Active substancePrimidonePrimidone
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  • Primidone
    pills inwards 
    AKRIKHIN HFK, JSC     Russia
  • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substance: hexamidine 0.125 g or 0.25 g;

    Excipients: potato starch, sodium starch glycolate, polyvinylpyrrolidone such as Kollidon 90 F", calcium stearic acid.

    Description:Tablets of white color, flat-cylindrical, with a facet; pills 0.25 g have a risk.
    Pharmacotherapeutic group:antiepileptic agent
    ATX: & nbsp

    N.03.A.A.03   Primidone

    Pharmacodynamics:

    The chemical structure is close to phenobarbital, but differs in that it has a stronger anticonvulsant effect, without exerting a general inhibitory effect on the central nervous system and a pronounced hypnotic effect.

    Pharmacokinetics:

    When ingested hexamidine is rapidly and almost completely absorbed. The peak concentration in the blood plasma is observed after about 3 hours. The half-life in plasma is 7-14 hours. The drug is metabolized with the formation of active metabolites - phenobarbital and phenylethylmalonamide. Up to 40% of the drug is excreted unchanged in the urine.

    Indications:

    Epilepsy, large seizures. Less effective in light abortive seizures and mental equivalents.In small forms, there is no permanent action, but in some cases a therapeutic effect is observed.

    Contraindications:

    - Hypersensitivity to the drug;

    - impaired liver or kidney function;

    - diseases of the hematopoiesis system;

    - pregnancy and lactation.

    Carefully:

    Children and the elderly (perhaps paradoxical and motor excitement).

    Dosing and Administration:

    The drug is administered orally after a meal.

    Initial daily dose for adults 0,125 grams per day (in 1-2 doses), then every 3 days the daily dose is increased by 0.25 g per day - until the desired effect is achieved. The maximum daily intake for adults is 2 g, single-dose 0.75 g.

    Children depending on the age, it is prescribed from 0.125 g to 0.5 g per day.

    Side effects:

    In the early days of hexamidine treatment, drowsiness, dizziness, headache, ataxia, nausea are possible. These phenomena usually pass by themselves.

    With a long reception possible:

    - from the nervous system: apathy, anxiety, psychotic reactions; nystagmus (rarely);

    - from the hematopoiesis system: leukopenia, lymphocytosis, anemia;

    - Other: lupus-like syndrome, arthralgia; drug dependence; deficiency of folic acid;

    - allergic reactions.

    Overdose:

    When an overdose of hexamidine occurs dizziness, nausea, ataxia, oppression of the central nervous system.

    First aid: gastric lavage, the appointment of activated charcoal. If necessary, symptomatic therapy in a hospital.

    Interaction:

    Hexamidine increases the effect of hypnotics, derivatives of sulfonylurea, cyclophosphamide, methotrexate. Increasing the activity of microsomal liver enzymes, it accelerates biotransformation of coumarin derivatives, estrogenic contraceptives, griseofulvin, doxycycline.

    With the simultaneous administration of stimulant drugs for microsomal liver enzymes (phenobarbital, carbamazepine, rifampicin, ethanol (for chronic use)) the metabolism of hexamidine is accelerated and its effectiveness is reduced.

    Special instructions:

    The drug is used only as prescribed by the doctor. If unusual reactions occur, tell your doctor.

    Care must be taken when working with mechanisms.

    Form release / dosage:

    Tablets, 0.125 and 0.25 g.

    Packaging:

    For 10 tablets in a contour-cell package.

    10, 20, 30, 40, 50 and 400 tablets in cans of orange glass.

    Each bank of 10, 20, 30, 40 or 50 tablets or 1, 2, 3, 4 or 5 contiguous cell packs, together with the instruction for use, is placed in a pack of cardboard.

    Storage conditions:

    In a dry place, at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:P N002876 / 01
    Date of registration:25.11.2008/19.12.2012
    The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp28.04.2016
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