• Home
  • A-B index
  • Pharmacological Index
  • Drug Classes
  • Active Ingredients
  • Companies
  • News
  • Dekinet
    / Rafa


    Active Ingredient
    Biperiden (as HCl) 2 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    30 X 2 mg

    full basket chart 676 4036

    Related information


    Dosage

    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.


    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


    Contra-Indications

    Known hypersensitivity to biperiden. Narrow-angle glaucoma. Bowel obstruction, achalasia and myasthenia gravis. Megacolon.


    Special Precautions

    NOTE: 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 overdose (see Overdose) 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.
    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.


    Side Effects

    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.


    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. 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.


    Pregnancy and Lactation

    Pregnancy: Safety of use of this drug in pregnancy has not been established. FDA pregnancy category C. 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.
    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.


    Overdose

    Manifestations: Overdose 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.


    Manufacturer
    Rafa Laboratories Ltd.
    CLOSE