Fenibut - instructions for use, doses, side effects, contraindications

Being a derivative of gamma-aminobutyric acid and phenylethamine, aminophenylbutyric acid facilitates GABA-mediated transmission of nerve impulses in the central nervous system (has a direct effect on GABA-ergic receptors).Has a tranquilizing effect that combines with the effects of stimulating the central nervous system effects: improves the functional state of the brain, normalizing its metabolism and blood flow in the brain (increases volume and linear velocity of blood flow, reduces vascular resistance and improves microcirculation), reduces vasovegetative symptoms (including headache and a sense of "heaviness" in the head, sleep disorders, irritability, emotional lability), eliminates psychoemotional tension, with osobstvuet reduce feelings of anxiety, anxiety, improves sleep. Does not affect cholino- and adrenergic receptors. It prolongs the latent period and shortens the duration and severity of nystagmus. At the course reception increases physical and mental efficiency (improves attention, memory, speed and accuracy sensory-motor reactions). Reduces the manifestations of asthenia, increases interest and initiative (promotes motivation to activity) without the effects of sedation or arousal.

People of advanced age do not cause central nervous system depression, muscle-relaxing aftereffect is most often absent.

Reduces the inhibitory effect of ethanol on the central nervous system.

Pharmacokinetics:

Absorption after ingestion is high, the drug penetrates well into all tissues of the body and across the blood-brain barrier (in the brain tissue penetrates about 0.1% of the accepted dose of the drug, and in young and elderly people it is possible to increase the degree of penetration into the brain). 80-95% of the drug is metabolized in the liver, metabolites are pharmacologically inactive. Do not cumulate in the body, including with repeated admission. After 3 hours begins to be excreted by the kidneys, while the concentration in the brain tissues does not decrease, and aminophenylbutyric acid is found in the brain for another 6 hours. About 5% of the accepted dose of the drug is excreted by the kidneys in an unchanged form, partially excreted with bile.

Indications:

- Asthenic and anxiety-neurotic states;

- Stammering, tics and enuresis in children from 3 years of age;

- Insomnia and nighttime anxiety in elderly people;

- 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 in the treatment of alcohol withdrawal syndrome, for the relief of psychopathological and somatovegetative disorders.

Contraindications:

Hypersensitivity to any of the components of the drug, acute renal failure, pregnancy, the period of breastfeeding, children under 3 years.

Do not use patients with hereditary intolerance to galactose or lactose, a deficiency of lactase or glucose-galactose malabsorption (due to the presence of lactose in the formulation).

Carefully:

With erosive and ulcerative lesions of the gastrointestinal tract, hepatic insufficiency.

Pregnancy and lactation:

Application in pregnancy and during breastfeeding is not recommended, due to the lack of sufficient clinical observations.

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

Dosing and Administration:

Inside, after eating, washed down with water.

Asthenic and anxiety-neurotic states in adults and elderly people:

Adults: 250-500 mg 3 times a day.Higher single doses: for adults - 750 mg, for patients of elderly and senile age (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:

Children from 3 to 8 years: 125 mg (1/2 tablet) 3 times a day.

Children aged 8 to 14 years: 250 mg (1 tablet) 3 times a day.

Children over the age of 14 take doses recommended for adults.

The course of treatment is 2-6 weeks.

Insomnia and nighttime anxiety in the elderly (60 years and older):

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 the exacerbation, the dose is 750 mg (3 tablets) 3 times a day for 5-7 days, with a decrease in the severity of vestibular disorders - 250-500 mg (1-2 tablets) 3 times a day for 5-7 days and then - 250 mg once a day for another 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.

To eliminate dizziness in dysfunctions of the vestibular analyzer of vascular and traumatic genesis:

250 mg 3 times a day for 12 days.

For prevention of motion sickness with kinetosis:

For 250-500 mg once for 1 hour before the expected start of travel or when the first symptoms of motion sickness appear. The anti-sweating effect of Phenibutum increases with an increase in the dose of the drug. At the onset of severe manifestations of seasickness (severe vomiting and others), the administration of the drug inside is ineffective.

As part of complex therapy for alcohol withdrawal syndrome with the aim 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 normal for adults.

Do not take a double dose to replace the missed dose.

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

With impaired liver function, high doses of the drug may contribute to the development of hepatotoxicity. In this case, patients are prescribed smaller doses.

Side effects:

Aminophenylbutyric acid preparations are usually well tolerated.Nevertheless, according to the experience of clinical use in some cases, the following side effects are noted. Classification of the incidence of side effects is given in accordance with WHO recommendations:

Very often: (> / = 1/10);

Often: (> / = 1/100 - <1/10);

Infrequently: (> / = 1/1000 - <1/100);

Rarely: (> / = 1/10000 - <1/1000);

Very rarely: (<1/10000, including individual cases);

The frequency is unknown (can not be determined from available data).

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

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

Immune system disorders: rarely - hypersensitivity reactions (skin rash, itching);

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

Overdose:

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

Symptoms: severe drowsiness, nausea, vomiting. With prolonged use of high doses of the drug (intake of more than 7 g), fatty liver disease can develop, as well as eosinophilia, lowering blood pressure, and impaired renal function.

Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy. There is no specific antidote.

Interaction:

In order to mutually potentiate the pharmacological effect, aminophenylbutyric acid preparations can be combined with other psychotropic drugs, reducing the doses of phenibut and combined drugs.

Extends and enhances the effect of hypnotics, narcotic analgesics, neuroleptics, antiparkinsonian and antiepileptic drugs.

Special instructions:

With prolonged use, it is necessary to monitor the indicators of the functional activity of the liver and hematological parameters. Peripheral blood parameters should be monitored when taking the drug for more than 2-3 weeks.

When taking aminophenylbutyric acid preparations, there is no development of addiction and drug dependence, as well as withdrawal syndrome.

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

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

Form release / dosage:Tablets 250 mg.

Packaging:

10 tablets per contour cell pack. For 1, 2, 3 or 5 contour squares with instructions for use are placed in a cardboard pack.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not take it after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-004785

Date of registration:04.04.2018

Expiration Date:04.04.2023

The owner of the registration certificate:TRIM, LLC TRIM, LLC Russia

Manufacturer: & nbsp

NGO Farmvilar, OOO Russia

Information update date: & nbsp25.04.2018

Illustrated instructions

Instructions

Fenibut (Phenybut)