Fenibut (Phenybut)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAminophenylbutyric acidAminophenylbutyric acid
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    • Dosage form: & nbsppills
    Composition:

    Composition per one tablet:

    Active substance:

    Aminophenylbutyric acid 250.0 mg

    Excipients:

    Microcrystalline cellulose 220.0 mg

    Silica colloidal dioxide 25.0 mg

    Sodium carboxymethyl starch 25.0 mg

    Calcium stearate 5.0 mg

    Description:

    Round flat cylindrical tablets white or white with a slightly yellowish tint of color with a facet and a risk.

    Pharmacotherapeutic group:psychostimulants and nootropic drugs
    ATX: & nbsp

    N.06.B   Psychostimulants and nootropic drugs

    Pharmacodynamics:

    Aminophenylbutyric acid is a derivative of y-aminobutyric acid and phenylethylamine.Possesses tranquilizing properties, stimulates memory and learning ability, increases physical ability to work, eliminates psychoemotional tension, anxiety, fear and improves sleep. Does not affect cholino- and adrenergic receptors.

    The drug lengthens the latent period and shortens the duration and severity of nystagmus. Significantly reduces the manifestations of asthenia and vasovegetative symptoms, including headache, a feeling of heaviness in the head, sleep disturbance, irritability, emotional lability, improves mental performance, improves well-being, increases interest and initiative, motivation for active activity without sedation or stimulation.

    Unlike tranquilizers under the influence of aminophenylbutyric, psychological indicators (attention, memory, speed and accuracy of sensory-motor reactions) are improved. No formation of addiction and dependence on the drug, the syndrome of "withdrawal" was noted.

    Pharmacokinetics:

    After ingestion, it is well absorbed and penetrates into all tissues of the body. In the brain tissue penetrates about 0.1% of y-amino-β-phenylbutyric acid from the accepted dose of the drug, in patients at young and old age it is possible to increase penetration through the blood-brain barrier.After 3 hours, y-amino-β-phenylbutyric acid is found in the urine, at the same time the concentration in the brain tissues does not decrease, it is found in the brain after 6 hours.

    80-95% of the drug is metabolized in the liver to pharmacologically inactive metabolites. 5% is excreted from the body by the kidneys in unchanged form. The day after the administration, y-amino-β-phenylbutyric acid can be detected only in the urine; it is determined in the urine after 2 days after administration, but the detectable amount is 5% of the administered dose. The greatest binding of y-amino-β-phenylbutyric acid occurs in the liver (80%), it is not specific. With multiple admission, the drug does not accumulate in the body.

    Indications:

    - Asthenic and anxiety-neurotic states.

    - Stammering, tics and enuresis in children from the age of 8.

    - Insomnia and nightly anxiety in the elderly.

    - Ménière's disease, dizziness associated with dysfunction of the vestibular analyzer of various genesis.

    - Prevention of motion sickness with kinetosis.

    - As part of complex therapy for alcohol withdrawal syndrome for the relief of psychopathological and somatovegetative disorders.

    Contraindications:

    - Hypersensitivity to the active substance or excipients of the drug.

    - Acute kidney failure.

    - Pregnancy, lactation.

    - Children up to 8 years of age (for this dosage form).

    Carefully:Patients with erosive and ulcerative diseases of the gastrointestinal tract because of the irritant effect of the drug is recommended to prescribe smaller doses of the drug.
    Pregnancy and lactation:

    Application during pregnancy and during breast-feeding is not recommended, because there is not enough clinical observation.

    In experimental animal studies, mutagenic, teratogenic and embryotoxic effects of the drug have not been established.

    Dosing and Administration:

    Inside after eating, squeezed with water. Do not chew.

    Asthenic and anxiety-neurotic states

    Adults: 250-500 mg 3 times a day. Higher single doses: for adults - 750 mg, for patients over 60 years - 500 mg. If necessary, the daily dose is increased to 2.5 g (2500 mg). The course of treatment is 4-6 weeks.

    Stammering, tics and enuresis in children

    8-14 years - 250 mg 2-3 times a day; children over 14 years of age - doses for adults.

