Download Untitled - Kementerian Kesihatan Malaysia

7. Pengarah
Hospital Universiti Kebangsaan Malaysia
Bandar Tun Razak
Kuala Lumpur
(u.p Ketua Pegawai Farmasi)
8. Pengarah
Hospital Universiti Sains Malaysia
Kubang Kerian
Kelantan
(u.p Ketua Pegawai Farmasi)
9. Pengarah Farmasi
Bahagian Perkhidmatan Kesihatan
Kementerian Pertahanan Malaysia
Jalan Padang Tembak
50634 Kuala Lumpur
10. Pegawai Farmasi
Bahagian Pembangunan Kesihatan Keluarga
Aras 5, Blok E6, Parcel E
Presint 1, Pusat Pentadbiran Kerajaan Persekutuan
62509 Putrajaya
11. Pengarah
Pusat Darah Negara
Jalan Tun Razak
50400 Kuala Lumpur
(u.p Pegawai Farmasi)
12. Unit Teknikal Bantuan Perubatan
Pejabat Timbalan Ketua Pengarah Kesihatan (Perubatan)
Aras 7, Blok E1, Parcel E
Presint 1, Pusat Pentadbiran Kerajaan Persekutuan
62509 Putrajaya
13. Pegawai Farmasi
Bahagian Kesihatan dan Perubatan
jabatan Hal Ehwal Orang Asli
KM.24, Jalan Pahang
53100 Gombak, Selangor
14. Penolong Pegawai Perpustakaan
Aras 4, Blok E7, Parcel E
Presint 1, Pusat Pentadbiran Kerajaan Persekutuan
62509 Putrajaya
15. Penolong Pegawai Perpustakaan
Institut Pengurusan Kesihatan
Kementerian Kesihatan Malaysia
Jalan BangsarKuala Lumpur
16. Semua Ketua Unit
Bahagian Perkhidmatan Farmasi
anis/azuwana/masitah
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PINDAAN BIL. 1 TAHUN 2011 KEPADA FORMULARI UBAT KKM
LAMPIRAN 1
1.
UBAT-UBAT YANG DIMANSUHKAN DARI FORMULARI UBAT KKM
No
MDC
Generic Name
Trade Name,
Category,
Dosage
Remarks
1
B01AB06390P5001XX
Nadroparin Calcium
0.2ml Injection
As in the MOH
formulary
Manufacturer has discontinued the
production of all strengths of
Nadroparin Calcium Injection
2
B01AB06390P5002XX
Nadroparin Calcium
0.3ml Injection
3
B01AB06390P5003XX
Nadroparin Calcium
0.4ml Injection
4
B01AB06390P5004XX
Nadroparin Calcium
0.6ml Injection
5
N05AH04138T1002XX
Quetiapine Fumarate
100mg Tablet
As in the MOH
formulary
6
N05AH04138T1004XX
Quetiapine Fumarate
200mg Tablet
All the strengths of the extendedrelease formulation are now
available in the MOH Drug
Formulary and thus will improve
patient’s compliance and reduce
the treatment cost.
However, quetiapine fumarate
100mg tablet can be purchased
until tender expires (23rd October
2011) and both quetiapine fumarate
100mg and 200mg tablets can be
used until stock finished.
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
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LAMPIRAN 2
2. UBAT–UBAT BARU YANG DILULUSKAN MASUK KE DALAM FORMULARI UBAT KKM
No
MDC
1
C02KX010
00T1001XX
Generic Name
Brand name
Price quoted
Bosentan 125 mg tablet
(Tracleer®)
Cost
RM 9,262.50/60’s
Prescriber
Category
A*
Details
Indication
For the treatment of pulmonary arterial
hypertension (PAH) in patients with WHO Class
III or IV symptoms, to improve exercise ability
and decrease the rate of clinical worsening (To
be used by those who are trained and
specialized in treating and managing PAH)
Dose:
Initially 62.5 mg bd for 4 weeks, then increase to
the maintenance dose of 125 mg bd
Precaution
Monitor liver function before starting therapy &
periodically thereafter. Discontinue use if liver
aminotransferase elevations accompanied by
clinical symptoms of liver injury occur. Monitor
Hb levels after 1 and 3 months of treatment and
3 months thereafter. Perform urine or serum
pregnancy tests monthly in women of
childbearing potential
Contraindication
Pregnancy & breastfeeding, co-administration
with cyclosporine A or glyburide or
hypersensitivity to bosentan
Interaction
Hormonal contraceptives (decreases the
efficacy of hormonal contraceptive agents),
cyclosporine A (increases plasma
concentrations of bosentan thus increase
chance of bosentan side effects),glyburide
(increase risk of liver enzyme elevations, also
decrease plasma concentration of glyburide and
other oral hypoglycemic agents), ketoconazole,
itraconazole, fluconazole (increase plasma
concentration of bosentan), statins (decrease
plasma concentrations of statins), warfarin
(decreases plasma concentration of warfarin),
sildenafil (reduction in sildenafil plasma
concentration), tacrolimus (increases plasma
concentration of bosentan), rifampicin (increases
bosentan trough levels), lopinavir/ ritonavir or
other ritonavir-containing HIV regimens
(increase plasma concentration of bosentan)
Adverse effect
Potential liver injury, haematologic changes
(decrease in hemoglobin concentration), fluid
retention, pulmonary veno-occlusive disease
(PVOD), headache, dizziness, gastrointestinal
disturbances, dry mouth, rectal haemorrhage,
nasopharyngitis, flushing, edema, hypotension,
palpitations, dyspepsia, fatigue, pruritus
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
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No
MDC
2
B02BD020
00P4001
XX
Generic Name
Brand name
Price quoted
Factor VIII (Recombinant)
Octocog Alfa 250 IU
Injection
Prescriber
Category
A*
(Advate®)
Cost
250 IU: RM 590/250 IU
3
B02BD020
00P4002
XX
Factor VIII (Recombinant)
Octocog Alfa 500 IU
Injection
A*
(Advate®)
Cost
500 IU: RM 1,180/500 IU
Details
Indication
Treatment and prophylaxis of bleeding in
patients with hemophilia A (Congenital Factor
VIII deficiency). It does not contain von
Willebrand factor and is not indicated in von
Willebrand’s disease.
