Download DEKINET TABLETS Product Information Composition Dekinet

DEKINET TABLETS
Product Information
Composition
Dekinet Tablets
Each tablet contains:
Biperiden hydrochloride 2mg
Inactive ingredients:
Corn starch, lactose, microcrystalline cellulose, calcium phosphate, povidone, talc, magnesium stearate.
Action
Dekinet is a centrally-acting anticholinergic agent with weak visceral effects, effective in the treatment of
symptoms of parkinsonism. Clinically, Dekinet reduces akinesia and rigidity, and to a lesser extent, tremor.
Indications
For use as an adjunct in the therapy of all forms of parkinsonism (postencephalitic, arteriosclerotic and
idiopathic).
Useful in the control of extrapyramidal disorders due to central nervous system drugs such as
phenothiazines and other groups of psychotropics.
Contraindications
Known hypersensitivity to biperiden.
Narrow-angle glaucoma.
Bowel obstruction, achalasia and myasthenia gravis.
Megacolon.
Warnings
Isolated instances of mental confusion, euphoria, agitation and disturbed behavior may occur. A set of
concurrent symptoms known as the central anticholinergic syndrome may also occur as an adverse reaction
to properly prescribed biperiden, although it is more frequently due to overdosage (see Overdosage) or the
concurrent administration of another anticholinergic drug or a drug that has secondary anticholinergic
actions.
Tardive dyskinesia induced by neuroleptics may be intensified by biperiden in some individuals.
Animal studies have demonstrated that centrally-acting anticholinergic drugs such as biperiden may lead to
an increased tendency to cerebral seizure. This should be taken into account in the management of
predisposed patients.
As with other centrally-acting anticholinergics, abuse of biperiden has been observed.
Caution should be observed in patients with manifest glaucoma, although no prohibitive rise in intraocular
pressure has been reported following either oral or parenteral administration. Periodic intraocular pressure
determinations are recommended in elderly patients and in all patients with glaucoma.
Exercise caution when administering this drug to patients with prostatism or with epilepsy.
Care should be taken when administering Dekinet to patients with cardiac arrhythmias. Patients with recent
myocardial infarction should be given Dekinet only if the heart rate is well controlled.
Occasionally drowsiness may occur, especially if biperiden is taken with other centrally-acting drugs.
Patients should be warned that their ability to perform potentially-hazardous tasks requiring mental alertness
or physical coordination, such as driving a vehicle or operating machinery, may be impaired. As with other
drugs action on the central nervous system, the consumption of alcohol should be avoided during Dekinet
therapy.
Use in Pregnancy
Safety of use of this drug in pregnancy has not been established.
FDA pregnancy category C.
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Animal reproduction studies have not been conducted with Dekinet. It is also not known whether Dekinet
can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Dekinet
should be given to a pregnant woman only if clearly needed.
Use in Breastfeeding
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human
milk, caution should be exercised when Dekinet is administered to a nursing woman.
Use in Pediatrics
Safety and effectiveness of use in children have not been established.
Use in the Elderly
Elderly patients, particularly those with cerebral lesions of a vascular or degenerative nature, may exhibit
increased sensitivity even to therapeutic doses of the drug. Cautious dosing is recommended. Chronic use
may predispose geriatric patients to glaucoma.
Adverse Reactions
Atropine-like side effects such as dry mouth; blurred vision; drowsiness; euphoria or disorientation; urinary
retention; postural hypotension; constipation; agitation; disturbed behavior may been seen. A case of
generalized choreic movements has been reported in a Parkinson's disease patient when biperiden was
added to carbidopa/levodopa. A reduction in rapid eye movement (REM) sleep, characterized by increased
REM latency and decreased percentage of REM sleep, has been reported.
If gastric irritation occurs following oral administration, it can be avoided by administering the drug during or
after meals.
The central anticholinergic syndrome can occur as an adverse reaction to properly prescribed anticholinergic
medication. See Overdosage for a description of the signs and symptoms of this syndrome, and for
treatment.
Precautions
Regular monitoring of blood counts is recommended.
