
injecting propranolol.
Indications: Hypertension, angina pectoris, cardiac arrythmias, prevention of migraine,
essential tremor, pheochromocytoma, SVT, hyperthyroidism, anxiety or stage fright.
Contra-Indications: AV block, bronchospasm, metabolic acidosis, concomitant
administration of verapamil, sinus bradycardia, in anaesthesia with agents that produce
myocardial depression. Hypoglycemia. IV administration in hypertension. Bronchial asthma,
diabetes, allergic rhinitis, Raynaud's disease, peripheral vascular disease, venom-sensitive
patients.
Special Precautions: In patients undergoing anaesthesia: either gradual withdrawal of drug
24 hrs before or protect patient against bradycardia by IV atropine of 1-2mg and avoid
agents causing myocardial depression. Reduce dosage in renal failure. Withdrawal of drug
should be gradual. Propranolol is not suitable for emergency treatment of hypertension.
Reduce oral dose in liver disease, late pregnancy and during breast-feeding. Given to
congestive heart failure only when patient is fully digitalised and with great caution.
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SOTALOL HCL
Dosage Form: Tablet 80 mg (I* - Physician)
Recommended Dose: By mouth with ECG monitoring and measurement of corrected QT
interval, arrhythmias, initially 80 mg daily in 1–2 divided doses increased gradually at
intervals of 2–3 days to usual dose of 160–320 mg daily in 2 divided doses; higher doses of
480–640 mg daily for life-threatening ventricular arrhythmias under specialist supervision
Indications: Hypertension, angina pectoris, thyrotoxicosis, arrhythmia, MI.
Contra-Indications: Bronchial asthma, COPD, cardiogenic shock, right ventricular failure
secondary to hypertension, severe sinus bradycardia, > 1st degree heart block, uncontrolled
CHF, renal failure.
Special Precautions: Prolonged fasting, diabetic ketoacidosis, metabolic acidosis, heart
rate at rest < 50 beats/min, surgery, anaesth that cause myocardial depression, history of
bronchial asthma, bronchospasm, abrupt w/drawal; IDDM. Monitor electrolyte balance.
9.7.5. a-Adrenoreceptor Blocking Agents
ALFUZOSIN
Dosage Form: Tablet XL 10 mg (I* - Urologist)
Recommended Dose: Adults : 10mg once daily
Indications: Treatment of functional symptoms of benign prostatic hypertrophy. Adjuvant
treatment to a catheter in acute urinary retention related to benign prostatic hypertrophy.
Contra-Indications: Alpha-blockers should be avoided in patients with a history of postural
hypotension and micturition syncope.
Special Precautions: Since selective alpha-blockers reduce blood pressure, patients
receiving antihypertensive treatment may require reduced dosage and specialist
supervision. Caution may be required in the elderly and in patients with hepatic impairment
and severe renal impairment.
DOXAZOSIN
Dosage Form: Tablet XL 4 mg (as mesylate) (I* - Urologist)
Recommended Dose: BPH 4 mg once daily. HTN 4 mg once daily, may increase to 8 mg
after 4 wk.
Indications: Urinary outflow obstruction & symptoms associated w/ benign prostatic
hyperplasia (BPH). Hypertension (HTN).
Contra-Indications: Hypersensitivity to quinazolines. History of GI obstruction,
oesophageal obstruction, pregnancy & lactation.
Special Precautions: Pregnancy, lactation. Impaired liver function, postural hypotension.
GI disorders.
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PRAZOSIN HCL
Dosage form : Tablet 1mg, 2mg (II)
Recommended dose: Hypertension, 500 micrograms 2–3 times daily for 3–7 days, the
initial dose on retiring to bed at night (to avoid collapse, see Cautions); increased to 1 mg 2–
3 times daily for a further 3–7 days; further increased if necessary to max. 20 mg daily in
divided doses. Congestive heart failure, 500 micrograms 2–4 times daily (initial dose at
bedtime, see above), increasing to 4 mg daily in divided doses; maintenance 4–20 mg daily
in divided doses (but rarely used). Raynaud's syndrome (but efficacy not established )
initially 500 micrograms twice daily (initial dose at bedtime, see above) increased, if
necessary, after 3–7 days to usual maintenance 1–2 mg twice daily
Indications: See under Dose
Contra-Indications: Not recommended for congestive heart failure due to mechanical
obstruction (e.g. aortic stenosis)
Special Precautions First dose may cause collapse due to hypotension (therefore should
be taken on retiring to bed); elderly; hepatic impairment, renal impairment, pregnancy,
breast-feeding.
TERAZOSIN HCL
Dosage Form: Tablet 1 mg, 2 mg, 5 mg (I*)
Recommended Dose: Benign prostatic hyperplasia (BPH) Initially 1 mg at bedtime,
increase in a stepwise fashion to 2 mg, 5 mg or 10 mg once daily. Hypertension Initially 1
mg at bedtime. Dose range 1-5 mg once daily.
Indications: Symptomatic benign prostatic hyperplasia (BPH). Hypertension.
Contra-Indications: Pregnancy.
Special Precautions: May impair ability to drive or operate machinery. Lactation.
9.7.6. Angiotensin Converting Enzyme-Inhibitors
CAPTOPRIL
Dosage Form: Tablet 25 mg (II)
Recommended Dose: Hypertension: initially 12.5 mg twice daily. With diuretic, elderly,
renal impairment: initially 6.25 mg bd (first dose at bedtime). Maintenance: 25 mg twice
daily. Max: 450 mg/day. Heart failure: initially 6.25-12.5 mg with a diuretic. Maintenance: 25
mg tds.
Indications: Treatment of hypertension and CHF where other therapy has failed.
Contra-Indications: Bilateral or unilateral renal artery stenosis. Hereditary or idiopathic
angioedema associated w/ previous treatment w/ ACE inhibitor. Hemodialysis. Pregnancy &
lactation.
Special Precautions: May get a severe fall in blood pressure in sodium-depleted patients,
on diuretics or under-going dialysis. Reduce dose or avoid in renal impairment. Serious
autoimmune disease including SLE. Patients on immunosurpressants. Hyperkalaemia.
Renal artery stenosis. Surgery/anaesthesia. Withraw if angioedema or laryngeal stridor
occurs.
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ENALAPRIL MALEATE
Dosage Form: Tablet 5 mg, 20 mg (I)
Recommended Dose: Initially: 5 mg daily. Maintenance: 10-30 mg daily. Max of 40 mg
daily.
Indications: Treatment of hypertension and CHF.
Contra-Indications: Hypersensitivity.
Special Precautions: Reduce dose in patients with renal impairment, symptomatic
hypotension, pregnancy and lactation. Febrile illness.
PERINDOPRIL ERBUMINE
Dosage Form: Tablet 4mg, 8mg (II)
Recommended Dose: Hypertension: 2mg daily. Usual maintenance dose 4mg once daily;
maximum 8mg daily. CHF (adjunct): Initial dose 2mg in the morning under close medical
supervision; maintenance 4 mg daily
Indications: Treatment of essential and renovascular hypertension and CHF (adjunct)
Contra-Indications: Bilateral or unilateral renal artery stenosis. Hereditary or idiopathic
angioedema associated with precious treatment with ACE inhibitor. Hemodialysis.
Pregnancy & lactation.
Special Precaution: Renal & hepatic impairment, collagen vascular disease, diabetic,
surgery & anaesthetic. Children. Elderly.
PERINDOPRIL ERBUMINE + INDAPAMIDE
Dosage Form: Tablet 4 mg + 1.25 mg (II)
Recommended Dose: 1 tablet daily.
Indications: Treatment of essential hypertension.
Contra-Indications: Bilateral renal artery stenosis or single functioning kidney, severe renal
failure (CrCl <30 mL/min), dialysis patients, hepatic encephalopathy, severe hepatic
impairment, hyperkalaemia or hypokalaemia, untreated decompensated cardiac
insufficiency. Avoid combinations w/ K-sparing diuretics, K salts, lithium & nonantiarrhythmic drugs causing torsades de pointes. Previous history of angioneurotic oedema
linked to treatment w/ ACE inhibitor; hereditary or idiopathic angioneurotic oedema.
Pregnancy & lactation.
Special Precautions: Renal insufficiency esp when associated w/ systemic autoimmune
collagen vascular diseases eg SLE or scleroderma. Concomitant treatment w/
immunosuppressants or treatment causing leukopenia. Marked Na & water depletion,
hypotension, CHF, cirrhosis w/ oedema & ascites, ischaemic heart disease, cerebral
circulatory insufficiency, severe cardiac insufficiency (grade IV) or IDDM patients. Monitor
serum K regularly. Surgery. Elderly. May impair ability to drive or operate machinery.
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RAMIPRIL
Dosage Tablet 2.5 mg, 5 mg (I)
Recommended Dose: It is recommended Ramipril is taken ones daily, starting with dose of
2.5 mg and then the dose be doubled at intervals of 2-3 weeks if necessary, and depending
on the patient’s responses. The usual maintenance dose is 2.5-5 mg daily where the
maximum permitted daily dose is 10 mg. In patients with impaired renal function, ie a
creatinine clearance between 50 and 20 ml/min/1.73 body surface area, the initial dose is
generally reduced to 1.25 mg. The maximum permitted daily dose is 5mg in such cases.
Indications: Hypertension
Contra-Indications: Hypersensitivity to Ramipril or any of recipients, allergy to starch,
patients with a history of angioneuratic oedema, flow reducing narrowing of the renal artery,
bilateral or unilateral in the single kidney. Ramipril must not be taken during pregnancy
Special Precautions: Requires regular medical supervision. It is recommended that
dehydration ,reduced blood volume or salt deficiency be corrected before initiating treatment
( in patients with concomitant heart failure however, this must be carefully weighed against
the risk of volume overload )
9.7.7. Angiotensin-II Receptor Antagonists
AMLODIPINE BESYLATE + VALSARTAN
Dosage Form: Tablet 5 mg + 80 mg, 5 mg + 160 mg, 10 mg + 160 mg (I)
Recommended Dose: 1 tab/day
Indications: Essential hypertension where BP is not adequately controlled on
antihypertensive monotherapy
Contra-Indications: Pregnancy
Special Precautions: Risk of hypotension in Na- &/or vol-depleted patients. ß-blocker
w/drawal should be gradual. Severe renal impairment (CrCl <10 mL/min), dialysis.
Unilateral/bilateral renal artery stenosis, stenosis to a solitary kidney, after recent kidney
transplantation, hepatic impairment, biliary obstructive disorders. Aortic or mitral stenosis,
obstructive hypertrophic cardiomyopathy. May impair ability to drive or operate machinery.
Avoid in women planning a pregnancy, lactation. Childn <18 yr
IRBESARTAN
Dosage Form: Tablet 150 mg, 300 mg (II)
Recommended Dose: Initial and recommended dose: 150 mg once daily. Maybe increased
to 300 mg or other antihypertensive agents may be added. In volume depleted patients,
correct prior to administration. Elderly >75 yrs and hemodialysis patients, consider initiating
with 75 mg.
Indications: Essential hypertension.
Contra-Indications: Pregnancy and lactation
Special Precautions: Increased risk of severe hypotension in patients with renal artery
stenosis. Monitoring of plasma-potassium concentration and serum creatinine in the elderly
and patients with renal impairment (lower initial doses may be more appropriate); Monitoring
of serum-potassium in heart failure patients.
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IRBESARTAN + HYDROCHLOROTHIAZIDE
Dosage Form: Tablet 150 mg + 12.5 mg, 300 mg +12.5 mg, 300 mg + 25 mg (II)
Criteria of use: Restricted for patients who not responding to Irbesartan monotherapy
Recommended dose: 1 tab once daily
Indications: Treatment of essential HTN in patients whose BP is inadequately controlled
on irbesartan or hydrochlorothiazide alone
Contra-Indications: Pregnancy, anuria and prior hypersensitivity to irbersartan or other
Angiotensin II receptor blocking agents or thiazide diuretics
Special Precautions: Patients with history of hypersensitivity to sulphonamide and derived
medication, sodium or volume depleted patients, electrolyte abnormalities
LOSARTAN
Dosage Form: Tablet 50 mg, 100 mg (II)
Recommended Dose: Initially 50 mg once daily. May increase to 100 mg once daily.
Intravascular volume depletion: Starting dose 25 mg. History of hepatic impairment: lower
doses.
Indications: Hypertension
Contra-Indications: Pregnancy
Special Precautions: Increased risk of severe hypotension in patients with renal artery
stenosis. Monitoring of plasma-potassium concentration and serum creatinine in the elderly
and patients with renal impairment (lower initial doses may be more appropriate); cirrhosis
and hepatic impairment, changes in renal function, lactation and children.
LOSARTAN + HYDROCHLOROTHIAZIDE
Dosage Form: Tablet 50 mg + 12.5 mg, 100 mg + 25 mg (II)
Recommended Dose: Fixed-dose combination is not indicated for initial therapy. A patient
not adequately controlled with losartan monotherapy or hydrochlorothiazide (HCTZ) 25 mg
daily may be switched to losartan/HCTZ 50/12.5 mg once daily. If after 3 weeks blood
pressure remains elevated, then dose may be increase to 100/25 mg. Maximal
antihypertensive effects are attained after approximately 3 weeks. More than 100/25 mg
daily is not recommended. Losartan/HCTZ may be administered with or without food.
Indication: Treatment of hypertension where combination therapy is appropriate.
Contra-Indications: Intravascularly volume depleted, severe renal impairment, hepatic
impairment, anuria, hypersensitivity to other sulfonamide-derived drugs, pregnancy.
Special Precautions: Bilateral renal artery stenosis or stenosis of the artery to a solitary
kidney, hypotension and electrolyte or fluid inbalance. Dosage adjustments in antidiabetic
agents including insulins may be required. Hyperparathyroidism, SLE, lactation, children.
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TELMISARTAN
Dosage Form: Tablet 40 mg, 80 mg (I)
Recommended Dose: Treatment of essential HTN Adult 20-40 mg once daily. Max: 80
mg once daily w/ or w/o diuretic. Severe HTN 160 mg alone or in combination w/ 12.5-25
mg hydrochlorothiazide. CV risk reduction Recommended dose: 80 mg once daily. Dose
may be adjusted depending on patient's BP.
Indication: Treatment of essential HTN. Reduction of the risk of MI, stroke or death in
patients ≥55 yr at high risk of CV events (history of coronary/peripheral arterial disease,
stroke, transient ischemic attack, diabetes). May be used as additonal treatment to
antihypertensive, antiplatelet or lipid-lowering therapy.
Contra-Indications: Biliary obstructive disorders, severe hepatic impairment. Pregnancy
(2nd & 3rd trimesters), lactation.
Special Precautions: Bilateral renal artery stenosis or stenosis of the artery to a single
functioning kidney, vol &/or Na depletion, severe CHF, aortic or mitral valve stenosis,
obstructive hypertrophic cardiomyopathy, hepatic insufficiency. Monitor serum K &
creatinine in renally impaired patients. Rare hereditary condition of fructose intolerance.
VALSARTAN
Dosage Form: Tablet 80 mg, 160 mg (II)
Recommended Dose: Hypertension, usually 80 mg once daily (elderly over 75 years, mild
to moderate hepatic impairment, moderate to severe renal impairment, intravascular volume
depletion, initially 40 mg once daily); if necessary increased after at least 4 weeks to 160 mg
daily. Myocardial infarction, initially 20 mg twice daily increased over several weeks to
160 mg twice daily if tolerated (consider lower dose in mild to moderate hepatic impairment)
Indication: Hypertension; myocardial infarction with left ventricular failure or left ventricular
systolic dysfunction
Contra-Indications: Severe hepatic impairment, cirrhosis, biliary obstruction, breastfeeding
Special Precautions: Severely sodium- or volume-depleted patients. No adjustment is
required for patients with renal impairment. However, in severe cases (creatinine clearance
< 10ml/min) no data are available and therefore caution is advised. Hepatic insufficiency,
Valsartan is mostly eliminated unchanged in the bile and patients with biliary obstructive
disorders showed lower Valsartan clearance, caution when driving or operating machinery,
children, lactation.
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VALSARTAN + HYDROCHLOROTHIAZIDE
Dosage Form: Tablet 80 mg + 12.5 mg, 160 mg + 12.5 mg, 160 mg + 25 mg (II)
Recommended Dose: 1 tablet daily. May be taken with or without food.
Indications: Treatment of Hypertension.
Contra-Indications: Pregnancy, severe hepatic impairment, biliary cirrhosis & cholestasis.
Anuria, severe renal impairment. Refractory hypokalaemia, hyponatraemia, hypercalcaemia
& symptomatic hyperuricaemia.
Special Precautions: Risk of hypotension in Na &/or vol depleted patients, renal artery
stenosis, renal & liver disease; disturbance of serum electrolyte balance. Caution when
driving or operating machinery. Lactation (avoid).
9.8. Inotropic Agents
9.8.1. Cardiac Glycosides (positive inotropic)
DIGOXIN
Dosage Form: Tablet 0.0625 mg, 0.25 mg; Elixir 50 mcg/ml; Injection 500 mcg/2 ml (II)
Recommended Dose: Adults and children over 10 yrs: Rapid digitalisation of 1-1.5 mg
followed by 0.25 mg every 6 hrs until desired therapeutic effect. Slow oral digitalisation: 0.51 mg daily over 1-3 weeks. Emergency parenteral digitalisation: slow IV inj. 0.5-1 mg
followed by 0.5 mg after few hours and repeated if necessary. Maintenance (all routes):
0.25-0.75 mg daily in divided doses. Infants and children under 10 yrs: Digitalisation (all
routes) 0.020 mg/kg repeated every 6 hrs until desired therapeutic effect. Maintenance
0.010-0.020 mg/kg is given daily foe few days. Geriatrics: Rapid oral digitalisation: 0.5-0.75
mg every 4-6 hrs, maintenance 0.125-0.5 mg daily. OR initial oral/IV loading doses of 10
mcg/kg of LBW followed with maintenance oral doses of 0.125-0.5 mg/day as a single daily
dose and adjusted according to desired serum concentrations. Paediatrics: individualised
and age-dependent ranging from loading doses of 8-12 mcg/kg/dose to 35-60mcg/kg/dose
with maintenance doses calculated as 25% to 35% of the oral loading dose.
Indications: Congestive heart failure. Cardiac arrythmias especiallly atrial fibrillation or
flutter.
Contra-Indications: Toxicity due to cardiac glycosides. In ventricular arrythmias. In patients
with Wolff-Parkinson-White Syndrome with atrial fibrillation.
Special Precautions: In heart block, severe pulmonary disease, advanced heart failure,
acute myocarditis. Patients on cardiac glycosides previously, reduce dosage in impaired
renal function, in elderly and in premature infants. Enhance effects in hypokalaemia,
hypercalcaemia, hypoxia, hypothyroidism and hypomagnesaemia. Bioavailability of the
various dosage forms must be considered when switching to a different preparation.
Cardioversion. Amiloid cardiomyopathy.
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9.8.2. Sympathomimetics
9.8.2.1 Inotropic
DOBUTAMINE HCL
Dosage Form: Injection 250 mg/20 ml (vial) (I)
Recommended Dose: By IV infusion: 1.0-10.0 mcg/kg/min adjusted according to response.
On rare occasions, infusion rates up to 40 mcg/kg/min have been required.
Indications: For inotropic support in the short-term treatment of adults with cardiac
decompensation due to depressed contractility resulting from organic heart disease (chronic
low-output cardiac failure or acute myocardial failure) or cardiac surgical procedures.
Contra-Indications: Idiopathic Hypertropic Subaortic Stenosis (IHSS).
Special Precautions: Continuous monitoring of ECG & BP required. Patients with
hypertension, myocardial infarction, arteriosclerosis, inotropic effect reversed by
concomitant administration of beta-blockers. Patients with atrial fibrillation should be
digitalised prior to adminstration of dobutamine. Hypovolaemia should be corrected with
suitable volume expanders prior treatment.
DOPAMINE HCL
Dosage Form: Injection 40 mg/ml (5 ml ampoule) (II)
Recommended Dose: By IV infusion: initially 1-5 mcg/kg/min, gradually increased by 1-4
mcg/kg/min at 10-30 min intervals, up to 20-50 mcg/kg/min. In advanced states of
circulatory decompensation, infusion rates of > 50 mcg/kg/min have been used. Paediatric:
0.3-25 mcg/kg/min as a continuous infusion to a maximum of 50 mcg/kg/min.
Indications: For correction of haemodynamic imbalances present in the shock syndrome
due to myocardial infarction, traumas, endotoxic septicaemia, open heart surgery, renal
failure and chronic cardiac decompensation, when patients do not respond to plasma
volume expansion.
Contra-Indications: Pheochromocytoma or uncorrected tachyarrythmias or ventricular
fibrillation.
Special Precautions: Hypovolaemia should be corrected prior to treatment. Use with
caution in patients with ischemic heart disease. Low dose in shock due to acute myocardial
infarction. When dose > 50 mg/kg/min are employed, urine output should be measured
frequently. Avoid extravasation of drug. MAO inhibitors. Angina. Peripheral vascular
disorders (dopamine can produce peripheral gangrene).
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9.8.2.2 Vasoconstrictor
EPHEDRINE
Dosage Form: Injection 30 mg/ml (II)
Recommended Dose: IM, SC or IV Severe, acute bronchospasm 12.5-25 mg. When used
as a pressor agent Adult 25-50 mg SC/IM. If necessary, a 2nd IM dose of 50 mg or an IV
dose of 25 mg may be given. Direct IV inj, 10-25 mg may be given slowly. Max parenteral
adult dose: 150 mg in 24 hr. Childn 3 mg/kg or 100 mg/m2 SC or IV daily, in 4-6 divided
doses.
Indications: Treatment of bronchial spasm in asthma & to produce cardiac stimulation &
vasoconstriction in the treatment of shock. Adjunct to correct haemodynamic imbalances
which persist after adequate fluid vol replacement. Treat hypotension during spinal anaesth.
Contra-Indications: Closed-angle glaucoma. Patients being treated w/ MAOIs or w/in 10
days of ceasing such treatment. Coronary thrombosis, HTN & hyperthyroidism.
Special Precautions: Geriatric males (esp those w/ an enlarged prostate), diabetics, &
patients w/ CV disease. Patients receiving chloroform, cyclopropane, halothane or other
halogenated anaesth.
NORADRENALINE (NOREPINEPHRINE) BITARTRATE
Dosage Form: Injection 4 mg/4 ml amp (I)
Recommended Dose: Acute hypotension, by IV infusion, via central venous catheter, of a
solution containing norepinephrine acid tartrate 80mcg/ml (equivalent to norepinephrine
base 40 mcg/ml) at a intial rate of 0.16-0.33ml/minute, adjusted according to response.
Indications: Acute hypotension
Contra-Indications: Pregnancy, hypertension
Special Precautions: Coronary, mesenteric, or peripheral vascular thrombosis; following
myocardial infarction, Prinzmetal’s variant angina, thyroid disease, diabetes mellitus;
hypoxia or hypercapnia; appropriate blood volume replacement required; elderly;
extravasation at injection site may cause necrosis.
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PHENYLEPHRINE HCL
Dosage Form: Injection 1% (10 mg/ml) (I*- ICL & OT Cardiology)
Recommended Dose: SUBCUTANEOUSLY OR INTRAMUSCULAR: Usual dose, from
2mg to 5 mg. Range, from 1mg to 10mg. Initial dose should not exceed 5mg.
INTRAVENOUSLY: Usual dose, 0.2mg. Range, from 0.1mg to 0.5mg. Initial dose should
not exceed 0.5 mg. Injections should not be repeated more often than every 10 to 15
minutes. A 5 mg intramuscular dose should raise blood pressure for one to two hours. A 0.5
mg intravenously dose should elevate the blood pressure for about 15 minutes.
Indications: For the maintenance of an adequate level of blood pressure during spinal and
inhalation anesthesia. For the treatment of vascular failure in shock, shock–like states and
drug induced hypertension or hypersensitivity. To overcome paroxysmal supraventricular
tachycardia, to prolong spinal anesthesia and as a vasoconstrictor in regional analgesia.
Contra-Indications: Should not be used in patients with severe hypertension, ventricular
tachycardia or in patients who are hypersensitivity to it or to any of the components.
Special Precautions: Phenylephrine hydrochloride should be employed only with extreme
caution in elderly patients or in patients with hyperthyroidism, bradycardia, partial heart
block, myocardial disease or severe arteriosclerosis.
9.8.2.3 Cardiopulmonary resuscitation
ADRENALINE ACID (EPINEPHRINE) TARTRATE
Dosage Form: Injection 1 mg/ml (1 ml ampoule) (II)
Recommended Dose: By SC, IM: 0.5-1 ml of 1 in 1000 solution diluted to 10 ml or 5-10 ml
of 1 in 10000 solution every 5 min. By intracardiac 1-2 mg per 10 ml. By IV, 0.1-0.25 mg
given slowly and repeat 5-15 min if necessary.
Indications: In cardiac resuscitation procedures.
Contra-Indications: In narrow angle glaucoma. Shock (other than anaphylactic shock),
organic heart disease, organic brain damage or cerebral arterio sclerosis.
Special Precautions: Diabetes, cardiovascular disease, geriatric patients, hyperthyroidism.
Avoid IV use with tricyclic antidepressant digoxin or quinidine because of the risk of
arrythmia.
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ISOPRENALINE HCL
Dosage Form: Injection 1 mg/5 ml ampoule (I)
Recommended Dose: For shock: By IV infusion: 0.5-5 mcg/min (0.25-2.5 ml diluted
solution 1:500000) up to 30 mcg/min if necessary. For management of broncospasm during
anaesthesia by IV inj. 0.01-0.02 mg (0.5-1 ml diluted solution 1:50000) repeated when
necessary. For cardiac standstill/arrythmias: By IV inj: 0.02-0.06 mg (1-3 ml of diluted
solution 1:50000) IV infusion 5 mcg/min (1.25 ml) of diluted solution 1:250000. By IM: 0.02-1
mg, SC: 0.15-0.2 mg.
Indications: Adjunct in management of shock treatment of cardiac standstill or arrest,
carotid sinus-stokes, ventricular tachycardia and arrythmias. Management of
bronchospasm, cardiac arrythmias.
Contra-Indications: Preexisting cardiac arrythmias and tachycardia caused by digitalis
intoxication. Concurrent administration with halogenated anaesthesia.
Special Precautions: Never give simultaneously with adrenaline, but may be used
alternately. Correct hypovolaemia prior to or during treatment. Monitor carefully patients in
shock. Use with caution in el inhibitors. Angina. Peripheral vascular disorders (dopamine
can produce peripheral gangrene).
9.9. Hypolipidaemic Products
ATORVASTATIN
Dosage Form: Tablet 10 mg, 20 mg (I)
Recommended Dose: Initially 10 mg once daily. Dose range: 10-80 mg once daily.
Indications: Reduction of elevated total & LDL cholesterol, apolipoprotein B & triglycerides
in patients with primary hypercholesterolaemia, mixed hyperlipidaemia, heterozygous &
homozygous familial hypercholesterolaemia.
Contra-Indications: Active liver disease or elevated serum transaminases > 3 times the
upper limit of normal. Pregnancy & lactation.
Special Precautions: Monitor of creatine phosphokinase & transaminase elevations. Avoid
alcohol consumption.Patients should be advised to report unexplained muscle pain.
CHOLESTYRAMINE
Dosage Form: Anhydrous powder 4g/sachet (I)
Recommended Dose: 4g tds-qid, to be mixed with 2-6 ounces of water or other fluids, up
to 36 g daily in some cases. Child over 6 yrs: 80 mg/kg tds.
Indications: Hypercholesterolaemia, pruritus associated with partial biliary obstruction,
intractable infantile diarrhoeas and those that are due to bile acid malabsorption.
Contra-Indications: Complete biliary obstruction, pregnancy, hyperlipoproteinaemia types
III, IV or V
Special Precautions: Other drugs should be taken one hour before or 4 hrs after
administration of cholestyramine. Give Vit. A, D and K supplements on prolonged therapy.
Should not be taken in its dry form.
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EZETIMIBE
Dosage Form: Tablet 10 mg (II)
Criteria of use: Follow malaysian lipid clinical practice guidelines and previously on
maximum dose of statins
Recommended Dose: 10 mg once daily, used alone or w/ a statin. When co-administered
w/ a statin, the dosage instructions for that particular statin should be consulted.
Indications: Administered alone or w/ an HMG-CoA reductase inhibitor (statin) indicated as
adjunctive therapy to diet in patients w/ primary (heterozygous familial & non-familial)
hypercholesterolemia. Administered w/ a statin for patients w/ homozygous familial
hypercholesterolemia. Patients may also receive adjunctive treatments (eg, LDL apheresis).
Reduction of elevated sitosterol & campesterol levels in patients w/ homozygous familial
sitosterolemia.
Contra-Indications: Hypersensitivity. Combination w/ an HMG-CoA reductase inhibitor is
contraindicated in patients w/ active liver disease or unexplained persistent elevations in
serum transaminases.
Special Precautions: When co-administered w/ a statin, perform liver function tests at
baseline & according to the recommendations of the statin. Not recommended for moderate
or severe liver dysfunction. Co-administration w/ fibrates not recommended. Caution when
initiating Ezetrol in the setting of cyclosporine. Monitor cyclosporine conc. Pregnancy,
lactation. Not recommended for childn <10 yr.
FENOFIBRATE
Dosage Form: Capsule Supra 160 mg (I* - Medical)
Recommended Dose: 1 capsule once daily.
Indications: Hyperlipidaemia types IIa, IIb, III and IV.
Contra-Indications: Impaired renal and hepatic function, pre-existing gall bladder disease,
pregnant and lactating women.
Special Precautions: Reduce the dosage of any concurrent administered anti-coagulants
approximately 1/3 and the prothrombin time should be monitored closely.
GEMFIBROZIL
Dosage Form: Capsule 300 mg (I)
Recommended Dose: 0.8-1.2 g daily in two divided doses, before morning and evening
meals.
Indications: Hyperlipidaemia types II and IV.
Contra-Indications: Impaired renal and hepatic function, biliary cirrhosis, pre-existing gall
bladder disease.
Special Precautions: Reduce the dosage of any concurrent administered anti-coagulants,
diabetes, hypothyroidism.
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LOVASTATIN
Dosage Form: Tablet 20 mg, 40 mg (I)
Recommended Dose: Initially 20 mg once daily. Adjust at 4-wk intervals up to 80 mg daily.
Indications: Reduction of total & LDL cholesterol in patients w/ primary
hypercholesterolaemia (type IIa & IIb) when response to diet alone has been inadequate.
Contra-Indications: Active liver disease or unexplained persistent elevation or serum
transaminases. Pregnancy & lactation.
Special Precautions: Persistent elevation of serum transaminases up to 3 times the normal
values (discontinue). Perform baseline & periodic liver function tests; & baseline serum
creatine kinase levels. Chronic or substantial alcohol consumption or history of liver disease.
Women of childbearing potential.
PRAVASTATIN
Dosage Form: Tablet 20 mg (I)
Recommended Dose: 10-40 mg administered once a day at bedtime.
Indications: Patients with primary hypercholesterolaemia, intolerant or non-responsive to
other forms of therapy.
Special Precautions: Pregnancy, not recommended for patients < 18 years old.
SIMVASTATIN
Dosage Form: Tablet 10 mg, 20 mg, 40 mg (I*- Physician)
Recommended Dose: Hypercholesterolemia; starting dose 10 mg/day in the evening. Max
40 mg/day. Adjust at 4 week intervals as required. Mild to moderate hypercholesterolemia;
initiate with 5mg/day. CHD; start 20 mg/day in the evening. Adjust at 4 week intervals as
required. Max: 40 mg/day.Patient taking immunosuppressives and in severe renal
insufficiency (CrCl<30mL/mins) Max: 10 mg/day.
Indication: Hypercholesterolemia, CHD.
Contra-Indications: Active liver disease or unexplained persistent elevation of serum
transaminase, pregnancy,lactation and hypersensitivity.
Special Precautions: Elevations of serum transaminase.If the transaminase level rise
persistently to 3 times the upper limit of normal, discontinue drug. Recommed that liver
function tests be performed before treatment begins and periodically thereafter. Caution in
patients who consume substantial quantities of alcohol and/or have a history of liver
disease. If muscle symptoms and/or marked elevation of CPK level occur, discontinue drug.
Women of childbearing age.
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9.10. Haematological Products
9.10.1. Anticoagulants, Antithrombotics and Clotting Agents
ACETYLSALICYLIC ACID
Dosage Form: Tablet 300 mg (II); Low Dose Preparation 100 mg,100 mg + 45 mg glycine
(I)
Recommended Dose: A single dose of 150-300 mg given as soon as possible after an
ischaemic event. Maintenance dose 75 mg daily. Adult 1 tab daily.
Indications: Prophylaxis of cerebrovascular disease or myocardial infarction.
Contra-Indications: Haemophiliac, intolerance to aspirin, peptic ulcer or dyspepsia.
Concomitant use with Probenecid or other uricosuric agent, bleeding ulcers, haemorrhage
state, anaemia, compromised cardiac funtion, hypoprothrombinaemia or Vitamin K
deficiency.
Special Precautions: In patients prone to dyspepsia, impaired renal or hepatic function,
dehydration, bronchial asthma, patients on anticoagulants or hypoglycaemic agents. Not
recommended for infants under one year of age. Pregnancy, lactation, allergis diseases,
G6PD deficiency.
CLOPIDOGREL
Dosage Form: Tablet 75 mg (I)
Recommended Dose: 75 mg once daily with or without food. No adjustment is necessary
for elderly patients or patients with renal disease.
Indications: Reduction of atherosclerotic events (myocardial infarction, stroke and vascular
death)
Contra-Indications: Hypersensitivity to clopidogrel or any components of it’s. Active
pathological bleeding eg: peptic ulcer or hemorrhage
Special Precautions: Should be use in precaution in patients who may be at risk of
increased bleeding from trauma, surgery or other pathological conditions.
DIPYRIDAMOLE
Dosage Form: Tablet 25 mg, 75 mg (II)
Recommended Dose: For thromboembolism: 100 mg tds-qid before food, increased to 600
mg daily if required. For angina, 50 mg tds. Prevention of stroke: 75 mg tds combined with
aspirin.
Indications: Thromboembolism, angina, prevention of stroke (combined with aspirin).
Contra-Indications: In hypotension following myocardial infarction. Hypersensitivity.
Special Precautions: In patients with hypotension. Use during percutaneous transluminal
coronary
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DROTRECOGIN ALFA
Dosage Form: Injection 5 mg/vial (activated) (I)
Criteria of use: Restricted to ICU patients for severe sepsis
Recommended Dose: Severe sepsis: 24 mcg/kg/hr IV for 96 hours.
Indications: Adjunctive treatment of Severe sepsis with multiple organ failure.
Contra-Indications: Internal bleeding, haemorrhagic stroke (recent 3 months), intracranial
or intraspinal surgery or severe head trauma (recent 2 months), intracranial
neoplasma/lesion/cerebral herniation, existing epidural catheter, trauma with life-threatening
bleeding, chronic severe hepatic diseases, thrombocytopenia.
Special Precautions: Patients at risk of bleeding (eg, chronic liver disease, history of organ
transplantation, chronic renal failure requiring dialysis, thrombocytopenia (less than
30,000/mm (3), history of recent stroke or recent GI ulceration, recent head or other trauma,
known bleeding diathesis or a prothrombin time-INR greater than 3.0) (potential for
bleeding). Patients with hypercoagulable conditions (eg, hereditary deficiencies of protein C,
protein S, or antithrombin III ; suspected thromboembolism; presence of anticardiolipin
antibody; resistance to activated protein C). Concurrent or recent use (within 7 days) of
aspirin (greater than 650 mg/day), other antiplatelet agents, warfarin, or glycoprotein IIb/IIIa
inhibitors; antithrombin III; thrombolytic agents (within 3 days); or heparin (therapeutic dose.
Prior sensitivity or other unexpected untoward effects associated with use of other protein
C/activated protein C formulations. Recent ischaemic stroke (within 3 months) or intracranial
arteriovenous malformation or aneurysm. Pregnancy and breast-feeding.
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ENOXAPARIN SODIUM (LOW MW)
Dosage Form: Injection 20 mg/0.2 ml, 40 mg/0.4 ml, 60 mg/0.6 ml (prefilled syringe) (II)
Recommended Dose: For Infant > 2 months and children < 18 years: prophylaxis; Initial:
0.5 mg/kg every 12 hours, treatment; Initial: 1 mg/kg every 12 hours. 1. Prophylaxis of deepvein thrombosis in surgical patients (s.c): 1. Moderate risk: 20 mg (2000 units) approx. 2
hours before surgery then 20 mg every 24 hours for 7-10 days. 2. High risk: 40 mg (4000
units) 12 hours before surgery then 40 mg for 7-10 days. 2. Prophylaxis of deep-vein
thrombosis in medical patients (s.c): 40 mg (4000 units) every 24 hours for at least 6 days
until patients ambulant (max, 14 days). 3.Treatment of deep-vein thrombosis (with or without
pulmonary embolism):s.c: 1.5 mg/kg (150 units/kg) every 24 hours, for at least 5 days. 4.
Unstable angina and non-Q-wave myocardial infarction, s.c: 1mg/kg (100 units/kg) every 12
hours for 2-8 days (min: 2 days).
Indications: 1. Prevention of deep-vein thrombosis following hip or knee replacement
surgery or abdominal surgery in patients at risk for thromboembolic complications. 2.
Prevention of deep-vein thrombosis in medical patients at risk thromboembolic
complications due to severely restricted mobility during acute illness. 3. Outpatients and
inpatients treatment of acute deep-vein thrombosis without pulmonary embolism when
administered in conjunction with warfarin sodium. 4. Prevention of ischemic complications of
unstable angina and non-Q-wave myocardial infarction (when administered with aspirin).
Contra-Indications: Patients with active major bleeding, thrombocytopenia associated with
a positive in vitro test for antiplatelet antibody or enoxaparin – induced platelet aggregation
hypersensitivity to enoxaparin; known hypersensitivity to heparin or pork product.
Special Precautions: Do not administered intramuscularly, in patients with a history of
heparin-induced thrombocytopenia, bacterial endocarditis, haemorrhagic stroke, recent CNS
or ophtalmological surgery, bleeding diathesis, uncontrolled arterial hypertension, or a
history of recent gastrointestinal ulceration and hemorrhage. Elderly and patients with renal
insufficiency may show delayed elimination of enoxaparin, avoid use in lactation.
FACTOR IX COMPLEX
Dosage Form: Injection 550 iu/vial (I)
Recommended Dose: Initially 15-75 IU/kg every 6-24 hrs depending on half-life; to raise
the concentration of factor IX to 15-39% in moderate bleeding and >50% in surgery.
Indications: Haemophilia B, reversal of coumarin-induced haemorrhage, bleeding episodes
in haemophilia A.
Contra-Indications: Disseminated intravascular coagulation without prior treatment with
heparin.
Special Precautions: Liver disease, high risk carrier of Hepatitis B. Do not administer with
aminocaproic acid
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FACTOR VIIa (RECOMBINANT)
Dosage Form: Injection 60 KIU (1.2 mg/vial) (I* - Neuroscience)
Criteria of use:
1. For intracerebral hematoma salvageable cases, less than 70 years, GCS more than 6/15,
pupils not fixed and dilated, controlled at least 15 minutes apart.
2. For 15 patients per year
Recommended Dose: Initially 4.5 KIU (90 mcg)/ kg body wt IV bolus over 2-5 mins,
followed by 3-6 KIU (60-120 mcg)/ kg body wt depending on type & severity of haemorrhage
or surgery performed. Dosing interval: initially 2-3 hr to obtain haemostasis & until clinically
improved.If continued therapy is needed, dose interval can be increased successively to
every 4, 6, 8 or 12 hr.
Indications: Treatment of bleeding episodes & prevention of excessive bleeding associated
w/ surgery in patients w/ inherited or acquired haemophilia w/ inhibitors to coagulation
factors VIII or IX.
Contra-Indications: Hypersensitivity to murine or bovine protein.
Special Precautions: Advanced atherosclerotic disease, crush injury, septicaemia.
Pregnancy & lactation.
FACTOR VIII (ANTI-HAEMOPHILIC FACTOR)
Dosage Form: Injection 250 iu/vial, High purity (I)
Recommended Dose: According to individual needs.
Indications: Classical haemophilia A.
Special Precautions: Particularly in persons with previous transfusion of blood and plasma
products, possibility of contacting viral hepatitis must be considered.
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FONDAPARINUX SODIUM
Dosage Form: Injection 2.5 mg/0.5 ml (prefilled syringe) (I)
Criteria of use: For Post-op orthopedic patients, and management of patients with unstable
angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) and ST segment
elevation myocardial infarction (STEMI)
Recommended Dose: 2.5 mg SC once daily administered 6 hr following surgical closure
provided haemostasis has been established. Treat for 5-9 days. Non-ST segment elevation
myocardial infarction, acute 2.5 milligrams (mg) daily subcutaneously for up to 8 days. Acute
ST segment elevation myocardial infarction: initial 2.5 mg IV, followed by 2.5 mg
subcutaneously once daily for the duration of hospitalization, up to 8 days.
Indications: Prevention of venous thromboembolic events (VTE) in patients undergoing
major orthopaedic surgery of the lower limbs eg hip fracture, major knee surgery or hip
replacement surgery.
Additional indications (refer P&T 66, 28 November 2008): Treatment of unstable angina
or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom
urgent (120 mins) invasive management (PCI) is not indicated. Treatment of ST segment
elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or
who initially are to receive no other form of reperfusion therapy.
Contra-Indications: Active clinically significant bleeding, acute bacterial endocarditis,
severe renal impairment (CrCl <30 mL/min), body wt <50 kg.
Special Precautions: Increased haemorrhagic risk eg congenital or acquired coagulopathy,
active ulcerative GI disease, recent intracranial haemorrhage or shortly after brain, spinal or
ophth surgery, diabetic retinopathy, uncontrolled arterial HTN, moderate renal impairment
(CrCl <30-50 mL/min), severe hepatic impairment. Measure platelet counts at baseline &
end of treatment. Elderly. Pregnancy & lactation. Avoid concurrent administration w/ drugs
that may increase haemorrhagic risk.
HEPARIN SODIUM (WITHOUT PRESERVATIVE)
Dosage Form: Injection 1000 units/ml, 5000 units/ml vial (II)
Recommended Dose: By IV inj.: 5000U initially, then 5000-10000U every 4-6 hrs.