Dose:
The usual dose for prophylaxis is between 20 to
40 IU per kg of body weight, administered at
intervals of 2 to 3 days. For treatment of bleeds,
the dose injected is individualized by the doctor
and is given every 8, 12 or 24 hours for at least
one day, until the bleeding episode, as indicated
by pain, is resolved or healing is achieved. In
patients under the age of 6, doses of 20 to 50 IU
of Factor VIII per kg body weight 3 to 4 times
weekly are recommended.
Precaution
Monitor patients for development of antibodies
to factor VIII. Pregnancy & lactation. Early signs
of allergic reactions such as rash, hives, wheals,
generalised itching, swelling of lips and tongue,
difficulty in breathing, wheezing, tightness in the
chest, general feeling of being unwell, and
dizziness (These symptoms can constitute an
early symptom of an anaphylactic shock,
manifestations of which may additionally include
extreme dizziness, loss of consciousness, and
extreme difficulty in breathing)
Contraindication
Hypersensitivity to mouse or hamster protein
Interaction
No interactions with other medicinal products
are known
Adverse effect
Dizziness, fever, headache, itching, increased
sweating, unusual taste in the mouth, hot
flushes, migraines, memory impairment, chills,
diarrhoea, nausea, vomiting, shortness of
breath, laryngitis, infection of the lymphatic
vessels, whitening of skin, eye inflammation,
rashes, excessive sweating, foot and leg
swelling, increase in enzymes that track liver
function, decrease in haematocrit and pain in the
upper abdomen or lower chest. During surgery:
catheter-related infection, decreased red cell
blood count, swelling of limbs and joints,
prolonged bleeding after drain removal,
decreased Factor VIII level and post-operative
haematoma.
4
B03AE109
03T1001XX
Ferrous Controlled Release
500 mg, Vitamin B1, B2,
B6, B12, Vitamin C 500 mg,
Niacinamide, Calcium
A
Indication
Anaemia due to iron deficiency, megaloblastic
anaemia when there is an associated deficiency
of vitamin C and vitamin B-complex particularly
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
3/17
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No
MDC
Generic Name
Brand name
Price quoted
Panthothenate and Folic
Acid 800 mcg Tablet
Prescriber
Category
Details
in pregnancy
Dose:
One tablet daily
(Iberet-Folic-500®)
Precaution
Folic acid alone is improper therapy in the
treatment of pernicious anemia and other
megaloblastic anemia where vitamin B12 is
deficient. There is the possibility of dark feces.
Not suitable to patients who received repeated
blood transfusion or non-iron deficiency anemia.
Long-term usage may cause iron accumulation.
Use in the elderly: Elderly people who have
tendency of vitamin B12 deficiency must have
regular monitoring of vitamin B12 serum
concentration while taking this drug.
Cost
RM 0.635/tablet
Contraindication
Patients with hypersensitivity to any of the
ingredients of this drug, patients with
thalassemia, sideroblastic anemia,
hemochromatosis, and hemosiderosis. Should
not be used in paediatric patients and also
contraindicated in the rare instance of
hypersensitivity to folic acid
Interaction
Magnesium trisilicate and antacid which
contains carbonate will inhibit the absorption of
iron. Ferrous sulfate affects tetracycline
absorption. Levodopa may produce reversed
effect due to pyridoxine. Administration with milk
or egg may inhibit the absorption of iron.
Adverse effect
Rare, occasionally with nausea, vomiting,
constipation or diarrhea, gastric pain at high
doses
5
L04AX0400
0C1001XX
Lenalidomide 5 mg
Capsule
A*
(Revlimid®)
Dose:
Recommended starting dose: 25 mg once daily
on days 1 to 21 of repeated 28 day cycle with
dexamethasone 40 mg once daily on days 1 to
4, 9 to 12 and 17 to 20 of each 28 day cycle for
the first 4 cycles of therapy, thereafter
dexamethasone 40 mg once daily on day 1 to 4
every 28 day cycle
Cost
Revlimid Assistance
Program (RAP): 2 + 4 + 7
(2 cycles FOC + 4 cycles
pay + 7 cycles FOC)
RM 20,071/21’s
6
L04AX0400
0C1002XX
Lenalidomide 10 mg
Capsule
(Revlimid®)
Cost
Indication
In combination with dexamethesone is indicated
for the treatment of multiple myeloma patients
who have received at least one prior therapy
A*
Precaution
Perform complete blood cell count including
WBC, platelet count, Hb & haematorcrit weekly
for the first 8 week of treatment & monthly
thereafter. Renal impairment. Monitor for
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
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No
MDC
Generic Name
Brand name
Price quoted
Revlimid Assistance
Program (RAP): 2 + 4 + 7
(2 cycles FOC + 4 cycles
pay + 7 cycles FOC)
Prescriber
Category
thromboembolism, signs of bleeding (petechiae
& epistaxes), thyroid function, risk of tumour
lysis syndrome. Lactose intolerance. May impair
ability to drive or operate machinery.