    Insomnia and nighttime anxiety in the elderly
    250-500 mg 3 times a day.

    To eliminate dizziness in the dysfunction of the vestibular analyzer of infectious genesis (otogenous labyrinthite) and Meniere's disease

    During an exacerbation appoint 750 mg 3 times a day for 5-7 days, with a decrease in the severity of vestibular disorders - 250-500 mg 3 times a day for 5-7 days, then 250 mg once a day for for 5 days. With a relatively easy course of the disease - 250 mg 2 times a day for 5-7 days, then 250 mg once a day for 7-10 days.

    For elimination of dizziness in dysfunctions of the vestibular analyzer of vascular and traumatic origin

    250 mg 3 times a day for 12 days.

    For prevention of motion sickness with kinetosis

    250-500 mg once for one hour before the proposed journey or when the first symptoms of motion sickness appear.

    The anti-sweating effect is enhanced by increasing the dose of the drug.

    At the onset of severe manifestations of seasickness ("indomitable" vomiting and others), taking the drug orally is ineffective, even at a dose of 750-1000 mg.

    As part of complex therapy for alcohol withdrawal syndrome for the purpose of arresting psychopathological and somatovegetative disorders

    In the first days of treatment, 250-500 mg are prescribed 3 times a day and 750 mg at night with a gradual decrease in the daily dose to the usual for adults.

    Never take a double dose to replace a missed dose.

    Patients with renal and (or) liver failure with prolonged use should monitor the performance of kidneys and / or liver.

    If liver function is impaired, high doses of the drug may cause hepatotoxicity. Patients are assigned less effective doses.

    Side effects:

    Like other medicines, aminobutyric acid can cause side effects, which are not apparent in all patients. Aminobutyric acid is usually well tolerated.

    Classification of adverse reactions according to the frequency of development: very frequent (> 10%); frequent> 1 but <10%); infrequent (> 0,1 but <1%); rare (> 0.01 but 0.1%); very rare (<0.01%), the frequency is unknown (can not be determined from available data).

    Violations from the nervous system: frequency unknown - drowsiness and increased symptoms (at the beginning of treatment), dizziness, headache;

    Disturbances from the gastrointestinal tract: frequency unknown - nausea (at the beginning of treatment);

    Disturbances from the skin and subcutaneous tissues: rarely - allergic reactions (skin rash, itching);

    Disturbances from the liver and bile ducts: the frequency is unknown hepatotoxicity (with prolonged use of high doses).

    If any of the undesirable reactions indicated in the instructions for use are aggravated, or if you notice other undesirable reactions not listed in the instructions, inform your doctor.

    Overdose:

    Aminophenylbutyric acid is low toxicity. Data on cases of overdose have not been reported.

    Symptoms

    Drowsiness, nausea, vomiting, dizziness. With prolonged use of high doses, eosinophilia, lowering blood pressure, disturbing renal activity, fatty liver disease (taking more than 7 g) may develop.

    Treatment

    Gastric lavage, symptomatic treatment, maintenance of vital functions. There is no specific antidote.

    Interaction:

    For the purposes of mutual potentiation aminophenylbutyric acid is allowed to be combined with other psychotropic drugs, reducing the dose of the drug and the combined medicines.

    Extends and intensifies the effect of hypnotic, neuroleptic and antiparkinsonian drugs.

    Special instructions:

    With prolonged use, it is necessary to control the cellular composition of the blood, the liver function indicators.

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

    During the treatment period, care should be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions, since some patients may have central nervous system disorders such as drowsiness and dizziness.

    Form release / dosage:Tablets 250 mg.
    Packaging:For 10 tablets in a planar cell package. By 1, 2, 3, or 5 contour mesh packages together with instructions for use in a pack of cardboard.
    Storage conditions:

    In the dark place at a temperature of no higher than 30 ° C.

    Keep out of the reach of children.

    Shelf life:3 years. Do not use the drug after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-002361
    Date of registration:06.02.2014
    The owner of the registration certificate:OBNINSKAYA CHEMICAL - PHARMACEUTICAL COMPANY, CJSC OBNINSKAYA CHEMICAL - PHARMACEUTICAL COMPANY, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp03.12.2014
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