Maintenance: 6000-12000U. IV infusion: 10000-20000U in dextrose saline over 12 hrs. By
SC inj: 5000U before surgery, then every 12 hrs until patient is ambulant. Child: Initially
50U/kg by infusion followed by 100U/kg or 25U/kg/h every 4 hrs according to clotting time.
Indications: Prevention of post operative thrombosis, disseminated intra vascular
coagulation, venous pulmonary thrombosis, deep vein thrombosis, or in maintaining
catheter patency.
Contra-Indications: Haemophilia and other haemorrhagic disorders, peptic ulcer,
threathened abortion, recent surgery, severe renal or hepatic disease, severe hypertension.
Special Precautions: Concomitant administration of oral anticoagulants such as aspirin
and dipyridamole which affect platelet function. IM inj: risk of haematoma formation.
Allergies, renal or hepatic disease, hypertension during menstruation, indwelling catheters,
long-term SC use in pregnant women.
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NADROPARIN CALCIUM (LOW MW)
Dosage Form: Injection 7500 Axa ICU x 0.3 ml (I*)
Recommended Dose: Prophylaxis; general surgery: 7500 Axa ICU daily, 1st inj 2-4 hr
before surgery (general anaesth): 100 Axa ICU kg/day for 3 days starting 12 hr before
surgery, then 150 AXaICU/kg/day from 4th post-po day onwards. Duration of prophylactic
administration shoul be at least 10 days. Treatment;0.1mL/10kg body wt SC bd.
Indications: Prophylaxis & treatment of thromboembolic disorders.
Contra-Indications: Previous thrombocytopenia with nadroparin therapy, signs or
increased risk of hemorrhage associated with hemostasis disorders except for disseminated
intravascular coagulation not in hemorrhagic CVA, acute infective endocarditis.
Special Precautions: Hepatic or renal insufficiency, uncontrolled arterial hypertension,
histoy of peptic ulceration, vascular chorioretinal disorder; post-op brain, spinal cord or eye
surgery.
PROTAMINE SULPHATE
Dosage Form: Injection 1% (50 mg/5ml) (II)
Recommended Dose: By slow IV inj: 1 mg neutralises 100U of heparin at rate of 0.5
ml/min. Max dose: 50 mg (5 ml) over period of 10-15 min.
Indications: Heparin antagonist.
Contra-Indications: Not suitable for reversing the effect of oral anticoagulants. Intolerance
to the drug.
Special Precautions: Overdose of protamine sulphate has an anticoagulant effect.
Anaphylaxis in patients previously exposed to protamine through use of protamine
containing insulins or during heparin neutralization.
TICLOPIDINE HCL
Dosage Form: Tablet 250 mg (I* - Physician)
Recommended Dose: 1 or 2 tablets daily during meals. Coronary artery bypass graft 250
mg orally BD. Placement stents in coronary artery in combination with aspirin 250 mg orally
bd for 30 days. Thromboembolic stroke, prophylaxis 250 mg orally bd.
Indications: Maintenance of potency of coronary bypass grafts. Maintenance of patency of
access sites in patients on chronic haemodialysis. Reducing risk of thrombotic stroke (fatal
or non fatal) in patients who have experienced stroke precursors & in patients who have had
a completed stroke.
Contra-Indications: Haemopathies & hemorrhagic diathesis where bleeding time is
prolonged. Organic lesions with a tendency to bleed. History of leukopenia,
thrombocytopenia & agranulocytosis.
Special Precautions: Avoid concomitant use of anticoagulant or aspirin in the absence of
monitoring of laboratory parameters. Bleeding; hematoma. In the event of fever, sore throat
or buccal ulceration, discontinue therapy.
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TIROFIBAN HCL
Dosage Form: Injection 0.25 mg/ml (I* - Medical)
Criteria of use: Restricted to PM Zurkurnai for unstable angina/ NSTEMI post ‘percutaneous
coronary intervention’.
Recommended Dose: 0.4 mcg/kg/min IV for 30 min then 0.1 mcg/kg/min for 12-24 hr after
angioplasty/atherectomy
Indications: Acute coronary syndrome in patient undergoing angioplasty/atherectomy or
managed medically
Contra-Indications: Aortic dissection, bleeding, major surgery, trauma, stroke within 30
days, concomitant use of another parenteral GPIIb/IIIa inhibitor, hemorrhagic stroke, history
of intracranial hemorrhage, neoplasm, arteriovenous malformation, or aneurysm,
hypersensitivity to tirofiban or other product components, pericarditis, severe hypertension
(systolic BP greater than 180 mmHg and/or diastolic BP greater than 110 mmHg),
thrombocytopenia following prior tirofiban administration
Special Precautions: Avoid unnecessary vascular and other trauma, concomitant use with
thrombolytic agents (no data available) or drugs that affect hemostasis, discontinue tirofiban
and heparin therapy if thrombocytopenia is confirmed, hemorrhagic retinopathy, in
angioplasty or atherectomy (do not remove catheter sheath from femoral access site until 34 hr after discontinuation of heparin and until after documentation of activated clotting time
(ACT) of less than 180 seconds and activated partial thromboplastin time (aPTT) of less
than 45 seconds), platelet count below 150,000/mm(3), severe renal insufficiency, chronic
hemodialysis.
TRANEXAMIC ACID
Dosage Form: Capsule 250 mg (II), Injection 100 mg/ ml, 5% (II)
Recommended Dose: Oral: 250 mg-1 g tds or qid. Slow IV: 1 g tds or 1-2 doses IM. By
mouth, local fibrinolysis, 15-25 mg 2-3 times daily.
Indications: Prevention and treatment of haemorrhages due to fibrinolysis.
Contra-Indications: Intravascular coagulation, arterial or venous thrombosis, or surgery.
Special Precautions: Reduce dose in patients with renal impairment
VITAMIN K (AS PHYTOMENADIONE)
Dosage Form: Injection 1 mg/ml, 10 mg/ml (as Phytomenadione) - (II)
Recommended Dose: 2.5-25 mg (exceptionally 50 mg) by IM/SC inj, repeated after 6-8 hrs
if necessary. Severe bleeding: 10-20 mg by rate not exceeding 1 mg/min, followed by
prothrombin level 3 hrs later. Not more than 40 mg should be given IV in 24 hrs.
Haemorrhagic disease in newborn: 1 mg IM, if necessary further doses may be given 8
hourly, 2-10 mg for prothrombin deficiencies. Prophylaxis: 0.5-1 mg IM or may be given to
the mother in dose of 1-5 mg by IM inj 12-24 hrs before delivery.
Indications: Haemorrhagic caused by anticoagulant therapy, hypoprothrombinaemia,
prevention of neonatal haemorrhage.
Contra-Indications: Hypersensitivity to drug.
Special Precautions: IV inj should be given slowly and only when absolutely necessary.
Not effective in overdosage with heparin.
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WARFARIN SODIUM
Dosage Form: Tab 1 mg, 2 mg, 3 mg, 5 mg (II)
Recommended Dose: Initially 10-15mg daily. Maintenance 3-10 mg daily (determine
prothrombin time: maintain prothrombin time at 1.2-2 times control).
Indications: Deep vein thrombosis, pulmonary embolism, transient ischemic attacks,
thrombosis associated with prosthetic heart valves, or after cardiac bypass surgery.
Contra-Indications: Threatened abortion, pregnancy, ulcerative disorders, haemophilia,
immediately after parturition or surgery, hepatic disorders, cerebrovascular accident,
trauma, malignant hypertension, retinopathy, recent lumbar block anaesthesia, arterial
aneurysm, infective endocarditis or acute pericarditis, thrombocytopenia.
Special Precautions: Impaired hepatic and renal function, severe hypertension, any
condition where there is a risk of serious haemorrhage. Elderly females (>60 yrs).
9.10.2. Fibrinolytic Agent
ALTEPLASE (RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR (rt - PA) ACTILYSE)
Dosage Form: Injection 50 mg/vial (I*)
Recommended Dose: Myocardial infarction, accelerated regimen (initiated within 6 hours),
15 mg by intravenous injection, followed by intravenous infusion of 50 mg over 30 minutes,
then 35 mg over 60 minutes (total dose 100 mg over 90 minutes); lower doses in patients
<65 kg. Myocardial infarction, initiated within 6-12 hours, 10 mg by intravenous injection
followed by intravenous infusion of 50 mg over 60 minutes, then 4 infusions each of 10 mg
over 30 minutes (total dose 100 mg over 3 hours; max. 1.5 mg/kg in patient <65 kg).
Pulmonary embolism, 10 mg by intravenous infusion over 1-2 minutes followed by
intravenous infusion of 90 mg over 2 hours; max. 1.5 mg/kg in patient <65 kg.
Indications: ACUTE MYOCARDIAL INFARCTION; PULMONARY EMBOLISM
Contra-Indications: No central venous puncture (CVP line) or noncompressible arterial
sticks. BP systolic 185, diastolic 110 unresponsive to nitrate or calcium antagonist; recent
(within 1 month): cerebrovascular accident, gastrointestinal bleeding, trauma or surgery,
prolonged external cardiac massage; intracranial neoplasm, suspected aortic dissection,
arteriovenous malformation or aneurysm, bleeding diathesis, hemostatic defects, seizure
occurring at the time of stroke, suspicion of subarachnoid hemorrhage.
Special Precautions: Bolus administration (increased risk of intracranial hemorrhage),
recent major surgery (within 10 days), cerebrovascular diseases, recent gastrointestinal or
genitourinary bleeding, recent trauma (within 10 days), hypertension (systolic BP greater
than 180 mm Hg or diastolic BP greater than 110 mm Hg), acute pericarditis, subacute
bacterial endocarditis, significant liver dysfunction, hemorrhagic ophthalmic conditions,
septic thromphlebitis, advanced age (older than age 75), patients currently receiving oral
anticoagulants , active menstrual bleeding.
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STREPTOKINASE
Dosage Form: Injection 1,500,000 units (I)
Recommended Dose: IV infusion: 250000U over 30 min. Then 100000U every hour for up
to 24-72 hrs according to condition. Myocardial infarction: 1500000U over 60 min, followed
by aspirin 150 mg daily orally for at least 4 weeks. Intracoronary infusion: bolus of 200000U
followed by infusion of 2000U/min for 60 minutes. Paediatric: IV infusion: bolus of 1000U5000U/kg followed by 400-1200U/kg/h.
Indications: Fibrinolytic agent in thromboembolic disorders such as acute massive
pulmonary embolism, arterial and venous occlusion, acute myocardial infarction, arterial and
deep vein thrombosis.
Contra-Indications: Recent haemorrhage surgery, severe trauma, liver or kidney damage,
coagulation defect, history of cerebrovasccular disease, recent streptococcal infection, or
streptokinase therapy (>5 days & < 3 months previously), severe hypertension,
arteriosclerosis, pulmonary disease with cavitation, severe bronchitis, acute pancreatitis,
severe diabetes, pregnancy, potential GI or genito-urinary bleeding, active internal bleeding,
recent CVA (within 2 months), intracranial/intraspinal surgery, intracranial neoplasm, severe
hypertension, predisposition to bleeding, surgery or biopsy within 10 days.
Special Precautions: Mitral valve defects or atrial fibrillation, recent or concurrent
anticoagulant/antiplatelet thaerapy. If streptokinase resistance is determined and resistance
level exceeds 1 million IU, the drug should not be given. Invasive arterial/venous
procedures, spontaneous bleeding, allergy/anaphylaxis.
9.10.3. Iron and Haematopoetic Agents
CYANOCOBALAMIN (VITAMIN B12)
Dosage Form: Injection 1 mg/ml (1 ml, 10 ml) (II)
Recommended Dose: By IM inj.: 250-1000mcg on alternate days for 1-2 weeks, followed
by 250mcg weekly until blood count is normal. Then maintain dose of 1000mcg monthly.
Pernicious anaemia: 300mcg daily.
Indications: Pernicious anaemia, macrocytic anaemia, vitamin B12 deficiency.
Contra-Indications: Cyanocobalamin is not a suitable form of Vit. B12 for the treatment of
optic neuropathies associated with raised plasma concentration of cyanocobalamin.
Special Precautions: Should not be given before diagnosis is fully established. Oral
therapy is markedly inferior to parenteral therapy and should be used only in treatment of
Vit. B12 deficiency with normal GI absorption.
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FERRIC AMMONIUM CITRATE
Dosage Form: Mixture [P] 400 mg/5 ml (Padiatric) (II)
Recommended Dose: Up to 6g daily taken well diluted with water.
Indications: Treatment of iron deficiency anaemia.
Contra-Indications: In patients receiving repeated blood transfusion, anaemia not due to
iron deficiency.
Special Precautions: Tetracyclines. Use straw to prevent discoloration of teeth. Care in
patients with iron storage or iron-absorption diseases, haemoglobinopathies or existing
disease.
FERROUS FUMARATE
Dosage Form: Tablet 200 mg (II)
Recommended Dose: Initially: 200 mg tds. Maintenance: 200 mg daily. Child: up to 1 yr: 35
mg tds., 1-5 yrs: 70 mg tds., 6-12 yrs: 140 mg tds.
Indications: Treatment of iron deficiency anaemia.
Contra-Indications: In patients receiving repeated blood transfusions or in anaemia not
due to iron deficiency. Peptic ulcer, regional enteritis and ulcerative colitis.
Special Precautions: Concomitant administration of tetracycline and antacids decrease
amount of iron absorbed.
FOLIC ACID
Dosage Form: Tablet 5 mg (II)
Recommended Dose: Initially 10-20 mg daily for 14 days. Maintenance: 2.5-10 mg daily.
Prophylaxis of megaloblastic anaemia of pregnancy: 200-500 mcg daily.
Indications: Treatment of megaloblastic anaemia, anaemia of sprue, pregnancy and
pellagra.
Contra-Indications: Megaloblastic anaemia secondary to Vit. B12 deficiency.
Special Precautions: Should not be given before diagnosis is fully established. Large
continuous doses of folic acid may lower the blood concentration of Vit. B12.
IRON SUCROSE
Dosage Form: Injection 100 mg (I)
Recommended Dose: By slow intravenous injection or by intravenous infusion, calculated
according to body-weight and iron deficit, consult product literature; child not recommended
Indications: iron-deficiency anaemia
Contra-Indications: history of allergic disorders including asthma, eczema and
anaphylaxis; liver disease; infection
Special Precautions: oral iron therapy should not be given until 5 days after last injection;
facilities for cardiopulmonary resuscitation must be at hand; pregnancy
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10. ANAESTHETIC AND ANTIMUSCARINIC AGENTS
10.1. General Anaesthetics
10.1.1. Inhalation Agents
DESFLURANE
Dosage Form: Liquid 250 ml (I* - Anaesthesiologist)
Prescribing criteria: 1. Not for patient having cardiovascular instability and cardiac
anesthesia (Isoflurane is preferred)
Recommended Dose: Using a specifically calibrated vaporiser, Induction, 4–11%; child not
recommended for induction, Maintenance, 2–6% in nitrous oxide; 2.5–8.5% in oxygen or
oxygen-enriched air; max. 17%
Indications: For induction and maintenance of anaesthesia in adults and maintenance of
anaesthesia in infants and children.
Contra-Indications: Should not be used for patients in whom general anaesthesia is
contraindicated, sensitive to halogenated agents and in patient in known or genetic
susceptibility to malignant hyperthermia. History of malignant hyperthermia or in whom liver
dysfunction, jaundice or unexplained fever, leucocytosis or eosinophilia has occurred after a
previous halogenated anaesthetic administration.
Special Precautions: Not recommended for use as an inhalation induction agent in
paediatric patients because of the frequent occurrence of cough, breathholding, apnoea,
laryngospasm and increased secretions in children under 12 years. Should not be used as
the sole agent for anaesthetic induction in patients at risk of coronary artery disease or in
patients where increases in heart rate or blood pressure are undesirable. Neurosurgical
patients may increase CSF or intracranial pressure in patients with space occupying lesion.
Should not be used in patients in whom liver dysfunction, unexplained fever orleucocytosis
has occurred after a previous halogenatod anaesthetic administration.
ETHER (ANAESTHETIC ETHER)
Dosage Form: Liquid 100 ml, 2500 ml (II)
Recommended Dose: Induction: up to 20% from an open mask or suitable vaporiser.
Maintenance: 3-10%.
Indications: For induction and maintenance of anaesthesia.
Contra-Indications: In patients with diabetes mellitus, impaired kidney function and severe
liver disease.
Special Precautions: Ether enhances the action of non-depolarising muscle relaxants to a
greater degree than most anaesthetics.
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HALOTHANE
Dosage Form: Liquid 250 ml (II)
Recommended Dose: Using a suitable vaporiser: induction, increased gradually to 2-4% in
oxygen or nitrous oxide-oxygen; Child: 1.5-2%. Maintenance: 0.5-2%.
Indications: For induction and maintenance of anaesthesia.
Contra-Indications: On patients who have shown unexplained pyrexia or jaundice after
halothane anaesthesia. Cardiac arrythmias. Susceptibility to malignant hyperthermia
Special Precautions: Ensure adequate room ventilation when using halothane. Cause
cardiorespiratory depression. Respiratory depression results in elevation of arterial carbon
dioxide tension and perhaps ventricular arrhythmias. Depresses the cardiac muscle fibres
and may cause bradycardia. The result is diminished cardiac output and fall of arterial
pressure.
ISOFLURANE
Dosage Form: Solution (100 ml, 250 ml) (I)
Recommended Dose: Individualised dosage.
Indications: Inhalation anaesth.
Contra-Indications: Genetic susceptibility to malignant hyperthermia.
Special Precautions: Uterine curettage. Patients w/ increased intracranial pressure.
SEVOFLURANE
Dosage Form: Liquid 250 ml (I*-anaesthesiologist)
Recommended Dose: Using a specifically calibrated vaporiser, Induction, up to 5% in
oxygen or nitrous oxide–oxygen; child up to 7%, Maintenance, 0.5–3%
Indications: For induction and maintenance of anaesthesia.
Contra-Indications: Known or suspected genetic susceptibility to malignant hyperthermia.
Special Precautions: Coronary artery disease; renal or hepatic impairment; patients at risk
for ICP elevation. Pregnancy and lactation.
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10.1.2. Intravenous Agents
ALFENTANIL
Dosage Form: Injection 0.5 mg [PSYCHOTROPIC] (I)
Recommended Dose: Anesthesia: individualized according to type and duration of surgical
procedure/anesthesia; Anesthesia: when used as primary anesthetic agent; 130-245 mcg/kg
induction dose followed by continuous IV infusion of 0.5-1.5 mcg/kg/min
Indications: For induction of anaesthesia
Contra-Indications: Intolerance to alfentanil or to morphinomimetics. In labor or before
clamping of the cord during caesarean section. Respiratory depression and obstructive
airways disease; acute alcoholism, convulsive disorders; head injuries, and conditions in
which intracranial pressure is raised.
Special Precautions: Decreased respiratory reserve and pulmonary disease; prostatic
hyperplasia; hypotension; shock; inflammatory or obstructive bowel disorders; myasthenia
gravis; hypovolaemia; uncontrolled hypothyroidism; renal or hepatic impairment; alcoholism;
chronic opioid therapy and history of opioid abuse. Avoid rapid bolus injection in
compromised intracerebral compliance. Do not administer during the last 10 min of surgery.
Elderly, debilitated patients, pregnancy and lactation. May affect ability to drive and operate
machinery.
ETOMIDATE
Dosage Form: Injection 2 mg/ml (10 ml ampoule) (I* - ICU, OT-Cardiology, A&E)
Recommended Dose: Anesthesia: individualized according to type and duration of surgical
procedure/anesthesia; Anesthesia: when used as primary anesthetic agent; 130-245 mcg/kg
induction dose followed by continuous IV infusion of 0.5-1.5 mcg/kg/min
Indications: For induction of anaesthesia
Contra-Indications: Intolerance to alfentanil or to morphinomimetics. In labor or before
clamping of the cord during caesarean section. Respiratory depression and obstructive
airways disease; acute alcoholism, convulsive disorders; head injuries, and conditions in
which intracranial pressure is raised.
Special Precautions: Decreased respiratory reserve and pulmonary disease; prostatic
hyperplasia; hypotension; shock; inflammatory or obstructive bowel disorders; myasthenia
gravis; hypovolaemia; uncontrolled hypothyroidism; renal or hepatic impairment; alcoholism;
chronic opioid therapy and history of opioid abuse. Avoid rapid bolus injection in
compromised intracerebral compliance. Do not administer during the last 10 min of surgery.
Elderly, debilitated patients, pregnancy and lactation. May affect ability to drive and operate
machinery.
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KETAMINE HCL
Dosage Form: Injection 10 mg/ml (20 ml/vial), 50 mg/ml (10 ml/vial) [PSYCHOTROPIC] (II)
Recommended Dose: By intramuscular injection, short procedures, initially 6.5–13 mg/kg
(10 mg/kg usually produces 12–25 minutes of surgical anaesthesia), Diagnostic
manoeuvres and procedures not involving intense pain, initially 4 mg/kg, By intravenous
injection over at least 60 seconds, short procedures, initially 1–4.5 mg/kg (2 mg/kg usually
produces 5–10 minutes of surgical anaesthesia), By intravenous infusion of a solution
containing 1 mg/mL, longer procedures, induction, total dose of 0.5–2 mg/kg; maintenance,
10–45 micrograms/kg/minute, rate adjusted according to response
Indications: For induction and maintenance of anaesthesia
Contra-Indications: In patients with hypertension, eclampsia or preeclamsia. Those prone
to hallucinations.
Special Precautions: In patients with preanaesthetic elevated intraocular or cerebrospinal
fluid pressure, pregnancy
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PROPOFOL
Dosage Form: Injection 1% (10 mg/ml) (20 ml amp) (I), 50 ml vial (I* - OT Cardiology)
Recommended Dose: Induction of General Anesthesia; Healthy Adults < 55 years: 40
mg every 10 seconds until induction onset (2 to 2.5 mg/kg). Elderly, Debilitated, or ASA
III/IV Patients: 20 mg every 10 seconds until induction onset (1 to 1.5 mg/kg). Cardiac
Anesthesia: 20 mg every 10 seconds until induction onset (0.5 to 1.5 mg/kg).
Neurosurgical Patients: 20 mg every 10 seconds until induction onset (1 to 2 mg/kg)
Pediatric Patients - healthy, from 3 - 16 years: 2.5 to 3.5 mg/kg administered over 20-30
seconds.
Maintenance of General Anesthesia: Infusion; Healthy Adults < 55 years: 100 to 200
µg/kg/min (6 to 12 mg/kg/h). Elderly, Debilitated, ASA III/IV Patients: 50 to 100 µg/kg/min (3
to 6 mg/kg/h). Cardiac Anesthesia: Most patients require:
Primary DIPRIVAN Injectable Emulsion with Secondary Opioid - 100 - 150 µg/kg/min
Low-dose DIPRIVAN Injectable Emulsion with Primary Opioid - 50 - 100 µg/kg/min
Neurosurgical Patients: 100 to 200 µg/kg/min (6 to 12 mg/kg/h). Pediatric Patients- healthy,
from 2 months - 16 years: 125 to 300 µg/kg/min (7.5 to 18 mg/kg/h)
Following the first half hour of maintenance, if clinical signs of light anesthesia are not
present, the infusion rate should be decreased.
Maintenance of General Anesthesia: Intermittent Bolus; Healthy Adults < 55 years:
Increments of 20 to 50 mg as needed.
Initiation of MAC Sedation; Healthy Adults < 55 years: Slow infusion or slow injection
techniques are recommended to avoid apnea or hypotension. Most patients require an
infusion of 100 to 150 µg/kg/min (6 to 9 mg/kg/h) for 3 to 5 minutes or a slow injection of 0.5
mg/kg over 3 to 5 minutes followed immediately by a maintenance infusion. Elderly,
Debilitated, Neurosurgical, or ASA III/IV Patients: Most patients require dosages similar to
healthy adults. Rapid boluses are to be avoided.
Maintenance of MAC Sedation; Healthy Adults < 55 years: A variable rate infusion
technique is preferable over an intermittent bolus technique. Most patients require an
infusion of 25 to 75 µg/kg/min (1.5 to 4.5 mg/kg/h) or incremental bolus doses of 10 mg or
20 mg. In Elderly, Debilitated, Neurosurgical, or ASA III/IV Patients: Most patients require
80% of the usual adult dose. A rapid (single or repeated) bolus dose should not be used.
Initiation and Maintenance of ICU Sedation in Intubated, Mechanically Ventilated
Adult Patients - Because of the residual effects of previous anesthetic or sedative agents, in
most patients the initial infusion should be 5 µg/kg/min (0.3 mg/kg/h) for at least 5 minutes.
Subsequent increments of 5 to 10 µg/kg/min (0.3 to 0.6mg/kg/h) over 5 to 10 minutes may
be used until desired clinical effect is achieved. Maintenance rates of 5 to 50 µg/kg/min (0.3
to 3 mg/kg/h) or higher may be required.
Indications: Sedative-hypnotic agent that can be used for both induction and/or
maintenance of anesthesia as part of a balanced anesthetic technique for inpatient and
outpatient surgery in adult patients and pediatric patients greater than 3 years of age.
For maintenance of anesthesia as part of a balanced anesthetic technique for inpatient and
outpatient surgery in adult patients and in pediatric patients greater than 2 months of age.
Contra-Indications: Known hypersensitivity to DIPRIVAN Injectable Emulsion or its
components, or when general anesthesia or sedation are contraindicated.
Special Precautions: Cardiac impairment, respiratory impairment, elderly, hypovolemic,
epilepsy, hypotension, raised intracranial pressure, monitor blood-lipid concentration if risk
of fat overload or if sedation longer than 3 days.
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THIOPENTONE SODIUM
Dosage Form: Injection 0.5 gm/vial (II) [PSYCHOTROPIC]
Recommended Dose: By IV inj. initially 100-150 mg (2.5% solution) over 10-15 sec.,
repeated if necessary according to the patient's response after 20-30 sec., or up to 4 mg/kg.
Child: induction, 4-8 mg/kg. By continuous IV infusion as a 0.2-0.4% solution according to
patient response.
Indications: Induction of general anaesthesia; anaesthesia of short duration; reduction of
raised intracranial pressure if ventilation controlled; status epilepticus
Contra-Indications: In respiratory obstruction, status asthmaticus, severe shock,
dystrophia myotonica and porphyria.
Special Precautions: In patients with cardiovascular disease, adrenocortical insufficiency,
or with increased intracranial pressure, asthma. Reduce dosage in elderly, severe hepatic
and liver disease, shock and dehydration. Overdosage may occur due to its potency.
Reconstituted solution is highly alkaline—extravasation causes tissue necrosis and severe
pain; avoid intra-arterial injection; pregnancy.
10.2. Local Anaesthetics
10.2.1. Injectable Agents
BUPIVACAINE HCL
Dosage Form: Injection 0.5% (20 ml/vial) (II)
Recommended Dose: For regional nerve block 15-30 ml of 0.5% solution used with or
without adrenaline.
Indications: Epidural anaesthesia in obstetric, lower abdominal and orthopaedic surgery,
nerve block of long duration. Regional nerve block, lumbar epidural block, retrobulbar block.
Contra-Indications: Myasthenia gravis, complete heart block, known hypersensitivity to
local anaesthetics of amide type. Do not use solutions containing adrenaline for anaesthesia
in appendeges such as digits.
Special Precautions: Epilepsy, hepatic impairment, impaired cardiac conduction. Reduce
dose in elderly or debilitated patients. Avoid intravascular injection.
BUPIVACAINE HCL HEAVY
Dosage Form: Injection 0.5% (4 ml) (Spinal) (I)
Recommended Dose: Intrathecal anaesthesia for surgery, 2–4 ml (dose may need to be
reduced in elderly and in late pregnancy)
Indications: Spinal anaesthesia.
Contra-Indications: As above.
Special Precautions: As above. Injection should be given slowly with frequent aspiration.
Adequate resuscitation equipment must be available.
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BUPIVACAINE HCL + ADRENALINE
Dosage Form: Injection 0.5% (20 ml) (II)
Recommended Dose: Nerve block of finger or toe: 2-6 ml of 0.5%. Lumbar epidural block:
15-20 ml of 0.5% solution. Caudal block: 15-25 ml of 0.5% solution. Max. recommended
dose: 2 mg/kg in any 4 hour period.
Indications: As above.
Contra-Indications: As above.
Special Precautions: As above. Geriatric patients and patients with cardiovascular disease
and patient receiving MAOI or tricyclic antidepressant, pregnancy.
LIGNOCAINE HCL
Dosage Form: Injection 100 mg/5 ml, 500 mg/5 ml (I)
Recommended Dose: Adult: total single dose not > 4.5 mg/kg (or 300 mg) and children not
> 4.5 mg/kg. For spinal anaesthesia, up to 100 mg. In children, induction of IV regional
anaesthesia not > 3 mg/kg.
Indications: Local anaesthetic for peripheral nerve block and infiltration anaesthesia.
Contra-Indications: Known hypersensitivity to local anaesthetics of the amide type,
myasthenia gravis, complete heart block and hypovolaemia.
Special Precautions: As in Bupivacaine HCl. Injection should be given slowly with frequent
aspirations. Adequate resuscitation equipment must be available. Reduce dosage in
children, geriatric or debilitated patients.
MEPIVACAINE + ADRENALINE
Dosage Form: Injection 1:100,000 (scandonest 2% special) 1.8 ml, 2.2 ml
Recommended Dose: For the management of localized pain (therapeutic block) is 1 to 5
milliliters (10 to 50 milligrams) of the 1% solution or 1 to 5 milliliters (20 to 100 milligrams) of
the 2% solution
Indications: Dental anaesthesia
Contra-Indications: In patients with severe hypertension or unstable cardiac rhythm, the
use of adrenaline in a local anaesthetic may be hazardous.
Special Precautions: Great care should be taken to avoid inadvertent intravenous
administration of a preparation containing adrenaline.
PROCAINE HCL + MAGNESIUM CHLORIDE HEXAHYDRATE + POTASSIUM
CHLORIDE (CARDIOPLEGIA SOLUTION)
Dosage Form: Injection 1 mmol + 16 mmol + 16 mmol (20 ml amp) (I*- OT Cardiology)
Recommended Dose: Dilute 20 mL to 1 L of Ringer's soln (cooled to 4°C prior to use).
Initial rapid instillation into aortic root at 300 mL/m2 body surface area/min for over a period
of about 2-4 mins. Should myocardial activity persist or recur, instill at 300 mL/m 2 body
surface area/min for 2 mins. Readminister every 20-30 mins or sooner if myocardial temp
reaches 15-20°C or cardiac activity returns.
Indications: For use in combination w/ ischaemia & hypothermia to induce cardiac arrest
during open-heart surgery & to preserve the myocardium during asystole.
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ROPIVACAINE HCL
Dosage Form: Injection 2 mg/ml, 7.5 mg/ml, 10 mg/ml (20 ml amp) (I* - Anaesthesiologist)
Recommended Dose: Surgical anaesthesia; lumbar epidural, 15–20 mL of 10 mg/mL
solution or 15–25 mL of 7.5 mg/mL solution; caesarean section, 15–20 mL of 7.5 mg/mL
solution in incremental doses (max. total dose 150 mg), thoracic epidural (to establish block
for postoperative pain), 5–15 mL of 7.5 mg/mL solution, major nerve block (brachial plexus
block), 30–40 mL of 7.5 mg/mL solution, field block, up to 30 mL of 7.5 mg/mL solution.
Acute pain; lumbar epidural, 10–20 mL of 2 mg/mL solution followed by 10–15 mL of
2 mg/mL solution at intervals of at least 30 minutes or 6–10 mL/hour of 2 mg/mL solution as
a continuous epidural infusion for labour pain or 6–14 mL/hour of 2 mg/mL solution as a
continuous epidural infusion for postoperative pain, thoracic epidural, 6–14 mL/hour of
2 mg/mL solution as a continuous infusion, field block, up to 100 mL of 2 mg/mL solution,
peripheral nerve block, 5–10 mL/hour of 2 mg/mL solution as a continuous infusion or by
intermittent injection, child over 1 year (body-weight up to 25 kg), caudal epidural (for preand post-operative pain only), 2 mg/kg of 2 mg/mL solution
Indications: Surgical anaesthesia; lumbar epidural, caesarean section, thoratic epidural,
field block.
Special Precautions: Recuscitative aquipment & drugs for treating toxic reactions should
be immediately available. Caution in severe liver disease.
10.2.2. Topical Agents
COCAINE SOLUTION
Dosage Form: Solution [P] 10% [DANGEROUS DRUG]
Recommended Dose: For local anesthesia; 1.5 to 2 mg/kg of 10% cocaine solution.
As a nasal decongestant; 0.5% to 2% solution is applied as a spray or on a tampon.
Indications: Applied topically to mucous membranes of the oral laryngeal and nasal
cavities to provide local anestetic activity.
Contra-Indications: Hypersensitivity to cocaine
Special Precautions: Topical cocaine should be used with caution on severely traumatized
mucosa or when sepsis is present in the area of intended application.
ETHYL CHLORIDE
Dosage Form: Spray (II)
Recommended Dose: Smallest dose needed to produce the desired effect should be used.
Indications: Local anaesthetic in minor operative procedures, to alleviate pain associated
with burns and insect stings. As a counterirritant for relief of myofascial and visceral pain
syndromes. For relief pain in sprains and myalgias and for treatment of cutaneous lava
migran.
Special Precautions: Because ethylchloride is highly flammable, it should not be used in
areas where ignition may occur. Do not apply to broken skin or mucous membrane. Avoid
inhalation of the vapour.
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LIGNOCAINE HCL JELLY
Dosage Form: Jelly 2%, 2% (Accordion) (II)
Recommended Dose: Anaesthesia of urethra: 5-15ml to be instilled about 5-10min before
the cathetherization. For adequate analgesia and lubrication: use 20ml.
Indications: Draining, probing, cystoscopy and other urological procedures. Pain control in
cystitis.
Contra-Indications: Hypersensitivity to anaesthetics of the amide type.
LIGNOCAINE HCL SPRAY
Dosage Form: Spray 10% (II)
Recommended Dose: In dental procedure: 1-5 applications onto mucous membrane. In
obstetrics: up to 20 applications. Puncture of maxilarry sinus: 3 applications. Max: 20 sprays
(200mg) in adult.
Indications: For surface anaesthesia in ENT, obstetric and dentistry procedures.
Contra-Indications: Known hypersensitivity to local anesthetics of the amide type.
Special Precautions: Reduce dosage in elderly, children acutely ill and debilitated patients.
LIGNOCAINE HCL TOPICAL SOLUTION
Dosage Form: Topical solution 4% (50 ml) (II)
Recommended Dose: 1-7.5 ml: surface anestatic achieved by instillation into a cavity or by
sprying. May also be applied from a swab.
Indications: Anaesthetic of mucous membranes of the oropharyngel, tracheal and
bronchial areas.
Special Precautions: Traumatised mucosa and sepsis
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LIGNOCAINE HCL + CHLORHEXIDINE JELLY
Dosage Form: Jelly 2% + 0.05% (II)
Recommended Dose: Urethral catheterisation, into urethra at least 5 minutes before
catheter insertion, MEN 10 mL followed by further 3–5 mL; WOMEN 3–5 mL; CHILD 1–5 mL
Mucocutaneous anaesthesia, 2–3 mL applied when necessary; CHILD 1–2 mL
Major aphthous ulcers in immunocompromised patients, 2–3 mL applied when necessary,
max. 15 mL in 24 hours; CHILD 1–2 mL, max. 8 mL in 24 hours
Indications: For surface anaesthesia
Contra-Indications: Hypersensitivity to anaesthetics of the amide type.
PROPARACAINE
Dosage Form: Eye drop 0.5% (I)
Recommended Dose: 1-2 drops up to 3 doses.
Indications: For procedures in which a rapid & short-acting topical ophth anaesth is
indicated eg suture removal from the cornea, tonometry, removal of foreign bodies & other
short procedures.
Contra-Indications: Hypersensitivity to proparacaine products
Special Precautions: Prolonged use may result in corneal infection &/or opacification w/
permanent visual loss or corneal perforation. Do not instill repeatedly.
10.3. Neuroleptanalgesics
FENTANYL
Dosage Form: Injection (as citrate) 50 mcg/ml (2 ml ampoule); Patch (as citrate) 12 mcg/hr,
25 mcg/hr [PSYCHOTROPIC] (I)
Recommended Dose: Premedication by IM 50-100 mcg 30-60 min prior to surgery. By IV
inj. as an adjunct to general anaesthesia, with spontaneous respiration 50-200 mcg then 50
mcg every 20-30 min as required. Child: 3-5 mcg/kg then 1 mcg/kg as required. With
assisted ventilation: 300-3500 mcg (up to 50 mcg/kg) then 100 – 200 mcg as required.
Child: 10-15 mcg/kg then 1 – 3 mcg/kg as required. Post operatively IM 50-100 mcg.
Repeat dose in 1-2 hrs as needed. Treatment of intractable chronic pain in adults,
transdermal patches 25-100 mcg/hour. Max dose adults/children regardless of weight is 400
mcg.
Indications: Analgesic in anaesthesia for all types of surgical intervention,
neuroleptanalgesia. It is also used as a respiratory depressant in the management of
mechanically ventilated patient under intensive care.
Contra-Indications: Children 2 yrs and under, bronchial asthma patients susceptible to
respiratory depression.
Special Precautions: Patients with myasthenia gravis. Reduced doses are used in the
elderly or debilitated patients.
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10.4. Neuromuscular Blocking Agents
10.4.1. Depolarizing Agents
SUXAMETHONIUM CHLORIDE
Dosage Form: Injection 50 mg/ml (2 ml amp.) (II)
Recommended Dose: By iv inj. initially 1 mg/kg; maintenance, usually 0.5–1 mg/kg at 5–10
minute intervals; max. 500 mg/hour; neonate and infant under 1 year, 2 mg/kg; child over 1
year, 1 mg/kg. By iv inf. of a solution containing 1–2 mg/mL (0.1–0.2%), 2.5–4 mg/minute;
max. 500 mg/hour; child reduce infusion rate according to body-weight. By IM, infant under
1 year, up to 4–5 mg/kg; child over 1 year, up to 4 mg/kg; max. 150 mg.
Indications: Wherever brief but profound relaxation required eg. for endotracheal
intubation, electroconvulsive therapy, examination under anaesthesia, orthopaedic
manipulation, reduction of fractures, cephalic version and bronchoscopy.
Contra-Indications: Patients with low serum pseudocholinesterase level, severe liver
disease, in burn patients, myasthenia gravis.
Special Precautions: Can cause respiratory paralysis. Facilities for artificial respiration
should be available. Caution in electrolytes disturbances, digitalized patient, neonates,
geriatrics, glaucoma. Interact with general anaesthetics, aminoglycosides, polimyxin
antibiotics, diazepam and potassium depleting agents.
10.4.2. Non-Depolarizing Agents
ATRACURIUM BESYLATE
Dosage Form: Injection 10 mg/ml (2.5 ml ampoule) - (I)
Recommended Dose: Surgery or intubation, adult and child over 1 month, by intravenous
injection, initially 300–600 micrograms/kg; maintenance, by intravenous injection, 100–
200 micrograms/kg as required or by intravenous infusion, 5–10 micrograms/kg/minute
(300–600 micrograms/kg/hour). Intensive care, adult and child over 1 month, by intravenous
injection, initially 300–600 micrograms/kg (optional) then by intravenous infusion 4.5–
29.5 micrograms/kg/minute (usual dose 11–13 micrograms/kg/minute)
Indications: Muscle relaxation (short to intermediate duration) for surgery or during
intensive care
Special Precautions: Inactivated by thiopentone and other alkaline solution. Duration of
action may be prolonged in hypothermia.
PANCURONIUM BROMIDE
Dosage Form: Injection 2 mg/ml (2 ml amp) (II)
Recommended Dose: Intubation, by intravenous injection, initially 50–100 micrograms/kg
then 10–20 micrograms/kg as required; child initially 60–100 micrograms/kg, then 10–
20 micrograms/kg, neonate 30–40 micrograms/kg initially then 10–20 micrograms/kg.
Intensive care, by intravenous injection, 60 micrograms/kg every 60–90 minutes
Indications: Muscle relaxation (long duration) for surgery or during intensive care
Contra-Indications: Known hypersensitivity to pancuronium or bromides.
Special Precautions: Reduce dose in obesity, in renal impairment and following
suxamethonium, myasthenia gravis.
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ROCURONIUM BROMIDE
Dosage Form: Injection 10 mg/ml (5 ml amp) (I* - Anaesthesiologist)
Recommended Dose: Intubation, adult and child over 1 month, by intravenous injection,
initially 600 micrograms/kg; maintenance by intravenous injection, 150 micrograms/kg
(elderly 75–100 micrograms/kg) or maintenance by intravenous infusion, 300600 micrograms/kg/hour (elderly up to 400 micrograms/kg/hour). Intensive care, by
intravenous injection, adult initially 600 micrograms/kg; maintenance by intravenous
infusion, 300–600 micrograms/kg/hour for first hour, then adjusted according to response
Indications: Muscle relaxation (intermediate duration) for surgery or during intensive care
Special Precautions: Hepatic & biliary tract & renal disease, conditions associated with
prolonged circulation time, neuromuscular disease, hypothermic conditions, obesity.
Hypokalaemia, hypermagnesaemia, hypocalcaemia, hypoproteinaemia, dehydration,
acidosis, hypercapnia, cachexia increase effects. Not recommended to drive or operate
machinery within 24 hr after full recovery.
VECURONIUM BROMIDE
Dosage Form: Injection 4 mg/ml (1 ml amp (I)
Recommended Dose: By intravenous injection, intubation, 80–100 micrograms/kg;
maintenance 20–30 micrograms/kg according to response; neonate and infant up to 4
months, initially 10–20 micrograms/kg then incremental doses to achieve response; child
over 5 months, as adult dose (up to 1 year onset more rapid and high intubation dose may
not be required). By intravenous infusion, 0.8–1.4 micrograms/kg/minute (after initial
intravenous injection of 40–100 micrograms/kg)
Indications: Muscle relaxation (intermediate duration) for surgery
Special Precautions: Large doses may cause cumulative effect.
10.5. Antimuscarinic Agents
ATROPINE SULPHATE
Dosage Form: Injection 1 mg/ml (1 ml ampoule) (II)
Recommended Dose: By IM, IV or SC: 400-600 mcg every 4-6 hrs. Premedication by
SC/IM: 300-600 mcg usually in conjunction with 10-15 mg of morphine about 1 hour before
anaesthesia. By IV 300-600 mcg before induction of anaesthesia, and in incremental doses
of 100 mcg for the treatment of bradycardia.
