Active substanceBiperidenBiperiden
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  • Dosage form: & nbsppills
    Composition:

    Each tablet contains:

    active substance: biperidene hydrochloride 2,000 mg;

    Excipients: magnesium stearate 2,000 mg, lactose monohydrate 65,000 mg, cellulose microcrystalline 131,000 mg.

    Description:

    White, round, biconvex tablets with a risk on one side.

    Pharmacotherapeutic group:Hollow block central
    ATX: & nbsp

    N.04.A.A.02   Biperiden

    Pharmacodynamics:

    Mendilex® (biperidene) - holinoblokiruyuschy drug of central action, with a moderate peripheral effect. As a result of selective blockade of cholinergic receptors, biperidene leads to a weakening of the signs of parkinsonism (akathisia, muscle rigidity, akinesia, dyskinetic tremor, oculogic crisis).

    Pharmacokinetics:

    Biperiden is rapidly absorbed from the gastrointestinal tract, but its bioavailability is 30%, which indicates an extensive metabolism during the "first passage" through the liver.

    Binding to plasma proteins is 93%, the volume of distribution is 24 ± 4.1 l / kg. The metabolism of biperidene has not been fully studied, but it is known that it is included in the hydroxylation process.

    The half-life of biperidene from the plasma is about 20 hours, so the concentration of the drug in the plasma (0.1-0.2 ng / ml) can be determined and 48 hours after its administration. It is excreted by the kidneys and the gastrointestinal tract.

    Indications:

    Parkinsonism syndrome (as part of combination therapy), including the initial stages of Parkinson's disease (monotherapy).

    Extrapyramidal disorders (tremor, muscle rigidity, torsion dystonia and local forms of dystonia, including paroxysmal dyskinesia, hyperkinesia of chorea, various forms of tics, myoclonia and hyperkinesia, dystonia of the muscles of the extremities, trunk, neck, face, akinesia, akathisia) caused by drugs (in particular neuroleptics).

    Contraindications:

    Hypersensitivity, myasthenia gravis, zakratougolnaya glaucoma, intestinal obstruction, obstruction of the urinary tract, paralytic obstruction of the intestine or intestinal atony, gastroesophageal reflux, ulcerative colitis, toxic megacolon, acute bleeding.

    Carefully:

    Elderly patients and patients suffering from prostatic hypertrophy, tachyarrhythmia, congestive heart failure, coronary heart disease, arterial hypertension, ileostomy / colostomy, epilepsy.

    Children under 18 years of age (effectiveness and safety of the drug in children is not established).

    Pregnancy and lactation:

    The appointment during pregnancy is possible if the benefit to the mother exceeds the possible risk to the fetus.

    When appointing during lactation it is necessary to stop breastfeeding. The drug is excreted in breast milk and the child may develop anticholinergic effects.

    Dosing and Administration:

    Inside.

    With Parkinson's disease and Parkinsonism the initial dose is 2 mg per day, divided into two doses. The dose is gradually increased to achieve the optimal daily dose, which for most patients is 3-12 mg (divided into 3-4 doses). The maximum daily dose is 16 mg.

    Usually adults with extrapyramidal disorders caused by drugs (in particular, antipsychotics), appoint 2 mg, 1-3 times a day.

    It is necessary to avoid sudden cessation of treatment because of the high probability of occurrence of abstinence.

    Side effects:

    In general, side effects develop as a result of the anticholinergic action of the drug.

    Most often observed dry mouth, mydriasis, paresis of accommodation, representing a dose-dependent side effects.

    Rarely - constipation, dyspepsia, fatigue, weakness, dizziness, drowsiness, anxiety, confusion, memory impairment, hallucinations, euphoria, disorientation in time and space, motor excitement, catalepsy, urinary retention, tachycardia, lowering of blood pressure, drug dependence, allergic reactions (skin rash).

    Overdose:

    Symptoms overdose similar to the symptoms arising from atropine poisoning: mydriasis, dry skin, hyperemia of the face, dry mouth and upper respiratory tract, fever, tachycardia, cardiac arrhythmias, weakness of intestinal peristalsis, urinary retention, delirium, disorientation, anxiousness, hallucinations, confusion , ataxia, aggression and convulsions.With severe poisoning, stupor, coma, stopping of breathing and heart, lethal outcome are possible.

    Giving help: gastric lavage, symptomatic therapy. It is recommended to prescribe physostigmine, as a specific antagonist at a dose of 1 mg intramuscularly or by slow intravenous infusion. This dose can be repeated every 20 minutes, but the total amount should not exceed 4 mg per day. Since physostigmine is rapidly metabolized, it is sometimes necessary to additionally inject physostigmine every 1-2 hours. For children and elderly patients, the administration of half the standard dose is recommended. The patient should be under the supervision of the doctor at least 8-12 hours after the last appearance of the symptoms.

    Interaction:

    Strengthens the effect of M-holinoblokatorov, antihistamine, antiparkinsonic and antiepileptic drugs, weakens the effect of metoclopramide.

    Incompatible with ethanol.

    Levodopa increases M-cholinoblocking action, quinidine increases the risk of dyskinesia.

    Special instructions:

    The use of biperidene can cause neuromuscular blockade, followed by muscle weakness and paralysis.

    During the treatment with biperidenom, you should not drink alcohol.

    Sensitive patients experience confusion, euphoria, motor excitement when an anticholinergic drug is prescribed in the recommended therapeutic doses.

    Effect on the ability to drive transp. cf. and fur:

    The drug has a strong influence on psychomotor reactions, so patients taking the drug should refrain from engaging in potentially dangerous activities that require rapid mental and motor reactions.

    Form release / dosage:

    Tablets, 2 mg.

    Packaging:

    For 10 tablets in a blister of aluminum foil and PVC film.

    Each 5 blisters together with instructions for use are placed in a cardboard box.

    Storage conditions:

    Store in a dark place at a temperature 15-25 FROM.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001389
    Date of registration:23.05.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:Alkaloid, JSCAlkaloid, JSC Macedonia
    Manufacturer: & nbsp
    ALKALOID, AD Macedonia
    Representation: & nbspALKALOID, AOALKALOID, AO
    Information update date: & nbsp28.04.2018
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