RM 21,004.00/21’s
7
L04AX0400
0C1003XX
Lenalidomide 15 mg
Capsule
A*
(Revlimid®)
Cost
Revlimid Assistance
Program (RAP): 2 + 4 + 7
(2 cycles FOC + 4 cycles
pay + 7 cycles FOC)
L04AX0400
0C1004XX
Lenalidomide 25 mg
Capsule
A*
Adverse effect
Neutropenia, thrombocytopenia, anaemia,
gastrointestinal disturbances, rash, muscle
cramp, muscle weakness, fatigue, asthenia,
peripheral oedema, insomnia; atrial fibrillation,
palpitations, cerebrovascular accident, syncope,
neuropathy, dizziness, ageusia, dysgeusia,
paraesthesia, headache, tremor, hypoaesthesia,
somnolence, memory impairment, eye
disorders, vertigo, respiratory, thoracic &
mediastinal disorders, renal failure, cushingoidlike symptoms, metabolism & nutrition disorders,
infections, vascular disorders, erectile
dysfunction, gynaecomastia, metrorrhagia,
nipple pain.
(Revlimid®)
Cost
Revlimid Assistance
Program (RAP): 2 + 4 + 7
(2 cycles FOC + 4 cycles
pay + 7 cycles FOC)
RM 24,307.00/21’s
9
N01BB029
84A4101X
X
Lignocaine HCl 5% and
Phenylephrine HCl 0.5%
Nasal Spray
(Co-Phenylcaine Forte
Spray®)
Cost
RM 198/50 ml
Flexishort nozzle: RM
350/50’s
Contraindication
Because lenalidomide is similar in structure to
thalidomide, a known human teratogen,
lenalidomide is contraindicated in pregnant
women and in women capable of becoming
pregnant. When there is no alternative,
females of childbearing potential may be treated
with lenalidomide, provided that adequate
precautions
Interaction
Erythropoietic agents, other agents associated
with increased risk of thrombosis (eg. Hormone
replacement therapy), oral contraceptive,
warfarin, digoxin
RM 23,383.00/21’s
8
Details
A*
Indication
Preparation of nasal mucosa for surgery (eg.
Cautery to Little’s area), aid the treatment of
acute nose bleeds and removal of foreign bodies
from the nose, topical anaesthesia of the
pharynx prior to direct or indirect laryngoscopy,
topical anaesthesia and local vasoconstriction
prior to endoscopy of the upper airways
Dose:
Adults and children over 12 years : 5 squirts per
nostril. Children: 8 to 12 years 3 squirts per
nostril, 4 to 8 years 2 squirts per nostril,
2 to 4 years 1 squirt per nostril. Doses are to be
administered once only.
Precaution
Elderly and debilitated: should reduce dose.
Eating and drinking: Food /drink should not be
ingested within 2 hours of local anaesthetic use.
Patients with cardiovascular disease,
hypertension, severe bradycardia, conduction
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
5/17
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No
MDC
Generic Name
Brand name
Price quoted
Prescriber
Category
Details
disturbances or severe digitalis intoxication.
Patients with impaired kidney or liver function.
Asthmatic patients: contains sodium
metabisulfite. Genetic predisposition to
malignant hyperthermia and pre-existing
abnormal neurological conditions. Should not be
used in pregnancy. May be used as directed in
breastfeeding mothers.
Contraindication
Known hypersensitivity to either of the active
ingredients or any of the non active ingredients,
hypersensitivity to other local anaesthetics of the
amide type and to other sympathomimetic
agents, pregnancy, children less than 2 years
old
Interaction
Propranolol or cimetidine may reduce the
clearance of lignocaine. Antiarrhythmic
drugs:lignocaine can have additive effects or
antagonistic effects. Suxamethonium: lignocaine
prolongs the action of suxamethonium.
Phenytoin: lignocaine and phenytoin have
additive cardiac depressant effects.
Antidepressants: may interact with
phenylephrine
Adverse effect
Phenylepherine may rarely cause tremor or
palpitations. Rarely nervousness, nausea,
vomiting, tinnitus, dizziness, numbness or
disorientation may occur following rapid
absorption of lignocaine. The most commonly
noted side effect is a transient bitter taste in the
mouth lasting 1-2 minutes.