Indications: To reduce salivary and bronchial secretions and diminish risk of vagal
inhibition before induction of general anaesthesia. With neostigmine for reversal of
competitive neuromuscular block, reversal of excessive bradycardia.
Contra-Indications: Enlarged prostate, pyloric stenosis, glaucoma.
Special Precautions: In patients with fever, cardiac insufficiency/failure.
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GLYCOPYRRONIUM BROMIDE (GLYCOPYRROLATE)
Dosage Form: Injection 200 mcg/ ml (1ml ampoule) (I* ICL, OT-Cardiology)
Recommended Dose:
Premedication or intraoperative use.
Adults: For permedication, the usual dose is 200 mcg (0.2mg) by IV or IM, or 4 to 5mcg/kg
(0.004-0.005mg/kg) to a a maximum of 400mcg (0.4mg). During the operation, the dose
may be given by IV and may be repeated if necessary.
Children: For premedication, the recommended dose is 4 to 8 mcg/kg by IV or IM to a
maximum of 200mcg (0.2mg). During the operation, the dose may be given by IV and may
be repeated if necessary.
Reversal of nondepolarising neuromuscular blockade
Adults: The usual dose is 200mcg (0.2mg) by IV per 1000 mcg of neostigmine or 5000mcg
of pyridostigmine. Alternatively, a dose of 10 to 15mcg/kg by IV per 50mcg/kg of
neostigmine.
Children: 10mcg/kg by IV per 50mcg/kg neostigmine or equivalent dose of pyridostigmine.
Indications: To protect against the peripheral muscarinic actions of anticholinesterases,
used to reverse residual neuromuscular blockade produced by non-depolarising muscle
relaxants.
As a preoperative antimuscarinic agent.
As a preoperative or intraoperative antimuscarinic to attenuate or prevent intraoperative
bradycardia associated with the use of suxamethonium or due to cardiac vagal reflexes.
Contra-Indications: Hypersensitive to active ingredient.
Patients with concurrent glaucoma, obstructive uropathy, obstructive disease of GIT,
paralytic ileus, intestinal atony of the elderly or debilitated patient, unstable cardiovascular
status in acute haemorrhage, severe ulcerative colitis, toxic megacolon complicating
ulcerative colitis and myasthenia gravis.
Special Precautions: Use with caution in patients with coronary artery disease, congestive
heart failure, hypertension, hyperthyroidism/thyrotoxicosis or in patients with cardiac
arrhythmias.
10.6. Antagonists for Central and Respiratory Depressants
FLUMAZENIL
Dosage Form: Injection 0.5 mg/5ml (ampoule) (II)
Recommended Dose: Slow IV inj: 200 mcg over 15 sec., then 100 mcg at 60 sec. intervals
if required, up to total dose of 1 mg. Usual dose: 300-600 mcg. Max: 2 mg in ICU. IV
infusion: if drowsiness recurs after injection, 100-400 mcg/h adjusted according to level of
arousal.
Indications: Reversal of sedative effects of benzodiazepines in anaesthetic, intensive care
and diagnostic procedures.
Contra-Indications: Epileptics who received prolonged benzodiazepine therapy.
Special Precautions: Hepatic impairment, benzodiazepine dependence. Ensure
neuromuscular blockade cleared before giving. Avoid rapid inj. in high risk or anxious
patients and following major surgery.
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11. DERMATOLOGICAL PRODUCTS
11.1. Antiinfectives
11.1.1. Antibiotics
FUSIDIC ACID (SODIUM FUSIDATE)
Dosage Form: Oinment 2%; Intertulle 2% (II)
Recommended Dose: Ointment; Apply to affected area 3-4 times daily for 7 days.
Intertulle; Apply daily.
Indications: Staphylococcal skin infections; penicillin-resistant staphylococcal infections.
Superficial, traumatic or surgical wounds, varicose ulcers, abscesses & burns.
Special Precautions: Avoid contact with eyes
FUSIDIC ACID + BETAMETHASONE VALERATE
Dosage Form: Cream 2% + 0.1% (15 g) (I* - Dermatologist)
Recommended Dose: Uncovered lesions: Apply 2 - 3 times a day. Covered lesions: Less
frequent applications may be adequate.
Indications: Inflammatory dermatoses where bacterial infection is present or likely to occur
eg, atopic eczema, discoid eczema, stasis eczema, seborrhoeic dermatitis, contact
dermatitis, lichen simplex chronicus, psoriasis, discoid lupus erythematosus.
Contra-Indications: Viral disease of the skin, perioral dermatitis, acne rosacea, fungal skin
infections and ulcerative conditions.
Special Precautions: Atrophic striae likely to occur on prolonged application (>4 weeks).
Systemic absorption resulting in adrenal suppression may occur especially under occlusion
with weekly doses of >30 g. Avoid prolonged use on flexures and intertriginous areas.
MUPIROCIN
Dosage Form: Ointment 2% (15 g); Cream 2% (15 g) (I* - Dermatologist)
Recommended Dose: Adults and children should be applied to affected area up to 3times
daily, for up to 10 days. The area may be covered with a dressing or occluded if desired.
Indications: It is effective for skin infections, particularly those due to Gram-positive
organisms but it is not indicated for pseudomonal infection.
Contra-Indications: Hypersensitivity to any component of this drug.
Special Precautions: When it’s used on the face, care should be taken to avoid the eyes,
it’s also should be used with caution if there is evidence of moderate or severe renal
impairment.
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NEOMYCIN SULPHATE
Dosage Form: Cream [P] 0.5% (II)
Recommended Dose: Apply sparingly to affected area tds.
Indications: Treatment of infection susceptible to staphylococci and Gram negative.
Contra-Indications: Hypersensitivity to neomycin.
Special Precautions: Caution in extensive dermatological condition where rapid absorption
is possible, because of the possibility of otoneuromuscular blockade.
11.1.2. Sulphonamides
SILVER SULPHADIAZINE
Dosage Form: Cream 1% (II)
Recommended Dose: Apply using sterile spatula or hand covered with a sterile glove, daily
to a thickness of 3-5 mm.
Indications: prophylaxis and treatment of infection in burn wounds; as an adjunct to shortterm treatment of infection in leg ulcers and pressure sores; as an adjunct to prophylaxis of
infection in skin graft donor sites and extensive abrasions; for conservative management of
finger-tip injuries
It is particularly effective against Gram negative organisms such as Pseudomonas
aureginosa.
Contra-Indications: pregnancy and breast-feeding, sensitivity to sulphonamides; not
recommended for neonates
Special Precautions: One jar to be reserved for one patient. Any remaining cream to be
discarded after completion of treatment.
Plasma-sulfadiazine concentrations may approach therapeutic levels with side-effects and
interactions as for sulphonamides if large areas of skin are treated. Owing to the association
of sulphonamides with severe blood and skin disorders treatment should be stopped
immediately if blood disorders or rashes develop—but leucopenia developing 2–3 days after
starting treatment of burns patients is reported usually to be self-limiting and silver
sulfadiazine need not usually be discontinued provided blood counts are monitored carefully
to ensure return to normality within a few days. Argyria may also occur if large areas of skin
are treated (or if application is prolonged
11.1.3. Antifungals
CLOTRIMAZOLE
Dosage Form: Cream 1% (II)
Recommended Dose: Apply thinly and rubbed in bd-tds.
Indications: Treatment of fungal skin infections.
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MICONAZOLE
Dosage Form: Cream 2% (as nitrate) (II)
Recommended Dose: For skin infections: apply twice daily continuing for 10 days after
lesions have healed. For nail infections: apply 1-2 times daily.
Indications: Treatment of dermatophytoses, superficial mycoses and cutaneous
candidiasis.
Contra-Indications: Known hypersensitivity to miconazole.
Special Precautions: Should not be allowed to come into contact with the eyes.
NYSTATIN
Dosage Form: Cream 100,000 units/gram (II)
Recommended Dose: Apply liberally to affected areas bd-qid as required.
Indications: Treatment of cutaneous and mucocutaneous infections caused by candida
albicans. Combined with corticosteroids & antibacterial agents for various dermatologic
conditions.
Contra-Indications: Hypersensitive to nystatin.
SELENIUM SULPHIDE
Dosage Form: Shampoo 2.5% (I* - Dermatologist)
Criteria of use: Indicated for Tinea Versicolor
Recommended Dose: May be used as a lotion (diluted with water to reduce irritation) and
left on for at least 30 minutes or overnight; it is applied 2–7 times over a fortnight and the
course repeated if necessary
Indications: Pityriasis versicolor (Tinea versicolor)
Special Precautions: Should not be applied to inflamed or exudative areas, or to extensive
areas of the skin. Avoid contact with the eyes.
SODIUM THIOSULPHATE
Dosage Form: Lotion [P] 20% (II)
Recommended Dose: Apply once or bd. Treatment must be continued for 6 weeks after an
apparent cure to prevent relapse.
Indications: Treatment of pityriasis versicolor.
Special Precautions: Discontinue if irritation or sensitivity occurs.
TINEA LOTION
Dosage Form: Lotion [P] (II)
Recommended Dose: Apply to affected area once or bd.
Indications: Treatment of tinea infections.
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TIOCONAZOLE
Dosage Form: Cream 1% (20 g) (II)
Recommended Dose: Gently massage into the affected & surrounding area once-bd.
Indications: Dermal infections due to susceptible fungi & bacteria.
Contra-Indications: Hypersensitivity to imidazole antifungal agents.
Special Precautions: Not for ophth use
11.1.4. Antiparasitics
BENZYL BENZOATE
Dosage Form: Emulsion 25% (120 ml) (II)
Recommended Dose: Adult: Apply 3 times at 12-hrly intervals over the whole body, washoff 12 hr after the last application.
Indications: Scabies
Contraindications: Broken or irritated skin; neonates; pregnancy.
Special Precautions: Prevent drug from entering the eyes, elderly (drying effects).
GAMMA BENZENE HEXACHLORIDE (BENZENE HEXACHLORIDE)
Dosage Form: Emulsion 0.3% (200 ml) (II)
Recommended Dose: For lice: Thoroughly moisten scalp with lotion and allowed to dry
naturally. Hair washed after 24 hrs. Repeat treatment 8 days later. For scabies: Apply lotion
over whole body omitting head and neck, wash off after 24 hrs. Repeat after 7 days if
required.
Indications: For treatment of head lice and scabies.
Special Precautions: Avoid contact with eyes. Repeated application can cause dermatitis.
Concurrent treatment of family and close contacts recommended. Topical application can be
absorbed and cause CNS toxicity.
CROTAMITON
Dosage Form: Lotion 10% (1L) (I)
Recommended Dose: Apply to entire body surface below the neck, after bathing and
drying. Application should be repeated once daily preferably in the evening, for 5 days in
succession. No baths until 2-3 days after completion of the treatment.
Indications: Pruritus (including pruritus after scabies
Contra-Indications: Acute exudative dermatoses
Special Precautions: Should not be allowed to come in contact with the eyes. Not to be
applied to acutely inflamed weeping skin conditions.
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MALATHION
Dosage Form: Lotion 0.5%
Recommended Dose: Headlice, rub 0.5% preparation into dry hair and scalp, allow to dry
naturally, remove by washing after 12. Crablice, apply 0.5% aqueous preparation over
whole body, allow to dry naturally, wash off after 12 hours or overnight. Scabies, apply 0.5%
preparation over whole body, and wash off after 24 hours; if hands are washed with soap
within 24 hours, they should be retreated
Indications: Head lice, Crab lice, Scabies
Special Precautions: Avoid contact with eyes; do not use on broken or secondarily
infected skin; do not use lotion more than once a week for 3 consecutive weeks; children
under 6 months, medical supervision required; alcoholic lotions not recommended for head
lice in severe eczema, asthma or in small children, or for scabies or crab lice.
PERMETHRIN
Dosage Form: Lotion 5% (II)
Recommended Dose: Scabies, apply 5% preparation over whole body and wash off after
8-12 hours; CHILD, apply over whole body including face, neck, scalp and ears; if hands
washed with soap within 8 hours of application, they should be treated again with cream;
repeat application after 7 days.
Crab lice, ADULT over 18 years, apply 5% cream over whole body, allow to dry naturally
and wash off after 12 hours or after leaving on overnight; repeat application after 7 days.
Indications: Effective for scabies and crab lice. Permethrin is active against head lice but
the formulation and licensed methods of application of the currents products make them
unsuitable for the treatment of head lice.
Contra-Indications: Hypersensitivity to permethrin/chrysanthemums.
Special Precautions: Avoid contact with eyes; do not use on broken or secondarily infected
skin; children under 6 months, medical supervision required for cream rinse (head lice);
children aged 2 months-2 years, medical supervision required for dermal cream (scabies).
11.1.5. Antivirals
ACYCLOVIR
Dosage Form: Cream 5% (I)
Recommended Dose: Apply to lesions every 4 hours (5 times daily) for 5–10 days, starting
at first sign of attack
Indications: Treatment of herpes simplex.
Contra-Indications: Hypersensitive to acyclovir.
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11.1.6. Miscellaneous Local Antiinfectives
BENZOIC ACID + SALICYLIC ACID (WHITFIELD’S)
Dosage Form: Ointments [P] 6% + 3% (II)
Recommended Dose: Apply bd or tds.
Indications: Treatment of fungus infections of the skin.
11.2. Antiinflammatory Agents
BETAMETHASONE VALERATE
Dosage Form: Cream 0.01% (II); Ointment 0.025%, 0.01%, (I* : Dermatologist)
Criteria of use: Restricted to A.P Dr. Mokhtar Nor)
Recommended Dose: Apply sparingly bd-tds in very thin palm and rub. Reduce strength
and frequency as condition responds. If necessary cover area with a dry dressing.
Indications: severe inflammatory skin disorders such as eczemas unresponsive to less
potent corticosteroids; psoriasis
Contra-Indications: Hypersensitivity, in untreated bacterial, fungal or viral skin lesions.
Special Precautions: Avoid prolonged use in infants and children, and on the face. Topical
steroids should never be used as prophylactic measure. Sudden withdrawal of prolonged
therapy can produce rebound exacerbation of condition.
CLOBETASOL PROPIONATE
Dosage Form: Cream 0.05%; Ointment 0.05% (I)
Recommended Dose: Apply once or bd changing to lower potency therapy as condition is
controlled.
Indications: Psoriasis, recalcitrant eczemas, lichen planus, discoid lupus erythematosus &
other conditions which do not respond satisfactorily to less active steroids.
Contra-Indications: Rosaceae, acne vulgaris, perioral dermatitis, primary cutaneous viral
infection; bacterial, fungal infected skin lesions; perianal & genital pruritis; children < 1 yr.
Special Precautions: Infants & children; prolonged facial use may exhibit atrophic
changes; avoid eye contact; pregnancy; long-term continuous therapy.
CLOBETASONE BUTYRATE
Dosage Form: Cream 0.05%; Ointment 0.05% (I* - Dermatologist)
Recommended Dose: Apply thinly 1 - 2 times daily for up to 4 weeks; max. 50 g of 0.05%
preparation per week.
Indications: Short-term treatment only of severe resistant inflammatory skin disorders such
as recalcitrant eczemas unresponsive to less potent corticosteroids; psoriasis.
Contra-Indications: Untreated bacterial, fungal, or viral skin lesions; ulcerative conditions;
rosacea (acne rosacea), perioral dermatitis; not recommended for acne vulgaris.
Special Precautions: Infants and children, prolonged and continuous use; pregnancy.
Discontinue if secondary infection develops.
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HYDROCORTISONE
Dosage Form: Cream 1% (as acetate) (II)
Recommended Dose: Apply sparingly bd-qid. Reduce strength and frequency as condition
responds.
Indications: Treatment of mild inflammatory skin disorders such as eczemas.
Contra-Indications: In untreated bacterial, fungal or viral skin lesions.
Special Precautions: Avoid prolonged use in infants and children, and on the face.
11.3. Antiinfectives with Antiinflammatory Agents
BETAMETHASONE DIPROPIONATE + SALICYLIC ACID
Dosage Form: Ointment 0.05% + 3%, (15 gm) (II)
Recommended Dose: Apply thinly 1–2 times daily; max. 60 g per week (1)
Indications: Subacute and chronic hyperkeratotic and dry dermatoses.
Contra-Indications: Viral infection of the skin, TB and acne rosacea
11.4. Antipruritic Agents
CALAMINE
Dosage Form: Lotion; Cream [P] (II)
Recommended Dose: Apply when needed.
Indications: For pruritis. Sunburn, ivy poisoning and other skin disorders.
CALAMINE + SULPHUR
Dosage Form: Lotion
Recommended Dose: Apply when needed.
Indications: For pruritis.
11.5. Keratolytic and Cleansing Agents
ACETIC ACID
Dosage form: Solution [P] 1%, 5%, 20% (II)
Indications: Use for daily dressing to infected burns and wounds or using as a cleansing
agent for skin. Also used for fungal infection.
Contra-Indications: Hypersensitivity to acetic acid product.
Special Precautions: Persistent stinging or burning.
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AQUA DERMIS
Dosage form: Liquid cleanser 250 ml, 750 ml (II)
Recommended Dose: Use as a soap substitute.
Indications: Mild non-irritant liqd cleanser w/ acidic pH of 5.8 for all skin conditions, eczema
& dermatitis.
CALCIPOTRIOL
Dosage Form: Cream 50 mcg/g; Ointment 50 mcg/g (I* - Dermatologist)
Recommended Dose: For cream and ointment: apply twice daily, maximum 100 g weekly.
Children: > 6 years old; twice daily, 6-12 years old; maximum 50 g wkly, > 12 years old;
maximum 75 g wkly.
Indications: Plaque psoriasis.
Contra- Indications: Disorder of calcium metabolism.
Special Precautions: Pregnancy, avoid use on face and inadvertent transfer to other body
areas, risk of hypercalcaemia if maximum recommended weekly dose exceeded.
CETRIMIDE
Dosage Form: Lotion [P] 2%, 20% (II)
Recommended Dose: For a 1% w/v solution for skin cleansing dilute 1:20 with water. As
shampoo 1-3% used. For perioperative scrubbing skin cleansing and disinfectant 1%
solution used. For cleansing in wounds and burns 0.1% solution used.
Indications: For skin disinfection, soap solution or shampoo substitute in acne, skin
infections and seborrhoea of the scalp.
Special Precautions: Avoid contact with eyes and in body cavities.
COAL TAR IN AQUEOUS CREAM
Dosage Form: Cream [P] 5%, 10% (II)
Recommended Dose: Apply 1–3 times daily starting with low-strength preparations
Indications: psoriasis and occasionally chronic atopic eczema
Special Precautions: not for use in sore, acute, or pustular psoriasis or in presence of
infection
OILATUM (LIGHT LIQUID PARAFFIN + WHITE SOFT PARAFFIN)
Dosage Form: Emollient 6% + 15% (I)
Recommended Dose: Soap as directed. Add 5-15 ml/bath and soap for 10-20 min.
Indications: For dry skin conditions including dermatitis, pruritus of the elderly and
ichthyosis; add 1–3 capfuls/bath (infant 0.5–2 capfuls)
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PODOPHYLLUM COMPOUND PAINT
Dosage Form: Paint [P] 15% (II)
Recommended Dose: Applied daily.
Indication: Removal of warts.
Contra-Indications: Patient using steroid or with poor blood circulation and diabetic patient.
It is not to be used on bleeding warts, moles, birthmarks or unusual warts with hair growing
from them.
Special Precautions: Keep away from the eyes.
SALICYLIC ACID + LACTIC ACID (DUOFILM)
Dosage Form: Paint 16.7% + 16.7% (II)
Recommended Dose: Soak warts in hot water for 5 minutes. Dry thoroughly. Apply without
touching surrounding areas and cover with plaster. Repeat once daily until warts are
completely cleared.
Indications: Warts, corns and calluses.
Contra-Indications: Diabetes, impaired blood circulation, moles, birthmarks, unusual skin
growths, face or ano-genital regions.
Special Precautions: Avoid contact with eyes, or mucosal membranes and application to
normal skin.
SALICYLIC ACID + DITHRANOL IN AQUEOUS CREAM
Dosage Form: Cream [P] 1% + 2% (II)
Recommended Dose: Concentration higher than 1% may be applied for very short
exposure periods of 20-30 minutes and then remove from the skin.
(For ointment preparation, it is intended for application to the scalp and is readily removed
with warm water.)
Indications: Psoriasis.
Contraindications: Hypersensitivity to salicylic acid.
Special Precautions: Avoid- broken and inflamed skin & contact with eyes.
SALICYLIC ACID + SULPHUR IN EMULSIFYING OINTMENT
Dosage Form: Ointment [P] 1% + 1%, 1% + 2%, 2% +2% (II)
Recommended Dose: As above.
Indications: As above.
Special Precautions: As above.
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SALICYLIC ACID IN AQUEOUS CREAM
Dosage Form: Cream 2%, 10% (II)
Recommended Dose: Applied to affected area.
Indications: Used in concentration of 0.5% to 10% for acne, 3% to 6% as a keratolytic and
in concentration of 5% to 40% for warts and corn removal.
Contra-Indications: Hypersensitivity to salicylic acid and children under 2 years old.
Special Precautions: Salicylate toxicity may occur after prolong used over large areas. It is
irritating and may cause dermatitis. Also avoid contact with eyes, face, genital and mucous
membranes.
SALICYLIC ACID IN WHITE SOFT PARAFFIN
Dosage Form: Ointment [P] 1%, 10%, 15%, 20% (II)
Recommended Dose: Apply bd as a thin layer.
Indications: Treatment of eczema, psoriasis, seborrhoiec dermatitis, hyperkeratosis.
Special Precautions: Avoid broken or inflamed skin.
SILVER NITRATE
Dosage Form: Lotion [P] 0.5%, 1%, 10% (II)
Recommended Dose: Applied to affected area or lesion.
Indications: As wet dressing of 0.1- 0.5% is used in treatment of burns and 10% solution is
used to treat impetigo vulgaris.
Contra-Indication: Hypersensitivity to any component of the preparation and do not apply
concentration higher than 0.5% and 1% silver nitrate to wounds, cuts or broken skin.
Special Precautions: If redness or irritation occur, discontinue use. Silver nitrate tends to
stain skin and utensils, handle carefully. With prolonged used, monitor methemoglobin level
of septic patient.
SULPHUR IN AQUEOUS CREAM
Dosage Form: Cream [P] 20% (II)
Recommended Dose: Applied topically once to three times daily for several days with
decreasing application frequency over time.
Indications: Treatment of acne, dandruff, rosacea, scabies and seborrheic dermatitis.
Contra-Indication: Hypersensitivity to sulphur or sulfonamide and kidney disease.
Special Precaution: Application to irritated or abraded skin (discontinue use if signs of
sensitization develop
11.6. Soothing and Protective Agents
AQUEOUS CREAM
Dosage Form: Cream [P] (II)
Recommended Dose: Apply as directed. Can be used as soap substitutes for hand
washing and in the bath; the preparation is rubbed on the skin before rinsing off completely
Indications: For dry scaling disorders.
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LACTACYD (LACTIC ACID + LACTOSERUM)
Dosage Form: Liquid (1 gm + 0.93 gm)/100 ml (II)
Recommended Dose: For facial & body wash Use as a soap substitute. For scalp care Use
as a shampoo. Baby bath 1 capful to a tub 1/3 filled w/ water.
Indications: For facial & body wash in acne, occupational & tropical dermatitis, prickly heat,
pruritus, eczema & seborrhoea. In paed for diaper rash, prickly heat, cradle cap, daily infant
hygiene.
METHYL SALICYLATE
Dosage Form: Liniment [P] (II)
Recommended Dose: Applied with gentle massage bd-tds.
Indications: For relief of pain, lumbago sciatica and rheumatic conditions.
Special Precautions: Avoid broken or inflamed skin.
ZINC OXIDE
Dosage Form: Cream (II)
Recommended Dose: Apply bd.
Indications: For soothing, antiseptic and protective application in eczema, acne vulgaris,
prickly heat, diaper rash and other skin disorders. For nappy and urinary rash and
eczematous conditions
11.7. Antiseptics and Disinfectants
ACETIC ACID
Dosage Form: Solution [P] 1%, 5%, 20% (II)
Indications: Use for daily dressing to infected burns and wounds or using as a cleansing
agent for skin. Also used for fungal infection.
Contra-Indication: Hypersensitivity to acetic acid product.
Special Precautions: Persistent stinging or burning.
ACRIFLAVINE
Dosage Form: Lotion [P] 0.1% (1:1000) (II)
Recommended Dose: Apply sparingly to affected part as required.
Indications: Skin disinfection for treatment of minor wounds, burns and infected skin.
ALCOHOL
Dosage Form: Lotion [P] 70%, 90% (II)
Indications: As an antiseptic/disinfectant; skin preparation before injection
Special Precautions: Avoid broken skin; patients have suffered severe burns when
diathermy has been preceded by application of alcoholic skin disinfectants.
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ADAZONE + PERACETIC ACID (ADASPOR)
Dosage Form: Liquid (II)
Recommended Dose: Achieves high level disinfection with 5 minutes of contact time and is
sporicidal after 10 minutes
Indications: Chemical germicide for use in either, automated endoscope reprocessors, or
for manual reprocessing.
Contraindications: Data not available
Special Precautions: NA
BENZALKONIUM CHLORIDE
Dosage form: Solution 4.225 gm/L (II)
Indications: As an antiseptic/disinfectant
BENZOIC ACID
Dosage Form: Solution [P] 5%. (II)
Recommended Dose: Apply topically to the affected area 1 or 2 times daily.
Indications: Treatment of fungal infections of the skin.
Special Precautions: Topical applications may produce mild irritation at the site.
CETRIMIDE
Dosage Form: Lotion [P] 2%, 20% (II)
Recommended Dose: For a 1% w/v solution for skin cleansing dilute 1:20 with water. As
shampoo 1-3% used. For perioperative scrubbing skin cleansing and disinfectant 1%
solution used. For cleansing in wounds and burns 0.1% solution used.
Indications: For skin disinfection, soap solution or shampoo substitute in acne, skin
infections and seborrhoea of the scalp.
Special Precautions: Avoid contact with eyes and in body cavities.
CHLORHEXIDINE GLUCONATE
Dosage Form: Scrub 4% (800 ml - Surgi Foam), (5 L - Hibiscrub) (II)
Recommended Dose: To be used instead of soap for pre-operative hand and skin
preparation and for general hand and skin disinfection
CHLORHEXIDINE GLUCONATE (5%)
Dosage Form: Solution 5% (II)
Indications: For dressing (General antisepsis)
Recommended Dose: To be used diluted 1 in 10 in alcohol 70% for pre-operative skin
operation, or 1 in 100 (0.05%) with water for general skin disinfection.
Special Precautions: Avoid prolonged skin contact w/ alcoholic soln. Avoid contact w/
eyes, brain, meninges, middle ear & body cavities. For external use only.
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CHLORHEXIDINE GLUCONATE (20% - DESMANOL)
Dosage Form: Solution 20% (II)
Indications: Instrument disinfection
Special Precautions: Avoid contact with eyes
CHLORHEXIDINE GLUCONATE AQUEOUS
Dosage Form: Solution [P] 0.5% (1:200) (II)
Recommended Dose: To be used undiluted for skin disinfection in wounds, burns and
obstetrics.
Special Precautions: Avoid prolonged skin contact w/ alcoholic soln. Avoid contact w/
eyes, brain, meninges, middle ear & body cavities. For external use only.
CHLORHEXIDINE GLUCONATE CREAM
Dosage Form: Cream [P] 1%, 1% (Gynae) (II)
Recommended Dose: Apply sparingly to affected area. To be used in obstetrics as vaginal
lubricant and for application to the vulva & perineum during labour.
CHLORHEXIDINE GLUCONATE IN ALCOHOL (HIBISOL)
Dosage Form: Solution 0.5% in 70% (II)
Indications: Disinfection of clean intact skin. Pre-op surgical hand disinfection, hand
disinfection on the ward prior to aseptic procedures or after handling contaminated material
& for disinfection of patient's skin prior to surgery or other invasive procedures.
Recommended Dose: Pre-op surgical hand disinfection Spread 5 mL thoroughly over both
hands & forearms, rubbing vigorously. When dry apply a further 5 mL & repeat procedure.
Antiseptic hand disinfection on the ward Spread 3 mL thoroughly over the hands & wrists
rubbing vigorously until dry. Disinfection of patient's skin Prior to surgery, apply to a sterile
swab & rub vigorously over the operation site for a min of 2 mins.
Special Precautions: Avoid contact w/ eyes, brain meninges, body cavities, middle ear.
Not for inj. Avoid prolonged skin contact. Allow to dry before proceeding.
CHLORHEXIDINE GLUCONATE IN ETHANOL
Dosage Form: Solution 0.5% in ethanol 70% [P] - (II)
Recommended Dose: To be used undiluted for hand and skin disinfection.
CHLORHEXIDINE GLUCONATE IN SPIRIT
Dosage Form: Solution 0.5% in spirit 70% [P] (II)
Recommended Dose: To be used undiluted for pre-operative skin preparation and
instruments.
Indications and Special Precautions: As above.
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FORMALDEHYDE AQUEOUS
Dosage Form: Liquid 10% (II)
Recommended Dose: For disinfectant: as spray with equal volume of methylated spirit. For
vaporisation by heat, with 2 parts of water. Treatment of warts as 1.5% solution. As
preservation for pathological specimens: 10% formalin solution.
Indications: As disinfectant, deodorant, treatment of warts, and preservation for
pathological specimens.
Special Precautions: Irritant to normal skin. Can cause dermatitis, allergic reaction and
possibly cancer.
FORMALDEHYDE IN NORMAL SALINE
Dosage Form: Lotion 10% (II)
Indications: As disinfectant
Special Precautions: Irritant to normal skin. Can cause dermatitis & allergic reaction
GIGASEPT®
(COCOSPROPYLENE
DIAMINEGUANIDINE
PHENOXYPROPANOL + BENZALKONIUM CHLORIDE)
Dosage Form: Solution (14 gm + 35 gm + 2.5 gm) per 100 gm (II)
Indications: As Instrument disinfectant
Special Precautions: Irritant to normal skin.
DIACETATE
+
HYDROGEN PEROXIDE
Dosage Form: Solution (20 volumes) - (II)
Indications: As disinfectant, for cleansing and deodorising wounds and ulcers.
Special Precautions: Bleaches fabric, solutions above 6% should be diluted before
application to the skin.
POTASSIUM PERMANGANATE
Dosage Form: Solution [P] 1:1000, 1:10,000 (II)
Recommended Dose: For cleansing ulcers and abcesses. As wet dressing 1-3 times a day
or as required.
Indications: Cleansing and deodorising suppurating eczematous reactions, acute
dermatoses and wounds.
Special Precautions: Irritant to mucous membrane. Repeated use of dilute solution may
cause corrosive burns.
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POVIDONE IODINE
Dosage Form: Solution 10% (Equivalent to 1% iodine) (II); Cutaneous solution 10%
(Equivalent to 1% iodine) (Sterile) (I* - ICL, OT)
Recommended Dose: Apply/paint the area 1-2 times a day and allow to dry. Cutaneous
solution; Apply undiluted to skin prior to surgery, or apply as appropriate to injured area.
Indications: Skin disinfection also can be used for contaminated wound, infection of the
mouth, herpes infection, candidiasis, vaginal trichomoniasis, acne vulgaris, other pyogenic
or seborrhoiec infections of scalp or skin and preoperative skin preparation.
Contra-Indications: Non-toxic nodular colloid goitre.
Special Precautions: Avoid application to large areas of broken skin.
SODIUM HYPOCHLORITE
Dosage Form: Solution [P] (10% available chlorine) (II)
Recommended Dose: To be diluted before use.
Indications: As disinfectant of hard surfaces, food and dairy equipment surgical purposes
and wounds.
Special Precautions: Solution unstable and should be freshly prepared. Dissolve blood
clots topically and may cause bleeding. Irritating to skin unless rinsed off promptly.
WEAK IODINE SOLUTION BP (IODINE TINCTURE)
Dosage Form: Solution 1% (4 L) (II)
Recommended Dose: To be used undiluted.
Indications: Skin disinfection in minor skin wound and perioperative preparation.
11.8. Medicated Surgical Dressings
CHLORHEXIDINE ACETATE (BACTIGRAS)
Dosage Form: Tulle 10 cm x 10 cm, 15 cm x 20 cm, 15 cm x 1 M (II)
Recommended Dose: Daily to twice wkly dressing or more often as required. Cleanse
wound before dressing.
Indications: Topical treatment of wounds w/ infective risk, infected wounds in conjunction
w/ systemic antibacterials, minor burns & scalds, lacerations, abrasions, donor & recipient
graft sites, leg ulcers.
Special Precautions: Avoid extensive use (>10% of body area). Avoid contact w/ eyes,
middle ear, meninges, brain.
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11.9. Miscellaneous
BENZOYL PEROXIDE
Dosage Form: Gel 2.5%, 5% (I)
Recommended Dose: Apply 1–2 times daily preferably after washing with soap and water,
start treatment with lower-strength preparations.
Indications: Acne vulgaris.
Special Precautions: Avoid contact with eyes, mouth or other mucous membranes. May
bleach dyed clothing and fabrics, avoid excessive exposure to sunlight.
ELASE (FIBRINOLYSIN LOOMIS + DESOXYRIBONUCLEASE)
Dosage Form: Ointment (135 u + 120,000 Christensen units)/100 gm
Recommended Dose: Apply a thin layer over dry, clean wound & cover w/ petrolatum
gauze or non-adhering dressing. Dressing to be changed bd-tds. Vaginitis & cervicitis 5 mL
of oint deposited deep in the vag once nightly for 5 applications.
Indications: Enzymatic debridement of necrotic tissue in wound & liquefaction & dissolution
of exudates of injured skin & mucous membrane.
Special Precautions: Hypersensitivity to bovine compound.
EMLA (LIDOCAINE + PRILOCAINE)
Dosage Form: Cream (25 mg + 25 mg/gm) (5 gm)
Recommended Dose: Apply thick layer w/under occlusive dressing. Adult Approx 1.5 g/10
cm2. Minor procedures eg needle insertion & surgical treatment of localised lesions Adult 2 g
(approx 1/2 tube) for a min of 1 hr, max 5 hr. Childn Approx 1 g/10 cm2. Application time:
approx 1 hr. Dermal procedures on larger areas eg split skin grafting Adult Approx 1.5-2
g/10 cm2 for a min of 2 hr, max 5 hr. Surgical treatment of localised lesions eg removal of
genital warts (condylomata acuminata) & prior to inj of local anaesth Adult Approx 5-10 g for
5-10 mins. No occlusive dressing required. Commence procedure immediately thereafter.
Mechanical cleansing/debridement of Leg ulcer Adult Approx 1-2 g/10 cm2 up to a total of 10
g. Cover w/ occulsive dressing. Application time: at least 30 mins. Up to 60 mins may
improve the anaesth further. Cleansing should start w/o delay after removal of cream.
Indications: Topical analgesia for use during needle insertion, superficial surgical
procedures; leg ulcers prior to cleaning & superficial surgical procedures eg removal of
fibrin, pus & necroses; genital mucosa.
Contra-Indications: Congenital or idiopathic methaemoglobinaemia. Open wounds other
than leg ulcers. Genital mucosa of childn.
Special Precautions: Atopic dermatitis, application in vicinity of the eyes.
HYDROXYETHYL CELLULOSE
Dosage Form: K - Y Jelly 82 gm (II)
Recommended Dose: Apply sufficient for lubricating purposes.
Indications: For lubricating purposes eg. catheterization.
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POLYTAR (TAR + CADE OIL + COAL TAR + ARACHIS OIL)
Dosage Form: Liquid 1% (0.3% + 0.3% + 0.1% + 0.3%) (I)
Recommended Dose: Use as scalp cleanser 2 - 3 times weekly for at least 3 weeks.
Indications: Scalp disorders including psoriasis, seborrhea, eczema, pruritis and dandruff
of scalp.
SOLCOSERYL
Dosage Form: Jelly 10% (20 g); eye gel 8.3 mg/g (5 g); dental paste 5 g (I)
Recommended Dose: Apply 3-5 times daily (start treatment with jelly until formation of
granulation tissue, then continue with oinment until complete epithelization).
Indications: Burns, scald, skin ulcers, traumatic and ischemic wounds and trophic lesions
due to severe disorders of blood circulation.
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TRETINOIN
Dosage Form: Cream 0.05% (II)
Recommended Dose: Apply thinly to affected area once or twice daily. Avoid exposure to
sunlight and UV lamps.
Indications: Acne vulgaris.
Contra-Indications: pregnancy; women of child-bearing age should take adequate
contraceptive precautions. Tretinoin is contra-indicated in personal or familial history of
cutaneous epithelioma.
Special Precautions: Keep away from the eyes, mouth, angles of the nose and from
mucous membrane.
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12. ONCOLOGY AGENTS
12.1. Alkylating Agents
12.1.1. Bis(chloroethyl)amines
CYCLOPHOSPHAMIDE
Dosage Form: Tablet 50 mg; Injection 200 mg/vial, 1 gm/vial (I)
Recommended Dose: 100-150 mg daily. Child: up to 1 yr: 10-30 mg. 1-5 yrs: 30-50 mg. 612 yrs: 50-100 mg. By IV: 100 mg daily, increased to 200-300 mg until a total dose of 60008000 mg has been given. Maintenance: 50-300 mg daily by mouth or 3-5 mg/kg by IV twice
weekly. Child: By IV 5 mg/kg daily. Maintenance: 2-5 mg/kg by mouth.
Indications: Treatment of acute and chronic lymphocytic leukaemia, AML, lymphomas,
solid tumours, mycosis fungoides, and management of auto-immune disorders. Cancers of
the colorectal, cervical, Wirm's tumors, pulmonary adenocarcinoma, Hodgkin's disease,
multiple myeloma and soft tissue sarcomas.
Contra-Indications: Haemorrhagic cystitis, previous life-threatening to cyclophosphamide,
significant to leukopenia, thrombocytopenias, severe renal impairment (Creatinine clearance
< 30ml/min), early pregnancy, systemic infections.
Special Precautions: Reduce dosage in patients with renal or hepatic failure, care in
patients with diabetes mellitus, ensure adequate fluid intake, pregnancy, nonmalignant,
inflammatory conditions. Adjustments required if andir myelosupression falls below
300/WBC's or 100000/mm3 platelets (to minimize risk of infection).
IFOSFAMIDE
Dosage Form: Injection 1 gm (I* - Oncologist)
Recommended Dose: Short IV infusion Usual dose 50-60 mg/kg IV daily for 5 consecutive
days or 50-60 mg/kg IV every 2 days (days 1,3,5,7,9) or 20-30 mg/kg IV for 10 consecutive
days; every 3 weeks with Mesna as a uroprotectant. Therapy resistant cases, 80 mg/kg
daily for 2-3 consecutive days. Continuous IV infusion 125-200 mg/kg/day (5-8 g/square
meter) together with uromitexan.
Indications: Third-line agent for the treatment of germ cell testicular cancer in combination
with other chemotherapeutic agents. Cancers of the head and neck, breast, cervix, ovaries,
soft tissue sarcomas, Ewing's sarcoma, osteosarcoma, both Hodgkin's and non-Hodgkin's
lymphomas, non-small cell lung cancer, acute lymphocytic leukemia, and neuroblastoma.
Contra-Indications: Known hypersensitivity to Ifosfamide, severe bone marrow depression,
impaired renal function, bilateral outflow obstruction, acute infection, acute haemorragic
cystitis, pregnancy.
Special Precautions: The dose-limiting toxicities; myelosuppression and urotoxicity.
Nephrotoxic with renal failure and Fanconi syndrome development occurring over the longterm in some patients. Certain CNS toxicities (somnolence, confusion, hallucinations,
coma); require therapy cessation. Unilateral nephrectomies, brain metastases, infection,
electrolyte imbalance.
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MELPHALAN
Dosage Form: Tablet 2 mg (I)
Recommended Dose: Up to 10 mg daily for 7 days, repeated after 4-6 weeks.
Indications: Treatment of multiple myeloma, malignant melanoma. Carcinoma of the breast
and ovary.
Contra-Indications: Documented hypersensitivity, inadequate marrow reserve.
Special Precautions: Reduce dosage in renal failure, regular blood counts should be done.
12.1.2. Alkyl Sulphonates
BUSULPHAN
Dosage Form: Tablet 2 mg (I)
Recommended Dose: Initially 2-4 mg daily. Maintenance: 0.5-2 mg daily. Child: 60 mcg/kg
daily.
Indications: Treatment of chronic myeloid leukemia (CML).
Contra-Indications: Documented hypersensitivity, inadequate marrow reserve.
Special Precautions: Regular blood counts required to be done
12.1.3. Others
CARBOPLATIN (PLATINUM - SALT ALKYLATING AGENT)
Dosage Form: Injection 150 mg/vial, 450 mg/vial (I)
Recommended Dose: The usual adult dose for treating recurrent ovarian cancer is IV 360
mg/square meter on day 1 every 4 weeks. Doses should be adjusted in patients with renal
failure or myelosuppression.
Indications: Ovarian cancer, head and neck cancer, and small cell lung cancer
Contra-Indications: Severe myelosuppression, preexisting severe renal impairment, dose
adjustment may allow use in the presence of mild renal impairment, history of severe
allergic reactions to carboplatin or other platinum-containing compounds.
Special Precautions: Myelosuppression, primarily thrombocytopenia and leukopenia, is the
major dose-limiting adverse effect. Nausea and vomiting are also fairly common, but are
only occasionally severe.
MITOMYCIN-C
Dosage Form: Injection 10 mg (I)
Recommended Dose: Usually administered at 6-weekly intervals.
Indications: To treat upper gastro-intestinal and breast cancers and by bladder instillation
for superficial bladder tumours.
Contra-Indications: Pregnancy & breast-feeding
Special Precautions: Prolonged use may result in permanent bone-marrow damage. It
may also cause lung fibrosis and renal damage.