Treatment should not be discontinued abruptly. The transfer of patients from other antiparkinsonism agents
should be made gradually, the original agent being reduced in dose as Dekinet is substituted.
Anhidrosis and subsequent hyperthermia may occur with antidyskinetics when patients, especially geriatric,
chronically ill, and alcoholic, are exposed to high environmental temperatures.
Drug Interactions
Biperiden/Antiparkinsonism Drugs/Opiate Agonists/ Phenothiazines and other Antipsychotics/Tricyclic
Antidepressants/Antihistamines/Antispasmodics
Concomitant administration of biperiden with other drugs having anticholinergic effects may increase the risk
of adverse anticholinergic reactions, including the central anticholinergic syndrome (see Overdosage).
Biperiden/Quinidine
Concomitant use may potentiate anticholinergic effects, including slowing of AV conduction.
Biperiden/Levodopa
Concomitant use may potentiate dyskinesia.
Biperiden/Alcohol/ CNS depressants
Concomitant use may enhance the sedative effects.
Biperiden/Metoclopramide/Cisapride
Biperiden may antagonize the effects of metoclopramide, cisapride and other prokinetics.
Biperiden/antacids or antidiarrheals
Wait at least 1-2 hours between taking these medications.
Dosage and Administration
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Parkinsonism
Dosage should be individualized. Begin with 1/2 a tablet twice daily, and gradually increase to 1 tablet, 3-4
times daily. Then decrease continuously to the lowest dosage regimen which adequately controls the
symptoms.
Drug-induced Extrapyramidal Symptoms
The oral dosage is 1 tablet, 1-3 times daily.
Dekinet may be taken with a small amount of food to avoid gastric irritation.
Overdosage
Manifestations
Overdosage with Dekinet produces typical central symptoms of atropine intoxication known as the central
anticholinergic syndrome. Correct diagnosis depends on recognition of the peripheral signs of
parasympathetic blockade, including dilated and sluggish pupils, warm dry skin, facial flushing, decreased
secretions of the mouth, pharynx, nose and bronchi, foul-smelling breath, elevated temperature, tachycardia,
cardiac arrhythmias, decreased bowel sounds and urinary retention. Neuropsychiatric signs such as
delirium, disorientation, anxiety, hallucinations, illusions, confusion, incoherence, agitation, hyperactivity,
ataxia, loss of memory, paranoia, combativeness and seizures may be present. The condition can progress
to stupor, coma and cardiac and respiratory arrest and death.
Treatment
Treatment of acute overdose revolves around symptomatic and supportive therapy. If Dekinet was
administered orally, gastric lavage or emesis induction should be instituted.
A small dose of diazepam or of a short-acting barbiturate may be administered if CNS excitation is
observed. Phenothiazines are contraindicated, because the toxicity may be intensified due to their
antimuscarinic action, causing coma.
Respiratory support, artificial respiration or vasopressor agents may be necessary. Hyperpyrexia must be
reversed, fluid volume replaced and acid-base balance maintained. Urinary catheretization may be
necessary. Routine use of physostigmine for overdose is controversial. Delirium, hallucinations, coma, and
supraventricular tachycardia (not ventricular tachycardias or conduction defects) seem to respond. If
indicated, 1mg (half this amount for children and the elderly) may be given intramuscularly or by slow
intravenous infusion. If there is no response within 20 minutes, an additional 1mg dose may be given. This
may be repeated until a total of 4mg has been administered a reversal of the toxic effects occur or excessive
cholinergic signs are seen.
Frequent monitoring of clinical signs should be considered. Since physostigmine is rapidly destroyed,
additional injections may be required every 1-2 hours to maintain control. The relapse intervals tend to
lengthen as the toxic anticholinergic agent is metabolized, so patients should be carefully observed for 8-12
hours following the last relapse.
Presentation
Dekinet Tablets: 30 tablets.
Store below 25ºC
Registration no. 435221351
Manufacturer:
Rafa Laboratories Ltd. POB 405Jerusalem 91003
The format and content of this document have been approved by the Ministry of Health in March 2011.
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