Phenibut, pills 250mg 30pcs

Composition

Composition per tablet:

Active ingredient:

aminophenylbutyric acid hydrochloride (phenibut) – 250 mg.

Auxiliary substances:

lactose monohydrate -180 mg,

potato starch -56 mg,

povidone K 30-9 mg,

calcium stearate monohydrate-5 mg

Pharmacological action

Pharmacotherapy group: Other psychostimulants and nootropic agents.

ATX code: N06 BX 22.

Pharmacological properties

Pharmacodynamics

Being a derivative of gamma-aminobutyric acid and phenylethylamine, aminophenylbutyric acid facilitates GABA-mediated transmission of nerve impulses in the central nervous system (it has a direct effect on GABA-ergic receptors). It has a tranquilizing effect, which is combined with effects that stimulate the activity of the central nervous system: it improves the functional state of the brain, normalizes its metabolism and blood flow in the brain (increases the volume and linear velocity of blood flow, reduces vascular resistance and improves microcirculation), reduces vasovegetative symptoms (including headache and a feeling of “heaviness” in the head, sleep disturbance, irritability, emotional lability), eliminates psychoemotional tension, helps reduce feelings of anxiety, anxiety, improves sleep.

It does not affect the choline and adrenergic receptors. It prolongs the latent period and shortens the duration and severity of nystagmus. During the course, it increases physical and mental performance (improves attention, memory, speed and accuracy of sensory-motor reactions). Reduces symptoms of asthenia, increases interest and initiative (promotes motivation for activity) without the effects of sedation or arousal.

In the elderly, it does not cause depression of the central nervous system, and most often there is no muscle-relaxing aftereffect.

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

Pharmacokinetics

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

Indications

– Asthenic and anxious-neurotic state;

– Stuttering, tics, and enuresis in children from 3 years;

– Insomnia and night anxiety in the elderly;

– Meniere’s Disease; vertigo, associated with dysfunction of the vestibular analyzer of various origin;

– Prevention of motion sickness when kinetosis;

In the complex therapy in the treatment of alcohol withdrawal syndrome for relief of psychopathological and somatic and vegetative disorders.

Use during pregnancy and lactation

Use during pregnancy and lactation is not recommended, due to the lack of a sufficient number of clinical observations.

No mutagenic, teratogenic, or embryotoxic effects of the drug have been established in experimental animal studies.

Contraindications

Hypersensitivity to any of the components of the drug, acute renal failure, pregnancy, breast-feeding, children under 3 years of age.

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

With caution

With erosive and ulcerative lesions of the gastrointestinal tract, liver failure.

Side effects

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

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

Often: (>/= 1/100 – >< 1/10);

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

Rarely: (>/= 1/10000 – >< 1/1000);

Very rare: (< 1/10000, including isolated cases);

Frequency unknown (cannot be determined from available data).

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

Gastrointestinal disorders: frequency unknown – nausea (at the beginning of treatment);

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

Liver and biliary tract disorders: frequency unknown-development of hepatotoxicity (with prolonged use of high doses).

Interaction

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

It prolongs and enhances the effect of sleeping pills, narcotic analgesics, neuroleptics, antiparkinsonian and antiepileptic drugs.

How to take, course of use and dosage

Inside, after eating, with water.

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

Adults: 250-500 mg 3 times a day. The highest single doses: for adults-750 mg, for elderly and senile 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.

Stuttering, 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 14 years of age should take the recommended dosage 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 patients with dysfunction of the vestibular analyzer of infectious origin (otogenic labyrinthitis) and Meniere’s disease:

During the acute period, 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 mild course of diseases – 250 mg 2 times a day for 5-7 days, then 250 mg once a day for 7-10 days.

To eliminate dizziness in cases of vestibular analyzer dysfunctions of vascular and traumatic origin:

250 mg 3 times a day for 12 days.

For the prevention of motion sickness in kinetoses:

250-500 mg once 1 hour before the expected start of the trip or when the first symptoms of motion sickness appear. The anti-motion sickness effect of phenibut increases with an increase in the dose of the drug. With the onset of severe manifestations of seasickness (severe vomiting and others), the use of the drug inside is ineffective.

As part of complex therapy for alcohol withdrawal syndrome with the aim of stopping psychopathological and somatovegetative disorders:

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

It is not allowed to take a double dose to replace the missed dose.

Patients with renal and / or hepatic insufficiency with prolonged use should monitor the indicators of renal and / or liver function.

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

Overdose

Aminophenylbutyric acid is low-toxic. No overdose cases were reported.

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

Treatment: gastric lavage, taking activated charcoal, and performing symptomatic therapy. There is no specific antidote.

Description

Round biconvex tablets are white or white with a slightly yellowish tinge of color with a risk.

Special instructions

With prolonged use, it is necessary to monitor the indicators of liver functional activity 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.

Influence on the ability to drive vehicles and mechanisms

During treatment, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, since some patients may experience central nervous system disorders, such as drowsiness and dizziness.

Form of production

Tablets 250 mg.

Storage conditions

In a dark place at a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf

life is 3 years.

Do not use after the expiration date.

Active ingredient

Aminophenylbutyric acid

Conditions of release from pharmacies

By prescription

Dosage form

Tablets