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MITOXANTRONE
Dosage Form: Injection 20 mg/ 10 ml (I)
Recommended Dose: Treatment Of Acute Leukaemia Adult: 8-12 mg/m2/day once daily
for 4-5 days. Child: >2 yrs: Same as adult dose; 2 yrs: 0.4 mg/kg/day once daily for 3-5
days. Treatment Of Breast Cancer, Prostate Cancer and Lymphomas Adult: 12-14 mg/m2
every 3-4 weeks or 2-4 mg/m2/day for 5 days every 4 weeks. Child: 18-20 mg/m2 every 3-4
weeks or 5-8 mg/m2 every week. Should be diluted in sodium chloride 0.9% or glucose 5%
before administration. Management Of Multiple Sclerosis Adult: 12 mg/m2 by IV infusion
over 5-15 min.
Indications: Treatment of acute leukaemia treatment of breast cancer, prostate cancer and
lymphomas management of multiple sclerosis
Contra-Indications: Pregnancy; lactation; hypersensitivity; severe myelosuppression;
cardiac dysfunction from earlier anthracycline exposure.
Special Precautions: Periodic blood counts to monitor blood picture; monitor cardiac
functions, especially after a cumulative dose of 160 mg/m 2. Caution is exercised in patients
with prior radiotherapy and other concomitant cytotoxic therapy. Extravasation to be avoided
as it causes tissue necrosis. May cause blurred vision (so exert caution when driving or
operating machinery).
OXALIPLATIN
Dosage Form: Injection 50 mg/vial (I* - Oncologist)
Recommended Dose: Dosed as 2 day regimen every 2 weeks:- DAY (1): 85 mg/m(2) IV in
250-500 mL D5W, leucovorin 200 mg/m(2) IV in D5W both over 2 hrs at same time using a
Y-line, followed by 5-fluorouracil 400 mg/m(2) IV bolus over 2-4 minutes, then 5-fluorouracil
600 mg/m(2) IV in 500 mL D5W over 22 hrs. DAY (2): leucovorin 200 mg/m(2) IV over 2 hrs,
then 5-fluorouracil 400 mg/m(2) IV bolus over 2-4 minutes, then 5-fluorouracil 600 mg/m(2)
IV over 22 hrs
Indications: Metastatic colorectal cancer in combination with 5-fluorouracil/leucovorin for
patients who have recurred/progressed during or within 6 months of 1st line therapy with 5fluorouracil/leucovorin/irinotecan
Contra-Indications: History of allergy to oxaliplatin or platinum compounds.
Special Precautions: Extravasation, hypersensitivity to other platinum analogs (eg,
cisplatin, carboplatin), infection, oxaliplatin has been associated with pulmonary fibosis,
presence or history of peripheral neuropathy, preexisting renal/hepatic impairment,
significant bone marrow suppression.
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CISPLATIN (PLATINUM DIAMINO DICHLORIDE)
Dosage Form: Injection 10 mg/vial, 50 mg/vial (I)
Recommended Dose: By IV: 15-20 mg/m2 daily for 5 days repeated every 3-4 weeks or
single dose of 50-120 mg/m2 every 3-4 weeks. Combination chemotherapy: lower dose
from 20 mg/m2 upwards, given every 3-4 weeks.
Indications: Metastatic tumors of the testis & ovary, solid tumors of bladder, prostate, head
and neck.
Contra-Indications: Hypersensitive to cis platinum, patients with renal or hearing
impairment.
Special Precautions: Renal function and hearing to be closely monitored; maintain
adequate hydration and urinary output. Leukopenia or thrombocytopenia.
12.2. Antitumor Antibiotics
12.2.1. Anthracyclines
DAUNORUBICIN
Dosage Form: Injection 20 mg/vial (I)
Recommended Dose: For AML: 45-60 mg/m2 daily repeated at intervals of 4-7 days. ALL:
25 mg/m2 once a week.
Indications: Acute lymphocytic and granulocytic leukaemia, chronic myeloid leukaemia.
Neuroblastoma.
Contra-Indications: Patients of heart disease and treatment best avoided in elderly
patients.
Special Precautions: Severe cardiotoxicity if total dose exceeds 550 mg/m2. Daily blood
counts shall be determined; cardiac monitoring required. Red discoloration of urine colour.
DOXORUBICIN (ADRIAMYCIN)
Dosage form: Injection 10 mg/vial, 50 mg/vial (I)
Recommended Dose: 60-75 mg/m2 as single dose IV every 3 weeks (or 1.2-2.4 mg/kg
single dose). Alternatively dose may be divided equally over 3 successive days and
repeated every 3 weeks.
Indications: Acute leukaemia, lymphomas Wilm's tumour and solid tumours.
Contra-Indications: Generally in patients with cardiac disease.
Special Precautions: Should not be given IM/SC; daily blood counts to be determined and
cardiac monitoring required, reduce dose in patients with hepatic function. Maximum total
dose should not exceed 550 mg/m2.
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EPIRUBICIN
Dosage form: Injection 10 mg/vial, 50 mg/vial (I)
Recommended Dose: For intravenous or intravesical administration only.
NOTE: The recommended lifetime cumulative dose limit is 1000 mg Epirubicin/m 2 body
surface area.
The recommended dosage in adults, is as a single intravenous injection administered at 21
day intervals. Standard doses are 75 to 90 mg/m 2. Higher doses, up to 135 mg/m2 as a
single agent and 120 mg/m2 in combination, every 3-4 weeks have been effective in the
treatment of breast cancer. In the adjuvant treatment of early breast cancer patients with
positive lymph nodes, doses ranging from 100 mg/m 2 to 120 mg/m2 every 3-4 weeks are
recommended.
Indications: Principally used for breast cancer but has activity in gastric, ovarian and small
cell lung cancers, lymphoma, metastatic soft tissue sarcoma, superficial bladder cancer.
Contra-Indications: Generally in patients with cardiac disease.
Special Precautions: Cardiac monitoring required. Red discoloration of urine colour.
IDARUBICIN
Dosage form: Injection 10 mg/vial (I)
Recommended Dose: Consult specialist protocols. Total cumulative dose ADULT, should
not exceed 160mg/m2 by IV route. Child should not exceed 90 mg/m 2 by IV
Indications: Advanced breast cancer after failure of first-line chemotherapy (not including
anthracyclines); acute leukaemias
Contra-Indications: Generally in patients with cardiac disease.
Special Precautions: Cardiac monitoring required. Red discoloration of urine colour.
12.2.2. Others
ASPARAGINASE
Dosage Form: Injection 10,000 units/vial (I)
Recommended Dose: 50-200 KU/kg body weight by IV infusion daily or every other day.
Dose should be adjusted according to age and severity of symptoms.
Indications: Acute leukemia (including chronic leukemia that turned acute), malignant
lymphoma.
Contra-Indications: History of hypersensitivity to asparaginase, pancreatitis, pregnancy
(not recommended whether in confirmed or suspected pregnancy)
Special Precautions: Bone marrow depression, infectious disease, varicella, liver or kidney
dysfunction as fatal systemic disorders may occur. Long-term administration carries the
potential of causing severe and protractive adverse reactions. Use in children.
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BLEOMYCIN SULPHATE
Dosage Form: Injection 15 mg/ampoule (I)
Recommended Dose: By SC, IM, IV or IA injection: 15-60 mg weekly in divided doses or
10-20 mg/m2 once or twice weekly to a total dose of 300 mg. Remission in Hodgkin's
disease maintained with weekly dose of 5 mg.
Indications: Treatment of testicular carcinoma, squamous cell carcinoma, Hodgkin's
disease, other lymphomas, malignant effusions.
Contra-Indications: Severe pulmonary disease.
Special Precautions: In patients with renal impairment or pulmonary incapacity.
Respiratory function to be monitored in all patients. Avoid skin contact. Geriatrics.
DACTINOMYCIN (ACTINOMYCIN D)
Dosage Form: Injection 0.5 mg/vial (I)
Recommended Dose: By IV: 0.5 mg daily for a max of 5 days, repeated after 2-6 weeks.
Child: 0.015 mg/kg daily in 4 divided doses for a max of 5 days OR 400-600 mcg/m2 daily
IV for 5 days.
Indications: Treatment of Wilm's tumour in children (in combination with vincristine),
rhabdomyosarcoma, solid tumours, kaposi's sarcoma, soft tissue sarcoma,
choriocarcinoma. Alternative therapy in Ewing's sarcoma and testicular carcinoma.
Special Precautions: In patients with renal impairment. Care must be taken to avoid
extravasation. Used under constant supervision, concomitant therapy with irradiation.
12.3. Antimetabolites
12.3.1. Folate Antagonists
METHOTREXATE
Dosage Form: Tablet 2.5 mg; Injection 50 mg/vial, 500 mg/20 ml, 1 gm/vial (I)
Recommended Dose: For choriocarcinoma: 15-30mg orally IM or IV for 5 days at intervals
of 1-2 weeks for 3-5 courses. Maintenance of ALL: 20mg/m2 weekly orally or IV. Meningeal
leukaemia: By IT injection: 12-15mg/m2 once or twice weekly.
Indications: Acute lymphoblastic leukaemia, meningeal leukaemia, non-Hodgkin's
lymphoma, choriocarcinoma, and other malignant diseases. AS immunosupression in
rheumatoid arthritis and SLE, severe cases of recalcitrant psoriasis.
Contra-Indications: Pre-existing blood disorders, significant renal impairment (Creatinine
clearance < 40ml/min), pregnancy, anuria, oliguria, pleural or peritoneal effusion, pregnant
patients with psoriasis or RA, nursing mothers, alcoholic, chronic liver disease,
immunodeficient, blood dyscrasias, active infection.
Special Precautions: In patients with renal/hepatic impairment. Avoid contact with skin and
mucous membranes. Caution in alcoholics and active ulcer disorders. Geriatrics. Parenteral
hydration with urinary alkalinization in HD MTX. Leucovorin rescue required. Pregnancy.
Women of child-bearing potential should not become pregnant for at least 1 ovulatory cycle
after completion of MTX therapy.
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12.3.1.1. Antidote to Folate Antagonists
CALCIUM FOLINATE (FOLINIC ACID @ LEUCOVORIN CALCIUM)
Dosage Form: Tablet 15 mg; Injection 3 mg/ml, 15 mg/3 ml, 50 mg/5 ml ampoule (I)
Recommended Dose: Antidote dose: severe cases- By IV infusion 75 mg within 12 hours
then 12 mg IM every 6 hours for 4 doses. Antidote dose: less severe- 6-12 mg IM every 6
hours for 4 doses. In conjunction with methotrexate to reduce toxicity of methotrexate and
treatment of megaloblastic anaemia.
Special Precautions: Should nor be given alone or in conjunction with inadequate amounts
of hydroxocobalamin for treatment of pernicious anaemia.
12.3.2. Purine Antagonists
AZATHIOPRINE
Dosage Forms: Tablet 50 mg (I)
Recommended Dose: Initilly: 3-5 mg/kg. In conjunction 1-2.5 mg/kg daily orally.
Maintenance: 1-3 mg/kg/day. In conjunction with corticosteroids: 1-2.5 mg/kg daily orally.
Indications: Immunosuppressant. For organ and tissue transplant, lupus erythromatus,
rheumatoid arthritis, chronic hepatic and severe skin disorders.
Special Precautions: Reduce dose in severe renal impairment and concomitant
administration with Allopurinol. Caution in liver damage or history of liver disease.
MERCAPTOPURINE
Dosage Form: Tablet 50 mg (I)
Recommended Dose: 2.5-5 mg/kg daily. Maintenance: 50-90 mg/m2 or 1.2-2.5 mg/kg
daily. Child: 2.5 mg/kg or 70 mg/m2 once daily.
Contra-Indications: Acute leukaemia, chronic granulocytic leukemia.
Special Precaution: Blood counts must be carefully monitored, to be used with care in
patients with hepatic or renal damage. Mercaptopurine dose should be reduced to about ¼
when allopurinol given concomitantly.
THIOGUANINE
Dosage Form: Tablet 40 mg (I)
Recommended Dose: Exact dose and duration depends on the nature and dosage of other
cytotoxic drugs in the regime used.Induction Therapy-Adult: 100-200 mg/m2 body surface
area /day as a single or b.d dose over a period of 5 - 20 days. Children: Either 100 - 200
mg/m2 (with appropriate correction for body surface area) or 60-75 mg/m2 regime have been
used. Maintenance-Adults & children: Intermittent or continuous daily maintenance doses of
60-200 body surface area have been used.
Indications: Acute leukemia, especially acute myelogenous leukaemia and acute
lymphoblastic leukaemia, chronic granulocytic leukaemia.
Contra-Indications: No absolute contraindications.
Special Precautions: Reduce dosage in impaired hepatic or renal function.
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12.3.3. Pyrimidine Antagonists
CAPECITABINE
Dosage Form: Tablet 500 mg (I* - Oncologist)
Recommended Dose: ADULT over 18 years, 1.25 g/m2 twice daily for 14 days; subsequent
courses repeated after a 7-day interval
Indication: It is used as monotherapy for metastatic colorectal cancer; it has been shown to
be of similar efficacy as a combination of fluorouracil and folinic acid. Capecitabine is also
licensed for adjuvant treatment of advanced colon cancer following surgery. It is also
licensed for second-line treatment of locally advanced or metastatic breast cancer either in
combination with docetaxel (where previous therapy included an anthracycline) or alone
(after failure of a taxane and anthracycline regimen or where further anthracycline treatment
is not indicated).
Contraindications: hepatic impairment, renal impairment, pregnancy & breast-feeding
Special Precautions: Use in person <18 years of age not establish
CYTARABINE (CYTOSINE ARABINOSIDE)
Dosage Form: Injection 100 mg/vial, 500 mg/vial, 1g/vial (I)
Recommended Dose: By IV: 2 mg/kg daily for 10 days increased to 4 mg/kg if no
response. For maintenance of remission: 1 mg/kg IV, SC once or twice weekly. Leukemic
meningitis: IT 30 mg/m2 every 4 days.
Indications: Acute leukaemia especially AML.
Special Precautions: In patients with impaired liver function; haematological monitoring is
required in the course of treatment.
FLUOROURACIL
Dosage Form: Injection 250 mg/5 ml, 500 mg/10 ml (I)
Recommended Dose: IV Inj. 12 mg/kg up to max. Of 1 g daily for 3-4 days, if there is no
evidence of toxicity, follow after 1 day with 6 mg/kg on alternate days for 3-4 doses, or an
alternative of 15 mg/kg once a week throughout the course.
Maintenance: 5-15 mg/kg weekly. IV Infusion: 15 mg/kg to max of 1 g daily, infused in 500
ml dextrose 5% over 4 hours and repeated on successive days until toxicity occurs or a total
of 12-15 g has been given. Repeat after 4-6 weeks.
Indication: Inoperable malignant neoplasms of gastrointestinal tract, breast and pancreas.
Contra-Indications: Pre-exiting severe myelosuppression.
Special Precautions: Hematological monitoring required during treatment. Avoid contact
with skin and mucous membrane.
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GEMCITABINE
Dosage Form: Injection 200mg, 1gm (I* - Oncologist)
Indication and Recommended Dose:
Non-small cell lung cancer; combination with Cisplatin; 4 weeks schedule: 1000 mg/m 2 on
D1, D8, D15 of each 28 days cycle over 30 minutes. 3 weeks schedule: 1250 mg/m 2 on D1,
D8 of each 21 days cycle over 30 minutes. Dose of cisplatin for both schedule: 100 mg/m 2
on D1 of each cycle after the gemcitabine infusion.
Pancreas cancer: 1000 mg/m2 weekly for up to 7 weeks. After a rest of period of 1 week,
subsequent infusion should be given once a week for 3 weeks and repeated every 4 weeks.
Contra-Indications: Hypersensitivity to gemcitabine
Special Precautions: Hepatic dysfunction, myelosuppression, renal impairment, infusion
time longer than 60 minutes, concurrent radiotherapy (gemcitabine is strong
radiosensitizer), pregnancy, and pulmonary toxicity.
12.4. Hormone Therapy
12.4.1. Progestines
MEDROXYPROGESTERONE ACETATE
Dosage Form: Tablet 5 mg, Injection 150 mg/3 ml (I)
Recommended Dose: Endometriosis: 50 mg IM weekly or 100 mg every 2 weeks for 6
months or more. Endometrial, renal and prostatic carcinoma: 400 mg-1 g daily for 28 days.
Reduce to 500 mg twice weekly for maintenance. Contraceptive: 150 mg at beginning of
cycle or early puerperium, effective for 3 months or 300-450 mg every 6 months.
Indications: carcinoma of beast prostate renal and endometrium, long acting contraceptive.
Contra-Indications: Pregnancy, thrombophlebitis, liver dysfunction, missed or incomplete
abortion, undiagnosed vaginal bleeding and breast pathology.
Special Precautions: Use with caution in patients with history of depression, diabetis and
conditions
12.4.2. Glucocorticoids
PREDNISOLONE
Dosage Form: Tablet 5 mg; Syrup 2.5 mg/5 ml, 3 mg/5 ml (II)
Recommended Dose: Adults: 5-100 mg daily in single or divided doses, or double dose on
alternate days up to 150 mg daily until response occurs. Diminish dose to smallest effective
maintenance dose. Child: 500 mcg-2 mg/kg or 15-60 mg/m2 daily in 3 divided dose.
Indications: Treatment of ALL, Hodgkin’s lymphoma and breast cancer.
Contra-Indications: Systemic fungal infections, psychoses, severe psychoneuroses, peptic
ulcer, osteoporosis.
Special Precautions: Haematological monitoring required during treatment. Avoid contact
with skin and mucous membrane.
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12.4.3. Antihormonal Agent-Antioestrogen
ANASTROZOLE
Dosage Form: Tablet 1 mg (I)
Criteria of use: Second choice drug after using Tamoxifen for breast cancer, except for
cases that are justified to be used as 1st line
Recommended Dose: 1 mg daily
Indications: Adjuvant treatment of oestrogen-receptor-positive early breast cancer in
postmenopausal women, either as sole therapy or following 2-3 years of tamoxifen therapy;
advanced breast cancer in postmenopausal women which is oestrogen-receptor positive or
responsive to tamoxifen.
Contra-Indications: Pregnancy and breast-feeding; moderate or severe hepatic disease;
moderate or severe renal impairment; not for premenopausal women.
Special Precautions: Laboratory test for menopause if doubt; susceptibility to osteoporosis
(assess bone mineral density before treatment and at regular intervals)
LETROZOLE
Dosage Form: Tablet 2.5 mg (I)
Prescribing criteria: Second choice drug after using Tamoxifen for ‘hormonal advanced
breast cancer’ in post-menopausal patients
Recommended Dose: 2.5 mg daily until tumor progression is evident.
Indications: Treatment of postmenopausal women with hormone receptor positive or
hormone receptor unknown locally advanced or metastatic breast cancer and treatment of
advanced breast cancer in postmenopausal women with disease progression following
antiestrogen therapy
Contra-Indications: Hypersensitivity to letrozole or any of its excipient, pregnancy
Special Precautions: Severe hepatic impairment, severe renal impairment
TAMOXIFEN CITRATE
Dosage Form: Tablet 20 mg (I)
Recommended Dose: 10-20 mg BD. Infertility: 10 mg BD on day 2,3,4 and 5 of menstrual
cycle. If necessary increased increased in subsequent cycles to 40 mg BD
Indications: Treatment of breast cancer and infertility.
Contra-Indications: Pregnancy
Special Precautions: Hepatic disease, neurologic deficiencies.
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12.5. Plant Alkaloids
VINCRISTINE SULPHATE
Dosage Form: Injection 1 mg vial, 2 mg vial (I)
Recommended Dose: Adult: 0.4-1.4 mg/m2/week (2 mg typical single dose limit). 12-20
yrs: 1.5-4.5 mg/m2/week. Child: 1.4-2 mg/m2/week (2 mg typical dose limit). Toxicity less if
weekly dose is kept below 100 mcg/kg.
Indications: Treatment of acute leukimia, especially ALL, Hodgkin’s disease, solid tumours.
Contra-Indications: pregnancy, bacterial infections, intrathecal route.
Special Precautions: Avoid extravasation. White blood counts to be done before each
dose. Neurologic and neuromuscular effects are severe and dose related.
VINBLASTINE SULPHATE
Dosage Form: Injection 10 mg (I)
Recommended Dose: Combination therapy IV 3-6 mg/m2 every 7 days
Indications: leukaemias, lymphomas, and some solid tumours (e.g. breast and lung
cancer)
Contra-Indications: Pregnacy & intrathecal route.
Special Precautions: For intravenous administration only. Stop vinblastine if pulmonary
symptoms occur. Monitor complete blood count before each dose.
12.6 Immunosuppressants
AZATHIOPRINE
Dosage Forms: Tablet 50 mg (I)
Recommended Dose: Prevention of rejection in organ and tissue transplant Adult: 1-5
mg/kg body weight. Immunosuppression in conjunction with a corticosteroid Adult: 1-3
mg/kg body weight daily. Dose in renal impairment: Crcl 10-50 ml/min: 75% of normal daily
dose; Crcl <10 ml/min: 50% of normal daily dose.
Indications: Prevention of rejection in organ and tissue transplant. Immunosuppression in
conjunction with a corticosteroid
Contra-Indications: Hypersensitivity; previous treatment with alkylating agents; pregnancy
and lactation.
Special Precautions: Neoplasia in chronic immunosuppression; leucopaenia,
thrombocytopaenia, renal or hepatic impairment; monitor haematological function closely.
Reduce dose in severe renal impairment and concomitant administration with Allopurinol.
Caution in liver damage or history of liver disease.
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CICLOSPORIN
Dosage Forms: Injection 50 mg/ ml; Tablet 25 mg; Capsule 100 mg; Syrup 100 mg/ml (I)
Recommended Dose: Oral Prophylaxis Of Graft Rejection In Organ Transplantation Adult:
Initially, 10-15 mg/kg body weight daily, starting at 4-12 hrs before procedure and continued
for 1-2 weeks. Maintenance: 2-6 mg/kg body weight. Intravenous Prevention Of Graft
Rejection In Bone Marrow Transplantation Adult: Initially, 3-5 mg/kg body weight daily
continued for up to 2 weeks or until oral therapy can be initiated at a maintenance of 12.5
mg/kg body weight. Prophylaxis Of Graft Rejection In Organ Transplantation Adult: 1/3 of
an oral a dose administered by slow IV infusion of a 0.05-0.025% ciclosporin solution in
DNSS
or
5%
glucose
injection
over
2-6
hrs.
Adjust dose in patients with deteriorating renal or hepatic function.
Indications: Prophylaxis of graft rejection in organ transplantation. Prevention of graft
rejection in bone marrow transplantation.
Contra-Indications: Hypersensitivity to the drug or other components; malignant
neoplasms; psoriasis; lactation.
Special Precautions: Dose should be carefully titrated. Renal and hepatic impairment;
hyperuricaemia; anaphylaxis; history of allergic reactions; pregnancy; monitor BP, serum
electrolytes, renal and hepatic function.
MYCOPHENOLATE MOFETIL
Dosage Forms: Capsule 250 mg, Tablet 500 mg (I*- Hematology Oncologist, Nephrologist
and Neurologist)
Criteria of use:
1. For lupus nephritis cases (10 patients per year)
2. For other cases like post transplant patients (10 patients per year)
3. Restricted for Hematology Oncologist (Prof. Dr. Abdul Aziz Baba and Dr. Abu Dzarr),
Nephrologist (PM Dr. Zainal Darus, PM Dr. Kamaliah and Dr. Azreen) and Neurologist
Recommended Dose: Renal transplantation, by mouth, 1 g twice daily starting within 72
hours of transplantation or by intravenous infusion, 1 g twice daily starting within 24 hours of
transplantation for up to max. 14 days (then transfer to oral therapy). CHILD and
ADOLESCENT 2-18 years, by mouth 600 mg/m2 twice daily (max. 2g daily). Lupus nephritis
500 to 3000 mg/day
Indications: Prophylaxis of acute organ rejection & treatment of refractory organ rejection in
patient receiving allogenic renal transplants. Prophylaxis of acute organ rejection & increase
graft and patient survival in patients receiving allogeneic cardiac transplants. To be used
concomitantly w/ cyclosporin & corticosteroids.
Contra-Indications: Hereditary deficiency of hypoxanthine-guanine phosphoribosyltransferase such as Lesch-Nyhan & Kelley-Seegmiller syndrome. Lactation.
Special Precautions: Increased risk for skin cancer, therefore avoid exposure to sunlight &
UV light, increased susceptibility to infection. Report immediately any evidence of infection,
unexpected bruising, bleeding or any other manifestation of bone marrow depression. Active
digestive system disease. Severe chronic renal impairment. Pregnancy. Monitor neutrophil
count. Elderly.
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12.7. Miscellaneous Agents
DACARBAZINE
Dosage Form: Injection 100 mg, 200 mg (I)
Recommended Dose: Melanoma; IV infusion, 250 mg/m2 daily on days 1-5 of each 21-day
cycle, or 800 mg/m2 on day 1 of each 21-day cycle. Hodgkin’s disease; Combination
treatment with other agents, adult, IV infusion 150 mg/m2 each day on days 1-5 of each 28day cycle, or 375 mg/m2 on day 1 and day 15 of each 28-day cycle.
Indications: Malignant melanoma, metatstic; Ewing’s sarcoma, rhabdomysarcoma;
Neuroblastoma. Hodgkin’s disease.
Contra-Indications: hepatic impairment, renal impairment, pregnancy
Special Precautions: IV infusion over 30-60 minutes
DOCETAXEL
Dosage Form: Injection 20 mg/0.5 ml, 80 mg/2 ml (I* - Oncologist)
Recommended Dose: (i) Breast cancer; 100 mg/m2 as monotherapy or 75 mg/m2 in
combination with 50 mg/m2 Doxorubicin. (ii) Non-small cell lung cancer; 75-100 mg/m2 as a
monotherapy or at a maximum of 75 mg/m 2 in combinaton with platinum derivatives. Infuse
over one hour every three weeks
Indications: Breast cancer; in combination with doxorubicin is indicated for the treatment of
patient with locally advanced or metastatic breast cancer, who have not previously received
cytotoxic therapy for this condition or previous therapy has failed. Non-small cell lung
cancer; for the treatment of patient with locally advanced or metastatic even after failure of
platinum-based chemotherapy.
Contra-Indications: Hypersensitivity to docetaxel, polysorbate 80 or other drugs formulated
with polysorbate 80 and Patients with neutrophil counts of less than 1500 cells/cubic
millimeter
Special Precautions: All patients should receive premedication with corticosteroids. Doses
of 100 mg/m(2) are associated with an increased incidence of toxic death in both patients
with non-small cell lung cancer and breast cancer. Extravasation. Hypersensitivity reactions,
Neutropenia, Patients with liver dysfunction, Severe asthenia, retention & neurosensory
symptoms. Pregnancy
ETOPOSIDE
Dosage Form: Injection 100 mg/5 ml (I)
Recommended Dose: By slow Iv infusion: 50-120 mg/m2 daily for 3-5 consecutive days
followed by treatment free interval of 14 days. Dilute with normal saline or dextrose 5% to a
concentration of 400 mcg/ml and give by slow infusion over ½ - 1 hour.
Indications: Carcinoma of lung, breast, testis, Hodgkin’s disease and solid tumours.
Contra-Indications: Severe hepatic dysfunction and lactation.
Special Precautions: Care should be taken to avoid extravasation. In pregnancy, give only
in exceptional circumstances.
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HYDROXYUREA
Dosage Form: Capsule 500 mg (I)
Recommended Dose: Single dose of 20-30 mg/kg daily or 80 mg/kg every 3rd day.
Indications: treatment of CML, malignant melanoma, tumours of the ovary squamous cell
carcinoma of head and neck.
Contra-Indications: Acute infections, inadequate marrow reserve.
Special Precautions: Caution in impaired renal function, pregnancy, blood cell population,
kidney and liver functions must be monitored weekly
IMATINIB MESILATE
Dosage Form: Tablet 100 mg, 400 mg (I)
Criteria of use:
1. Restricted for chronic myeloid leukemia (CML) cases only
2. A total of 5 patients (at any one time)
Recommended Dose: CML: ADULT: 400 mg/day for chronic phase CML and 600
mg/day for accelerated phase or blast crisis. Maximum dose: 800 mg/day. CHIDREN:
260 mg/m2/day (Maximum dose: 400 mg) for chronic phase CML; 340 mg/m 2/day
(Maximum dose: 600 mg) for advanced phases CML. GIST: 400 mg/day. Maximum
dose: 800 mg/day. ALL, Philadeplhia chromosome-positive: 400-600 mg/day
Indications: Treatment of newly diagnosed chronic myeloid leukemia (CML),
unresectable and/or metastatic gastrointestinal stromal tumours (GIST), and acute
lymphoid leukemia (ALL), relapsed/refractory Philadelphia chromosome-positive.
Contra-Indications: Pregnancy; breast-feeding, Hypersensitivity to the active substance
or to any of the excipients.
Special Precautions: Hepatic or severe renal impairment. History of cardiac disease.
Severe fluid retention may occur. It is recommended that patients be weighed regularly.
Regular monitoring of complete blood counts & liver function tests. Children <3 yr.
Pregnancy, lactation (avoid).
IRINOTECAN HCL TRIHYDRATE
Dosage Form: Injection 40 mg/2 ml, 100 mg/5 ml (II)
Criteria of use: For metastatic colorectal cancer
Recommended Dose: Monotherapy (for previously treated patients) 350 mg/m 2
administered as a 30-90 min IV infusion every three weeks. In combinaton therapy (for
previously untreated patient) 180 mg/m2 administered as a 30-90 min IV infusion every two
weeks, followed by infusion with folinoc acid and 5-FU.
Indications: Treatment of advanced colorectal cancer in patient without prior chemotherapy
for advanced disease or as a single agent in patient who have failed an established 5-FU
containing treatment regimen.
Contra-Indications: Chronic inflammatory bowel disease and/or bowel obstruction,
pregnancy and lactation, bilirubin more than 1.5 times the ULN of normal range, severe
bone marrow failure; who performance status more than 2.
Special Precautions: Delayed diarrhea, liver impairment, asthma, impaired renal function,
elderly, may impair ability to drive or operate machine, bowel obstruction.
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MUSTINE HCL (NITROGEN MUSTARD)
Dosage Form: Injection 10 mg (I)
Recommended Dose: Adult
a) Chronic lymphoid leukemia, Palliative treatment -total IV dose 0.4 mg/kg/course, as
single dose or may divide into 0.1-0.2 mg/kg daily doses; may repeat after hematologic
recovery
b) Chronic myeloid leukemia, Palliative treatment-total IV dose 0.4 mg/kg/course, as single
dose or may divide into 0.1-0.2 mg/kg daily doses; may repeat after hematologic recovery
c) Hodgkin's disease, Palliative treatment (Stages III and IV) - total IV dose 0.4
mg/kg/course, as single dose or may divide into 0.1-0.2 mg/kg daily doses; may repeat after
hematologic recovery
d) Lymphosarcoma, Palliative treatment - total IV dose 0.4 mg/kg/course, as single dose or
may divide into 0.1-0.2 mg/kg daily doses; may repeat after hematologic recovery
e) Malignant effusion, Palliative treatment for intrapleural, intraperitoneal, or intrapericardial
-intracavitary injection, 0.4 mg/kg; 0.2 mg/kg by intrapericardial route (after injection, change
the position of the patient every 5 to 10 minutes for an hour for a more uniform distribution of
the drug); doses reported in the literature vary widely and published articles regarding
intracavitary use should be consulted
f) Mycosis fungoides (clinical), Palliative treatment - total IV dose 0.4 mg/kg/course, as
single dose or may divide into 0.1-0.2 mg/kg daily doses; may repeat after hematologic
recovery
g) Polycythemia vera, Palliative treatment -total IV dose 0.4 mg/kg/course, as single dose or
may divide into 0.1-0.2 mg/kg daily doses; may repeat after hematologic recovery
h) Squamous cell carcinoma of bronchus, Palliative treatment - total IV dose 0.4
mg/kg/course, as single dose or may divide into 0.1-0.2 mg/kg daily doses; may repeat after
hematologic recovery
Indications: Refer to recommended dose
Contra-Indications: Presence of known infectious diseases, previous anaphylactic
reactions to mechlorethamine
Special Precautions:
1) Accurate histologic diagnosis and hematologic status of patient needed before initiating
therapy
2) Do not use if foci of acute and chronic suppurative inflammation are present
3) Alternating courses of mechlorethamine with other chemotherapy or x-ray therapy
4) Chronic lymphatic leukemia
5) Hyperuricemia- especially in the treatment of lymphoma
6) Patients with leukopenia, thrombocytopenia, and anemia due to invasion of the bone
marrow by tumor
7) Radiotherapy; use caution with mechlorethamine and x-ray or other chemotherapy
8) Use proper procedures for handling and disposal of chemotherapy
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PACLITAXEL
Dosage Form: Injection 6 mg/ml, 300 mg/50 ml (II)
Recommended Dose: Ovarian cancer 175mg/m2 given over 3hours or 135mg/m2 given
over 24 hours with cisplatin or carboplatin. Metastatic ovarian cancer, breast cancer and
non small cell lung cacner. 175mg/m 2, given over 3 hours. Kaposi’s sarcoma either
135mg/m2, repeat every 3 weeks or 100mg/m2, repeat every 2 weeks
Indications: Ovarian cancer (advanced or residual disease following laparotomy) in
combination with cisplatin; metastatic ovarian cancer where platinum-containing therapy has
failed; locally advanced or metastatic breast cancer (in combination with other cytotoxics or
alone if other cytotoxics have failed or are inappropriate); adjuvant treatment of nodepositive breast cancer following treatment with anthracycline and cyclophosphamide; nonsmall cell lung cancer (in combination with cisplatin) when surgery or radiotherapy not
appropriate; advanced AIDS-related Kaposi’s sarcoma where liposomal anthracycline
therapy has failed
Contra-Indications: Severe hepatic impairment; pregnancy & breast-feeding
Special Precautions: People with previous allergies may be at higher risk of anaphylaxis
PROCARBAZINE HCL
Dosage Form: Capsule 50 mg (I)
Recommended Dose: Adult: PO Monotherapy: Initial: 50 mg/day, increase gradually if
needed. Maintenance: 50-150 mg/day until a cumulative dose of at least 6 g. Combination
Therapy: 100 mg/m2 on days 1-14 of each 4 or 6-wk cycle. Child: Initially, 50 mg/m2 daily,
up to 100 mg/m2 adjust according to response
Indications: Hodgkin's disease.
Contraindications: Pregnancy. Lactation. Myelosuppression. Severe hepatic and renal
impairment.
Special Precautions: May increase blood glucose in diabetics. Monitor peripheral blood
counts regularly. Monitor hepatic and renal function wkly. Pheochromocytoma, epilepsy, CV
or cerebrovascular disease, hepatic or renal impairment. Discontinue use if hypersensitivity
occurs
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TENIPOSIDE
Dosage Form: Injection 50 mg/5 ml (II)
Recommended Dose: Dosage, Adult (usual); Non-Hodgkin's lymphoma: single agent, 30
mg/m(2) IV daily for 10 days OR every 5 days, Non-Hodgkin's lymphoma: single agent, 50100 mg/m(2) IV once weekly, Non-Hodgkin's lymphoma: in combination with other
anticancer agents, 60-70 mg/m(2) IV once weekly. Dosage, Pediatric, (usual); Acute
lymphoid leukemia, Refractory, as induction therapy in combination with other agents: 165
mg/m(2) IV, with 300 mg/m(2) IV cytarabine, twice weekly for 8-9 doses, Acute lymphoid
leukemia, Refractory, as induction therapy in combination with other agents: 250 mg/m(2)
IV, with 1.5 mg/m(2) IV vincristine, weekly for 4-8 wks (with 40 mg/m(2) prednisone
ORALLY for 28 days), Neuroblastoma: optimal dose and timing not defined
Indications: Acute lymphoid leukemia, Refractory, as induction therapy in combination with
other agents
Contra-Indications: Hypersensitivity to teniposide or polyoxylated castor oil
Special Precautions: Concomitant administration of tolbutamide, sodium salicylate,
sulfamethizole; may potentiate drug toxicity Down's syndrome, irritant, avoid extravasation,
risk of inducing a secondary leukemia, use proper procedures for handling and disposal of
chemotherapy
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13. EAR AND NOSE PRODUCTS
ACETIC ACID
Dosage Form: Ear drop [P] 1% (II)
Recommended Dose: 4-6 drops in the affected ear every 2-3 hours.
Indications: Treatment of external otitis and prevention of Swimmer’s Ear.
BECLOMETHASONE DIPROPIONATE
Dosage Form: Nasal spray 50 mcg/dose (I* - Medical, Paediatric)
Recommended Dose: Nasal inhalation: One puff into each nostril three times daily with a
maximum of: 20 puffs daily for adults and 10 puffs daily for paediatrics. Oral inhalation:
Adult: 2 puffs, 3-4 times a day. Severe case: Initial dose may be doubled. On improvement,
dosage adjusted according to response. Child: 1-2 puffs, 3-4 times a day.
Indications: Allergic rhinitis, vasomotor rhinitis, nasal polyps, bronchial asthma, chronic
obstructive bronchitis.
Contra-Indications: Untreated nasal infection, haemorrhagic-diathesis or history of
recurrent nasal bleeding. Hypersensitivity to beclomethasone and first trimester of
pregnancy.
Special Precautions: If infection of respiratory tract, nassal passages or paranasal sinuses
occurs during treatment, antibacterial therapy should be promptly instituted.
BENZOIN + STORAX + MENTHOL + EUCALYPTUS OIL (BENZOIN-CO.)
Dosage Form: Tincture for inhalation (II)
Recommended Dose: As directed for local use.
Indications: As an inhalation in brochitis and acute laryngitis.
CHLORAMPHENICOL
Dosage Form: Ear drop 5% (II)
Recommended Dose: 2-3 drops tds-qid.
Indications: Bacterial infection in otitis externa.
Special Precautions: Caution in presence of perforations of the tympanic membrane.
Avoid prolonged use.
CLOTRIMAZOLE
Dosage Form: Ear drop 1% (II)
Recommended Dose: 4-5 drops tds-qds
Indications: Otomycosis. Prophylaxis for swimmers.
Special Precautions: Perforated eardrum. Pregnancy & lactation
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DESMOPRESSIN ACETATE
Dosage Form: Nasal drops 0.1 mg/ml; Nasal spray 10 mcg/metered spray (I)
Recommended Dose: 10-20 mcg daily or bd. Child: 5-10 mcg daily or bd. To be instilled
intranasally using a graduated plastic tube filled from a bottle.
Indications: Diagnosis and treatment of cranial diabetes insipidus.
Special Precautions: Should not be administered to dehydrated or overhydrated patients
until water balance is adequately restored; in presence of nasal infection or rhinorrhoea.
EPHEDRINE
Dosage Form: Nasal drops [P] 0.5% (II)
Recommended Dose: 2 drops tds. Max use for 1 week.
Indications: Nasal decongestion.
Special Precautions: Avoid excessive use, caution in infants under 3 months.
FUSAFUNGINE
Dosage Form: Nasal spray 1% (I)
Recommended Dose: With nasal adapter: 4 metered doses in each nostril 4 times a day.
With oral adapter: 4 metered doses 4 times a day. Child above 2 yrs: according to age.
Indications: Rhinitis, rhinopharyngitis, sinusitis, sore throat, tonsilitis, bronchitis, respiratory
complications of influenza and pre and post instrumental investigations.
Special Precautions: Asthma.
HYDROGEN PEROXIDE 1.5%
Dosage Form: Ear drops 5 vol. (£,II)
Recommended Dose: 1-2 drops to be instilled as required.
Indications: For removal of ear wax.
ICHTHAMMOL IN GLYCERIN
Dosage Form: Ear drop [P] 10% (II)
Recommended Dose: 2-3 drops tds-qid.
Indications: For inflammatory conditions of the external ear.
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MOMETASONE FUROATE
Dosage Form: Nasal spray 50 mcg/actuation 60 doses, 140 doses (I* - ORL)
Criteria of use: For ORL specialist in patients with perennial allergic rhinitis
Recommended Dose: For treating seasonal and perennial allergic rhinitis, usual dose is 2
sprays in each nostril once daily. If used for seasonal allergic rhinitis, initiation of treatment 2
to 4 weeks before exposure to the allergen is recommended. Symptom improvement occurs
1-2 days after starting treatment, and maximum benefit occurs within 1-2 weeks.
Indications: Treatment of seasonal and perennial allergic rhinitis.
Contra-Indications: Hypersensitivity to mometasone.
Special Precautions: a) May cause hypothalamic-pituitary-adrenal axis suppression,
Cushing’s Syndrome, hyperglycemic or glycosuria, especially in patients with liver failure. b)
Children are more susceptible to systemic absorption and toxicity. c) Discontinue if local
irritation develops. d) Avoid use in uncontrolled infection. e) Avoid contact with eyes and
surrounding areas. f) After prolong use of systemic corticosteroids, switching to nasal
mometasone may result in signs of adrenal insufficiency. g) Mometasone may increase the
risk of serious or fatal infection in individuals exposed to viral illness such as chicken pox or
measles. h) May cause nasal Candida infections. k) Ocular herpes simplex. l) May cause
glaucoma or cataracts. m) Avoid until wound heals after nasal surgery, nasal trauma, or
nasal ulcers. n) Active or quiescent tuberculosis. o) Untreated fungal, bacterial, systemic
viral infections.
OFLOXACIN
Dosage Form: Ear Drop 0.3% (3 mg/ml) (I)
Recommended Dose: For the treatment of otitis externa: Child: Five drops (0.25 mL, 0.75
mg ofloxacin) instilled into the affected ear twice daily for ten days. Adult: Ten drops (0.5
mL, 1.5 mg ofloxacin) instilled into the affected ear twice daily for ten days. Acute Otitis
Media in Pediatric with Tympanostomy Tubes: Five drops (0.25 mL, 0.75 mg ofloxacin)
instilled into the affected ear twice daily for ten days. Chronic Suppurative Otitis Media with
Perforated Tympanic Membranes: Adult: Ten drops (0.5 mL, 1.5 mg ofloxacin) instilled into
the affected ear twice daily for fourteen days.
Indications: Otitis Externa due to Staphylococcus aureus and Pseudomonas aeruginosa,
Chronic Suppurative Otitis Media with perforated tympanic membranes due to
Staphylococcus aureus, Proteus mirabilis, and Pseudomonas aeruginosa. Acute Otitis
Media with tympanostomy tubes due to Staphylococcus aureus, Streptococcus
pneumoniae, Haemophilus influenzae, Moraxella catarrhalis,
and Pseudomonas
aeruginosa .
Contra-Indications: History of hypersensitivity to ofloxacin, to other quinolones, or to any of
the components in this medication.