10
L01BC0800
0P3001XX
Decitabine 50 mg Injection
(Dacogen®)
Cost
RM 3,325/vial of 500 mg
A*
Indication
Myelodysplastic syndromes (MDS) including:
Previously treated and untreated de novo and
secondary MDS of all French-American-British
subtypes (refractory anemia, refractory anemia
with ringed sideroblasts, refractory anemia with
excess blasts, refractory anemia with excess
blasts in transformation, and chronic
myelomonocytic leukemia) and Intermediate-1,
Intermediate-2, and High-Risk International
Prognostic Scoring System (IPSS) groups
Dose:
2
15 mg/m by continuous IV infusion over 3 hours
repeated every 8 hours for 3 days. Repeat this
treatment cycle every 6 weeks for a minimum of
4 cycles. However, complete or partial response
may take longer than 4 cycles. Treatment may
be continued as long as there is continued
benefit
Precaution
Fertilization: males should not father a child
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
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No
MDC
Generic Name
Brand name
Price quoted
Prescriber
Category
Details
while receiving decitabine and for 2 months
afterwards. Hepatic impairment: potential
exacerbation of toxicity. Myelosuppression.
Renal impairment: potential exacerbation of
toxicity
Contraindication
Patients with a known hypersensitivity to
decitabine
Interaction
No formal assessments of drug-drug interactions
between decitabine and other agents have been
conducted
Adverse effect
Edema, heart murmur, peripheral edema,
cellulitis, ecchymosis, erythema, pallor,
petechiae, pruritus, rash, skin lesion,
hyperglycemia, hyperkalemia,
hypoalbuminemia, hypokalemia,
hypomagnesemia, hyponatremia, serum
bicarbonate level abnormal, abdominal pain,
constipation, decrease in appetite, diarrhea,
indigestion, loss of appetite, nausea, petechiae,
oral mucosal, stomatitis, vomiting, leukopenia,
alkaline phosphatase raised, ascites,
hyperbilirubinemia, increased liver
aminotransferase level, lymphadenopathy,
arthralgia, backache, pain in limb, dizziness,
dysesthesia, headache, lethargy, anxiety,
fatigue, insomnia, serum blood urea nitrogen
raised, cough, decreased breath sounds,
hypoxia, pharyngitis, respiratory crackles,
candidiasis, fever, pain, sepsis, shivering or
rigors, tenderness, atrial fibrillation, cardiac
arrest, heart failure, myocardial infarction,
anemia, febrile neutropenia, neutropenia,
thrombocytopenia, cerebral hemorrhage,
intracranial hemorrhage, pneumonia, pulmonary
edema, infection due to Mycobacterium avium,
infectious disease
11
N01BB539
74P3001X
X
Mepivacaine HCl 2% with
Adrenaline (1:100,000)
Injection
(Scandonest 2% Special®)
Cost
1.8 ml (36 mg):
RM 180/100’s + 100’s
needles
2.2 ml (44 mg):
RM 188/100’s + 100’s
needles
B
Indication
For local anaesthesia including infiltration and
nerve blocks
Dose:
Adult: Single site in the jaw: 36 mg (1.8ml).
Entire oral cavity: 180 mg (9 ml). Max: 400 mg
(20 ml) per single dental procedure
Precaution
Rate of injection should not be too rapid. Avoid
prolonged use. In elderly, child, debilitated
patients, epilepsy, impaired respiratory function
or cardiac conduction, shock, hepatic
impairment, renal disease.
In pregnancy and lactation.
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
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No
MDC
Generic Name
Brand name
Price quoted
Prescriber
Category
Details
Contraindication
Complete heart block, porphyria.
Interaction
Potentially Fatal: Administration of mepivacaine
solutions containing epinephrine or
norepinephrine to patients receiving MAOIs or
tricyclic antidepressants (TCAs) may lead to
severe hypertension. Antiarrhythmics (risk of
myocardial depression).
Adverse effect
Restlessness, excitement, nervousness,
paraesthesias, dizziness, tinnitus, blurred vision,
nausea, vomiting, muscle twitching, tremors,
convulsions, numbness of the tongue and
perioral region, lightheadedness, drowsiness,
respiratory failure, coma, hypotension.
Potentially Fatal: Myocardial depression,
bradycardia, cardiac arrhythmias, cardiac arrest.
12
N01BB031
10P3001X
X
(Scandonest 3% Plain®)
Indication
For dental local anaesthesia including infiltration
and nerve blocks on patients in whom adrenalin
might be contraindicated
Cost
1.8 ml (54 mg):
RM 188/100’s + 100’s
needles
Dose:
Adult: Single site in the jaw: 54 mg (1.8 ml).
Entire oral cavity: 270 mg (9 ml). Max: 400 mg
(13.3 ml) per single dental procedure
2.2 ml (66 mg):
RM 198/100’s + 100’s
needles
Precaution
Rate of injection should not be too rapid. Avoid
prolonged use. In elderly, child, debilitated
patients, epilepsy, impaired respiratory function
or cardiac conduction, shock, hepatic
impairment, renal disease.
In pregnancy and lactation
Mepivacaine HCl 3%
Injection
B
Contraindication
Complete heart block, porphyria.
Interaction
Mepivacaine has an additive effect with alcuronii
chloridum
Adverse effect
Restlessness, excitement, nervousness,
paraesthesias, dizziness, tinnitus, blurred vision,
nausea, vomiting, muscle twitching, tremors,
convulsions, numbness of the tongue and
perioral region, lightheadedness, drowsiness,
respiratory failure, coma, hypotension.
Potentially Fatal: Myocardial depression,
bradycardia, cardiac arrhythmias, cardiac arrest.