Special Precautions: If the infection is not improved after one week, cultures should be
obtained to guide further treatment. If otorrhea persists after a full course of therapy, or if
two or more episodes of otorrhea occur within six months, further evaluation is
recommended to exclude an underlying condition such as cholesteatoma, foreign body, or a
tumor.
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OXYMETAZOLINE HYDROCHLORIDE
Dosage Form: Nasal drop 0.05% (Adult), 0.025% (Paediatric); Nasal spray 0.05% (I)
Recommended Dose: 1-3 drops, 2-3 times daily in each nostril. Spray bd in each nostril.
Indications: Nasal decongestant in acute rhinitis, sinusitis, nasopharingitis, Eustachian
salpingitis.
Contra-Indications: Hypersensitivity to oxymethazoline.
Special Precautions: Avoid prolonged use; caution in patients with hypertension, cardiac
disease.
POLYMYXIN B SULPHATE + NEOMYCIN SULPHATE WITH HYDROCORTISONE
Dosage Form: Ear drop 10,000 U + 3,400 U + 10 mg (II)
Recommended Dose: 3 drops instilled into affected ear tds-qid. External auditory meatus
and canal to be thoroughly cleaned and dried before each application but soap should not
be used as the antibiotics may be inactivated by it.
Indications: Treatment of bacterial infection and inflammation of the external auditory
meatus.
Special Precautions: Should not be used if the ear drum is perforated, avoid prolonged
use.
SODIUM BICARBONATE
Dosage Form: Ear drops [P] 5% (II)
Recommended Dose: 2-3 drops tds-qid.
Indications: For removal of ear wax.
TRIAMCINOLONE ACETONIDE, NEOMYCIN, GRAMICIDIN WITH NYSTATIN
(KENACOMB)
Dosage Form: Ear drops 0.1% + 0.25% + 0.025% + 100,000 Units / gram (I)
Recommended Dose: 2-3 drops tds-qid.
Indications: Treatment of bacterial infection and inflammation of the external auditory
meatus.
Special Precautions: Should not be used if the ear drum is perforated. Avoid prolonged
use.
TRIPOLIDINE HYDROCHLORIDE WITH PSEUDOEPHEDRINE (ACTIFED)
Dosage Form: Tablet 2.5 mg + 60 mg; Syrup 1.2 mg + 30 mg in 5 ml (II)
Recommended Dose: Adults (over 12 years) 1 tablet or 10 ml every 4-6 hrs. Child: every
4-6 hrs. Infants up to 12 months: 2.5 ml. 1-5 yrs: 5 ml. 6-12 yrs: 5-7.5 ml.
Indications: Nasal and respiratory congestion, common cold, acute sinusitis, allergic rhinitis
and other allergic conditions.
Contra-Indications: Concurrent treatment with MAO inhibitors and within 2 weeks of
stopping treatment.
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14. RESPIRATORY PRODUCTS
14.1. Antiasthmatics
ADRENALINE ACID (EPINEPHRINE) TARTRATE
Dosage Form: Injection 1 mg/ml (1 ml amp) (II)
Recommended Dose: 0.2-0.5 mg SC as single dose for anaphylaxis and acute allergy.
Adult: 0.1-1mg IV inj. 0.2-0.5mg SC/IM inj. followed by 0.025-0.05 mg every 5-15 min as
needed. Child: 0.3 mg IV/IM repeated every 15 min for 3-4 doses if necessary. For bronchial
spasm in acute asthma. Adult: 0.2-0.5 mg SC. Child: 0.01 mg/kg to max total dose of 0.5
mg. Repeat at 15-20 min interval for 2 doses. Then every 4 hours if needed.
Indications: Management of allergic emergencies such as acute anaphylaxis, bronchial
spasm, angioneurotic edema, giant urticaria, serum sickness and status asthmaticus.
Contra-Indications: Cardiac dilatation, coronary insufficiency, during anaesthesia, organic
brain damage, anaesthesia of extremities, labour, narrow-angle glaucoma.
Special Precautions: Patients with hypertension, ischaemic heart disease, elderly patients.
AMINOPHYLLINE
Dosage Form: Injection 25 mg/ml (2.5%) 10 ml ampoule (II)
Recommended Dose: Slow IV inj: 250-500 mg in 10-20 ml of water over minimum period
of 10-15 min. Deep infusion may be given in dextrose or NaCl.
Indications: Asthma, cardiovascular diseases, bronchitis, bronchopneumonia, oedema.
Special Precautions: Elderly, cardiac and liver disease, peptic ulcer, concurrent
administration with sympathomimetics and other xanthines.
BECLOMETHASONE DIPROPIONATE
Dosage Form: Inhaler 50 mcg/dose (200 doses) (I* - Medical, Paediatric)
Recommended Dose: Adult: 100 mcg tds-qid. Severe asthma: 600-800 mcg daily initially,
subsequently adjusted according to response. Max. 1 mg daily. Child: 50-100 mcg bd-qid.
Indications: Bronchial asthma in which bronchodilators and sod. chromoglycate are
ineffective, and severe asthma dependent on systemic corticosteroids or ACTH or its
synthetic equivalent.
Special Precautions: In respiratory infection, active or quiescent tuberculosis, pregnancy.
Systemic therapy may need to be reinstituted without delay during stress and where airways
obstruction or mucus prevents absorption from inhalation.
BUDESONIDE
Dosage Form: Inhaler 100 mcg/dose (300 doses), 200 mcg/dose (300 doses); Nasal spray
50 mcg/dose, 64 mcg/dose; Turbuhaler 100 mcg/dose, 200 mcg/dose (100 doses) (II)
Recommended Dose: 200 mcg (1 puff) bd adjusted according to response. Severe
asthma: may be increased to 1.6 mg (8 puff) daily. Child: 50-200 mcg daily.
Indications and Special Precautions: As Beclomethasone.
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BUDESONIDE + FORMOTEROL
Dosage Form: Turbuhaler 160 mcg + 4.5 mcg/dose (II)
Criteria of use: For asthmatic patient of GINA 3 class who needs steroid maintenance
treatment
Recommended Dose: Adult: 1-2 inhalations twice daily. Children: Not recommended
Indications: Asthmatic patients who need combination therapy of steroid and long acting
beta agonist
Contra-Indication: Hypersensitivity to budesonide, formoterol or inhaled lactose.
Special Precautions: Patients with history of allergic-type responses associated with use of
other beta-2 agonist or other corticosteroids, arrhytmias, coronary artery disease or
hypertension, hypokalemia, DM, herpes simplex ocular infection, hyperthyroidism.
CICLESONIDE
Dosage Form: Inhaler 160 mcg/dose (II)
Recommended Dose: By aerosol inhalation, ADULT and CHILD over 12 years, 160 mcg
daily as a single dose reduced to 80 mcg daily if control maintained.
Indications: Prophylaxis of asthma.
Special Precautions: Systemic therapy may be required during periods of stress or when
either airways obstruction or mucus prevent drug access to smaller airways.
FENOTEROL HYDROBROMIDE
Dosage Form: Inhaler 100 mcg/dose (200 doses); Inhalation solution 0.5% (20 ml) (I)
Recommended Dose: Symptomatic treatment of acute asthma attacks 1 puff stat. If
breathing has not improved after 5 mins, a 2nd puff may be taken. Prophylaxis against
exercise-induced asthma 1-2 puffs to be given each time. Max 8 puffs/day. Symptomatic
treatment of bronchial asthma & other conditions w/ reversible airways narrowing If
repeated dosing is required, 1-2 puffs to be given each time. Max 8 puffs/day.
Indications: Listed in Dosage.
Contra-Indication: Hypertrophic obstructive cardiomyopathy, tachyarrhythmia.
Special Precautions: Poorly controlled diabetes mellitus, recent MI, severe organic heart
or vascular disorders, hyperthyroidism, phaeochromocytoma. Concomitant use w/ other
sympathomimetic bronchodilators, MAOIs or tricyclic antidepressants.
IPRATROPIUM BROMIDE
Dosage Form: Inhalation Solution 0.0125% (250 mcg/2 ml), 0.25% (500 mcg/2 ml) (II)
Recommended Dose: 1-2 puffs, 3-4 times daily. Up to 4 puffs being used initially. Child:
below 6 years: 1 puff tds. 6-12 years: 20-40 mcg tds.
Indications: Chronic reversible airways obstruction particularly chronic bronchitis.
Contra-Indications: Prostatic enlargement, pyloric stenosis, closed-angle glaucoma.
Special Precautions: Elderly conditions characterised by tachycardia. May cause mental
confusion, especially in elderly.
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IPRATROPIUM BROMIDE + SALBUTAMOL SULPHATE
Dosage Form: Inhaler 20 mcg + 100 mcg; Nebulising solution 0.5 mg + 2.5 mg (II)
Criteria of use: For COPD patients who require combination therapy
Recommended Dose: ADULTS (including elderly patients): 2 puffs 4 times daily. The dose
may be increased as required up to a limit of 12 puffs in 24 hours. CHILDREN (<12 years):
there is no experience of the use of this MDI in children.
Indications: Management of reversible bronchospasm associated with obstructive airway
disease in patients who require more than a single bronchodilator.
Contra-Indications: Patient with hypertrophic obstructive cardiomyopathy or
tachyarrhyythmia, patient with a history of hypersensitivity to soya lecithin or related food
products such as soyabean and peanut, patient with hypersensitivity to atropine or its
derivatives or to any other component of the product.
Special Precautions: immediate hypersensitivity reactions may occur after administration,
as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm &
oropharyngeal oedema.
MONTELUKAST SODIUM
Dosage Form: Tablet 10 mg (film coated), 4 mg, 5 mg (chewable) (I* - Medical)
Criteria of use: Restricted to medical specialist prescription only
Recommended Dose: Adult and children 15 years old and above; 10 mg at bedtime.
Children 6-14 years old; 5 mg at bedtime.
Indications: Prophylaxis and treatment of chronic asthma in adult and children 2 years old
and above and for and seasonal.
Contra-Indications: Hypersensitivity to montelukast or its compoents.
Special Precautions: Not for treatment of acute asthma attacks. Not to be abruptly
substituted for inhaled or oral corticosteroid. Pregnancy and lactation. Children less than 2
years old. Patient with known aspirin sensitivity should continue avoidance of aspirin or
NSAIDs while taking montelukast.
SALBUTAMOL SULPHATE
Dosage Form: Tablet 2 mg, 4 mg; Syrup 2 mg/5 ml ; Injection 0.5 mg/ml amp; Inhaler 200
mcg/ dose (200 doses, 400 doses); Respiratory Solution 0.5% (10 ml) (II)
Recommended Dose: SC/IM Injection: 0.5 mg 4 hourly. Slow IV Injection: 0.25 mg
repeated if necessary. IV infusion: Initially 5 mcg/min adjusted to 3-20 mcg/min or more if
necessary. Syrup: Child: 2-6 yrs: 2.5-5ml. 6-12 yrs: 5ml. Tablet: 2-4 mg tds-qid (increased if
necessary to 8 mg). Child: 2-6 yrs: 1-2 mg. 6-12 yrs: 2 mg. Inhaler: 1-2 puffs repeated 4
hourly if required. Maintenance: 2 puffs tds-qid. Child: 1 puff. Maintenance: 1 puff tds-qid.
Respiratory Solution: 2.5-5 mg incresed if necessary to 10mg as 0.5% solution over a period
of 3-5 min per inhalation, up to 4 times daily. Or by continuous inhalation: 1-2 mg/h as
0.005-0.01% solution in sterile water or normal saline.
Indications: Bronchial asthma, status asthmaticus.
Special Precautions: Patients with hypertension, cardiac disorders, pregnancy, diabetes,
elderly patients.
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SALMETEROL XINAFOATE
Dosage Form: Inhaler 25 mcg/dose (60 doses, 120 doses), 50 mcg/dose; Accuhaler 50
mcg/dose (60 doses) (II)
Recommended Dose: Adult & childn > 6 yr 2 inhalations bd. Severe cases: 4 inhalations
bd.
Indications: Long-term regular treatment of reversible airways obstruction in asthma
(including patients w/ nocturnal asthma & exercise-induced asthma), emphysema & chronic
bronchitis.
Contra-Indication: Hypersensitivity to salmeterol or components.
Special Precautions: Not for relief in acute severe asthma. Thyrotoxicosis.
SALMETEROL XINAFOATE + FLUTICASONE PROPIONATE
Dosage Form: Accuhaler 50 mcg + 100 mcg, 50 mcg + 250 mcg, 50 mcg + 250 mcg.
Evohaler 25 mcg + 125 mcg, 25 mcg + 250 mcg (II)
Criteria of use: For patients who specially need this combination only
Recommended Dose: Patients should be given the strength containing the appropiate
fluticasone propionate dosage for the severity of their disease. The dose should be titrated
to the lowest dose at which effective control of symptoms is maintained.
Adults and adolescents 12 years and above:
Accuhaler; One inhalation (50/100 mcg) BD, one inhalation (50/250 mcg) BD,
one inhalation (50/500 mcg) BD.
Evohaler; Two inhalation of 25/125 mcg BD.
Children 4 years and above:
Accuhaler; One inhalation (50/100 mcg) BD.
Indications: Regular treatment of reversible obstructive airway disease (ROAD), including
asthma in children and adults, where use of a combination (bronchodilator and inhaled
corticosteroid) is appropriate. Fluticasone/salmeterol inhalation SHOULD NOT be used to
for the treatment of status asthmaticus or other acute episodes of asthma.
Contra-Indication: Hypersensitivity to salmeterol, fluticasone or components.
Special Precautions: a) Not for relief of acute symptoms. b) This drug should not be
initiated in patients with unstable or acutely deteriorating asthma, which may be a lifethreatening condition. c) Administer with caution in patients with active or quiescent
pulmonary tuberculosis and patients with thyrotoxicosis.
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TERBUTALINE SULPHATE
Dosage Form: Tablet 2.5 mg; Injection 500 mcg/ml; Inhaler 0.25 mg/dose (400 doses);
Turbuhaler 0.5 mg/dose (200 doses) (II)
Recommended Dose: Tablet: 2.5-5 mg bd-tds. Child: 3-7 yrs: 0.75-1.5 mg tds, 7-15 yrs:
2.5 mg twice or thrice daily. Nebulising soln: 10 mg/mL soln Adult 0.25-0.5 mL. Severe
cases: ≤1mL. Chronic administration: 1-2 mg/hr in a soln of 100 mcg/ml. Childn 0.02 mL/kg
body wt. Severe cases: 0.03 mL/kg body wt. 2.5 mg/mL soln Adult 1 amp. Childn >20 kg
body wt 1 amp, <20 kg body wt 1/2 amp. Doses inhaled up to 4 times/24 hr. Turbuhaler
Adult & childn >12 yr 1 inhalation 6 hrly. Severe cases: Single dose may be increased to 3
inhalations. Max: 12 inhalation/24 hr. Childn 3-12 yr 1 inhalation 6 hrly. Severe cases:
Single dose may be increased to 2 inhalations. Max: 8 inhalation/24 hr.
Indications: As brochodilator in bronchial asthma and other conditions accompanied by
bronchospasm.
Special Precautions: As Salbutamol.
THEOPHYLLINE
Dosage Form: Tablet 50 mg, 125 mg; SR 200 mg, SR 250 mg, SR 300 mg (II)
Recommended Dose: 125-250 mg 6 hourly with food. Child over 2 yrs: 5 mg/kg 6 hourly
with food. 250-500 mg bd. Child over 6 yrs: 125-250 mg bd or at night. 200-300 mg bd
increase if necessary. Child up to 35 kg: 100 mg bd. Over 35 kg: 200 mg bd. Increased or
decreased as necessary.
Indications: Bronchial asthma and other conditions accompanied by bronchospasm.
Contra-Indications: History of peptic ulcer.
Special Precautions: Caution in concurrent use of xanthine preparation, phenobarbitones,
pregnancy, children, elderly patients, hypersensitivity to xanthine derivatives. Pulmonary,
cardiovascular, renal or hepatic diseases.
TIOTROPIUM BROMIDE
Dosage Form: Inhalation capsules (18 mcg) + handihaler (I)
Recommended Dose: 18 mcg daily
Indications: Long-term maintenance treatment of broncospasm and dyspnoea associated
with COPD.
Contra-Indications: Hypersensitivity to atropine or its derivatives or to any component of
this product.
Special Precautions: Acute urinary retention, sensitivity to ipratropium, narrow-angle
glaucoma, prostatic hyperplasia and bladder neck obstruction. Should not be used more
than once daily.
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14.2. Cough and Cold Remedies
BROMHEXINE HCL
Dosage Form: Tablet 8 mg; Elixir 4 mg/5 ml; Syrup 4 ml/5 ml (60 ml); Injection 2 mg/ml (2
ml ampoule) (II)
Recommended Dose: Oral- Adult: 8-16 mg tds-qid. Child- <5 yrs: 4 mg (5 ml) bd; 5-10
yrs.: 4 mg (5 ml) qid; >10 yrs: 8 mg (10 ml) tds. Slow IV/IM inj.: 8 - 24 mg daily. By IV
infusion: 4-20 mg in 500 ml Dextrose 5% or 4-20 mg in 500 ml Sod. Chloride 0.9%.
Indications: Bronchitis, chronic inflammatory pulmonary conditions. Bronchiectasis, other
mucous problem. otitis media with effusion (glue-ear). Keratoconjunctivitis sicca (dry eye).
Special Precautions: Patients with gastric ulceration.
DIPHENHYDRAMINE HCL + AMMONIUM CHLORIDE + SODIUM CITRATE
Dosage Form: Syrup (14 mg + 135 mg/5ml) (Benadryl) (II)
Recommended Dose: 5-10 ml bd or tds. Child: 2.5-5ml bd-tds.
Indications: As an expectorant.
Contra-Indications: Patients on MAO inhibitors, chicken pox.
Special Precautions: May produce drowsiness. Caution in glaucoma, symptomatic
prostatic hypertrophy, bladder neck obstruction, pyloroduodenal obstruction and stenosing
peptic ulcer, history of lower respiratory disease (including asthma), hyperthyroidism,
cardiovascular disease or hypertension. Caution in G6PD deficiency in the presence of
infection or stress.
FLUTICASONE FUROATE
Dosage Form: Nasal spray 27.5 mcg/spray (120 doses) (I)
Recommended Dose: Adult &adolescents ≥12 yr Initially 2 sprays in each nostril once
daily. Maintenance dose: 1 spray in each nostril once daily. Childn 2-11 yr Initially 1 spray
in each nostril once daily, may be increased to 2 sprays in each nostril once daily.
Maintenance dose: 1 spray in each nostril once daily.
Indications: Treatment of nasal (eg rhinorrhea, nasal congestion/itching, sneezing) &
ocular (itching/burning, tearing/watering, redness of the eye) symptoms of seasonal &
perennial rhinitis.
Special Precautions: Severe liver disease. Prolonged treatment in childn. Pregnancy.
Childn <2 yr.
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MESNA
Dosage Form: Injection 400 mg/4 ml ampoule (I)
Recommended Dose: Nebulisation 1-2 amp/ in 1-4 sessions daily. Instillation 1-2 mL
diluted w/ an equal vol of distilled water or saline hrly. Maxillary sinusitis 2-3 mL undiluted.
May be repeated every 2-3 days.
Indications: Nebulisation Bronchial clogging, cystic fibrosis, status asthmaticus, chronic
bronchitis, asthma-like bronchitis, bronchial emphysema & bronchiectasis, obstructive
pulmonary atelectasis. Instillation To prevent formation of a mucous plug, facilitate
bronchial aspiration in intensive care & anesth. To facilitate drainage in maxillary sinusitis.
Contra-Indications: Asthma w/o mucous clogging; intolerance to aerosols; inability to
cough or expectorate effectively.
Special Precautions: Status asthmaticus. Pregnancy.
TRIPOLIDINE HCL WITH PSEUDOEPHEDRINE HCL
Dosage Form: Tablet 2.5 mg + 60 mg; Syrup 1.25 + 30 mg in 5 ml (II) (Actifed)
Recommended Dose: 1 tab. 3 times daily. Adults: 10 ml 3 times daily. Child: 2-5 yrs: 2.5 ml
tds. 6-12 yrs: 5 ml tds.
Indications: Nasal and respiratory congestion, common cold, acute sinusitis, allergic
rhinitis.
Contra-Indications: Angle-closure glaucoma, neonates.
Special Precautions: May produce drowsiness. Caution in hypertension and cardiac
diseases. Conditions or factors predisposed to anticholinergic effects such as prostatic
hypertrophy, COPD etc. Geriatrics, Hyperthyroidism. Use in children. Asthma.
14.3. Antihistamines
CETIRIZINE DHCL
Dosage Form: Tablet 10 mg (II)
Recommended Dose: Adult; 5-10 mg daily. Maximum 20 mg daily. Paed; 2-5 yrs: 2.5-5
mg daily, 6-11 yrs: 5-10 mg daily,  12 yrs: 5-10 mg daily.
Indications: Effective in seasonal & perennial allergic rhinitis, uncomplicated skin
manifestations of chronic idiopathic urticaria.
Contra-Indication: Hypersensitivity to cetirizine & hydroxizine, lactation.
Special Precautions: Pregnancy.
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CHLORPHENIRAMINE MALEATE
Dosage Form: Tablet 4 mg; Syrup 4 mg/ 5 ml; Injection 10 mg/ ml (1 ml, 10 ml ampoule) (II)
Recommended Dose: 4 mg tds-qid. Child: up to 1 yr: 1 mg bd. 1-5 yrs: 1-2 mg tds. 6-12
yrs: 2-4 mg tds-qid. Syrup: 5-10 ml. Child: up to 1 yr 2.5 ml bd., 1-5 yrs: 2.5-5 ml tds. 612yrs: 10 ml tds-qid. Inj: allergic emergencies: By SC/IM or slow IV inj: 10-20 mg when
necessary to max of 40 mg in 24 hrs. Child: By IV inj. 200 mcg/kg when necessary.
Indications: Allergic conditions, emergency treatment of anaphylactic conditions.
Special Precautions: May cause drowsiness, asthma, narrow angle glaucoma, stenosing
peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy or bladder neck
obstruction.
HYDROXYZINE HCL
Dosage Form: Tablet 25 mg (II)
Recommended Dose: Pruritis initially 25 mg at night increased if necessary to 25 mg 3 - 4
times daily; CHILD- 6 mths - 6 years initially 5-15 mg daily increased to 50 mg daily in
divided doses; >6 years initially 15-25 mg daily increased if necessary to 50-100 mg daily in
divided doses. Anxiety (adults only)- 50-100 mg 4 times daily.
Indications: Pruritis, anxiety (short-term).
Contra-Indications: Pregnancy and breast-feeding.
Special Precautions: Driving, may cause drowsiness; renal impairment.
LEVOCETIRIZINE DHCL
Dosage Form: Tablet 5 mg (1* - ORL)
Recommended Dose: Adult & childn ≥ (greater than or equal to) 6 yr 1 tab daily.
Indications: Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis)
& chronic idiopathic urticaria.
Contra-Indication: Severe renal impairment (creatinine clearance < 10 mL/min).
Hypersensitivity to piperazine derivatives.
Special Precautions: Patients w/ hereditary problems of galactose intolerance, Lapp
lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation. Childn < 6 yr.
LORATADINE
Dosage Form: Tablet 10 mg; Syrup 1 mg/ml (II)
Recommended Dose: Adult and children > 12 years old: 10 mg daily. Children 2-12 years
old: BW > 30 kg: 10 mg daily, BW < 30 kg: 5 mg daily.
Indications: Relief of symptoms associated with allergic rhinitis eg; sneezing,rhinorrhea
and itching. Relief of symptoms and sign of chronic urticaria and other allergic
dermatological disorder.
Contra-Indications: Hypersensitivity or idiosyncrasy to any of the components.
Special Precautions: Severe liver impairment: dose 5 mg daily or 10 mg every other day.
Pregnancy: use only if benefit > potential risk to fetus. Lactation; it is excreated in breast
milk and high risk of anti-histamine for infants, a decision should be made whether to
discontinue nursing or to discontinue the drug.
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LORATADINE + PSEUDOEPHEDRINE SULPHATE
Dosage Form: Tablet 5 mg + 120 mg (II)
Criteria of use: For acute rhinitis and sinusitis (short term treatment) cases at ORL
department only
Recommended Dose: Adult and children > 12 years old: 5/120 mg 1 tab twice daily or 2
tab daily.
Indications: Relief of symptoms associated with allergic rhinitis and common cold including
nasal congestion, sneezing, rhinorrhea, pruritus and lacrimation.
Contra-Indications: a) Hypersensitivity to this medication or any of its ingredients. b)
Concomitant use of monoamine oxidase inhibitor therapy or use within 14 days of stopping
these agents. c) History or difficulty in swallowing tablets, or known upper gastrointestinal
narrowing or abnormal aesophageal peristalsis. d) Hypersensitivity or idiosyncratic
responses (ie.insomnia, dizziness, weekness, tremor or arrhythmias) to adrenergic agents
or drugs with similar chemical structures. e) Narrow-angle glaucoma. f) Severe coronary
artery diseases. g) Severe hypertension. h) Urinary retention.
Special Precautions: a) Diabetes mellitus. b) Elderly (patients greter than 60 years old). c)
Hepatic insufficiency. d) Hypertension. e) Hyperthyroidism. f) Increased intraocular
pressure. g) Ischemic heart disease. h) Lactating women. i) Prostatic hypertrophy. j) Renal
impairment. k) Renal insufficiency (glomerular filtration rate less than 30ml/mmute)
PROMETHAZINE HCL
Dosage Form: Syrup 5 mg/5 ml, 10 mg/5 ml; Injection 50 mg/2 ml (II)
Recommended Dose: Severe allergies: Injection 25-50 mg deep IM or slow IV after dilution
to 0.25% with water for injection. Max: 100 mg. Hypnosis: Injection by IM: Up to 1 year: 2-5
mg. 1-5 yrs: 5-10 mg. Above 5 yrs: 10-12.5 mg. Anti-emetic: Adult: 25-50 mg. Children: 5-12
yrs: 12.5 mg by IM. Insomnia: Adult: orally 25 mg initially at night and may be increased to
50-75 mg if necessary. Children: 1/2 to 1 yr: 10mg. 1-5 yrs: 15-20 mg. 5-10 yrs: 20-25 mg
single night dose. Allergy: Adult: orally 10-20 mg in divided doses and increased when
necessary. Children: 1/2 to 1 yr: 5-10 mg. 1-5 yrs: 5-15 mg. Above 5 yrs: 10-25 mg.
Indications: Allergic conditions, antiemetic, hypnotic and sedative, treatment of Parkinson's
syndrome, combined with narcotics as perioperative medication to prevent nausea.
Contra-Indications: Stenosing peptic ulcer, narrow angle glaucoma, prostatic hypertrophy,
convulsive disorders, bladder neck obstruction or pyloroduodenal obstruction, MAO
inhibitors. Children < 2 years.
Special Precautions: May cause drowsiness; IV injection must be given slowly and
extreme care must be taken to avoid perivascular extravasation. Not to be administered
intra-arterially or subcutaneously. In cardiovascular disease, impaired liver function,
asthmatic attack, acute or chronic respiratory impairment. As for other anti-histamines.
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PROMETHAZINE THEOCLATE
Dosage Form: Tablet 25 mg (II)
Recommended Dose: Prevention of motion sickness: Adults and children above 10 yrs: 25
mg, children 5-10 yrs: 1/2 of the adult dose, given 1 or 2 hours before the journey.
Treatment of motion sickness: Given as soon as possible followed by second tablet on the
evening and a third tablet on the following evening.
Indications: Long acting anti-emetic especially motion sickness.
Contra-Indications: Enhance the effect of any sedative or other central nervous system
depressant. Avoid alcoholic drinks.
Special Precautions: Establish the diagnosis of nausea and vomiting of unknown origin
before giving an anti-emetic.
14.4. Respiratory Stimulants and Surfactants
14.4.1. Respiratory Surfactant
COLFOSCERIL PALMITATE
Dosage Form: Injection 200 mg/8 ml (I*)
Recommended Dose: By endotracheal tube, treatment, 67.5 mg/kg; if still intubated, may
be repeated after 24 hr; prophylaxis, first dose soon after birth, if still intubated, may be
repeated 12-24 hr later.
Indications: Treatment of respiratory distress syndrome in preterm infants who are
intubated and receiving mechanical ventilation, whose heart rate and arterial oxygenation
are continuously monitored.
Special Precautions: Continuous monitoring required to avoid hyperoxaemia (due to rapid
improvement in arterial oxygen concentration.
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15. VACCINES, ANTISERA & IMMUNOLOGICALS
15.1. Vaccines
BACILLUS CALMETE GUERIN (BCG) VACCINE
Dosage Form: Injection 1 ml/vial (II)
Recommended Dose: 0.1 ml by intradermal injection. Neonates: 0.05 ml.
Indications: Immunization against tuberculosis.
Contra-Indications: Blood transfusion or immunoglobulin injection within previous 3
months, acute febrile infections, impaired immune responsiveness (including AIDS), patients
with a positive tuberculin test, burn patients or fresh smallpox vaccinations.
Special Precautions: Asthmatic patients, groups at high risk of HIV infection. May need to
be repeated since protection is only relative. Avoid contact (for those handling). Sterilise
equipments before disposal.
HAEMOPHILUS INFLUENZAE B VACCINE
Dosage Form: Injection 0.5 ml/dose (vial) (II)
Criteria of use: For cases of splenectomy
Recommended Dose: Haemophilus influenzae type b (Hib) vaccine
IM inj only. Primary vaccination 3 doses in the 1st 6 mth of life & may be started from 6 wk
of age. Booster dose Recommended in the 2nd yr of life. Previously unvaccinated infant
6-12 mth 2 inj at 1 mth-interval, followed by a booster in the 2nd yr of life. Previously
unvaccinated child 1-5 yr 1 dose. Splenectomy, should be given once to all individuals > 2
years of age.
Indications: Active immunisation of infants ≥6 wk against disease caused by H influenzae
type b.
Contra-Indications: Acute severe febrile illness.
Special Precautions: Administer SC to subjects w/ thrombocytopenia or bleeding
disorders. Immunocompromised patients. Pregnancy & lactation.
HEPATITIS B VACCINE
Dosage Form: Injection Paediatric, Adult (II)
Recommended Dose: By IM injection; ADULT and CHILD over 10 yrs 500 units; CHILD
under 5 yrs 200 units;
5-9 yrs 300 units; NEONATES 200 units as soon as possible after birth
Indications: Immunisation against Hepatitis B virus infection as primary vaccination or as
booster dose.
Contra-Indications: Previous severe adverse reaction (eg. Anaphylaxis) to the vaccine
Special Precautions: It must not be given intravenously. In dialysis patient and patients
who have impaired immune system, adequate antibody concentration may not be obtained
& require repeated administration of vaccine.
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INFLUENZA VACCINE
Dosage Form: Injection 0.5 ml (I)
Criteria of use:
1. Use according to Guidelines for Using Influenza Vaccine
2. Estimated usage for 100 patients per year
Recommended Dose: IM/deep subcutaneous injection: Adult & children ≥36 months 0.5
mL. Children 6-35 mth 0.25 or 0.5 mL. For children who have not previously been
vaccinated, a 2nd dose should be given after an interval of at least 4 wk.
Indications: Prevention of flu in persons ≥65 years; adults & children with chronic
pulmonary & CV disorders, chronic metabolic diseases, chronic renal dysfunction &
immunodeficiencies; children 6 months-18 years on long-term acetylsalicylic acid.
Contra-Indications: Febrile illness or acute infection. Hypersensitivity to eggs, chicken
protein, formaldehyde, cetyltrimethyl ammonium bromide, polysorbate 80, gentamicin.
Anaphylactic reaction with preceding dose of vaccine, pregnancy, individual being treated
for malignant condition and impaired immune response (unless with specialist advice).
Special Precautions: Endogenous or iatrogenic immunosuppression. Do not administer
intravascularly. Subcutaneous route is used for patients with bleeding disorder.
PNEUMOCOCCAL VACCINE
Dosage Form: Injection 0.5 ml/dose per vial (II)
Criteria of use: For cases of splenectomy
Recommended Dose: Purified Strep pneumoniae polysaccharides of 23 serotypes
Primary vaccination: One 0.5 mL inj. Revaccination: One 0.5 mL inj.
Indications: Prevention of pneumococcal infections particularly of the resp tract, in high risk
subjects in principle from the age of 2 yr, including patients w/ sickle-cell disease, asplenia,
a history of splenectomy or scheduled splenectomy.
Contra-Indications: Marked reaction after a previous inj. Previous inj (or pneumococcal
infection) w/in previous 5 yr.
Special Precautions: Pregnancy.
POLIO ORAL VACCINE
Dosage Form: Oral drop (II)
Recommended Dose: 1 vaccinating dose: 2 drops (0.1 mL).
Primary immunisation: 1 oral dose at 3, 4 & 5 mth of age followed by 2 booster doses at 1-4
yr & 7 yr.
Indications: Active immunization against poliomyelitis.
Contra-Indications: Hypersensitivity to erythromycin & kanamycin. Acute or developing
infectious diseases. Leukemia, lymphoma or generalized malignancy. Acquired or
congenital immunodepression. Acute intestinal diseases.
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RABIES VACCINE
Dosage Form: Injection (II)
Recommended Dose: Prophylactic, by deep subcutaneous or intramuscular injection in the
deltoid region, 1 mL on days 0, 7, and 28; also booster doses every 2–3 years to those at
continued risk
Post-exposure, by deep subcutaneous or intramuscular injection in the deltoid region, 1 mL.
Indications: For prophylactic or post-exposure to rabies
Contra-Indications: Pre-exposure prophylaxis in those with a previous severe adverse
reaction to the vaccine or Allergy to neomycin
TETANUS (TETANUS TOXOID) VACCINE
Dosage Form: Injection 5 ml per vial (II)
Recommended Dose: Prophylaxis: By deep IM or SC injection: 3 doses each of 0.5 or 1 ml
with intervals of 6-12 weeks and 6-12 months respectively between doses.
Indications: Active immunization against tetanus. Booster doses are indicated following
tetanus-prone wounds.
Contra-Indications: As for BCG. Hypersensitivity to any component, including thiomersal.
Previous history of CNS reactions to DPT vaccine. Acute febrile illness or infection, outbreak
of poliomyelitis, acute tetanus infections or immediate prophylaxis of unimmunized patients
(TIG is indicated).
Special Precautions: Immunosurpressants, febrile convulsions in infants. Avoid cuatneous
testing.
15.2. Antisera and Immunologicals
ANTI RH-D GAMMAGLOBULIN (RHOGAM)
Dosage Form: Injection 250 mcg/2 ml (II)
Recommended Dose: By IM inj: 50-100 mcg within 72 hrs after delivery. After transfusion
of Rh incompatible blood: up to 10 mcg/ml of blood transfused, administered within 72 hrs
after the blood transfusion.
Indications: To prevent a rhesus negative mother from forming antibodies to foetal rhesuspositice cells which may pass into the maternal circulation during childbirth or abortion; and
after transfusion of Rh-incompatible blood.
Contra-Indications: In a rhesus positive or rhesus immunised mothers or to infants as it
may cause haemolysis.
Special Precautions: Should never be administered IV. Must be administered by IM only.
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HEPATITIS B IMMUNOGLOBULIN
Dosage Form: Injection 100 iu/0.5 ml, 200 iu/1 ml (I)
Recommended Dose: By IM inj Only. Adult 1000-2000 iu. Should be administered within 7
days following exposure to HBV (preferably within 48 hr) & if necessary, repeat the same or
increase the dose. Prophylaxis in neonates from HbsAg +ve mothers inject within 5 days
after birth (preferably within 48 hr) & repeat 2 or 3 month after 1 st administration. Initial dose:
100-200 iu. Booster dose: 32-48 iu/kg body wt.
Indications: Post-exposure prophylaxis following percutaneous exposure, direct mucous
membrane contact or ingestion of material containing hepatitis B virus or a HbsAg +ve
source of known identity. Post-exposure prophylaxis following sexual or intimate contact to
an HbsAg +ve individual. Prophylaxis in neonates from HbsAg +ve mothers.
Contra-Indications: HbsAg +ve individuals.
Special Precautions: Should not be administered IV. History or prior systemic allergic
reaction following administration of human IG prep. Patients with IgA deficiency syndrome.
Live virus vaccines.
HUMAN IMMUNOGLOBULIN
Dosage Form: Injection 2.5 gm, 3 gm (I*)
Recommended Dose: Congenital or acquired immunodeficiency 100-400 mg/kg IV,
generally every 3-4 wk. Severe bacterial & viral infection Not < 100-400 mg/kg initially.
Repeated administration of the same dose may be required. Idiophatic thrombocytopenic
purpura Initially 5 x 0.4 g/kg IV for 5 consecutive days, further administration of the same
dose (0.4 g/kg) depends on the platlet count, severe bacterial & viral infections
Indications: Protection of susceptible contacts against hepatitis A virus, measles, rubella.
Contra-Indications: Patients with known class specific antibody to immunoglobulin A (IgA).
Special Precautions: Severe thrombocytopenia, bleeding disorders.
INTERFERON BETA-1a (REBIF®)
Dosage Form: Injection 22 mcg, 44 mcg (I)
Recommended Dose: 44 mcg SC 3 times wkly. Patients who cannot tolerate the higher
dose 22 mcg SC 3 times wkly. When starting Rebif for the 1st time, administer 8.8 mcg
during the 1st 2 wk, then 22 mcg in wk 3 & 4, then 44 mcg from wk 5 onwards. Use 22 mcg
for dose titration.
Indications: Multiple sclerosis of the relapsing/remitting type characterized by at least 2
repeated attacks w/ neurological symptoms during the previous 2 yr.
Contra-Indications: Pregnancy & lactation. Severe depressive disorders &/or suicidal
ideation. Epileptic patients w/ a history of seizures not adequately controlled by treatment.
Special Precautions: Cardiac disease eg angina, CHF or arrhythmia, severe renal &
hepatic failure, severe myelosuppression. Depression. Monitor serum ALT levels at
baseline, mth 1, 3 & 6 of therapy & periodically thereafter in the absence of clinical
symptoms. Monitor FBC w/ differential & platelet count. Preexisting seizure disorders.
Thyroid function testing is recommended at baseline & if abnormal, 6-12 mthly following
initiation of therapy.
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INTERFERON BETA-1b (BETAFERON®)
Dosage Form: Injection 250 mcg (8 MIU) (I)
Criteria of use: Use according to Interferon Beta-1b Flowchart
Recommended Dose: 250 mcg (8 MIU) by SC inj every other day.
Indications: Reduction of frequency & degree of severity of clinical relapses, in ambulatory
patients w/ relapsing-remitting multiple sclerosis, characterized by at least 2 attacks of
neurological dysfunction over the preceding 2 yr period, followed by complete or incomplete
recovery. Reduction of frequency & severity of clinical relapses, & slowing progression of
disease in patients w/ secondary progressive multiple sclerosis.
Contra-Indications: Pregnancy, lactation. Childn <18 yr. History of severe depressive
illness &/or suicidal thoughts, liver failure or inadequately treated epilepsy.
Special Precautions: History of seizures, depression, preexisting heart disorders, bone
marrow disorder, anaemia or a low platelet level. Fever or infection. Renal insufficiency.
Discontinue therapy until healing from multiple lesions has taken place. Monoclonal
gammopathy.
SNAKE ANTIVENOM COBRA/ POLYVALENT
Dosage Form: Injection 100 mg/10 ml (II) (subject to supply by company)
Recommended Dose: By IM, slow IV (over 30 minutes) or SC, 1-5 vials for mild case.
Larger doses for moderate or severe cases.
Indications: Treatment of Malayan Cobra and Tiger snake bites.
Contra-Indications: Personal or familial history of allergy and previous exposure to horse
protein.
Special Precautions: Possible anaphylactic reaction. Resuscitation facilities should be
available.
SNAKE ANTIVENOM MALAYAN PIT VIPER
Dosage Form: Injection 10 ml (II)
Recommended Dose: By IM, IV or SC, 1-2 vials for a mild case. Larger doses for moderate
or severe cases by IV infusion over 30 min.
Indications: Treatment of poisonous viper bites, normally Russel's Viper and Green Pit
Viper.
Special Precautions: Conduct skin test by injecting intracutaneously 0.1ml of 1:10 diluted
serum. Positive reaction is indicated by appearance of a wheal surrounded by a zone of
redness.
SNAKE ANTIVENOM POLYVALENT
Dosage Form: Injection 40000U/50 ml amp (II)
Dosage Form: By IV infusion: 50 ml over 1/2 to 1 hour according to type of snakes.
Indications: Snake bite whereby the snake has not been identified.
Special Precautions: Possible anaphylactic reaction. Resuscitation facilities should be
available.
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TETANUS IMMUNOGLOBULINE
Dosage Form: Injection 250 units/vial
Recommended Dose: Prophylaxis: 250 iu by IM inj. Therapy: 1000-10,000 iu by IM inj.
Active immunisation should be performed simultaneously.
Indications: Prophylaxis & therapy of tetanus.
Contra-Indications: IgA deficiency.
Special Precautions: Agammaglobulinemia or extreme hypogammaglobulinemia. Bleeding
disorders.
TUBERCULINE PPD
Dosage Form: Injection 2 units/0.1 ml (1.5 ml) (II)
Recommended Dose: Mantoux test 10 U intradermally to upper part of forearm. Read
result 48-72 hr later.
Indications: Diagnostic agent in Mantoux test (in the diagnosis of TB).
Contraindications: Known tuberculin positive reactors.
Special Precautions: Avoid s/c inj. Active TB. Reactivity of test reduced by viral infection,
viral vaccines, administration of corticosteroids, malnutrition.
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16. ANTI-INFECTIVES
16.1. Antiamoebics
METRONIDAZOLE
Dosage Form: Tablet 200 mg; Suspension 200 mg/5 ml; Injection 500 mg/100 ml (II)
Recommended Dose: Amoebiasis: 400-800 mg tds for 5-10 days; Anaerobic infection:
Initially 800 mg then 400 mg tds for 7 days. IV infusion: 500 mg tds up to 7 days. Child: 7.5
mg/kg tds. Tablets to be taken with meals; Leg ulcers and pressure sores: 400 mg tds for 7
days; Bacterial vaginosis: 400-500 mg bd for 5-7 day or 2 gm as a single dose; Pelvic
inflammatory disease: 400 mg bd orally for 14 days; Acute ulcerative gingivitis: 200-250 mg
tds for 3 days; child 1-3 yrs: 50 mg tds for 3 days, 3-7 yrs: 100 mg bd, 7-10 yrs: 100 mg tds;
Acute dental infection: 200 mg tds orally for 3-7 days; Surgical prophylaxis: 400-500 mg 2
hrs before surgery, high risk procedures: up to 3 further doses 400-500 mg tds; child: 7.5
mg/kg 2 hrs before surgery, high risk procedures: up to 3 further doses of 7.5 mg/kg tds. IV
infusion: 500 mg at induction, high risk procedures: up to 3 further doses of 500 mg tds;
child: 7.5 mg/kg at induction, high risk procedures: up to 3 further doses of 7.5 mg/kg tds;
Trichomoniasis: 200 mg tds for 7-10 days, 2nd course may be given for 7 days after an
interval of 4-6 wks or 2 gm single oral dose. Giardiasis: 2 gm daily for 3 days.
Indications: Anaerobic infection, protozoal infections, H. pylori eradication & skin.
Contra-Indications: Patients with blood dyscrasias, or with active CNS disease,
pregnancy, breast-feeding, and hypersensitivity to metronidazole or other imidazole
derivatives.
Special Precautions: Perform blood count if administered for more than 10 days/doses
exceeding 2 gm/24 hrs. Patient should be monitored for neurological signs and candida
overgrowth. It interacts with alcohol and warfarin. Hepatic disease, concomitant anticoagulant administration, phenytoin and phenobarbital.
16.2. Antibacterials
16.2.1. Aminoglycosides
AMIKACIN SULPHATE
Dosage Form: Injection 100 mg/2 ml (vial), 250 mg/2 ml (vial) (II)
Recommended Dose: IM/Slow IV injection or infusion: 15 mg/kg daily in 2 or 3 divided
doses, severe infections: up to 22.5 mg/kg/day in 3 divided doses, Max: 1.5 gm daily for up
to 10 days; Child: 15 mg/kg/day in 2 divided doses; Newborn: 10 mg/kg initially followed with
7.5 mg/kg every 12 hours. UTI: 500 mg/day in single or 2 divided doses.
Indications: Treatment of severe Gram negative infections, gentamycin/tobramycin
resistant strains neonatal sepsis.
Contra-Indications: Hypersensitivity to amikacin, myasthaenia gravis.
Special Precautions: Pregnancy, lactation and kidney diseases, increase dose interval in
patients with renal impairment, concurrent administration with neuromuscular blocking
agents, anesthetics and potent diuretics. Should monitor renal and 8 cranial nerve functions
during therapy. Narrow therapeutic index, advise to monitor serum drug concentration.
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GENTAMICIN SULPHATE
Dosage Form: Injection 20 mg/2ml, 80 mg/2ml (ampoule)
Recommended Dose: IM/Slow injection over at least 3 minutes or infusion, adult: 3-5
mg/kg/day in 3 divided doses. Child <2 wks: 3 mg/kg bd; 2 wks-12 yrs: 2 mg/kg tds. Usual
duration of treatment 7-10 days.
Intrathecal injection: 1 mg daily increased if necessary to 5 mg daily.
Indications: Treatment of severe Gram-negative infections, septicaemia and neonatal
sepsis, meningitis and other CNS infections; billiary tract infection, acute pylonephritis or
prostatitis, endocarditis; pneumonia in hospital patients, adjunct in lisyterial meningitis.
Contra-Indications: See under Amikacin.
Special Precautions: See under Amikacin.
NEOMYCIN SULPHATE
Dosage Form: Suspension [P] 125 mg/5 ml; Powder; Cream 0.5% (Refer to 11.1.1)
Recommended Dose: Pre-operative use: 1 gm every hour for 4 hrs then 1 gm every 4 hrs
for 2-3 days; Hepatic coma: up to 4 gm daily in divided doses usually for maximum 14 days;
Infectious diarrhoea: 50 mg/kg daily in divided doses. Paediatric: 50 mg/kg/day in 4 divided
doses.
Indications: Bowel sterilisation, before surgery, hepatic coma, diarrhoea due to E. Coli.
Contra-Indications: Intestinal obstruction.
Special Precautions: See under Amikacin.
NETILMYCIN SULPHATE
Dosage Form: Injection 150 mg/1.5 ml (II)
Recommended Dose: IM/IV over 3-5 minutes or infusion. Adult: 4-6 mg/kg/day as a single
daily dose or in 2-3 divided doses. Severe infections: up to 7.5 mg/kg daily in 3 divided
doses, reduced as soon as clinically indicated in 48 hours; Neonates: 3 mg/kg bd; Infant:
2.5-3 mg/kg tds; Child: 2-2.5 mg/kg tds. UTI: 150mg daily dose for 5 days. Gonorrhoea: 300
mg as a single dose.
Indications: Treatment of severe Gram-negative infections resistant to Gentamicin and
other aminoglycosides.
Contra-Indications: See under Amikacin.
Special Precautions: See under Amikacin.
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STREPTOMYCIN SULPHATE
Dosage Form: Injection 1 gm/vial (II);
Recommended Dose: Tuberculosis: IM 15 mg/kg daily (Max: 1 gm), administered 2 or 3
days a week, or administered everyday for the first 1-3 months and then 2 days a week.
Elderly: 0.5-0.75 gm. Decreased dose in children or patients with very low body weight.
Other Infections: IM 1-2 g in 1 or 2 divided doses. The dosage may be adjusted according to
the age or severity of the symptoms.
Indications: Treatment of Pulmonary & other TB, bacterial endocarditis, tularemia, Weil's
disease
Contra-Indications: Patients with a history of hypersensitivity to the ingredient of
streptomycin sulfate, aminoglycoside antibiotics or bacitracin.
Special Precautions: Renal & hepatic impairment. Elderly, poor oral & parenteral nutrition.
Pregnancy & lactation.
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16.2.2. Cephalosporins
CEFEPIME
Dosage Form: Injection 1 gm/ vial (II)
Criteria of use: Standard for management of febrile neutropenia, and for treatment in HDU
Recommended Dose: IM/IV adult: 1 gm bd. Mild to moderate UTI: 500 mg-1 gm bd. Mild
to moderate infections other than UTI: 1-2 gm bd. Severe infections: 2 gm bd. Febrile
Neutropenia and Pseudomonas Infection: 2 gm tds. Child < 40 kg: Pneumonia, UTI, Skin &
Skin structures infections: 50 mg/kg bd for 10 days. Child 1-2 mths: 30 mg/kg bd for 10
days. Septicaemia & empiric treatment of febrile neutropenia: Child > 2 mths, < 40 kg: 50
mg/kg tds for 7-10 days. Child 1-2 mths: 30mg/kg tds for 7-10 days.
Maintenance Dosing Schedule in Adult Patients With Renal Impairment.
Creatinine
Clearance
Recommended Maintenance Dosage
(ml/min)
Usual dose, no adjustment necessary
MildVery severe/
moderate
MildSevere
life-threatening
infections
moderate
infections
infections
other than
infections UTI
UTI
500 mg Q12h
>50
2 g Q8h
2 g Q12h
1 g Q12h
30-50
2 g Q12h
2 g Q24h
11-29
2 g Q24h
1 g Q24h
10
1 g Q24h
500 mg Q24h
1 g Q24h
500 mg Q24h
500 mg Q24h
500 mg Q24h
250 mg Q24h
250 mg Q24h
Dosage Adjustment During Dialysis
Hemodialysis: During a 3 hr hemodialysis session 68% of a dose of cefepime is removed. A
supplemental dose, the same as the initial dose, is recommended after dialysis.
Peritoneal Dialysis: For patients on continuous ambulatory peritoneal dialysis (CAPD) the
normal recommended dose should be administered every 48 hrs.
Indications: Adult lower respiratory tract infection, UTI, Skin & Skin structures infections,
Intraabdominal infection, gynaecologic infection, Septicaemia, empiric treatment in febrile
neutropenic patient. Paediatric Pneumonia, UTI, Skin & Skin structures infections,
Septicaemia & empiric treatment in febrile neutropenia.
Contra-Indications: Hypersensitivity to Cephalosporins, penicillins, or beta lactam
antibiotics
Special Precautions: Pregnancy, breast-feeding, renal impairment. Hypersensitivity,
pseudomembranous colitis, superinfection may occur. Discontinue therapy if allergic
reactions occur.
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CEFOPERAZONE
Dosage Form: Injection 1 gm/vial (II)
Recommended Dose: Adult 1-2 g bd IM or IV. IV adult dose may be doubled. Max 16 g
daily in divided doses. Childn & infant 50-200 mg/kg/day in ≥ (greater than or equal to) 2
divided doses. Neonate <8 days 50-200 mg/kg/day 12 hrly.
Indications: Resp tract infections, UTI, peritonitis, cholecystitis, cholangitis & other intraabdominal infections, septicaemia, meningitis, skin & soft tissue infections, infections of
bones & joints, pelvic inflammatory disease, endometritis, gonorrhoea & other infections of
the genital tract. Prophylaxis of post-op infection in patients undergoing abdominal &
gynaecological surgery, CV & orthopaedic surgery.
Contra-Indications: Hypersensitivity to cephalosporins.
Special Precautions: Penicillin-sensitive patients. Severe biliary obstruction. Severe
hepatic disease or coexistent renal dysfunction.
CEFOPERAZONE + SULBACTAM
Dosage Form: Injection 1 gm/visl (500 mg + 500 mg) (I)
Recommended Dose: Adult 2-4 g/day IV in divided doses 12 hrly up to a max daily dose of
4 g sulbactam.
Indications: Resp tract infection, UTI, peritonitis, cholecystitis, cholangitis & other intraabdominal infection, septicaemia, meningitis, skin & soft tissue infection, bone & joint
infection, pelvic inflammatory disease, endometritis, gonorrhoea & other infections of the
genital tract.
Contra-Indications: Known allergy to penicillins, sulbactam or cephalosporins.
Special Precautions: Hepatic dysfunction & concomitant renal impairment; ingestion of
alcoholic beverages; overgrowth of nonsusceptible organisms.
CEFOTAXIME
Dosage Form: Injection 1 gm/vial (II)
Recommended Dose: IM/IV: 1 gm bd. Severe infections: up to 12 gm in 3-4 divided doses.
Neonates: 50 mg/kg daily in 2-4 divided doses. Severe infections: 150-200 mg/kg daily.
Children: 100-150 mg/kg daily in 2-4 divided doses. Severe infection: 200 mg/kg daily.
Gonorrhoea: 0.5 gm as single dose IM.
Indications: Respiratory and urinary tract infections, gonorrhoea, surgical prophylaxis,
haemophilus epiglottitis, meningitis and severe infections due to Gram-positive and Gramnegative bacteria including H.Influenza, Klebsiella, Streptococcus, Staph. aureus, Proteus,
Serratia, Enterobacter and E.coli.
Contra-Indications: Hypersensitivity to Cephalosporins.
Special Precautions: Reduce dose in impaired renal function. Should not be used during
breast-feeding and pregnancy especially the first 3 months, unless strictly indicated.
Discontinue immediately if antibiotic induced preudomembranous colitis is suspected.
Sensitivity to beta-lactam antibacterials, false positive urinary glucose (if tested for reducing
substances) and false positive Coombs' test.
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CEFTAZIDIME
Dosage Form: Injection 1 gm/vial (II)
Recommended Dose: 1 gm tds or 2 gm bd. Severe infections: 2 gm every 8–12 hours or
3 gm bd; ELDERLY: max. 3 gm daily; CHILD < 2 mths 25–60 mg/kg/day in 2 divided doses, >2
mths: 30–100 mg/kg/day in 2-3 divided doses; (intravenous route recommended for
children). Single doses over 1 gm intravenous route only.
Immunocompromised/Meningitis & Pseudomonal lung infection in cystic fibrosis: up to
150 mg/kg/day in 3 divided doses(max. 6 g daily). UTI and less serious infections: 0.5–1 gm
bd; Surgical prophylaxis, prostatic surgery, 1 gm at induction of anaesthesia repeated if
necessary when catheter removed.
Indications: see under Cephalexin
Contra-Indications: Hypersensitivity to cephalosporins.
Special Precautions: see under Cephalexin
CEFTRIAXONE
Dosage Form: Injection 1 gm/vial (II)
Recommended Dose: IM/IV over 2-4 minutes or infusion 1 gm daily. Severe infection: 2-4
gm daily. Infant & childn: 20-50 mg/kg body wt daily. Severe infection: up to 80 mg/kg daily.
Child body wt > 50 kg: Adult dose. Neonate: IV infusion over 60 minutes, 20-50 mg/kg body
wt daily. (intramuscular doses over 1 g divided between more than one site)
Uncomplicated gonorrhoea: IM 250 mg as a single dose; Surgical prophylaxis: IM/IV over at
least 2–4 minutes 1 gm at induction; colorectal surgery: IM/IV over at least 2–4 minutes or
infusion 2 gm at induction.
Indications: Resp. tract, ENT, renal, bones, joints, soft tissue, skin, abdominal, biliary tract,
GIT & genital infections. UTI, gonorrhoea, sepsis, meningitis, perioperative prophylaxis,
pneumonia.
Contra-Indications: Hypersensitivity to cephalosporins, neonates with jaundice,
hypoalbuminaemia, acidosis or impaired bilirubin binding.
Special Precautions: Anaphylactic shock. Hypersensitivity to Penicillin, severe renal &
hepatic failure, pregnancy, premature neonates.
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CEFUROXIME
Dosage Form: Tablet 250 mg (as axetil); Suspension 125 mg/ 5 ml (as axetil); Injection 750
mg/vial, 1.5 gm/vial (as sodium) (II)
Recommended Dose: 250 mg bd in most infections including mild to moderate lower
respiratory tract infections. Double for more severe lower respiratory tract infections or if
pneumonia suspected; UTI: 125 mg bd, double in pyelonephritis; Gonorrhea: 1 gm as single
dose. Child >3 mths: 125 mg bd if necessary double in child >2 yrs with otitis media; Lyme
disease: 500 mg bd for 20 days.
IM/IV or infusion, 750 mg every 6–8 hours. Severe infections: 1.5 g every 6–8 hours (single
doses over 750 mg intravenous route only); CHILD: 60 mg/kg daily (range 30–100 mg/kg
daily) in 3-4 divided doses; NEONATES usual dose 60 mg/kg daily (range 30–100 mg/kg
daily) in 2-3 divided doses. Gonorrhoea: IM 1.5gm as a single dose (divided between 2
sites). Surgical prophylaxis: IV 1.5gm at induction; up to 3 further doses of 750 mg may be
given by IM/IV every 8 hours for high-risk procedures. Meningitis: IV 3 g every 8 hours;
CHILD: 200–240 mg/kg/day in 3-4 divided doses, reduced to 100 mg/kg daily after 3 days or
on clinical improvement; NEONATE: 100 mg/kg daily reduced to 50 mg/kg daily.
Indications: Bronchitis, pneumonia, URTI, GUT, skin, & soft tissue infections,
pyelonephritis, UTI, Uncomplicated gonorrhea, lyme disease.
Contra-Indications: Hypersensitivity to cephalosporins.
Special Precautions: See under Cephalexin
CEPHALEXIN
Dosage Form: Tablet 250 mg; Granule for suspension 125 mg/5 ml (II)
Recommended Dose: Urinary/respiratory tract infection: 250 mg qid. Recurrent chronic
infection, bronchitis: 250-500 mg qid. Pneumonia, severe, deep-seated infection: 1-1.5 gm
every 6-8 hrs. Max: 4 gm daily. CHILD: 25 mg/kg daily in divided doses, doubled for severe
infections, max: 100 mg/kg daily; >1 yr: 125 mg bd, 1–5 yrs 125 mg tds, 6–12 yrs 250 mg
tds. Prophylaxis of recurrent urinary-tract infection: ADULT 125 mg at night.
Indications: Infections due to sensitive Gram-positive and Gram-negative bacteria
(e.g.respiratory and urinary tract infection. ENT, skin, soft tissue and bone infection).
Contra-Indications: Hypersensitivity to cephalosporins.
Special Precautions: See under Cefotaxime.
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16.2.3. Chloramphenicol
CHLORAMPHENICOL PALMITATE
Dosage Form: Capsule 250 mg (II)
Recommended Dose: 50 mg/kg daily in 4 divided doses. Severe infections: double the
dose & reduced as soon as clinically indicated; CHILD: haemophilus epiglottitis and pyogenic
meningitis, 50–100 mg/kg daily in divided doses decreased as soon as clinically indicated;
NEONATE: 25 mg/kg/day in 4 divided doses; INFANT: 50 mg/kg/day in 4 divided doses.
Indications: Treatment of typhoid fever, meningitis and anaerobic infections.
Contra-Indications: Minor infection or prophylaxis, pregnancy, breast-feeding, porphyria
Special Precautions: Repeated courses and prolonged treatment should be avoided;
reduce dosage in impaired renal/hepatic, neonates.
16.2.4. Macrolide
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AZITHROMYCIN
Dosage Form: Capsule 250 mg; Suspension 200 mg/5 ml; Injection 500mg (I* - Physician)
Criteria of use: Restricted to Community Acquired Pneumonia and STD cases
Recommended Dose: Adult Treatment of STD caused by C. trachomatis or susceptible N.
gonorrhoea & chancroid due to H. ducreyi: Oral: 1 g as single dose. Prophylaxis against
M.avium complex (MAC) infections in patients w/ HIV infection: Oral: 1200 mg once wkly.
DMAC treatment 600 mg once daily. For all other indications in which the oral formulation is
administered, the total dosage of 1500 mg should be given as 500 mg daily for 3 days. As
an alternative, the same total dose can be given over 5 days with 500 mg given on day 1,
then 250 mg on days 2-5.
Childn >45 kg Adult dose, 36-45 kg 400 mg, 26-35 kg 300 mg, 15-25 kg 200 mg, <15 kg 10
mg/kg. To be taken only daily for 3 days or to be taken as a single dose on day 1, then ½
the daily dose on days 2-5. Ped strep pharyngitis 10 or 20 mg/kg as a single dose for 3
days. Max: 500 mg/day.
Adults: Treatment of community acquired pneumonia due to the indicated organisms: 500
mg as single daily dose by the IV route for at least 2 days. IV therapy should be followed by
azithromycin by the oral route as a single daily dose of 500 mg to complete a 7-10 day
course of therapy. The timing of the conversion to oral therapy should be done at the
discretion of the physician and in accordance with clinical response.
Treatment of pelvic inflammatory disease due to the indicated organisms: 500 mg as a
single daily dose by the IV route for 1-2 days. IV therapy should be followed by azithromycin
by the oral route at a single daily dose of 250 mg to complete a 7-day course of therapy.
The timing of the conversion to oral therapy should be done at the discretion of the
physician and in accordance with clinical response. If anaerobic microorganism are
suspected of contributing to the infection, an antimicrobial anaerobic agent may be
administered in combination with azithromycin.
Elderly: The same dosage as in adult patients is used in the elderly.
Patients with Renal Impairment: No dosage adjustment is necessary in patients with mild to
moderate (GFR 10-80 mL/min) or severe (GFR <10 mL/min) renal impairment.
Patients with Hepatic Impairment: The same dosage as in patients with normal hepatic
function may be used in patients with mild to moderate hepatic impairment.
Indications: Lower resp tract infections including bronchitis & pneumonia; skin & soft tissue
infections; acute otitis media; upper resp tract infections including sinusitis &
pharyngitis/tonsillitis. Uncomplicated genital infections due to Chlamydia trachomatis & nonmultiresistant Neisseria gonorrhoea. Chancroid due to H ducreyi. Prophylaxis against
Mycobacterium avium-intracellulare complex (MAC) infection. In combination w/ ethambutol
for treatment of disseminated Mycobacterium avium complex (DMAC) infections w/
advanced HIV infection.
Contra-Indications: Hypersensitivity to macrolides
Special Precautions: Moderate or severe renal impairment, severe liver impairment;
patients at increased risk for prolonged cardiac repolarization; pregnancy & lactation. Avoid
coadministration w/ ergot derivatives.
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CLARITHROMYCIN
Dosage Form: Tablet 250 mg, 500 mg; Suspension 125 mg/ 5 ml (30 ml) (I* - Medical)
Recommended Dose: 250 mg bd for 7 days. Severe infections: up to 500 mg bd up to 14
days. Child < 8 kg: 7.5 mg/kg bd, 8-11 kg (1-2 yrs): 62.5 mg/kg bd, 12-19 kg (3-6 yrs): 125
mg/kg bd, 20-29 kg (7-9 yrs) 187.5 mg/kg bd, 30-40 kg (10-12 yrs) 250 mg/kg bd.
Indications: Treatment of respiratory tract infections, mild to moderate skin and soft tissue
infections, otitis media, H. pylori eradication.
Special Precautions: In patients with hepatic and renal impairment, pregnancy and breastfeeding, porphyria, avoid concomitant administration with pimozide or terfenadine.
ERYTHROMYCIN
Dosage Form: Tablet 400 mg (Ethyl Succinate, EES); Granules for Suspension 400 mg/5
ml (Ethyl Succinate, EES) (II); Lactobionate Injection 500 mg/vial (I)
Recommended Dose: 250-500 mg every 6 hours. Children: 125-250 mg every 6 hours to
be taken 1 hour before food. Slow IV injection/infusion: Adult: 2 g daily in divided doses
increased to 4 g in severe infections. Children: 30-50 mg/kg daily in divided doses.
ADULT and CHILD over 8 years, 250–500 mg every 6 hours or 0.5–1 g every 12 hours (see
notes above); up to 4 gm daily in severe infections; CHILD up to 2 years 125 mg every 6
hours, 2–8 years 250 mg every 6 hours, doses doubled for severe infections
Early syphilis, 500 mg 4 times daily for 14 days
Uncomplicated genital chlamydia, non-gonococcal urethritis, 500 mg twice daily for 14 days
By IV infusion, ADULT and CHILD severe infections, 50 mg/kg daily by continuous infusion or
in divided doses every 6 hours; mild infections (oral treatment not possible), 25 mg/kg daily;
NEONATE 30–45 mg/kg daily in 3 divided doses
Indications: Treatment of Streptococcal, mycoplasma pneumoniae, chlamydia and
staphylococcal infection, gonorrhoea, syphillis whoopiing cough, Legionnaire disease,
Diphteria, tetanus.
Contra-Indications: Porphyria, IM in patients with hypersensitivity to local anesthetics of
the PABA type.
Special Precautions: In patients with impaired hepatic function; concomitant Theophylline
administration.
16.2.5. Penicillins
16.2.5.1. Natural Penicillins
PENICILLIN G
Dosage Forms: Injection 1.8 gm (2.4 M)/ vial (II)
Recommended dose: IM streptoccal infection: 900 mg (1.2 MU). Syphilis: 1.8 gm (2.4
MU) as single dose repeat twice weekly for 5 inj.
Indications: All penicillin sensitive infection especilly streptoccal and syphilis infection.
Contra-Indications: Hypersensitivity to penicillin and cephalosporins.
Special Precautions: History of allergies,history of asthma,hypersensitivity to
cephalosporins or other allergens
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BENZYLPENICILLIN (CRYSTALLINE)
Dosage Form: Injection 600 mg (1 M)/vial, 3 gm (5 M)/ vial (II)
Recommended Dose: IM/IV or infusion: 2.4–4.8 gm/day in 4 divided doses, Serious
infections: single doses over 1.2 gm intravenous route only; PRETERM NEONATE and NEONATE
under 1 week: 50 mg/kg/day in 2 divided doses; NEONATE 1–4 wks: 75 mg/kg/day in 3
divided doses; CHILD 1 mth–12 yrs: 100 mg/kg/day in 4 divided doses (higher doses may be
required). Intravenous route recommended in neonates and infants.
Endocarditis: 7.2gm/day in 6 divided doses in combination with other antibacterials,
increased to 14.4 g every 4 hours if necessary (e.g. in enterococcal endocarditis or if used
alone).
Anthrax: (in combination with other antibacterials) IV or infusion 2.4 gm every 4 hours;
CHILD : 150 mg/kg/day in 4 divided doses.
Intrapartum prophylaxis against group B streptococcal infection: IV or infusion initially 3 g
then 1.5 g every 4 hours until delivery.
Meningococcal disease: IV or infusion 2.4 gm every 4 hours; CHILD 1 mth–12 yrs: 180–
300 mg/kg/day in 4-6 divided doses; NEONATE 1–4 wks: 150 mg/kg/day in 3 divided doses;
PRETERM NEONATE and NEONATE <1 wk:100 mg/kg/day in 2 divided doses.
Indications: All penicillin sensitive infections eg. meningitis, gonorrhoea, streptoccal
endocarditis, pneumonia, anthrax, throat, prophylaxis in limb amputation, cellulitis and otitis
media.
Contra-Indications: Hypersensitivity to penicillin and cephalosporins
Special Precautions: Care to be taken if large doses of sodium salts are given to patients
with impaired renal function or congestive heart failure, history of allergy; false-positive
urinary glucose.
PHENOXYMETHYLPENICILLIN
Dosage Form: Tablet 125 mg; Suspension 125 mg/5 ml (II)
Recommended Dose: 500 mg qid. Severe infections: up to 1 gm qid
CHILD < 1 yr: 62.5 mg qid; 1–5 yrs: 125 mg qid; 6–12 yrs: 250 mg qid. Severe infections: up
to 12.5 mg/kg qid.
Indications: Mild to severe infections due to penicillin G sensitive microorganism eg
streptococcal infections rheumatic fever, oral infections and pneumococcal infection
prophylaxis
Contra-Indications: Hypersensitivity to penicillin and cephalosporins.
Special Precautions: See under Benzylpenicillin.
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16.2.5.2. Semi Synthetic Penicillins
AMOXYCILLIN TRIHYDRATE
Dosage Form: Capsule 250 mg; Suspension 125 mg/5 ml (II)
Recommended Dose: Adult: 250 mg tds, doubled in severe infections; CHILD <10 years:
125 mg tds, doubled in severe infections.
Otitis media: 1 gm tds; CHILD: 40 mg/kg daily in 3 divided doses (max. 3 g daily).
Pneumonia: 0.5–1 gm tds.
Anthrax (treatment and post-exposure prophylaxis): 500 mg tds; CHILD <20 kg: 80 mg/kg
daily in 3 divided doses; >20 kg = adult dose.
Typhoid: 2 gm tds for 28 days.
Dental abscess:3 gmrepeated after 8 hours.
Urinary-tract infections:3 gm repeated after 10–12 hours. IM 500 mg tds; CHILD: 50–
100 mg/kg daily in divided doses. IV or infusion 500 mg tds. Severe infections: max 1 g qid;
CHILD: 50–100 mg/kg daily in divided doses.
Listerial meningitis (in combination with another antibiotic) IV infusion 2 gm every 4 hours for
10–14 days.
Endocarditis (in combination with another antibiotic if necessary), IV infusion, 2 gm qid, up
to 2 gm every 4 hours e.g. in enterococcal endocarditis or if amoxicillin used alone.
Indications: Anthrax, respiratory tract GIT and urinary tract infections, H.pylori eradication,
gonorrhoea, ENT, syphilis, enteric fever, skin and soft tissue infections, meningitis,
endocarditis prophylaxis and septicaemia.
Contra-Indications: Hypersensitivity to penicillin.
Special Precautions: History of allergy; renal impairment; erythematous rashes common in
glandular fever, cytomegalovirus infection, and acute or chronic lymphocytic leukaemia. In
high doses, particularly by bolus injection adequte fluid intake and urinary output must be
maintained.
AMOXYCILLIN TRIHYDRATE + CLAVULANIC ACID (CO-AMOXICLAV)
Dosage Form: Tablet 500 mg + 125 mg (625 mg); Syrup 125 mg + 31.25 mg (156.25 mg/5
ml); Injection 1 gm + 0.2 gm (1.2 gm) (II)
Recommended Dose: Mild to moderate infections 375 mg tds or 625 mg bd. Severe
infections: 625 mg tds or 1 gm bd. Child: 25 mg/kg/day in three divided doses.
IV over 3–4 minutes or infusion 1 gm tds. Severe infections: up to 1 gm qid. INFANTS <3
mths: 25 mg/kg tds (every 12 hours in the perinatal period and in premature infants); CHILD 3
mths–12 yrs: 25 mg/kg tds. Severe infections: up to 25 mg/kg qid.
Surgical prophylaxis: 1 gm at induction, high risk procedures: up to 2–3 further doses of
1 gm may be given tds.
Indications: Infections due to beta-lactamase-producing strains (where amoxycillin alone is
not appropriate) including respiratory tract, genito-urinary and abdominal infections,
cellulitis, severe dental infections with spreading cellulites.
Contra-Indications: Hypersensitivity to penicillin, history of co-amoxiclav-assoc. or
penicillin-assoc. jaundice or hepatic dysfunction.
Special Precautions: see under Amoxycillin.
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AMPICILLIN SODIUM
Dosage Form: Capsule 250 mg; Suspension 125 mg/5 ml; Injection 500 mg/vial (II)
Recommended Dose: 0.25–1 gm qid; CHILD <10 yrs: half adult dose.
UTI: 500 mg tds; CHILD <10 yrs: half adult dose. IM/IV or infusion: 500 mg every 4–6 hours;
CHILD <10 yrs: half adult dose.
Endocarditis: (in combination with another antibiotic if necessary) IV infusion 2 gm qid, up to
2 gm every 4 hours e.g. in enterococcal endocarditis or if ampicillin used alone.
Listerial meningitis: (in combination with another antibiotic) IV infusion 2 gm every 4 hours
for 10–14 days; NEONATE: 50 mg/kg qid; INFANT 1–3 mths: 50–100 mg/kg qid; CHILD 3 mths–
12 yrs: 100 mg/kg qid (max. 12 g daily).
Indications: Treatment of urinary-tract infections, otitis media, sinusitis, oral infections,
bronchitis, uncomplicated community-acquired pneumonia, Haemophilus influenzae
infections, invasive salmonellosis, listerial meningitis and gonorrhoea.
Contra-Indications: Hypersensitivity to penicillin.
Special Precautions: See under Amoxycillin
AMPICILLIN SODIUM + SULBACTAM SODIUM
Dosage Form: Tablet 220 mg + 147 mg (375 mg); Injection 1 gm + 0.5 gm (1.5 gm), 2 gm +
1 gm (3.0 gm) (I)
Criteria of use:
1. For surgical prophylaxis (cases of abdominal and O&G-dirty wound operations)
2. Cases of diabetic foot recommended by microbiologist
Recommended Dose: By mouth Adult 375-750 mg bd. Childn ≥ (greater than or equal to)
30 kg Adult dose, <30 kg 25-50 mg/kg/day in 2 divided doses. Gonorrhoea 2.25 g as single
dose. Concomitant probenecid: Administer 1 g in order to prolong plasma conc of Unasyn.
By intravenous route Adult 1.5-12 g/day in divided doses 6-8 hrly. Max: 4 g sulbactam.
Prophylaxis of surgical infections: 1.5-3 g at induction of anesth. May be repeated 6-8 hrly.
Treatment of uncomplicated gonorrhoea 1.5 g as single dose. Childn 150 mg/kg/day 6-8
hrly. Neonates during 1st wk of life, 75 mg/kg/day in divided doses every 12 hr.
Indications: Tablet Upper resp tract infections including sinusitis, otitis media & tonsillitis;
lower resp tract infections including bacterial pneumonias & bronchitis, UTI & pyelonephritis;
skin & soft tissue infections & gonococcal infections. Oral follow-up therapy to Unasyn IM/IV.
IV Injection UTI, pyelonephritis, peritonitis, cholecystitis, endometritis, pelvic cellulitis,
bacterial septicemia. Skin & soft tissue, resp, intra-abdominal, bone, joint & gonococcal
infections. Prophylaxis against post-op sepsis.
Contra-Indications: History of allergic reaction to any penicillins.
Special Precautions: Overgrowth of non-susceptible organism. Check periodically for
organ system dysfunction during prolonged therapy.
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BACAMPICILLIN
Dosage Form: Tablet 400 mg (II)
Recommended Dose: Adult and Child over 7 yrs: mild infection 400 mg bd, Severe
infection: 800 mg bd. Child <7 yrs: 25 mg/kg/day in divided doses every 12 hours. Severe:
50 mg/kg/day in two divided doses every 12 hours.
Indications: Treatment of ENT, urinary tract, lower respiratory tract, URTI and gonorrhoea.
Contra-Indications: Hypersensitivity to penicillin.
Special Precautions: Hypersensitivity to cephalosporins, patients with mononucleosis are
more likely to develop a skin rash.
CLOXACILLIN SODIUM
Dosage Form: Capsule 250 mg; Suspension 125 mg/5 ml (60 ml); Injection 250 mg/vial,
500 mg/vial (II)
Recommended Dose: Adult/child >20 kg: 250-500 mg qid. Child < 20 kg: 50 to 100
mg/kg/day in 4 divided doses. Severe infection: a parenteral antistaphylococcal agent is
preferred.
Endocarditis: IV 2 g m every 4 hours for 14 days.
Indications: Treatment of lower respiratory tract infections, skeletal infections, surgical
prophylaxis and staphylococcal infections.
Contra-Indications: Hypersensitivity to penicillins.
Special Precautions: Cephalosporin hypersensitivity, gastrointestinal disease, history of
asthma, liver disease.
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16.2.5.3. Anti-Pseudomonal Penicillin
PIPERACILLIN SODIUM + TAZOBACTAM (TAZOSIN)
Dosage Form: Injection 4.5 gm/vial (4 gm + 0.5 gm) (II)
Criteria of use: Restricted for febrile neutropenia and infection cases in neonate and
Pseudomonas. For Pseudomonas infection, the first choice is Ceftazidime, followed by
Tazosin then Imipenem
Recommended Dose: lower respiratory-tract, urinary-tract, intra-abdominal and skin
infections, and septicaemia: IV over 3–5 minutes or infusion 2.25–4.5 gm every 6–8 hours,
usually 4.5 gm tds.
Complicated appendicitis: IV over 3–5 minutes or infusion CHILD: 112.5 mg/kg tds (max. 4.5
gm tds) for 5–14 days; CHILD <2 yrs, not recommended.
Neutropenic patients: (in combination with an aminoglycoside), IV over 3–5 minutes or
infusion, ADULT and CHILD >50 kg: 4.5 gm qid; CHILD <50 kg: 90 mg/kg qid.
Indications: Treatment of lower respiratory-tract, urinary-tract, intra-abdominal and skin
infections, septicaemia, appendicitis, diverticulitis, E.Coli infections, febrile neutropenia,
gynecological infections, community-acquired and nosocomial pneumonia.
Contraindications: Hypersensitivity to penicillins/cephalosporins or beta-lactamase
inhibitors
Special Precautions: Bleeding manifestations especially in patients with renal impairment;
increased risk for fever and rash in individuals with cystic fibrosis; high doses and
associated neuromuscular excitability or seizure activity, especially in patients with renal
impairment; patients requiring sodium restriction (2.35 mEq of sodium per gram); patients
with low potassium reserves, or patients receiving cytotoxic therapies or diuretics, falsepositive urinary glucose, pregnancy and breast-feeding.
16.2.6 Tetracyclines
DOXYCYCLINE HCL
Dosage Form: Capsule 100 mg (II)
Recommended Dose: 200 mg on first day then 100 mg daily. To be taken with food.
Severe infections: 200 mg daily.
Early syphilis: 100 mg bd for 14 days; late latent syphilis 200 mg bd for 28 days.
Uncomplicated genital chlamydia, non-gonococcal urethritis: 100 mg bd for 7 days (14 days
in pelvic inflammatory disease)
Indications: Chronic prostatitis; sinusitis, syphilis, pelvic inflammatory disease; malaria
treatment and prophylaxis; recurrent aphthous ulceration, adjunct to gingival scaling and
root planing for periodontitis; oral herpes simplex, acne vulgaris.
Contra-Indications: In late pregnancy not recommened for children under 12 yrs of age as
it causes tooth discolouration.
Special Precautions: In patients with renal impairment; alcohol dependence;
photosensitivity reported (avoid exposure to sunlight or sun lamps); avoid in porphyria.
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TETRACYCLINE
Dosage Form: Capsule 250 mg (II)
Recommended Dose: 250 mg qid, Severe infections: up to 500 mg every 6–8 hrs. To be
taken one hour before food.
Acne: 500 mg bd. Maximum improvement usually occurs after 4 to 6 mths but in more
severe cases treatment may need to be continued for 2 yrs or longer.
Non-gonococcal urethritis: 500 mg qid for 7–14 days (21 days if failure or relapse after first
course)
Indications: Respiratory and genito-urinary tract infections, acne, infections caused by
chlamydia (trachoma, psittacosis, salpingitis, urethritis, and lymphogranuloma venereum),
rickettsia (including Q-fever), and the spirochaete, Lyme disease. periodontal disease, in
exacerbations of chronic bronchitis, and for leptospirosis in penicillin hypersensitivity (as an
alternative to erythromycin).
Contra-Indications: children under 12 years, pregnancy and breast-feeding.
Special Precautions: hepatic impairment, myasthenia gravis, SLE.
16.3. Other Antibacterials
CIPROFLOXACIN
Dosage Form: Tablet 250 mg, 500 mg (as hydrochloride); Injection 100 mg/vial (50 ml),
200 mg/vial (100 ml) (as lactate) (I)
Recommended Dose: Respiratory tract infection 250-750 mg bd. UTI 250-500 mg bd.
Chronic prostatitis, 500 mg bd for 28 days. Gonorrhea 500 mg as single dose. Pseudomonal
lower respiratory tract in cystitis fibrosis, 750 mg bd. CHILD 5–17 yrs: up to 20 mg/kg bd
(max. 1.5 g daily). Surgical prophylaxis: 750 mg, 60-90 minutes before procedure. Most
other infections: 500–750 mg bd. Anthrax (treatment and post-exposure prophylaxis):
500 mg bd; CHILD 30 mg/kg daily in 2 divided doses (max. 1g daily). IV infusion (over 30–60
minutes; 400mg over 60 minutes) 200–400 mg bd.
Pseudomonal lower respiratory-tract infection in cystic fibrosis: 400 mg bd; CHILD 5–17 yrs:
up to 10 mg/kg tds (max. 1.2 g daily).UTI: 100 mg bd. Gonorrhoea: 100 mg as a single
dose. IV infusion, 400mg bd; CHILD 20 mg/kg/day in 2 divided doses (max. 800 mg daily).
CHILD not recommended but where benefit outweighs risk, by mouth, 10–30 mg/kg/day in 2
divided doses or infusion, 8–16 mg/kg/day in 2 divided doses.
Indications: Respiratory tract infection, UTI, chronic prostatitis, gonorrhea, pseudomonal
lower respiratory-tract infection in cystic fibrosis, surgical prophylaxis.
Contra-Indications: Hypersensitivity to ciprofloxacin or other quinolones, children,
adolescents, pregnancy, lactation.
Special Precautions: Epilepsy, CNS damage, renal and hepatic impairment, G6PD
deficiency, myasthenia gravis, pregnancy, breast-feeding, elderly. Avoid UV exposure. May
impair ability to drive or operate machinery. Avoid excessive alkalinity of urine and ensure
adequate fluid intake (risk of crystalluria).
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CLINDAMYCIN
Dosage Form: Tablet 300 mg (as hydrochloride); Injection 300 mg/2 ml (as phosphate) (I)
Recommended Dose: Tablet: Mild to moderately severe infection Adult 150 mg 6 hrly.
Childn >1 mth 8-25 mg/kg/day in 3-4 divided doses. Severe infection Adult 300 mg or
more 6 hrly. Childn 16 mg/kg/day or more if required. To be given in 3-4 divided doses.
Upper resp tract infections Adult 300 mg bd for 10 days. Toxoplasmic encephalitis
Adult 600 mg qds + pyrimethamine 50 mg.
Injection: Adult 600-1200 mg/day in 2-4 equally divided doses. Severe infections: 12002700 mg/day. Max: 4800 mg/day. Childn >1 mth 15-25 mg/kg/day or 350 mg/m2/day.
Severe infections: 25-40 mg/kg/day or 450 mg/m2/day. Doses to be given in 3-4 equally
divided doses. Neonate <1 mth 15-20 mg/kg/day in 3-4 equally divided doses.
Indications: Upper & lower resp tract, skin & soft tissue infections, bone & joint infections,
prophylaxis for dental procedures, bacterial vaginosis, toxoplasmic encephalitis in AIDS
patients.
Contra-Indications: Hypersensitivity to clindamycin or lincomycin. Patients w/ diarrhoea.
Special Precautions: History of GI disease, esp colitis. Renal or hepatic impairment.
Perform periodic liver & kidney function tests w/ prolonged therapy & in neonates & infants.
Discontinue immediately if diarrhoea or colitis develops. Pregnancy & lactation.
FUSIDIC ACID
Dosage Form: Tablet 250 mg; Suspension 50 mg/ml; Injection 500 mg/vial (II)
Recommended Dose: 750 mg tds with meals, doubled in severe infections. Child <1 yr: 50
mg/kg in 3 divided doses; 1-5 yrs: 250 mg tds; 5-12 yrs: 500 mg tds. IV infusion ADULT >
50 kg: 500 mg tds; ADULT <50 kg & CHILD: 6–7 mg/kg tds.
Indications: Osteomyelitis, endocarditis, septicaemia and other penicillin resistant
staphylococcal infections.
Special Precautions: Hepatic impairment; elimination may be reduced in hepatic
impairment or biliary disease or biliary obstruction; pregnancy; breast-feeding.
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IMIPENEM + CILASTATIN
Dosage Form: Injection 250 mg + 250 mg, 500 mg + 500 mg (I*)
Recommended Dose: mild to moderate infections: IM 500–750 mg bd.
IV infusion: 1–2 gm daily (in 3–4 divided doses); less sensitive organisms, up to
50 mg/kg/day (max. 4 gm daily) in 3–4 divided doses; CHILD >3 months: 60 mg/kg (up to
max. of 2 g) daily in 4 divided doses; > 40 kg, adult dose.
Surgical prophylaxis: IV infusion 1 gm at induction repeated after 3 hrs, supplemented in
high risk (e.g. colorectal) surgery by doses of 500 mg 8 and 16 hrs after induction.
Indications: Aerobic and anaerobic Gram-positive and Gram-negative infections, surgical
prophylaxis, hospital-acquired septicaemia.
Contra-Indications: Hypersensitivity any component of this drug,to local anesthetics of the
amide type and in patient with severe shock/heart block.