13
J01MA141
10T1001XX
Moxifloxacin 400mg Tablet
(Avelox®)
A*
Indication
Second line therapy for Severe Community
Acquired Pneumonia (CAP) patients with comorbidity or with recent antibiotic therapy,
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
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No
14
MDC
J01MA141
10P3001X
X
Generic Name
Brand name
Price quoted
Cost
RM 49.50/5’s
Prescriber
Category
Moxifloxacin 400mg
Injection
(Avelox®)
Cost
RM 110/vial of 250ml
A*
Details
suspected infections of resistant pathogens
including Streptococcus pneumoniae,
Haemophilus influenzae & Mycoplasma
pneumoniae.
Dose:
IV or Oral: 400 mg once daily. The
recommended total treatment duration for
sequential administration (intravenous followed
by oral therapy) is 7 to 14 days
Precaution
Maintain adequate fluid intake. Exposure to strong
sunlight/sunlamp. Epilepsy, history of CNS
disorders. Diabetes mellitus. Not recommended in
severe hepatic impairment. May worsen
myasthenia gravis. Discontinue in case of tendon
pain, inflammation or rupture. Increased risk of
tendon inflammation/rupture especially in elderly
taking corticosteroids and in kidney, heart, and
lung transport recipients. High level of resistance
with S. aureus infections. Caution in patients with
proarrhythmic conditions e.g. clinically significant
bradycardia or acute myocardial infarction. Existing
QT prolongation, bradycardia, heart failure with
reduced left ventricular ejection fraction,
uncorrected hypokalaemia. Avoid concomitant
usage with drugs that are known to prolong QT
interval. Prolonged use may increase risk of fungal
or bacterial superinfection.
Contraindication
Hypersensitivity to quinolones. Children less
than 18 years old. Pregnancy & lactation.
Interaction
Atenolol, sotalol, ranitidine, calcium
supplements, theophylline, oral contraceptives,
glibenclamide, itraconazole, digoxin, morphine,
probenecid, antacids preparations containing
magnesium, aluminium, ferrous, zinc, sucralfate,
multivitamins. Warfarin, charcoal, cisapride,
erythromycin, antipsychotics, tricyclic
antidepressants, antiretroviral drugs, NSAIDs,
anti-arrhythmics, terfenadine, quinines and
cyclosporine.
Adverse effect
Diarrhea, nausea, headache, dry eyes, reduced
visual acuity, photosensitivity, prolonged qt interval,
torsades de pointes, Stevens-Johnson Syndrome,
toxic epidermal necrolysis, agranulocytosis,
aplastic anemia, hemolytic anemia, pancytopenia,
thrombocytopenia (less than 0.1% ), hepatic
necrosis, hepatitis, liver failure, anaphylactoid
reaction, immune hypersensitivity reaction, pain at
injection site, rupture of tendon, tendinitis, seizure,
acute renal failure, extrinsic allergic alveolitis,
serum sickness due to drug, abnormal ECG,
abnormal hepatic function test, anxiety, anorexia,
vaginitis
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
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LAMPIRAN 3
3. TAMBAHAN DAN PINDAAN FORMULASI/ KATEGORI/ BENTUK DOSEJ/ INDIKASI YANG
DILULUSKAN UNTUK DIMASUKKAN KE DALAM FORMULARI UBAT KKM
A. Tambah Formulasi/ Kekuatan
No
MDC
1
N03AX1400
0P3001XX
Generic Name
Brand name
Price quoted
Levetiracetam
100 mg/ ml
Injection
(Keppra®)
Cost
RM 102/vial of
500 mg (5 ml)
Prescriber
Category
A*
Details
Indications
i) Monotherapy therapy in the treatment of partial onset
seizures with or without secondary generalization in
patients from age 16 years of age with newly
diagnosed epilepsy ii) Adjunctive treatment in partial
onset seizures with or without secondary
generalization in adults and children from 4 years of
age with epilepsy; juvenile myoclonic epilepsy and
idiopathic generalized tonic clonic epilepsy from 12
years of age. To be initiated when conventional IV
antiepileptic drugs failed to achieve control, or oral
form is temporarily not feasible in seizure emergencies
only
Dose
i) ADULTS and ADOLESCENT (from 16 years):
Starting dose: 250 mg twice daily, Increase dose to
500 mg twice daily after 2 week. Dose can be further
increased by 250 mg twice daily every 2 weeks
depending upon the clinical response. Max: 1500 mg
twice daily. ii) ADULT more than 18 years and
ADOLESCENT (12 to 17 years) more than or equal to
50 kg: Initially 500 mg twice daily may be increased up
to 1500 mg twice daily. Dose changes can be made in
500 mg twice daily increments or decrements 2 to 4
weekly. CHILD (4 to 11 years) and ADOLESCENT (12
to 17 years) less than 50 kg : Initially 10 mg/kg twice
daily, may be increased up to 30 mg/kg twice daily.
Dose changes should not exceed increments or
decrements of 10 mg/kg twice daily every 2 weeks.
CHILD more than or equal to 50 kg: Adult dose
Precautions
If levetiracetam has to be discontinued, it is
recommended to withdraw it gradually (e.g. in adults:
500 mg twice daily decrements every two to four
weeks; in children: dose decrease should not exceed
decrements of 10 mg/kg twice daily every two weeks).
The administration of Keppra to patients with renal
impairment may require dose adaptation. In patients
with severely impaired hepatic function, assessment of
renal function is recommended before dose selection.
Suicide, suicide attempt and suicidal ideation have
been reported in patients treated with levetiracetam.
Patients should be advised to immediately report any
symptoms of depression and/or suicidal ideation to
their prescribing physician
Contraindications
Hypersensitivity to levetiracetam or other pyrrolidone
derivatives or any of the excipients
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
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No
MDC
Generic Name
Brand name
Price quoted
Prescriber
Category
Details
Interactions
Antidepressants: anticonvulsant effect of antiepileptics
possibly antagonised by MAOIs and tricyclic-related
antidepressants (convulsive threshold lowered).
Anticonvulsant effect of antiepileptics antagonised by
SSRIs and tricyclics (convulsive threshold lowered).
Avoid concomitant use of antiepileptics with St John’s
wort . Antimalarials: possible increased risk of
convulsions when antiepileptics given with chloroquine
and hydroxychloroquine. Anticonvulsant effect of
antiepileptics antagonised by mefloquine
Adverse effects
Asthenia, somnolence/fatigue, thrombocytopenia,
abdominal pain, diarrhoea, dyspepsia, nausea,
vomiting, amnesia, ataxia, convulsion, dizziness,
headache, hyperkinesia, tremor, balance disorder,
disturbance in attention, memory impairment,
aggression, agitation, depression, emotional
lability/mood swings, hostility, insomnia, irritability,
nervousness, personality disorders, thinking abnormal,
anorexia, weight increase. The risk of anorexia is
higher when topiramate is co administered with
levetiracetam, vertigo, diplopia, vision blurred, myalgia,
accidental injury, infection, nasopharyngitis, cough
increased, eczema, pruritus, rash
2
N02AA0511
0C1001XX
Oxycodone HCl 5
mg Immediate
Release Capsules
A*
(Oxynorm®)
Cost
RM 22.12/28’s
3
N02AA0511
0C1002XX
Oxycodone HCl
10 mg Immediate
Release Capsules
A*
Cost
RM 37.52/28’s
N02AA0511
0C1003XX
Oxycodone HCl
20 mg Immediate
Release Capsules
Dose
Initially 5 mg every 4 to 6 hours, increased if necessary
according to severity of pain, usual max. 400 mg daily,
but some patients may require higher doses
Precautions/ Contraindications/ Interactions/ Adverse
effects
Same as Oxycodone HCl 10 mg Prolonged Release
Tablet
(Oxynorm®)
4
Indications
i)As a second line drug in the management of opioid
responsive, moderate to severe chronic cancer pain
ii)As a step-down analgesic drug in post-operative
procedures (Initiated by palliative medicine physicians,
oncologists, anaesthesiologists, haematologists and
pain specialists only)
A*
(Oxynorm®)
Cost
RM 70.56/28’s
5
N02AA0511
0T5003XX
Oxycodone HCl
40 mg Prolonged
Release Tablet
(Oxycontin®)
A*
Indications
Management of moderate to severe chronic cancer
pain non-responsive to morphine (Initiated by palliative
medicine physicians, oncologists, anaesthesiologists,
haematologists and pain specialists only)
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
11/17
TERHAD - Edaran dalaman sahaja
No
MDC
Generic Name
Brand name
Price quoted
Cost
RM 256.20/28’s
Prescriber
Category
Details
Dose
Initially, 10 mg every 12 hours, increased if necessary
according to severity of pain, usual max. 200 mg every
12 hours, but some patients may require higher doses
Precautions/ Contraindications/ Interactions/ Adverse
effects
Same as Oxycodone HCl 10 mg Prolonged Release
Tablet
6
N05AX1300
0P2002XX
Paliperidone 50
mg Prolonged
Release Injection
A*
(Invega
Sustenna®)
Dose
Initiation: Deltoid IM 150 mg eq on Day1, followed by
deltoid IM 100 mg eq on one week later. Maintenance:
Monthly dose of 75 mg eq ( this can be increased or
decreased based on individual patient’s tolerability
and/or efficacy). These monthly maintenace dose can
be administered in either the deltoid or gluteal muscle
Cost
RM 720/ prefilled
syringe
7
N05AX1300
0P2003XX
Paliperidone 75
mg Prolonged
Release Injection
A*
(Invega
Sustenna®)
Cost
RM 720/ prefilled
syringe
8
N05AX1300
0P2004XX
Paliperidone 100
mg Prolonged
Release Injection
A*
Interactions
Centrally acting drugs, alcohol, levodopa & other
dopamine agonists, carbamazepine. Drugs known to
prolong QT interval
Cost
RM 860/ prefilled
syringe
N05AX1300
0P2005XX
Paliperidone 150
mg Prolonged
Release Injection
(Invega
Sustenna®)
Cost
RM 860/ prefilled
syringe
Precautions
Neuroleptic malignant syndrome, congenital long QT
syndrome, tardive dyskinesia, hyperglycemia &
diabetes mellitus, hyperprolactinemia, cardiovascular
or cerebrovascular disease or conditions predisposing
to hypotension. Monitor complete blood count
regularly. History of seizures & cardiac arrhythmias,
risk for aspiration pneumonia. Conditions that
contribute to core body temperature elevation or
dehydration. Parkinson's disease, dementia with Lewy
bodies. Pregnancy. Elderly. Adolescents & children.