Special Precautions: Sensitivity to beta-lactam antibacterials (avoid if history of immediate
hypersensitivity reaction), renal impairment, CNS disorders (e.g. epilepsy), pregnancy,
breast-feeding.
MEROPENEM
Dosage Form: Injection 500 mg/vial, 1 gm/vial (II)
Criteria of use: Restricted for ICU, HDU and neuro patients
Recommended Dose: IV over 5 minutes or infusion 500 mg tds; hospital-acquired
pneumonia, peritonitis, septicaemia and infections in neutropenic patients: dose doubled.
[CHILD 3 months–12 years not licensed for infection in neutropenia] 10–20 mg/kg tds, >
50 kg body weight adult dose.
Meningitis: 2 gm tds; CHILD 3 mths–12 yrs: 40 mg/kg tds, >50 kg body weight adult dose.
Exacerbations of chronic lower respiratory-tract infection in cystic fibrosis: up to 2 gm tds;
CHILD 4–18 yrs: 25–40 mg/kg tds.
Indications: Aerobic and anaerobic Gram positive and Gram negative infections.
Contra-Indications: Patients with known hypersensitivity to meropenem, any component or
other carbapenem (imipenem).
Special Precautions: Hypersensitivity to penicillins, cephalosporins and other beta lactams
antibiotic; hepatic impairment, renal impairment, pregnancy and breast- feeding.
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OFLOXACIN
Dosage Form: Tablet 200 mg (I)
Recommended Dose: Adult: PO Part of multidrug therapy in leprosy 400 mg/day or
intermittently, depending on regimen. Uncomplicated gonorrhoea Single dose of 400 mg.
Acute bacterial exacerbation of chronic bronchitis; Community-acquired pneumonia;
Uncomplicated skin infections 400 mg twice daily for 10 days. Pelvic inflammatory disease
400 mg twice daily for 14 days. Postexposure prophylaxis following exposure to inhalational
anthrax 400 mg twice daily for ≥60 days. Legionnaire's disease 400 mg twice daily for 2-3
wk. Mixed infection of the urethra and cervix due to C. trachomatis and Neisseria
gonorrhoeae; Nongonococcal cervicitis; Urethritis due to< Chlamydia trachomatis 200-300
mg twice daily for 7 days. Uncomplicated cystitis 200 mg twice daily for 3-7 days. Duration
depends on causative agent. Complicated UTI 200 mg twice daily for 10 days. Traveller's
diarrhoea 300 mg twice daily for 1-3 days. Chronic bacterial prostatis 300 mg twice daily for
6 wk. Typhoid fever 200-400 mg twice daily for 7-14 days. IV Susceptible infections;
Complicated UTI 200 mg/day. Max: 400 mg twice daily. Skin and soft tissue infections 400
mg twice daily.
Indications: See dose
Contra-Indications: Hypersensitivity to quinolones; pregnancy and lactation; prolongation
of the QT interval; uncorrected hypokalaemia.
Special Precautions: Epilepsy or other predisposition to seizures; known or suspected
CNS disorders; renal, hepatic impairment; myasthaenia gravis; superinfection; children <18
yr; exposure to strong sunlight and UV light; ensure adequate hydration; elderly.
TEICOPLANIN
TEICOPLANIN is a glycopeptide antibiotic, similar to vancomycin.
Dosage Form: Injection 200 mg (II)
Criteria of use: For neonatal and neonatal ICU only
Recommended Dose: IM/IV or infusion initially 400 mg, then 200 mg daily. Severe
infections: IV or infusion, initially 400 mg every 12 hours for 3 doses then 400 mg daily;
patients >85 kg and in severe burns or endocarditis: higher doses may be required.
CHILD over 2 months: IV or infusion initially 10 mg/kg every 12 hours for 3 doses,
subsequently 6 mg/kg daily (severe infections or in neutropenia, 10 mg/kg daily);
subsequent doses can be given by IM (but intravenous administration preferred in children);
NEONATE: IV infusion initially a single dose of 16 mg/kg then 8 mg/kg daily.
Orthopaedic surgery prophylaxis: IV 400 mg at induction of anaesthesia.
Indications: Potentially serious Gram-positive infections including endocarditis, dialysisassociated peritonitis, and serious infections due to Staphylococcus aureus and in
orthopaedic surgery at risk of infection with Gram-positive organisms.
Special Precautions: vancomycin sensitivity; renal impairment, monitor renal and auditory
function on prolonged administration or if other nephrotoxic or neurotoxic drugs given;
pregnancy and breast-feeding.
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TRIMETHOPRIM
Dosage Form: Tablet 100 mg, 300 mg (I)
Recommended Dose: UTI (Treatment And Prophylaxis) Adult: Acute infections: 200 mg
bid, or 200 or 300 mg/day as a single dose. Child: 6-8 mg/kg/day in 2 divided doses; 6-12
yrs: 100 mg bid; 6 months-5 yrs: 50 mg bid; 6 weeks-5 months: 25 mg bid. Gastroenteritis
Adult: Acute infections: 200 mg bid, or 200 or 300 mg/day as a single dose. Child: 6-8
mg/kg/day in 2 divided doses; 6-12 yrs: 100 mg bid; 6 months-5 yrs: 50 mg bid; 6 weeks-5
months: 25 mg bid. Infections Caused By Susceptible Organisms Adult: Acute infections:
200 mg bid, or 200 or 300 mg/day as a single dose. Child: 6-8 mg/kg/day in 2 divided
doses; 6-12 yrs: 100 mg bid; 6 months-5 yrs: 50 mg bid; 6 weeks-5 months: 25 mg bid.
Respiratory Tract Infections Adult: Acute infections: 200 mg bid, or 200 or 300 mg/day as a
single dose. Child: 6-8 mg/kg/day in 2 divided doses; 6-12 yrs: 100 mg bid; 6 months-5 yrs:
50 mg bid; 6 weeks-5 months: 25 mg bid. Long-Term Prophylaxis Adult: 100 mg at night.
Child: 6-12 yrs: 50 mg at night; 6 months-5 yrs: 25 mg at night. Pneumocystis Carinii
Pneumonia Adult: Up to 20 mg/kg body weight/day in combination with dapsone.
Indications: UTI (treatment and prophylaxis), gastroenteritis, infections caused by
susceptible organisms, respiratory tract infections, long-term prophylaxis, pneumocystis
carinii pneumonia.
Contra-Indications: Hypersensitivity; serious haematological disorders; severe renal
impairment; megaloblastic anaemia secondary to folate depletion.
Special Precautions: Renal impairment; actual or possible folate deficiency; elderly;
pregnancy; lactation; child with fragile X chromosome associated with mental retardation;
discontinue in case of skin rash; severe hepatic damage; perform regular haematological
examination.
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CO -TRIMOXAZOLE (TRIMETHOPRIM + SULPHAMETHOXAZOLE)
Dosage Form: Tablet 80 mg + 400 mg (480 mg); Suspension (40 mg + 200 mg)/5 ml;
Injection 80 mg + 400 mg (480 mg) (II)
Recommended Dose: 960 mg bd, Severe infections: up to 1.44 gm. Child 6 wks-5 mth:
120 mg bd, 6 mth-5 yrs: 240 mg bd, 6 yrs –12 yrs: 480mg bd. Pneumocystis carinii
infections: PO/IV infusion 120 mg/kg daily in 2-4 divided doses for 14 days.
Prophylaxis of Pneumocystis carinii infections: 960 mg OD (may be reduced to 480 mg OD
to improve tolerance) or 960 mg EOD (3X per week) or 960 mg bd EOD (3X per week).
CHILD 6 wks–5 mths: 120 mg bd on 3 consecutive days per week or 7 days per week; 6
mths–5 yrs: 240 mg; 6–12yrs: 480 mg.
IV infusion: 960 mg bd. Severe infections: up to 1.44 gm bd; CHILD: 36 mg/kg daily in 2
divided doses. Severe infections: up to 54 mg/kg daily.
Indications: Toxoplasmosis and nocardiasis, Pneumocystis carinii pneumonia, UTI,
salmonellosis, otitis media, sinusitis, exacerbation of chronic bronchitis.
Contra-Indications: Porphyria, Hypersensitivity to sulfonamides or trimethoprim,
pregnancy, infants< 2months(risk of kernicterus), renal or hepatic failure, megaloblastic
anemia due to folate deficiency.
Special Precautions: Hepatic and renal impairment; Maintain adequate fluid intake, breast
feeding, photosensitivity, elderly, avoid in blood disorder, G6PD deficiency, predisposition to
folate deficiency, blood counts in prolonged treatment.
VANCOMYCIN
Dosage Form: Injection 500 mg (I)
Recommended Dose: IV infusion: 500 mg QID or 1 g BD; ELDERLY: 500 mg BD or 1 g OD,
NEONATE <1 wk: 15 mg/kg initially then 10 mg/kg BD, 1–4 wks: 15 mg/kg initially then
10 mg/kg TDS, CHILD >1mths: 10 mg/kg QID.
Indications: prophylaxis and treatment of endocarditis, and other serious infections caused
by gram +ve cocci, treatment of antibiotic associated colitis, systemic infections, Serious or
severe infections due to susceptible strains of methicillin-resistant (beta-lactam resistant)
staphylococci.
Contra-Indications: Known hypersensitivity to vancomycin.
Special Precautions: Pregnancy and breast-feeding, avoid intramuscular administration
(vancomycin causes tissue necrosis). Extreme caution is required in patients with renal
insufficiency and history of hearing loss. Dosage adjustments are required in renal
insufficiency and premature infants. Concurrent use of other nephrotoxic or ototoxic drugs
requires extreme caution. Periodic assessment of haematological status and kidney and
liver functions are advised for all patients.
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16.4. Antifungal/Candicidal/Mycotic Agents
AMPHOTERICIN B
Dosage Form: Injection 50 mg/vial (II)
Recommended Dose: IV infusion, initial test dose: 1 mg over 20–30 minutes then
250 micrograms/kg daily, gradually increased if tolerated to 1 mg/kg daily; Severe infection:
1.5 mg/kg daily or EOD.
Indications: Treatment of systemic fungal infections including North American
blastomycosis, candidiasis, coccidiodomycosis, crytococcosis and histoplasmosis.
Special Precautions: Renal impairment; monitor hepatic and renal-function tests, blood
counts, and plasma electrolyte; pregnancy; breast-feeding; avoid rapid infusion (risk of
arrhythmias); corticosteroids (avoid except to control reactions)
CASPOFUNGIN
Dosage Form: Injection 50 mg/vial, 70 mg/vial (I)
Criteria of use: For Aspergillosis case that not response to amphotericin B
Recommended Dose: IV Infusion, adult, 70 mg loading dose followed by 50 mg daily has
been effective in invasive aspergillosis refractory to prior antifungal therapy. In candidal
esophagitis, 50 mg daily is recommended. (70 mg OD if BW > 80 kg)
Indications: Invasive aspergillosis either unresponsive to amphotericin or itraconazole or in
patients intolerant of amphotericin or itraconazole, Invasive candidiasis and Empirical
treatment of systemic fungal infections in patients with neutropenia
Contra-Indications: Prior hypersensitivity to caspofungin, Ampho. B or any component of
its formulations, breast-feeding
Special
Precautions:
Myelosuppression,
liver
disease/impairment,
renal
insufficiency, pregnancy.
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FLUCONAZOLE
Dosage Form: Tablet 50 mg, 100 mg; Injection 2 mg/ml (50 ml) (vial) (I*)
Recommended Dose: Systemic candidiasis and cryptococcal infections (including
meningitis): IV infusion: 400 mg initially then 200 mg daily, increased if necessary to 400 mg
daily, continue treatment according to response (at least 6-8 weeks for cryptococcal
meningitis). Child > 1 yr, Superficial candidal infections: 1 – 2 mg/ kg daily, Systemic
candidiasis and cryptococcal infections, 3 – 6 mg/ kg daily. neonate> 2 weeks: every 72
hours, > 2-4weeks old: every 48 hours.
Vaginal candidiasis: 150mg single dose.
Oropharyngeal candidiasis: 50 mg OD for 7–14 days (Difficult infections:100 mg OD)
Atrophic oral candidiasis associated with dentures: 50mg for 14 days.
Oesophagitis, candiduria, non-invasive bronchopulmonary: 50mg daily for 14–30 days.
Tinea pedis, corporis, cruris, pityriasis versicolor, and dermal candidiasis: 50 mg OD for 2–4
weeks (up to 6 weeks in tinea pedis); max. duration of treatment 6 weeks
Prevention of relapse of cryptococcal meningitis in AIDS patients after completion of primary
therapy: 200 mg daily or IV infusion: 100–200 mg daily.
Prevention of fungal infections in immunocompromised patients: 50–400 mg daily adjusted
according to risk; 400 mg daily if high risk of systemic infections & continue for 7 days after
neutrophil count in desirable range; child according to extent and duration of neutropenia:
3–12 mg/kg daily (neonate < 2 weeks old: every 72 hours, neonate 2–4 weeks old: every 48
hours in); Max:. 400 mg daily
Indications: Management of fungal infections strictly in patients with underlying renal
problem (which renders amphotericin B unapplicable). *To be prescribed by Physicians only
Contra-Indications: Previous hypersensitivity to fluconazole or its excipients.
Coadministration with terfenadine.
Special Precautions: Patients with hypersensitivity to other azoles. Monitor hepatic
function and discontinue where signs and symptoms of liver disease are evident.Reduce
dosage in renal impairment. Monitor closely for development of skin rashes in
immunocompromised patients and discontinue should the lesions progress.
FLUCYTOSINE
Dosage Form: Injection 1% (I)
Recommended Dose: Usually 37.5-50 mg/kg qds.
Indications: Mycosis esp cryptococcosis, candidiasis & chromoblastomycosis.
Contra-Indications: Hypersensitivity.
Special Precautions: Renal or hepatic impairment. Monitor haematopoietic system &
hepatic function during therapy. Pregnancy & lactation.
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GRISEOFULVIN
Dosage Form: Tablet 125 mg (II)
Recommended Dose: 500 mg daily in single or divided doses. Severe: 1 gm daily in
divided doses or single dose. Child 10 mg/kg daily in single or divided doses after meals.
Indications: Dermatophyte fungal infections of hand, foot, skin and nails.
Contra-Indications: Porphyria, liver failure, pregnancy (during & 1 month after treatment),
men should not father children within 6 months of treatment, breast-feeding, SLE.
Special Precautions: Photosensitivity, hypersensitivity to Penicillin. Concomitant
administration of barbiturates may diminish effects of griseofulvin. May diminish the effects
of anti coagulants if administer together.
ITRACONAZOLE
Dosage Form: Capsule 100 mg; Syrup 10 mg/ml (150 ml) (I*)
Recommended Dose: Oropharyngeal candidiasis: 100 mg daily (200 mg daily in AIDS or
neutropenia) for 15 days, Vulvovaginal candidiasis: 200 mg bBD for 1 day, Pityriasis
versicolor: 200 mg daily for 7 days, Tinea corporis and tinea cruris: 100 mg daily for 15 days
or 200 mg daily for 7 days, Tinea pedis and tinea manuum: 100 mg daily for 30 days or
200 mg BD for 7 days, Onychomycosis: 200 mg daily for 3 months or course (‘pulse') of
200 mg BD for 7 days, subsequent courses repeated after 21-day interval (fingernails 2
courses, toenails 3 courses). Histoplasmosis: 200 mg 1–2 times daily.
Systemic aspergillosis, candidiasis and cryptococcosis where other antifungal drugs
inappropriate or ineffective: 200 mg OD (candidiasis 100–200 mg OD), Invasive or
disseminated disease & cryptococcal meningitis: up to 200 mg BD.
Maintenance in AIDS patients to prevent relapse of underlying fungal infection and
prophylaxis in neutropenia when standard therapy inappropriate: 200 mg OD, up to 200 mg
BD.
child and elderly safety and efficacy not established
Indications: Oropharyngeal candidiasis, pityriasis versicolor, tinea pedis, tinea manuum,
tinea corporis, tinea cruris, onychomycosis, histoplasmosis, neutropenia prophylaxis in AIDS
patients.
Contra-Indications: Previous hypersensitivity to itraconazole, congestive heart failure or
history of congestive heart failure, pregnant women
Special Precautions: Lactation, history of renal or liver disease, childn, decrease gastric
acidity, absorption reduced in AIDS and neutropenia
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KETOCONAZOLE
Dosage Form: Tablet 200 mg (I)
Recommended Dose: 200 mg OD or BD with meals for 14 days, if response inadequate
after 14 days, continue until at least 1 week after symptoms have cleared and cultures
negative. Max: 400 mg (elderly 200 mg) OD. Child: 50-100 mg OD or 3 mg/kg/day.
Chronic resistant vaginal candidiasis: 400 mg OD with food for 5 days
Prophylaxis and maintenance treatment in immunosuppressed patients: 200 mg daily.
Indications: Systemic mycoses, serious chronic resistant mucocutaneous candidiasis,
serious resistant gastro-intestinal mycoses, chronic resistant vaginal candidiasis, resistant
dermatophyte infections of skin or finger nails (not toe nails); prophylaxis of mycoses in
immunosuppressed patients
Contra-Indications: Pregnancyand breast feeding, hepatic impairment, porphyria.
Special Precautions: Concomitant administration of drugs that reduce acidity such as
anticholinergics, antacids and cimetidine. May reduce absorption of ketoconazole.
NYSTATIN
Dosage Form: Tablet 500,000 units; Suspension 100,000 units/ml; Pessary 100,000 units
(II); Cream
Recommended Dose: 1-2 tab TDS for 4-5 days. Child: 1 MU (1 ml) QID. To be continue
treatment for at least 48 hours after clinical cure. 1-2 pessaries at night at least 14 nights
Intestinal candidiasis: 5 MU QID, Severe: double the dose; child: 1 MU 4 times daily
neonate: 1 MU OD.
Prophylaxis: 1 MU OD
Indications: Candidiasis, moniliasis, vaginal infection, oral infection, skin infection
Contra-Indications: Hypersensitivity to NYSTATIN or any components.
TERBINAFINE HCL
Dosage Form: Tablet 250 mg; Cream 1% (15 gm) (I* - Dermatologist)
Recommended Dose: Adult; Tinea Unguium (Onychomichosis): 250 mg daily for 6 weeks
in fingernail infections & 12 weeks in toenail infections. Tinea Corporis (Ringworm), Tinea
Cruris (Josk Itch), Cutaneous Candidiasis: 125 mg bd for up to 6 weeks. Paed: Terbinafine
has not generally been recommended for use in children.
Indications: Dermatophytosis, Onychomichosis, Ringworm infections.
Contra-Indications: Hypersensitivity to terbinafine products.
Special Precautions: Pre-existing liver disease, Suspected or known immunodeficiency,
Renal impairment (Clcr [50ml/min), pregnancy, breast-feeding, psoriasis, autoimmune
disease.
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VORICONAZOLE
Dosage Form: Tablet 50 mg, 200 mg; Injection 200 mg (I)
Recommended Dose: Oral Invasive Aspergillosis Adult: and adolescent >12 yrs: >40 kg
body weight: 400 mg every 12 hrs for 2 doses then 200 mg every 12 hrs, increase if
necessay to 300 mg every 12 hrs; <40 kg: 200 mg every 12 hrs for 2 doses then 100 mg
every 12 hrs, increase if necessary to 150 mg every 12 hrs. Child: 2-11 yrs: 6 mg/kg every
12 hrs for 2 doses then 4 mg/kg every 12 hrs. Invasive Fluconazole-Resistant Candida Spp
(Including C. Krusei) Adult: and adolescent >12 yrs: >40 kg body weight: 400 mg every 12
hrs for 2 doses then 200 mg every 12 hrs, increase if necessay to 300 mg every 12 hrs; <40
kg: 200 mg every 12 hrs for 2 doses then 100 mg every 12 hrs, increase if necessary to 150
mg every 12 hrs. Child: 2-11 yrs: 6 mg/kg every 12 hrs for 2 doses then 4 mg/kg every 12
hrs. Serious Infections Caused By Scedosporium Spp, Flusarium Spp Adult: and
adolescent >12 yrs: >40 kg body weight: 400 mg every 12 hrs for 2 doses then 200 mg
every 12 hrs, increase if necessay to 300 mg every 12 hrs; <40 kg: 200 mg every 12 hrs for
2 doses then 100 mg every 12 hrs, increase if necessary to 150 mg every 12 hrs. Child: 211 yrs: 6 mg/kg every 12 hrs for 2 doses then 4 mg/kg every 12 hrs.
Intravenous Invasive Aspergillosis Adult: Loading dose: 6 mg/kg every 12 hrs for 2 doses
then 4 mg/kg every 12 hrs (reduce in adult and adolescent >12 yrs if not tolerated) for max
of 6 months. Child: >2 yrs: Same as adult dose. Invasive Fluconazole-Resistant Candida
Spp (Including C. Krusei) Adult: Loading dose: 6 mg/kg every 12 hrs for 2 doses then 4
mg/kg every 12 hrs (reduce in adult and adolescent >12 yrs if not tolerated) for max of 6
months. Child: >2 yrs: Same as adult dose. Serious Infections Caused By Scedosporium
Spp, Flusarium Spp Adult: Loading dose: 6 mg/kg every 12 hrs for 2 doses then 4 mg/kg
every 12 hrs (reduce in adult and adolescent >12 yrs if not tolerated) for max of 6 months.
Child: >2 yrs: Same as adult dose.
Indications: Invasive aspergillosis, invasive fluconazole-resistant candida spp (including c.
Krusei), serious infections caused by scedosporium spp, flusarium spp
Contra-Indications: Hypersensitivity. Lactation.
Special Precautions: Monitor renal and hepatic function before and during treatment.
Haematological malignancy; hepatic and renal impairment; pregnancy (ensure effective
contraceptions during treatment); avoid exposure to sunlight. May affect ability to drive or
operate machinery.
16.5. Antihelminthics
ALBENDAZOLE
Dosage Form: Tablet 200 mg; Suspension 200 mg/5 ml (II)
Recommended Dose: Adult & childn > 2 yr: 400 mg as a single dose. Threadworm &
tapeworm: 400 mg as a single dose for 3 consecutive days. Childn 12-24 mth: ½ adult dose.
Indications: Infestations of common worms eg roundworm, whipworm, hookworm &
pinworm, threadworm & tapeworm.
Contra-Indications: Pregnancy, child less than 12 months.
Special Precautions: Women of child-bearing age should initiate treatment during 1st wk of
menstruation or after a -ve pregnancy test.
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16.6. Antileprotics
DAPSONE
Dosage Form: Tablet 100 mg (II)
Recommended Dose: 100 mg daily (50 mg daily or 1 - 2 mg/kg daily for patients weighing
<35 kg).
Indications: Leprosy, dermatitis herpetiformis, Pneumocystis carinii pneumonia.
Contra-Indications: Hypersensitivity to dapsone or its derivatives.
Special Precautions: Cardiac or pulmonary disease; anaemia (treat severe anaemia
before starting); G6PD-deficiency (including breast-feeding of affected children); pregnancy
& porphyria.
RIFAMPICIN
Dosage Form: Capsule 150 mg, 300 mg (II)
Recommended Dose: Brucellosis, legionnaires' disease, endocarditis and serious
staphylococcal infections, in combination with other drugs: 0.6–1.2 gm daily in 2–4 divided
doses.
Tuberculosis in combination with other drugs: ADULT <50 kg: 450 mg daily, >50 kg: 600 mg
daily; CHILD: 10 mg/kg daily. Max: 600 mg for 2-month initial and 4-month continuation
phases.
Leprosy: 600 mg once-monthly, supervised (450 mg for adults <35 kg).
Prophylaxis of meningococcal meningitis: 600 mg bd for 2 days; CHILD: 10 mg/kg bd for 2
days. CHILD <1 YEAR: 5 MG/KG.
Haemophilus influenzae (type b) infection: 600 mg once daily for 4 days; CHILD 1–3 mths:
10 mg/kg once daily for 4 days; > 3 months: 20 mg/kg once daily for 4 days (max. 600 mg
daily)
Indications: Brucellosis, legionnaires' disease, endocarditis and serious staphylococcal
infections, tuberculosis, leprosy patients, Prophylaxis of meningococcal meningitis &
Haemophilus influenzae (type b) infection.
Contra-Indications: Hypersensitivity to rifampicin, jaundice.
Special Precautions: Patients with hepatic dysfunction and/or receiving other hepatotoxic
agents impaired liver function. Rifampin is a hepatic enzyme inducer; enhanced metabolism
of certain hormones, electrolytes, vitamins, and drugs.
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16.7. Antimalarials
CHLOROQUINE PHOSPHATE
Dosage Form: Tablet 250 mg (150 mg chloroquine base) (II)
Recommended Dose: Treatment of acute attack: Initially 600 mg base, followed by 300 mg
after 6-8 hrs and a further 300 mg on each of 2 following days. Child: initial dose of
10 mg/kg (of base) then a single dose of 5 mg/kg after 6–8 hours then a single dose of
5 mg/kg daily for 2 days
Prophylaxis of malaria: started 1 wk before entering endemic area and continued for 4 wks
after leaving, 300 mg once wkly; infant up to 12 wks (<6 kg): 37.5 mg once wkly; 12 wks–11
mths (6–10 kg): 75 mg once wkly; child 1–3 yrs(10–16 kg): 112.5 mg once wkly; 4–7 yrs
(16–25 kg): 150 mg once wkly; 8–12 yrs (25–45 kg): 225 mg once wkly; >13 yrs (>45 kg),
adult dose.
Indications: Chemoprophylaxis and treatment of malaria, rheumatoid arthritis and lupus
erythematosus
Contra-Indications: Hypersensitivity to 4-aminoquinoline compounds or to any of its
derivatives, retinal or visual field changes attributable to the drug or any other etiology
Special Precautions: In patients with impaired renal function, pregnancy and G6PD
deficiency. Regular opthalmic examinations should be carried out in long-term therapy.
Also may exacerbate psoriasis, neurological disorders, may aggravate myasthenia gravis &
severe gastro-intestinal disorders.
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PYRIMETHAMINE
Dosage Form: Tablet 25 mg (II)
Recommended Dose: See indications
Indications: For Treatment of Toxoplasmosis: The dosage of pyrimethamine for the
treatment of toxoplasmosis must be carefully adjusted so as to provide maximum
therapeutic effect and a minimum of side effects. At the dosage required, there is a marked
variation in the tolerance to the drug. Young patients may tolerate higher doses than older
individuals. Concurrent administration of folinic acid is strongly recommended in all patients.
The adult starting dose is 50 to 75 mg of the drug daily, together with 1 to 4 g daily of a
sulfonamide of the sulfapyrimidine type, e.g., sulfadoxine. This dosage is ordinarily
continued for 1 to 3 weeks, depending on the response of the patient and tolerance to
therapy. The dosage may then be reduced to about one half that previously given for each
drug and continued for an additional 4 to 5 weeks. The pediatric dosage of pyrimethamine is
1 mg/kg/day divided into 2 equal daily doses; after 2 to 4 days this dose may be reduced to
one half and continued for approximately 1 month. The usual pediatric sulfonamide dosage
is used in conjunction with pyrimethamine.
For Treatment of Acute Malaria: Not recommended alone in the treatmentof acute
malaria. Fast-acting schizonticides, such as chloroquine or quinine, are indicated for
treatment of acute malaria. However, pyrimethamine at a dosage of 25 mg daily for 2 days
with a sulfonamide will initiate transmission control and suppression of non-falciparum
malaria. Recommended for patients infected in areas where susceptible plasmodia exist.
Should circumstances arise wherein pyrimethamine must be used alone in semi-immune
persons, the adult dosage for acute malaria is 50 mg for 2 days; children 4 through 10 years
old may be given 25 mg daily for 2 days. In any event, clinical cure should be followed by
the once-weekly regimen described below for chemoprophylaxis. Regimens which include
suppression should be extended through any characteristic periods of early recrudescence
and late relapse, i.e., for at least 10 weeks in each case.
For Chemoprophylaxis of Malaria: Adults and pediatric patients over 10 years. 25 mg (1
tablet) once weekly. Children 4 through 10 years. 12.5 mg (1/2 tablet) once weekly
Infants and children under 4 years. 6.25 mg (1/4 tablet) once weekly
Treatment of Toxoplasmosis: Indicated for the treatment of toxoplasmosis when used
conjointly with a sulfonamide, since synergism exists with this combination.
Treatment of Acute Malaria: For the treatment of acute malaria. It should not be used
alone to treat acute malaria. Fast-acting schizonticides such as chloroquine or quinine are
indicated and preferable for the treatment of acute malaria. However, conjoint use with a
sulfonamide (e.g., sulfadoxine) will initiate transmission control and suppression of
susceptible strains of plasmodia.
Chemoprophylaxis of Malaria: For the chemoprophylaxis of malaria due to susceptible
strains of plasmodia. However, resistance to pyrimethamine is prevalent worldwide. It is not
suitable as a prophylactic agent for travelers to most areas.
Contraindications: In patients with known hypersensitivity to pyrimethamine or to any
component of the formulation. Use of the drug is also contraindicated in patients with
documented megaloblastic anemia due to folate deficiency.
Special Precautions: General: The recommended dosage for chemoprophylaxis of
malaria should not be exceeded.
A small starting dose for toxoplasmosis is recommended in patients with convulsive
disorders to avoid the potential nervous system toxicity of pyrimethamine. DARAPRIM
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should be used with caution in patients with impaired renal or hepatic function or in patients
with possible folate deficiency, such as individuals with malabsorption syndrome,
alcoholism, or pregnancy, and those receiving therapy, such as phenytoin, affecting folate
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QUININE
Dosage Form: Injection 300 mg as Dihydrochloride; Tablet 300 mg as Sulphate (II)
Recommended Dose: 600 mg tds for 5–7 days. IV infusion: loading dose of 20 mg/kg over
4 hrs (up to max. 1.4 g), then after 8 hours maintenance dose; 10 mg/kg (up to maximum
700 mg) infused over 4 hrs every 8 hrs until patient can swallow tablets to complete the 7day course.
Indications: Falciparum malaria, nocturnal leg cramps.
Contra-Indications: Optic neuritis, haemoglobinaemia & myasthenia gravis.
Special Precautions: Atrial fibrillation, conduction defects, heart block, pregnancy, G6PD
deficiency. Loading dose should not be used if patient has received
quinine/quinidine/mefloquine or chloroquine during previous 12 hours.
SULPHADOXINE + PYRIMETHAMINE
Dosage Form: Tablet 500 mg + 25 mg (II)
Recommended Dose: Give alone or on day 3 or 4 of oral quinine treatment. Adult, 3 tablets
as a single dose; child 9-14 years, 2 tablets; child 4-8 years, 1 tablet; child 1-3 years, half a
tablet; infant 6 weeks – 1 year, quarter of a tablet.
Indications: adjunct to quinine in treatment of Plasmodium falciparum malaria; not
recommended for prophylaxis
Contra-Indications: previous allergic reaction to pyrimethamine or sulfonamides
Special Precautions: hepatic or renal impairment, pregnancy, breast-feeding, blood counts
required with prolonged treatment, history of seizures—avoid large loading doses
16.8. Antituberculars
ETHAMBUTOL
Dosage Form: Tablet 400 mg (II)
Recommended Dose: unsupervised treatment: 15 mg/kg as single dose daily. In fully
supervised intermittent treatment: 30 mg/kg 3 times a week for 2-month initial phase only.
Indications: Treatment of tuberculosis, in combination with other drugs.
Contra-Indications: Optic neuritis, poor vision.
Special Precautions: Reduce dose in patients with impaired renal function. Regular ocular
examination required during treatment. Not recommended for use in young children, elderly
patients and pregnancy.
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ISONIAZID
Dosage Form: Tablet 100 mg (II)
Recommended Dose: Unsupervised treatment: 300 mg daily; child: 5–10 mg/kg (max.
300 mg) daily. In fully supervised intermittent treatment: adult & child: 15 mg/kg (max.
900 mg) 3 times a week for 2-month initial and 4-month continuation phases.
Indications: Treatment of pulmonary tuberculosis in combination with other drugs.
Contra-Indications: Previous isoniazid associated hepatitis, liver disease.
Special Precautions: In patients with impaired renal or hepatic function, epilepsy, history of
psychosis, malnutrition, HIV infection, diabetes mellitus, alcoholism,porphyria, breastfeeding & pregnancy.
PYRAZINAMIDE
Dosage Form: Tablet 500 mg (II)
Recommended Dose: Unsupervised treatment: adult < 50 kg: 1.5 gm daily, >50 kg: 2 gm
daily; child: 35 mg/kg daily. In fully supervised intermittent treatment: adult <50 kg 2 g 3
times a week, >50 kg: 2.5 gm 3 times a week; child: 50 mg/kg 3 times a week for 2-month
initial phase only.
Indications: Treatment of pulmonary tuberculosis in combination with other drugs.
Contra-Indications: Severe hepatic dysfunction, hypersensitivity to pyrazinamide & acute
gout.
Special Precautions: In patients with impaired renal function, pregnancy, diabetes, gout.
RIFAMPICIN
Dosage Form: Capsule 150 mg, 300 mg (II)
Recommended Dose: Brucellosis, legionnaires' disease, endocarditis and serious
staphylococcal infections, in combination with other drugs: 0.6–1.2 gm daily in 2–4 divided
doses.
Tuberculosis in combination with other drugs: adult <50 kg: 450 mg daily, >50 kg: 600 mg
daily; child: 10 mg/kg daily. Max: 600 mg for 2-month initial and 4-month continuation
phases.
Leprosy: 600 mg once-monthly, supervised (450 mg for adults <35 kg).
Prophylaxis of meningococcal meningitis: 600 mg bd for 2 days; child: 10 mg/kg bd for 2
days. Child <1 year: 5 mg/kg.
Haemophilus influenzae (type b) infection: 600 mg once daily for 4 days; child 1–3 mths:
10 mg/kg once daily for 4 days; > 3 months: 20 mg/kg once daily for 4 days (max. 600 mg
daily)
Indications: Brucellosis, legionnaires' disease, endocarditis and serious staphylococcal
infections, tuberculosis, leprosy patients, Prophylaxis of meningococcal meningitis &
Haemophilus influenzae (type b) infection.
Contra-Indications: Hypersensitivity to rifampicin, jaundice.
Special Precautions: Patients with hepatic dysfunction and/or receiving other hepatotoxic
agents, impaired liver function. Rifampin is a hepatic enzyme inducer; enhanced
metabolism of certain hormones, electrolytes, vitamins, and drugs.
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STREPTOMYCIN SULPHATE
Dosage Form: Injection 1 gm/vial (II)
Recommended Dose: Tuberculosis: IM 15 mg/kg daily (Max: 1 gm), administered 2 or 3
days a week, or administered everyday for the first 1-3 months and then 2 days a week.
Elderly: 0.5-0.75 gm. Decreased dose in children or patients with very low body weight.
Other Infections: IM 1-2 g in 1 or 2 divided doses. The dosage may be adjusted according to
the age or severity of the symptoms.
Indications: Treatment of Pulmonary & other TB, bacterial endocarditis, tularemia, Weil's
disease
Contra-Indications: Patients with a history of hypersensitivity to the ingredient of
streptomycin sulfate, aminoglycoside antibiotics or bacitracin.
Special Precautions: Renal & hepatic impairment. Elderly, poor oral & parenteral nutrition.
Pregnancy & lactation.
16.9. Antivirals
ACYCLOVIR
Dosage Form: Tablet 200 mg, 800 mg; Injection 250 mg/vial, 500 mg/vial (I)
Recommended Dose: Herpes simplex: 200 mg (immunocompromised: 400 mg) 5 times
daily for 5 days; Prevention of recurrence: 200 mg qid or 400 mg bd possibly reduced to
200 mg 2 or 3 times daily and interrupted every 6–12 months; Prophylaxis in
immunocompromised: 200–400 mg qid. child <2 yrs: half adult dose.
Varicella and herpes zoster: 800 mg 5 times daily for 7 days; child: 20 mg/kg qid for 5 days;
<2 yrs: 200 mg qid; 2–5 yrs: 400 mg qid,;>6 yrs: 800 mg qid daily. Max: 800 mg.
IV infusion, herpes simplex in immunocompromised, severe initial genital herpes, and
varicella–zoster: 5 mg/kg tds for 5 days; varicella–zoster in the immunocompromised and in
simplex encephalitis: doubled to 10 mg/kg tds given for at least 10 days in encephalitis,
possibly for 14–21 days; prophylaxis of herpes simplex in immunocompromise: 5 mg/kg tds.
Indications: Treatment of Herpes Simplex infection and varicella–zoster
Contra-Indications: Hypersensitivity to acyclovir.
Special Precautions: Maintain adequate hydration. Reduce dose in renal impairment,
pregnancy & breast-feeding.
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ADEFOVIR DIPIVOXIL
Dosage Form: Tablet 10 mg (I* - Gastroenterologist)
Criteria of use:
1. Restricted for Dr. Amry, Dr. Aizan and Dr. Lee Yeong
2. For Hepatitis B as 2nd line drug (1st line- Lamivudine and 3rd line- Entecavir)
Recommended Dose: ADULT over 18 years, 10 mg once daily
Indications: Chronic hepatitis B infection with either compensated liver disease with
evidence of viral replication, and histologically documented active liver inflammation and
fibrosis or decompensated liver disease.
Contra-Indications: Breast-feeding
Special Precautions: Monitor liver function, and viral and serological markers for hepatitis
B every 6 months; discontinue if deterioration in liver function, hepatic steatosis, progressive
hepatomegaly or unexplained lactic acidosis; recurrent hepatitis may occur on
discontinuation; monitor renal function every 3 months, more frequently in renal impairment
or in patients receiving nephrotoxic drugs; pregnancy; elderly; HIV infection (particularly if
uncontrolled - theoretical risk of HIV resistance)
ENTECAVIR
Dosage Form: Tablet 0.5 mg, 1 mg (I)
Recommended Dose: Adult over 18 years, not previously treated with nucleoside
analogues, 500 micrograms once daily; Adult over 18 years with lamivudine-resistant
chronic hepatitis B, 1 mg once daily. To be taken at least 2 hours before or 2 hours after
food
Indications: Chronic hepatitis B infection with compensated liver disease, evidence of viral
replication, and histologically documented active liver inflammation or fibrosis.
Contra-Indications: Breast-feeding.
Special Precautions: Monitor liver function; discontinue if deterioration in liver function,
hepatic steatosis, progressive hepatomegaly or unexplained lactic acidosis; recurrent
hepatitis may occur on discontinuation; renal impairment; pregnancy.
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GANCICLOVIR
Dosage Form: Tablet 250 mg; Injection 500 mg/5 ml (I)
Recommended Dose: Oral CMV Prophylaxis Adult: For immunocompromised and
advanced HIV patients: 1 g tid. Intravenous Treatment Of CMV Infections Adult: 5 mg/kg
infused every 12 hrs for 14-21 days. Maintenance: 5 mg/kg infused once daily for 7 days a
week or 6 mg/kg once daily for 5 days a week. Prevention Of CMV Infections Adult: Initially,
5 mg/kg body weight every 12 hrs for 7-14 days following maintenance therapy, for patients
receiving immunosuppressant after organ transplant.
Indications: Prophylaxis and treatment of cytomegalovirus (CMV) infections
Contra-Indications: Hypersensitivity; absolute neutrophil count below 500 cells/mm 3;
platelet count below 25,000/mm3; pregnancy and lactation. Not to be administered as a
bolus injection.
Special Precautions: Renal impairment; preexisting cytopaenias or history of cytopaenic
reactions to drugs; child; contraceptive precautions to be followed during and at least 90
days thereafter; care in administering only into veins with good blood flow. Avoid contact
with the skin and eyes.
LAMIVUDINE
Dosage Form: Tablet 100 mg; Oral solution 10 mg/ml (240 ml) (I* - Gastroenterologist)
Recommended Dose: chronic hepatitis B infection: 100 mg daily; HIV: adults >16 yrs (>50
kg) 300 mg daily in combination with other antiretrovirals.
Indications: Treatment of patients ≥ (greater than or equal to) 16 yr w/ chronic hepatitis B &
evidence of hepatitis B virus replication.
Contra-Indications: Hypersensitivity to lamivudine
Special Precautions: Monitor regularly during treatment. Moderate to severe renal
impairment. Pregnancy, lactation.
TELBIVUDINE
Dosage Form: Tablet 600 mg (I*)
Criteria of use: 1. Use according to Flow Chart of Chronic Viral Hepatitis B Pre Core Mutant
HbeAg Negative
2. Restricted for Dr. Amry, Dr. Nor Aizal Che Ngah and Dr. Lee Yeong
3. A total of ten patients per year (for duration of 18 months)
Recommended Dose: Type B viral hepatitis, chronic, Adult: 600 mg daily. Renal
Impairment: CrCl >50 mL/min: usual dose; CrCl 30 to 49 mL/min: 600 mg every 48 hours,
CrCl < 30 mL/min not requiring hemodialysis: 600 mg every 72 hours; End-stage renal
disease requiring hemodialysis: 600 mg every 96 hours, to be given after hemodialysis.
Indications: Treatment of chronic hepatitis B in adults with evidence of viral replication and
active liver inflammation.
Contra-Indications: Hypersensitivity to telbivudine; lactation
Special Precautions: Monitor renal and hepatic function. Myopathy. Liver transplants
recipient. Elderly. Children < 16 yr. Pregnancy.
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VALACICLOVIR
Dosage Form: Tablet 500 mg (I* -Medical)
Recommended Dose: Adult: PO Herpes zoster 1 g 3 times/day for 7 days. Genita herpes
Initial episode: 1 g twice daily for up to 10 days. Prophylaxis of herpes simplex infections
500 mg/day in 1-2 divided doses. Immunocompromised patients: 500 mg twice daily.
Herpes simplex infections of skin and mucous membranes Initial episode: 500 mg twice
daily for up to 10 days. Recurrent episodes: 500 mg twice daily for 5 days. Recurrent genital
herpes 500 mg twice daily for 3 days. Suppression of recurrent episodes of genital herpes 1
g once daily or 500 mg once daily for patients w/ ≤9 recurrences per year; HIV infected
patients with CD4 cells count ≥100 cells/mm 3: 500 mg twice daily,up to 6 mth. Reduction of
transmission of genital herpes W/ safe sex practices and abstinence: 500 mg once daily for
infected partner w/ history of ≤9 recurrences per yr. Prevention of CMV infections in
immunocompromised patients 2 g 4 times/day for 90 days w/in 72 hr after transplant.
Herpes labialis 2 g12 hrly for 1 day.