May impair ability to drive or operate machinery
Contraindications
Moderate to severe renal impairment, dementia-related
psychosis, lactation
(Invega
Sustenna®)
9
Indications
Second or third line treatment of acute and
maintenance treatment of schizophrenia in adults
A*
Adverse effects
Insomnia, headache, agitation, somnolence, sedation,
dizziness, injection site pain, akathisia, extrapyrimidal
disorder, constipation, nausea, vomiting,
nasopharyngitis, bradycardia, bundle branch block,
postural orthostatic tachycardia syndrome, tachycardia,
blood cholesterol increased, blood glucose increased,
convulsion, dizziness postural, drooling, dysarthria,
dyskinesia, dystonia, hypertonia, lethargy, neuroleptic
malignant syndrome, oromandibular dystonia,
parkinsonism, psychomotor hyperactivity, syncope,
oculogyric crisis, eye rolling, vision blurred,
amenorrhea, erectile dysfunction, galactorrhea,
gynecomastia, menstruation irregular, sexual
dysfunction
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
12/17
TERHAD - Edaran dalaman sahaja
No
MDC
10
G03DA0400
0C1001XX
Generic Name
Brand name
Price quoted
Progesterone
100mg capsule
Prescriber
Category
A*
Details
Indications
Supplementation of the luteal phase during IVF cycles
and frozen embryo transfer cycle
(Utrogestan®)
Dose
Vaginal route, 4 to 6 capsules (in 2 to 3 divided doses)
per day starting from the day of the HCG injection until
the 12th week of pregnancy.
Cost
RM 1.25/ capsule
Precautions
Delay evacuation of dead egg or interruption of non
progressive pregnancy. May impair ability to drive or
operate machinery.
Contraindications
Vaginal: Unknown
Interactions
Unknown
Adverse effects
Local discomfort (erythema/ burning or itching),
bloating, vaginal discharge, spotting, metrorrhagia,
breast fullness
11
J07BB02963
P5001XX
Influenzae
Vaccine
(Inactivated,Trival
ent) Type A
(H1N1) 9 mcg,
Type A (H3N2) 9
mcg & Type B 9
mcg
Haemagglutinin
Injection
B
Indications
Prevention of influenza and influenza related
complications in high risk adult patients, in particular
individuals who have chronic cardiovascular,
pulmonary, metabolic or renal disease, or who are
immunocompromized and elderly patients
Dose
18 to 59 years: Single dose of 0.1ml 9mcg/strain
intradermally. More than or equal to 60 years: Single
dose of 0.1ml 15mcg/strain intradermally
(Intanza®)
Precautions
History concerning possible hypersensitivity to the
vaccine or similar vaccine, presence of any
contraindications to immunization, febrile or acute
disease, immunocompromised persons,
Cost
RM 35/prefilled
syringe
12
J07BB02963
P5002XX
Influenzae
Vaccine
(Inactivated,Trival
ent) Type A
(H1N1) 15 mcg,
Type A (H3N2) 15
mcg & Type B 15
mcg
Haemagglutinin
Injection
(Intanza®)
Cost
RM 40/prefilled
syringe
B
®
hypersensitivity to formaldehyde, Triton X-100 and
neomycin, active neurologic disorder, avoid vaccinating
persons who are known to have experienced GuillainBarré syndrome (GBS) within 6 to 8 weeks after a
previous influenza vaccination. Pregnant Women:
Should be given to pregnant women following an
assessment of the risks and benefits in the person to
be vaccinated. Nursing Women: Caution must be
exercised when administered to a nursing mother.
Paediatrics: Not indicated for persons less than 18
years of age.
Contraindications
History of severe allergic reaction to any component of
the vaccine or after previous administration of the
vaccine or a vaccine containing the same components
or constituents.
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
13/17
TERHAD - Edaran dalaman sahaja
No
MDC
Generic Name
Brand name
Price quoted
Prescriber
Category
Details
Interactions
Immunosuppressive treatments may interfere with the
development of the expected immune response.
Adverse effects
Injection site reactions (erythema, swelling, induration,
pruritus, pain, echymosis), systemic reactions
(headache, myalgia, malaise, shivering, fever),
arthralgia, asthenia (including fatigue), increased
sweating, paresthesia, rash, transient
thrombocytopenia, lymphadenopathy. Allergic
reactions: urticaria, dyspnea, angioneurotic edema,
anaphylaxis including shock. Guillain-Barré syndrome
(GBS), neuritis, neuralgia, convulsions,
encephalomyelitis, vasculitis, such as HenochSchonlein purpura, with transient renal involvement in
certain cases
13
A10BB0900
0T5001XX
Gliclazide 60 mg
Modified Release
Tablet
B
(Diamicron MR®)
Cost
RM 24.72/60’s
Indications
As monotherapy or in combination with other oral
antidiabetic agents in type 2 diabetes in adults when
dietary measures, physical exercise and weight loss
alone are not sufficient to control blood glucose
Dose
Initially 30 mg daily, adjusted according to response
every 4 weeks (after 2 weeks if no decrease in blood
glucose). Max. 120 mg daily
Precautions/ Contraindications/ Interactions/ Adverse
effects
Same as Gliclazide 30 mg Modified Release Tablet
B. Tukar kategori Preskriber
No
MDC
Generic name
1
J07BM01000P3001
XX
Human Papillomavirus (Types 6,
11, 16, 18) Vaccine Injection
Old
Category
A
New
Category
A/KK
A
A/KK
Other Details
As in MOH Formulary
(Gardasil®)
Cost
RM 180.00/prefilled syringe
2
J07BM02000P3001
XX
Human Papillomavirus (Types
16, 18) Vaccine Injection
As in MOH Formulary
(Cervarix®)
Cost
RM 53.80/prefilled syringe
(Contract item)
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
14/17
TERHAD - Edaran dalaman sahaja
C. Tambah Indikasi
No
MDC
Generic name
1
C09CA0700
0T1002XX
Telmisartan 80 mg
Tablet
Cost
RM 1.225/tablet
(Contract item)
Old
Indication
Hypertension in
patients who
cannot tolerate
ACE inhibitors
because of cough
New
Indication
i)Hypertension in
patients who cannot
tolerate ACE inhibitors
because of cough
ii)Reduction of the risk
of myocardial
infarction, stroke, or
death from
cardiovascular causes
in patients 55 years or
older at high risk of
developing major
cardiovascular events
who are unable to take
ACE inhibitors
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
Other Details
Dose
i)40 to 80 mg once
daily ii)80 mg once
daily
Others
As in MOH
Formulary
15/17
TERHAD - Edaran dalaman sahaja
LAMPIRAN 4
4. Kemaskini Maklumat Ubat Rosiglitazone 4 mg dan 8 mg Tablet
No
MDC
Generic
name
Old Details
New Details
Other
Details
1
A10BG020
00T1002XX
Rosiglitazone
4 mg Tablet
A10BG020
00T1001XX
Rosiglitazone
8 mg Tablet
Indication
Type 2 diabetes with insulin
resistant features. Prescribed
to new patients only if
inadequate glycaemic control
with all other combination of
oral antidiabetic medications
(such as sulphonylureas,
metformin, acarbose or DPPIV
inhibitors) and is the only
suitable alternative.
Use of rosiglitazone in
combination with insulin (for
new patients) is not
recommended. Combined use
with insulin should be limited to
existing cases with stable
glycaemic control and requires
close monitoring in view of
increased risk of fluid
retention, weight gain and
hypoglycaemia.
In cases of existing use in
patients with optimal glycaemic
control, rosiglitazone should be
continued with close
monitoring of cardiovascular,
osteoporosis and fracture risk.
As in MOH
drug
formulary
2
Indication
Diabetes mellitus with
insulin resistant features,
combined with
sulphonylureas,
metformin, acarbose and
or insulin, delays
introduction of insulin in
type 2 diabetes mellitus
already on maximal doses
of two or more oral
hypoglycaemic agents
Contraindication
Hepatic impairment,
history of heart failure,
combination with insulin
(risk of heart failure),
pregnancy and breast
feeding, diabetic
ketoacidosis,
hypersensitivity to
rosiglitazone product
Precaution
Active liver disease,
alanine transaminase
levels more than 2.5 times
upper limit of normal,
chronic heart failure (class
I-II), diabetes mellitus type
I, oedema, lack of
adequate contraception in
premenopausal
anovulatory women.
Potential increased risk of
myocardial ischaemia,
exacerbate heart failure
and other concurrent CV
diseases such as
hypertension
Contraindication
Patients with cardiac failure
(NYHA Class I-IV) or history of
cardiac failure, known
ischeamic heart disease,
hepatic impairment, pregnancy
and breastfeeding, diabetic
ketoacidosis, hypersensitivity
to rosiglitazone product
Precaution
Increased risk of myocardial
ischeamia, exacerbate heart
failure. Increased risk of
fracture, especially in women.
Active liver disease, alanine
transaminase level more than
2.5 times upper limit of normal,
type 1 diabetes, oedema
(especially when used in
combination with insulin), lack
of adequate contraception in
premenopausal anovulatory
women
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
16/17
TERHAD - Edaran dalaman sahaja
LAMPIRAN 5
5. PERMOHONAN-PERMOHONAN YANG TIDAK DILULUSKAN
Proforma B
BIL
1
NAMA UBAT
Rosiglitazone
Maleate 4mg
Tablet
PINDAAN YANG
DICADANGKAN
Tukar kategori
preskriber daripada A*
kepada A/KK
ALASAN
Reports on the cardiovascular safety of rosiglitazone have
been highlighted and published recently and resulted in
withdrawal or restricted use in many countries.
The use of this rosiglitazone in primary care may be
difficult to monitor, especially with current
recommendations requiring doctors to closely monitor
patients, regularly inform patients on safety issues such
as cardiovascular risk, osteoporosis and fracture risk as
well as attest to and document patient’s eligibility for
starting and continuing this drug.
National Pharmaceutical Control Bureau (NPCB) had
issued a circular to restrict the use of this drug due to
reports on elevated risks of cardiovascular events.
Not supported by TDWC* of Endocrine
Proforma D
BIL
NAMA UBAT
ALASAN
1
Cefdinir 125mg/5ml Oral
Suspension
i)
There are no overt advantages over current option. Most studies
showed that it is as efficacious as other beta lactam antibiotics.
ii) Currently available alternatives are sufficient to treat the indications
applied for.
iii) Not supported by TDWC* of Antimicrobial.
2
Prasugrel HCL 10mg Tablet
i)
There are no added advantages over the current alternative drug
available in MOH drug formulary.
ii) The currently available alternative is much cheaper compared to
prasugrel tablet.
*TDWC = Therapeutic Drug Working Committee
Pindaan FUKKM Bil. 1/2011 (Mac 2011)
17/17