Indications: See dose.
Contra-Indications: Hypersensitvity to valaciclovir, aciclovir.
Special Precautions: Dehydration; renal or hepatic impairment, pregnancy, lactation.
Maintain adequate hydration. Monitor renal function daily especially during first 10 days post
transplant.
ZIDOVUDINE
Dosage Form: Capsule 100 mg; Syrup 10 mg/ml
Recommended Dose: 500–600 mg daily in 2–3 divided doses; child >3 months: 360–
480 mg/m2 daily in 3–4 divided doses. Max: 200 mg qid.
Indications: HIV infection in combination with other antiretroviral drugs, prevention of
maternal-fetal HIV transmission.
Contra-Indications: Abnormal low neutrophil cell count (< 7.5 x 10 9) or abnormal low Hb
levels (<7.7g/dL), breast-feeding.
Special Precautions: Monitor carefully haematological parameters. In severe anaemia or
myelosuppression occurs dose adjustments are suggested. Patients with pre-existing bone
marrow compromise, elderly.
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17. INTRAVENOUS PRODUCTS
17.1. Alkalinizing Agents
SODIUM BICARBONATE 8.4%
Dosage Form: Injection 1 mmol/ml (10 ml, 50 ml) (II)
Recommended Dose: Slow IV injection, a strong solution (4.2% up to 8.4 %), or by
continuous IV infusion, a weak solution (usually 1.26 %), an amount appropriate to the body
base deficit.
Indications: Treatment of metabolic acidosis caused by cardiac arrest, urinary
alkalinisation, relief of discomfort in mild urinary tract infection and management of
hyperkalaemia.
Contra-Indications: Hypochloraemia, respiratory alkalosis and hypocalcaemia.
Special Precautions: History of CHF, hypertension, history of renal impairment, Concurrent
corticosteroid and Cirrhosis.
17.2. Caloric and Nutrient Solution
AMINO ACIDS
Dosage Form: Injection 100ml, 500 ml (Vaminolact), 10% with electrolytes (500 ml)
(Aminoplasma), 10% without electrolytes (500 ml) (Vamin 18 EF) (I)
Recommended Dose: According to needs of patients.
The usual amino acid adult dose is 1 to 2 g/kg/day infused in a central vein. The usual
pediatric dose is 1 to 3 g/kg/day. Protein requirements differ widely depending on the
degree of metabolic stress.
Indications: Amino acids are used as a protein source in patients requiring nutrition
support. As an adjunct to other appropriate nutrients in the prevention of nitrogen loss or in
the treatment of negative nitrogen balance, and in total parenteral nutrition (TPN).
Note: Amino acids have induced blood dyscrasias, encephalopathy, hyperammonemia, and
cholestasis
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DEXTROSE
Dosage Form: Injection 5% (100 ml, 250 ml, 500 ml), 10% (500 ml), 50% (10 ml, 500 ml);
Dextrose + sodium chloride: Injection 4.23% + 0.18% (500 ml), 5% + 0.9% (500 ml), 5% +
0.45% (500 ml), 10% + 0.18% (500 ml), 10% + 0.45% (500 ml) (II)
Recommended Dose: According to needs of patients (energy source, 1–3 litres daily of
20–50% solution) Hypoglycemia: Adult- IV, 10-25 grams, repeat if necessary. Neonates:
250-500 mg/kg/dose (5 to 10 mL of 25% dextrose). Infants: 10-12 mL of 25% dextrose.
Repeat doses as necessary and carefully follow blood glucoses. Peripheral intravenous
solutions should be 2.5% to 5%. Due to hypertonicity; solutions greater than 10% dextrose
should be infused through central lines.
Indications: Fluid replacement, provision of energy and in TPN.
(Generally dextrose is used in many preparations for oral, enteral, and parenteral nutrition
and is the preferred source of carbohydrate. Dextrose is effective in the treatment of
hypoglycemia from any cause including alcoholism, hyperinsulinemia, or insulin shock.
Dextrose has also been used as a sclerosing agent and for oral rehydration.)
Contra-Indications: Allergy to corn or corn products. And do not use concentrated
solutions of dextrose in patients with: anuria, diabetic coma and hyperglycemia, intracranial
or intraspinal hemorrhage, delirium tremens in dehydrated patients, glucose-galactose
malabsorption syndrome
Special Precautions: Patients with diabetes mellitus or carbohydrate intolerance. Regular
monitoring of blood glucose, serum electrolytes and water balance. Should not be
administered through the same infusion set through which also blood has or may be given
because of risk of pseudo-agglutination
Note: Adverse effects of dextrose include rebound hypoglycemia after abrupt withdrawal of
highly concentrated dextrose infusions, local vein irritation with hypertonic dextrose,
hyperglycemia, glycosuria, and worsened neurologic outcome with hyperglycemia after
ischemic brain injury. Improper dextrose solution administration can result in fluid overload
and poor outcome. Do not use concentrated solutions in patients with anuria,
hyperglycemia, intracranial or intraspinal hemorrhage, delirium tremens and dehydration or
in patients with glucose-galactose malabsorption syndrome.(glucose injections especially if
hypertonic may have a low pH and may cause venous irritation and thrombophlebitis)
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FAT EMULSION
Dosage Form: Injection 10% 500 ml, 20% 100 ml, 250 ml, 500 ml (II)
Recommended Dose: Adult: Calorie supplementation: up to 2.5 g/kg/day IV (to provide no
more than 60% of calorie requirement) Essential fatty acid deficiency, prevention: IV, 8-10%
of calorie input as fat emulsion. Paed: Calorie supplementation: 0.5 g/kg/day IV (to provide
no more than 60% of calorie requirement); MAX 3 g/kg/day. Essential fatty acid deficiency,
prevention: 8-10% of calorie input as fat emulsion.
Indications: Calorie supplementation and essential fatty acid deficiency; prevention
Contra-Indications: In patients with severe liver disease, renal failure, septicemia,
immunocompromised and jaundice, abnormal fat metabolism, including pathological
hyperlipidemia, lipid nephrosis, or acute pancreatitis with hyperlipidemia
Special Precautions: Should be used with caution in neonates with hyperbilirubinemia.
Patients with cross sensitivity to eggs, soybeans and legums may be sensitive to fat
emulsions. Anemia, blood coagulation disorders, fat embolism risk such as post traumatic
fracture of the pelvis and or long bones, Intralipid(R) 10%, 20%, and 30% Intravenous Fat
Emulsions contain aluminum that may cause central nervous system and bone toxicity,
pulmonary disease and severe liver damage
Notes: Initial infusion rate: Adults: 0.1 g fat/min for first 15-30 min; if no adverse effects, can
double rate. Paed: 0.01 g fat/min for first 10 to 15 min; if no adverse reactions, rate can be
increased to 0.1 g fat/kg/hr.
17.3. Diuretic Solution
MANNITOL
Dosage Form: Injection 10% (10 gm/100 ml) (500 ml), 20% (20 gm/100 ml) (500 ml) (II)
Recommended Dose: IV infusion 50-200 gm over 24 hrs, preceded by a test dose of 200
mg/kg by slow IV injection. Cerebral oedema— rapid IV infusion, typical dose: 1 g/kg as a
20% solution.
Indications: In cerebral oedema and forced diuresis. Intracranial pressure, Intraocular
pressure, renal impairment-oliguria & prophylaxis, toxicity of drug
Contra-Indications: Pulmonary oedema, congestive heart failure, active intracranial
bleeding, severe dehydration, anuria
Special Precautions: Extravasation causes inflammation and thrombophlebitis. Careful
observation for signs of fluid and electrolyte imbalance, extravasation causes inflammation
and thrombophlebitis, cardiopulmonary dysfunction, electrolyte imbalance & renal
impairment.
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17.4. Electrolyte Additives
CALCIUM CHLORIDE
Dosage Form: Injection 10% (1g/10 ml) ampoule Each ml contains approximately 0.68
mmol of calcium ions and 1.36 mmol chloride ions (II)
Recommended Dose: Acute Hypocalcaemia; Adults: An initial dose of 3.5 - 7 mmol (7 to
14 mEq) calcium is recommended repeated every 1-3 days as necessary. Children: An
initial dose of 0.5 - 3.5 mmol (1 to 7 mEq) calcium/kg is recommended. The dose may be
repeated every 1-3 days as necessary. Hypocalcaemic Tetany; Adults: An initial dose of
2.25 - 8 mmol (4.5 to 16 mEq) calcium is recommended, repeated until a response is
achieved. Children: An initial dose of 0.25 - 0.35 mmol calcium/kg, is recommended,
repeated every 6-8 hours until a response is achieved. Hyperkalaemia with Secondary
Cardiac Toxicity; Adults: An initial dose of 1.12 - 7 mmol (2.25 to 14mEq) calcium is
recommended. The dose may be repeated after 1-2 minutes if necessary. ECG should be
monitored during administration.
Indications: Parenteral administration of calcium is indicated in the treatment of
hypocalcaemia where a rapid increase in plasma calcium is required, such as in
hypocalcaemic tetany and tetany due to parathyroid deficiency. Intravenous calcium is also
indicated to antagonise the cardiotoxicity of hyperkalaemia.
Contra-Indications: Hypercalcaemia, hypercalcuria or severe renal disease, ventricular
fibrillation, renal calculi, sarcoidosis, digitalised patients. Should never be administered
orally to infants since it may result in severe irritation to the gastrointestinal tract.
Special Precautions: Should not be administered intramuscularly or subcutaneously or into
peri vascular tissue. Stopped if the patient complains of discomfort. Direct injection into
heart tissues should be avoided. Must be administered slowly via a small needle into a large
vein, at a rate not exceeding 0.35 -0.7 mmol per minute. Continuous ECG monitoring should
be performed when using calcium salts to antagonise cardiac toxicity associated with
hyperkalaemia.
CALCIUM GLUCONATE
Dosage Form: Injection 10% (1g/10 ml) (2.2 mmol) ampoule (II)
Recommended Dose: Advanced cardiac life support, Adult: 5-8 mL, paed: 0.6-1.0 mL (60100 mg)/kg slow IV push, preferably into a central vein; intraosseous administration is
acceptable. Hypocalcemia, Adult: 10 mL (2.25 mmol) of calcium gluconate injection 10%,
followed by the continuous infusion of about 40 mL (9 mmol) daily, but plasma calcium
should be monitored or 0.5-2 grams (5 -20 milliliters) administered slowly in a rate 1.5
mL/min. Paed: 200-500 mg (2-5 mL). INFANTS: <200 mg (2 mL). Calcium gluconate should
be injected through a small needle into a large vein at a rate of approximately 1.5 milliliters
per minute. EXCHANGE TRANSFUSIONS, Paeds: 1 mL of IV calcium gluconate after each
100 mL of blood exchange. NUTRITIONAL SUPPLEMENTATION, Adult: 50-100 mg/kg,
Paeds: 100-200 mg/kg. Neonate: 300-500 mg/kg. Magnesium overload: IV injection, 10-20
mL of a 10% calcium gluconate.
Indications: Severe hyperkalaemia, cardiac arrest, acute hypocalcemia.
Contra-Indications: See Calcium Chloride.
Special Precautions: See Calcium Chloride.
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MAGNESIUM SULPHATE
Dosage Form: Injection 49.3% (2.47 g/5 ml) (10 mmol) ampoule (Magnesium sulphate 1 g
equivalent to Mg2+ approx. 4 mmol) (I)
Recommended Dose: Cardiac dysrhythmia, Adult: initially IV 1-2 gm, maintenance,
continuous IV infusion 0.5-1 gm/Hr. Paed: 25-50 mg/kg IV up to 2 grams.
Hypomagnesemia, Adult: up to 5 grams IV or 1 gram (magnesium sulfate 50% solution) IM
every 6 hours for 4 doses. Paed: 100-200 mg/kg IV 4 times daily. Neonates: 25-50 mg/kg IV
every 8-12 hours for 2-3 doses. Pre-eclampsia, Adult: initially, 4 gm, maintenance 1
gram/hour IV for 24 hours OR 10 grams IM every 4 hours for 24 hours. Torsades de
pointes, Adult: initially IV 1-2 gm, maintenance continuous IV infusion magnesium sulfate
0.5-1 gm/Hr. Paed: 25-50 mg/kg IV up to 2 gm.
Prevention of seizure recurrence in eclampsia, initially by intravenous injection over 5–15
minutes, 4 g, followed by intravenous infusion, 1 g/hour for at least 24 hours after last
seizure; if seizure recurs, additional dose by intravenous injection, 2 g (4 g if body-weight
over 70 kg)
INTRAVENOUS ADMINISTRATION: For intravenous injection concentration of magnesium
sulphate should not exceed 20% (dilute 1 part of magnesium sulphate injection 50% with at
least 1.5 parts of water for injections)
Indications: Hypomagnesemia, Eclampsia, cardiac arrest, cardiac dysrhytmia
Contra-Indications: Patients with severe renal impairment, heart block and toxemia of
pregnancy 2 hours preceding delivery.
Special Precautions: Avoid rapid IV administration, impaired renal function & patients
receiving IV/IM magnesium should be monitored for toxicity
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POTASSIUM ACETATE
Dosage Form: Injection 2 mEq/ml in 20ml vial (I* ICU)
Recommended Dose: Potassium acetate injection, USP, 40 mEq is administered
intravenously only after dilution in a large volume of fluid. The dose and rate of
administration are dependent upon the individual needs of the patient. ECG and serum
potassium should be monitored as a guide to dosage. Using aseptic technique, all or part of
the contents of one or more may be added to other intravenously fluid to provide any desire
number of milliequivalents (mEq) of potassium (K+) with an equal number of milliequivalents
of acetate (CH3COO-)
Maximum infusion rate: the infusion rate should not exceed 1 mEq/kg/hr.
Normal daily requirements:
Newborn :2-6 mEq/kg/24 hr
Children : 2-3 mEq/kg/24 hr
Adult : 40-80 mEq/24 hr
Intraosseous infusion can be an alternate route for drug administration when intravenous
access is not available.
Indications: As a source of potassium, for the addition to large volume intravenous fluids,
to prevent or correct hypokalemia in patients with restricted or no oral intake.
As an additive for preparing specific intravenous fluid formulas when the needs of the
patient cannot be met by standard electrolyte or nutrient solutions.
Contra-Indications: In patients with severe renal insufficiency or adrenal insufficiency and
in diseases where high potassium levels may be encountered.
Special Precautions: Do not administer unless solution is clear and seal is intact. Discard
unused portion. Potassium replacement therapy should be guided primarily by ECG
monitoring and secondarily by the serum potassium level. High plasma concentrations of
potassium may cause death by cardiac depression, arrhythmias or arrest.
Use with caution in the presence of cardiac disease or renal disease. Solutions containing
acetate ion should be used with caution as excess administration may result in metabolic
alkalosis.
Geriatric use: In general, dose selection for an elderly patient should be cautious, usually
starting at the low end of the dosing range, reflecting the greater frequency of decreased
hepatic, renal or cardiac function and of concomitant disease or other drug therapy.
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POTASSIUM CHLORIDE
Dosage Form: Injection 10% (1 gm/10 ml) amp (13.4 mmol) (II)
Recommended Dose: Serum potassium >2.5 mEq/L with minimal neuromuscular and
cardiac abnormalities (and renal function is not impaired): IV infusion pot. Chloride
concentrations <40 mEq/L at a rate of 10-15 mEq/Hr. (Doses<100 to 300 mEq/day)
Serum potassium <2 mEq/L with muscle paralysis, cardiac abnormalities: IV infusion pot.
chloride concentrations <60 mEq/L/liter at a rate of 40 mEq/Hr. (Doses<400 mEq/day).Child:
IV infusion, up to 3 mEq/kg/day
Indications: Electrolyte imbalance; potassium depletion, initial treatment for the correction
of severe hypokalaemia, and when sufficient potassium cannot be taken by mouth.
Cautions: Elderly, mild-moderate renal impairment, intestinal stricture, history of peptic
ulcer, Sickle cell disease
Contra-Indications: Severe renal impairment, plasma potassium concentrations above
5 mmol/litre
Notes: Dilute pot.chloride before infusion. Do not administer intravenously with glucose
solution for treatment of hypokalemia.
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POTASSIUM DIHYDROGEN PHOSPHATE
Dosage Form: Injection 10 ml (1 mmol Potassium + 0.6 mmol Phosphate) per ml (I)
Recommended Dose: DIABETIC KETOACIDOSIS AND ALCOHOL WITHDRAWAL
SYMPTOMS, Adult: 20 millimoles potassium phosphate, 20 mmol potassium chloride, and 4
milliliters of 50% magnesium sulfate in 0.45% saline, this solution being infused every 8
hours. Diabetic Ketoacidosis,Paed: Add approximately 20 mEq/L of intravenous fluids.
SEVERE HYPOPHOSPHATEMIA, Adult: 9 mmol (approximately 300mg phosphorus) in
half-normal saline as a continuous intravenous infusion during a 12-hour period, repeating
this dose at 12-hour intervals until serum phosphorus concentrations exceed 1
milligram/deciliter. Paed: 0.15 to 0.33 mmol/kg/dose intravenously over 6 hours, with repeat
doses as required to maintain serum phosphorus greater than 2 milligrams/deciliter.
Potassium or sodium phosphate should be diluted in intravenous fluids and infused at a rate
not greater than 0.2 mmol/kg/Hr. Total parenteral nutrition, Adult: 12-15 mmol/L to prevent
hypophosphatemia in patients receiving HYPERALIMENTATION. Paeds: 0.5-2
mmol/kg/day.
Indications: Calcium and phosphate metabolic disorders additive in TPN.
Contra-Indications: Renal failure, Hyperphosphatemia, Hypocalcemia, Hypokalemia,
Hypernatremia, Addison's disease, Congenital or acquired abnormalities of the intestine (for
sodium phosphate enema), Congestive heart failure, Unstable angina pectoris, Ascites,
Ileus or acute obstruction or pseudo-obstruction, Bowel perforation, Severe chronic
constipation, Acute colitis, Toxic megacolon, Hypomotility syndrome (such as
hypothyroidism, scleroderma) and Gastric retention
Special Precautions: Mild-to-moderate renal impairment, Cirrhosis, Other edematous
condition, Concomitant use of antacids containing aluminum or magnesium should be
avoided, Patients with kidney stones may pass old stones during phosphate therapy, Do not
administer laxatives when nausea, vomiting, or abdominal pain is present, Chronic
inflammatory bowel disease, Acute myocardial infarction or cardiac surgery within previous
3 months.
SODIUM CHLORIDE
Dosage Form: Injection 0.9% 10 ml, 20% 10 ml (II)
Recommended Dose: According to needs of patients.
Indications: Electrolyte imbalance, dehydration.
Special Precautions: Caution in patients with cardiac failure, impaired renal function,
hypertension. May cause oedema in large concentration.
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17.5. Electrolyte Solutions (large volumes)
DEXTROSE WITH SODIUM CHLORIDE
Dosage Form: Injection 4.23% + 0.18% (500 ml), 5% + 0.9% (500 ml), 5% + 0.45% (500
ml), 10% + 0.18% (500 ml), 10% + 0.45% (500 ml) (¥¥¥,I)
Recommended Dose: According to needs of patients.
Indications: For sodium and water depletion.
Contra-Indications: Hyperhydration, oedema, hypernatremia, hypertension, hypotonic
dehydration, acidotic situations and diabetes mellitus.
Special Precautions: Caution in patients with cardiac failure, impaired renal function,
hypertension. The compatibility of any additives to this solution should be checked before
use.
RINGER’S
Dosage Form: Solution 1000 ml. Each 100 mL contains: Sodium Chloride USP 0.86 g;
Potassium Chloride USP 0.03 g, Calcium Chloride Dihydrate USP 0.033 g; Water for
Injection USP qs. (I*- OT Cardiology)
Recommended Dose: The dose is dependent upon the capacity or surface area of the
structure to be irrigated and the nature of the procedure. When used as a vehicle for other
drugs, the manufacturer's recommendations should be followed.
Indications: For all general irrigation, washing and rinsing purposes which permit use of a
sterile, nonpyrogenic electrolyte solution.
Contra-Indications: Not for injection by usual parenteral routes. An electrolyte solution
should not be used for irrigation during electrosurgical procedures.
Special Precautions: Do not use for irrigation that may result in absorption into the blood.
Caution should be observed when the solution is used for continuous irrigation or allowed to
"dwell" inside body cavities because of possible absorption into the blood stream and the
production of circulatory overload.
Aseptic technique is essential with the use of sterile solutions for irrigation of body cavities,
wounds and urethral catheters or for wetting dressings that come in contact with body
tissues.
When used as a "pour" irrigation, no part of the contents should be allowed to contact the
surface below the outer protected thread area of the semi-rigid wide mouth container. When
used for irrigation via irrigation equipment, the administration set should be attached
promptly. Unused portions should be discarded and a fresh container of appropriate size
used for the start-up of each cycle or repeat procedure. For repeated irrigations of urethral
catheters, a separate container should be used for each patient.
Use only if solution is clear and container and seal are intact. Discard unused portion.
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SODIUM CHLORIDE
Dosage Form: Injection 0.45% (500 ml), 0.9% (100 ml, 250 ml, 500 ml), 3% (500 ml) (II)
Recommended Dose: According to needs of patients. Adult, average daily requirements: 1
liter of 0.9% sodium chloride (154 mEq Na and 154 mEq Cl). To calculate sodium deficit:
(140 mEq/L - patient's serum Na) x (total body water in liters) = mEq Na.
Hypertonic (3% or 5%) solutions for replacement: administer half of dose over 8 hours, <100
ml/Hr. Continue treatment until serum sodium is 130 mEq/L or neurologic symptoms
improve.
Indications: Electrolyte imbalance, dehydration/hyponatremia. nasal sinus irrigation,
induction of emesis, cutaneous leishmaniasis, flushing cannula, hypovolemic shock,
Induction of emesis, wound care. 3 Hypochloremic alkalosis
Contra-Indications: Hypertension, hypernatremia, hyperchloremic acidosis, hypokalemia
Special Precautions: Young child, elderly, restrict intake in impaired renal function, cardiac
failure, hypertension, peripheral and pulmonary oedema, toxaemia of pregnancy
SODIUM LACTATE COMPOUND [HARTMAN'S @ RINGER-LACTATE]
Dosage Form: Injection 500 ml (II)
Recommended Dose: According to needs of patients: acidosis severity, laboratory values,
patient's age, weight, and clinical condition. IV infusion rate: <300 mL/Hr of the 1/6 molar
injection.. Dose in milliliters of 1/6 molar solution = (60 - plasma CO2) X (O.8 X body weight
in pounds).
Indications: Diabetic coma, diminished alkali reserve, metabolic acidosis, initial
management of the injured or wound.
Contra-Indications: In patients with severe liver damage. Lactic acidosis, Severe acidosis
requiring immediate repletion of plasma bicarbonate, Hypernatremia, Conditions where
sodium administration would be detrimental.
Special Precautions: Metabolic or respiratory alkalosis, Congestive heart failure, Other
sodium-retaining conditions, Concurrent corticosteroids, Conditions impairing lactate
utilization (severe hepatic insufficiency, shock, beriberi, hypoxia). Monitor fluid balance,
electrolytes, acid-base balance during prolonged therapy
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17.6. Plasma Expanding Agents
ALBUMIN
Dosage Form: Injection 20% (50 ml vial), 25% (50 ml vial) (II)
Recommended Dose: Burn :Adult- IV, use 25% solution to achieve plasma albumin level of
approximately 2.5 g/100 mL (total plasma protein concentration of 5.2 g/100 mL).
Hypovolemic shock: Adult- IV, 100-200 mL of 25% solution, may repeat in 15-30 min. PaedIV, 2.5-5 mL of 25% solution, may repeat in 15-30 min. Hemolytic disease of fetus OR
newborn due to isoimmunization: Paed- IV, 1 g/kg of 25% solution prior to or during
exchange transfusion
Indications: Concentrated solutions (20–25%): severe hypoalbuminaemia associated with
low plasma volume and generalised oedema where salt and water restriction with plasma
volume expansion are required; adjunct in the treatment of hyperbilirubinaemia by exchange
transfusion in the newborn; paracentesis of large volume ascites associated with portal
hypertension.
Contra-Indications: In patients with severe anaemia or cardiac failure, hypersensitivity to
albumin.
Special Precautions: Caution in patients with history of cardiac or circulatory disease
(administer slowly to avoid rapid rise in blood pressure and cardiac failure, and monitor
cardiovascular and respiratory function); increased capillary permeability; correct
dehydration when administering concentrated solution
DEXTRAN 40 IN SODIUM CHLORIDE
Dosage Form: Injection (+ 0.9%) 500 ml (II)
Recommended Dose: IV infusion; Initially 500-1000ml rapidly, (total dosage <20 mL/kg
during initial 24 hours), followed by 500 ml later if necessary, but slow continuous therapy
should not exceed 5 days.;Children : total dosage <20 ml/kg.
Indications: Dextran 40: Conditions associated with peripheral local slowing of the blood
flow, prophylaxis of post-surgical thromboembolic disease.
Contra-Indications: Patients with thrombocytopenia, pulmonary edema, severe congestive
heart failure and renal failure, severe bleeding disorders, Hypersensitive to Dextran or corn
product
Special Precautions: Patients with cardiac disease,liver disease, or renal impairment, care
should be taken to avoid haematocrit concentration from falling below 25-30% and the
patient should be monitored for hypersensitivity reactions; pregnancy
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FILGRASTIM (GRANULOCYTE - COLONY STIMULATING FACTOR)
Dosage Form: Injection 300 mg (30 mu/ml) (I*)
Criteria of use: 1. Standard for chemotheraphy patient only
Recommended Dose: Cytotoxic-induced neutropenia, S.C injection or IV infusion (over 30
minutes), adult and child: 500 000 units/kg daily started not less than 24 hours after
cytotoxic chemotherapy, continued until neutrophil count in normal range, usually for up to
14 days (up to 38 days in acute myeloid leukaemia)
Myeloablative therapy followed by bone-marrow transplantation, by IV infusion over 30
minutes or over 24 hours or S.C infusion over 24 hours, 1 million units/kg daily, started not
less than 24 hours following cytotoxic chemotherapy (and within 24 hours of bone-marrow
infusion), then adjusted according to absolute neutrophil count (consult product literature)
Mobilisation of peripheral blood progenitor cells for autologous infusion, used alone, by S.C
injection or S.C infusion over 24 hours, 1 million units/kg daily for 5-7 days; used following
adjunctive myelosuppressive chemotherapy (to improve yield), by S.C injection,
500 000 units/kg daily, started the day after completion of chemotherapy and continued until
neutrophil count in normal range; for timing of leucopheresis consult product literature
Mobilisation of peripheral blood progenitor cells in normal donors for allogeneic infusion, by
S.C injection, adult16-60 years: 1 million units/kg daily for 4–5 days; for timing of
leucopheresis consult product literature
Severe chronic neutropenia, by S.C injection, adult and child: initially 1.2 million units/kg
daily in single or divided doses (initially 500 000 units/kg daily in idiopathic or cyclic
neutropenia), adjusted according to response (consult product literature)
Indication: Reduction in duration of neutropenia in myeloablative therapy followed by bonemarrow transplantation; mobilisation of peripheral blood progenitor cells for harvesting and
subsequent autologous or allogeneic infusion; severe congenital neutropenia, cyclic
neutropenia, or idiopathic neutropenia and history of severe or recurrent infections
persistent neutropenia in advanced HIV infection
Contra Indications: severe congenital neutropenia (Kostman's syndrome) with abnormal
cytogenetics
Special Precautions: Reduced myeloid precursors; regular morphological and cytogenetic
bone-marrow examinations recommended in severe congenital neutropenia (possible risk of
myelodysplastic syndromes or leukaemia); secondary acute myeloid leukaemia, sickle-cell
disease; monitor spleen size (risk of rupture); osteoporotic bone disease (monitor bone
density if given for more than 6 months)
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HAEMACCEL (MODIFIED POLYPEPTIDES – POLYGELINE)
Dosage Form: Injection 3.5% (II)
Recommended Dose: The usual dose is 500 to 1000 milliliters (mL), with total dosage not
to exceed 2500 mL daily (or approximately 20 mL/kg/day). Patients losing volumes of blood
greater 1500 mL will require blood transfusion other than polygeline and crystalloid
solutions.
Indications: Volume expander
Contra-Indications: Hypersensitivity to polygeline, Asthma, Histamine release
predisposition, Hemostatic defects, Cardiac failure, Hypercalcemia
Special Precautions: Patients with impaired renal function, patients at risk of developing
pulmonary edema and/or congestive heart failure
PENTASTARCH (HYDROXYETHYL STARCH)
Dosage Form: Injection 6% (130/0.42) (I)
Intravenous infusion, pentastarch (weight average molecular weight 130 000) 6% in sodium
chloride intravenous infusion 0.9% (500 ml bag)
Recommended Dose: IV infusion, up to 50 mL/kg daily.
Indications: Hemorrhagic shock, acute, Transfusion of blood expander
Contraindications: Hypersensitivity to pentastarch, severe bleeding disorders, severe
CHF, severe renal failure
Special Precautions: Plasma substitutes should be used with caution in patients with
cardiac disease, liver disease, or renal impairment; urine output should be monitored. Care
should be taken to avoid hematocrit concentration from falling below 25-30% and the patient
should be monitored for hypersensitivity reactions.
PLASMANATE
Dosage Form: Injection 250 ml (I)
Recommended Dose: Adult (usual), Hypovolemia: 12.5-25 g (250-500 mL) IV, repeat as
needed
Indications: Hypovolemia
Contra-Indications: cardiopulmonary bypass, congestive heart failure, hypersensitivity to
albumin, hypoproteinemia associated with chronic nephrosis, chronic cirrhosis,
malabsorption, protein-losing enteropathies, pancreatic insufficiency, and undernutrition,
increased or normal intravascular volume, renal insufficiency, severe anemia
Special Precautions: hepatic dysfunction, plasma protein fraction is made from human
plasma and products made from human plasma may contain infectious agents (hepatitis C)
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POLYMERISATE OF DEGRADED GELATIN + ELECTROLYTES (GELAFUNDIN @
GELAFUSIN)
Dosage Form: Injection 500 ml (I)
Recommended Dose: IV Infusion, initially 500–1000 mL of a 3.5–4% solution.
Indications: low blood volume
Contra-Indications: Hypersensitivity to gelatin.
Special Precautions: cardiac disease, liver disease, or renal impairment; urine output
should be monitored. Monitored hypersensitivity reactions and hematocrit level from falling
below 25–30%.
17.7. Electrolytes and Trace Element Solutions
ADDAMEL-N (TRACE ELEMENTS AND ELECTROLYTES (ADULTS) SOLUTIONS)
Dosage Form: Injection 10 ml (vials (Polypropylene plastic) (I)
Recommended Dose: Must not be given undiluted. Adult 1 amp added to 500 mL or 1000
mL of compatible soln & infused over 2-3 hr.
Indications: Used as part of a complete IV nutrition of adults providing a source of trace
elements.
Contra-Indications: Impaired renal function, fructose intolerance, total biliary obstruction.
Special Precautions: Liver or renal impairment. Monitor manganese levels regularly in
biliary disorders.
PEDITRACE (TRACE ELEMENTS AND ELECTROLYTES (PAEDIATRICS) SOLUTION)
Dosage Form: Injection 10 ml vials (Polypropylene plastic) (I)
Recommended Dose: Must not be given undiluted, added to either an amino acid solution
or glucose solution and given during a minimum infusion period of 8 hours. Infants& Child: 1
mL/kg/day to a maximum dose of 15 mL. Child >15kg: 15 mL/day.
Indications: Additive solution for paediatric (infants& chidren) patients on total parenteral
nutrition.
Contra-Indications: Wilson’s Disease.
Special Precautions: Used with caution when the excretion in bile is reduced, particularly
in cholestatic liver disease, or when the urinary excretion is markedly reduced. Control the
manganese level if the treatment is continued for more than 4 weeks.
17.8. Water for Injections
WATER FOR INJECTIONS
Dosage Form: Injection 10 ml, 500 ml (II)
Recommended Dose: For dilution or reconstitution of drugs, etc.
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17.9. Miscellaneous
INTRAPERITONEAL DIALYSIS SOLUTION + DEXTROSE
Dosage Form: Intraperitoneal Dialysis Solution + 1.5% Dextrose (2 litre), 4.25% Dextrose
(2 litre) (II)
Recommended Dose: Depending on individual.
Indications: For peritoneal dialysis.
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18. DETOXIFYING AGENTS AND ANTIDOTES
ACETYLCYSTEINE
Dosage Form: Injection 200 mg/ml (10 ml ampoule), 200 mg/ml (25 ml ampoule); Tablet
600 mg (I)
Recommended Dose: By intravenous infusion, adult and child, initially 150 mg/kg over 15
minutes, then 50 mg/kg over 4 hours then 100 mg/kg over 16 hours
Indications: For Paracetamol overdosage
Special Precautions: Asthma
ATROPINE SULPHATE
Dosage Form: Injection 1 mg/ml (1 ml amp) (II)
Recommended Dose: By IV Injection: 2-4mg followed by 2mg every 5-10 min.
Indications: Treatment of poisoning due to irreversible anticholinesterases.
Contra-Indications: In patients with prostatic enlargement (urinary retention), paralytic ileus
or pyloric stenosis, closed-angle glaucoma, myasthenia gravis
Special Precautions: Pregnancy, patients over 40 years old, fever, children.
BENTONITE
Dosage Form: Paste [P] (II)
Recommended Dose: Applied to the skin at least 15 minutes prior to potential contact with
poison ivy, oak or sumac. Reapplication every 4 hours is suggested for continous protection.
Indications: Reduced od prevented contact dermatitis induced by experimental challenge
with urushiol, the allergen in poison oak, ivy and sumac.
Contra-Indications: Hypersensitivity to bentoquatam
Special Precautions: Avoid contact with the eyes, For external use only, History of allergictype responses to medications, especially topical formulations, Open wounds, psoriatic
lesions, or other cutaneous conditions, Post-exposure to poison oak, ivy, or sumac (lack of
efficacy)
CALCIUM POLYSTYRENE SULFONATE (KALIMATE)
Dosage Form: Powder (II)
Recommended Dose: Adult 15-30 g PO daily in 2-3 divided doses. Suspend each dose in
30-50 mL water.
Indications: hyperkalaemia associated with anuria or severe oliguria, and in dialysis
patients
Contra-Indications: obstructive bowel disease; oral administration or reduced gut motility in
neonates; avoid calcium-containing resin in hyperparathyroidism, multiple myeloma,
sarcoidosis, or metastatic carcinoma
Special Precautions: children (impaction of resin with excessive dosage or inadequate
dilution); monitor for electrolyte disturbances (stop if plasma-potassium concentration below
5 mmol/litre); pregnancy and breast-feeding; sodium-containing resin in congestive heart
failure, hypertension, renal impairment, and oedema
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CHARCOAL ACTIVATED
Dosage Form: Tablet 250 mg (II)
Recommended Dose: 1-2 tabs several times daily. In cases of poisoning: 5-10g initially as
suspension in 100 ml water, followed by further 5-10g 20 min later. Repeat at interval of 1520 min until max of 50-100 gm has been given.
Indications: Adsorption of potent poisons, and antidote for most of oral poisoning and drug
such as salicylates, paracetamols, barbiturates and tricyclic antidepressants.
Special Precautions: Not useful in poisoning by strong acids or alkalis, iron salts, cyanide,
mineral acids or organic solvents.
DEFERASIROX
Dosage Form: Tablet 125 mg, 250 mg, 500 mg (dispersible) (I*)
Criteria of use:
1. Use according to Flow Chart of Thalassaemia Patient with Iron Overload
2. Restricted for Dr. Norsarwany and Dr. Ariffin Nasir
3. A total of ten patients per year (at any one time)
Recommended Dose: Initial dose: 20 mg/kg orally once daily. Patients receiving >14
mL/kg/mth of packed RBC (>4 u/mth), and for reduction of Fe overload 30 mg/kg. Patients
receiving <7 mL/kg/mth of packed RBC (<2 u/mth), and for maintenance of Fe level 10
mg/kg. Maintenance dose: Adjust in increments of 5 or 10mg/kg every 3-6 months based on
serum ferritin trends. Interrupt Exjade if serum ferritin falls consistently below 500 mcg/L.
Max dose: 30 mg/kg/day
Renal impairment: For increases of serum creatinine of more than 33% in adults or greater
than the age-appropriate upper limit of normal on two consecutive visits, reduce the daily
dose by 10 mg/kg
Indications: Chronic iron overload in adults and children over 6 years with thalassaemia
major who receive frequent blood transfusions (more than 7 ml/kg/month packed red blood
cells). Also for chronic iron overload when desferrioxamine is contra-indicated or inadequate
in patients with thalassaemia major who receive infrequent blood transfusions (less than 7
ml/kg/month packed red blood cells, in patients with other anaemias, and in children aged 2
to 5 years.
Contra-Indications: Hypersensitivity to deferasirox or any of the excipients of the tablet.
Special Precautions: Eye and ear examinations required before treatment and annually
during treatment, monitor body weight, height, and sexual development in children at 12
months intervals, test liver function monthly, hepatic impairment; measure baseline serum
creatinine and monitor renal function weekly during the first month of treatment and monthly
thereafter; test for proteinuria monthly; renal impairment.
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DESFERRIOXAMINE MESYLATE
Dosage Form: Injection 500 mg/vial (I)
Recommended Dose: In haemochromatosis: By IM injection 0.5-1g daily. Acute iron
poisoning: By IV infusion up to 15 mg/kg/hr, with max of 80 mg/kg in 24 hrs, if necessary
repeat IM inj of 2g every 12 hrs. Diagnostic: By IM injection 0.5-1g
Indications: Therapeutic: Primary haemochromatosis and acute iron poisoning. Diagnostic:
Diagnosis of pathological iron overload.
Contra-Indications: In severe renal disease or anuria, first trimester of pregnancy.
Special Precautions: IM administration should be by deep intragluteal injection. IV
administration should not be rapid. Should be used with caution in impaired renal function.
D-PENICILLAMINE
Dosage Form: Capsule 250 mg (I)
Recommended Dose: For poisoning: 0.5-2g daily. Child: 20 mg/kg daily in divided doses.
Wilson's disease: 0.5-2 gm daily in divided doses before meals.
Indications: Poisoning particularly by copper, lead and mercury. Elimination of copper in
Wilson's disease.
Contra-Indications: In patients receiving gold therapy or antimalarial drugs. Patients with
lupus erythematous or a history of penicillamine-induced agranulocytosis, aplastic anemia
or severe thrombocytopenia.
Special Precautions: In patients with renal or hepatic impairments.
FLUMAZENIL
Dosage Form: Injection 0.5 mg/5ml (ampoule) (II)
Recommended Dose: Slow IV inj: 200 mcg over 15 sec., then 100 mcg at 60 sec. intervals
if required, up to total dose of 1 mg. Usual dose: 300-600 mcg. Max: 2 mg in ICU. IV
infusion: if drowsiness recurs after injection, 100-400 mcg/h adjusted according to level of
arousal.
Indications: Reversal of sedative effects of benzodiazepines in anaesthetic, intensive care
and diagnostic procedures.
Contra-Indications: Epileptics who received prolonged benzodiazepine therapy.
Special Precautions: Hepatic impairment, benzodiazepine dependence. Ensure
neuromuscular blockade cleared before giving. Avoid rapid inj. in high risk or anxious
patients and following major surgery.
FULLER’S EARTH
Dosage Form: Suspension 30% (II)
Recommended Dose: 300 ml of 30% Fuller’s Earth suspension every 2-4 hrs for several
days.
Indications: Treatment of paraquat poisoning
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METHYLENE BLUE
Dosage Form: Injection 1% (I)
Recommended Dose: 0.1 to 0.2 mL per kilogram of body weight (0.045 to 0.09 mL per
pound of body weight). Inject Methylene Blue intravenously very slowly over a period of
several minutes.
Indications: Drug-induced methemoglobinemia, antidote for cyanide poisoning.
Contraindications: Intraspinal injection is contraindicated.
Special Precautions: Methylene Blue must be injected intravenously very slowly over a
period of several minutes to prevent local high concentration of the compound from
producing additional methemoglobin. Do not exceed recommended dosage.
NALOXONE HCL
Dosage Form: Injection 20 mcg/ml, 400 mcg/ml (I)
Recommended Dose: By IV/IM/SC injection: 400-2000 mcg repeated at intervals of 2-3
min according to patient's needs. Newborn: 10 mcg/kg body weight repeated at intervals of
2-3 min according to patient's needs.
Indications: Treatment of known or suspected narcotic overdose.
Contra-Indications: Patients hypersensitive to it.
Special Precautions: Pregnancy, narcotic dependence, cardiac irritability.
PRALIDOXIME CHLORIDE
Dosage Form: Injection 1 gm/20 ml (II)
Recommended Dose: IV inj: Adult for accidental intoxication; 1-2g injected in 15-30 min, to
be repeated after an hour if muscle weakness persists. Cholinergic crisis due to
echothiophate; initially 50 mg and increase dose every 5 min until remission occurs.
Cholinergic crisis due to neostigmine, pyridostigmine; initially 1-2g followed by 250 mg every
5 min until remission occurs. Child: 20-40 mg/kg given in 5 min. IV infusion: 1-2 g in 100 ml
sodium chloride over period of 15-30 min. Repeat in 1-2 hours if necessary. Child: 20-40
mg/kg in 100 ml.
Indications: Cholinesterase reactivator in treatment of poisoning by organophosphorus
compounds. In neostigmine and physostigmine poisoning, it is only slightly effective and of
questionable values.
Contra-Indications: Poisoning by carbamate poisoning.
Special Precautions: Impaired renal function, myasthenia gravis. When injected more
rapidly than recommended rate, dizziness, nausea, headache, mild weakness, blurred
vision, diplopia or tachycardia may result.
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PROTAMINE SULPHATE
Dosage Form: Injection 1% (50 mg/5ml) (II)
Recommended Dose: By slow injection: 1 mg neutralises 100 units of heparin when given
within 15 min. If a longer time has elapsed, less protamine is required as heparin is rapidly
excreted. Max. dose: 50 mg.
Indications: Neutralisation of the anticoagulant effect of heparin.
Contra-Indications: Not suitable for reversing the effect of oral anticoagulants.
Special Precautions: Overdose of protamine sulphate has an anticoagulant effect. Rapid
IV inj. may cause hypotension, bradycardia, dyspnea, transient flushing and a feeling of
warmth.
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