Manufacturer: Vertex, Russia
Active ingredient: Aminophenylbutyric acid
Shelf life: Long shelf life
One box contains 20 tablets of 250mg aminophenylbutyric acid hydrochloride (phenibut)

Pharmacotherapeutic group: Other psychostimulants and nootropic drugs. 

Pharmacodynamics
Aminophenylbutyric acid is a derivative of g-aminobutyric acid and phenylethylamine. It has tranquilizing properties, stimulates memory and learning ability, increases physical performance, eliminates psychoemotional tension, anxiety and fear, improves sleep. Does not affect cholino- and adrenoreceptors.

Aminophenylbutyric acid prolongs the latent period, shortens the duration and severity of nystagmus. Noticeably reduces the manifestations of asthenia and vasovegetative symptoms, including headache, a feeling of heaviness in the head, sleep disturbances, irritability, emotional lability, increases interest and initiative, motivation for active work without a sedative effect or excitement.

Unlike tranquilizers, under the influence of aminophenylbutyric acid, psychological indicators improve (attention, memory, speed and accuracy of sensory-motor reactions). The formation of addiction and dependence on the drug, withdrawal syndrome is not noted.

Pharmacokinetics
After oral administration, aminophenylbutyric acid is well absorbed and penetrates into all tissues of the body.

About 0.1% of g-amino-β-phenylbutyric acid from the administered dose of the drug penetrates into the brain tissue.

In young and elderly patients, penetration through the blood-brain barrier may increase. After 3 hours, g-amino-β-phenylbutyric acid is detected in the urine. At the same time, the concentration in the brain tissue does not decrease, g-amino-β-phenylbutyric acid is detected in the brain after another 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 unchanged. The next day after administration, g-amino-β-phenylbutyric acid can be detected only in the urine. It is determined in the urine two days after administration, but the detectable amount is 5% of the administered dose.

The greatest binding of g-amino-β-phenylbutyric acid occurs in the liver (80%), it is not specific. With repeated administration, the drug does not accumulate in the body.
Indications
- asthenic and anxiety-neurotic states;
- stuttering, tics, enuresis in children;
- insomnia and night anxiety in the elderly;
- Meniere's disease, dizziness associated with dysfunctions of the vestibular analyzer of various origins;
- prevention of motion sickness in motion sickness;
- as part of complex therapy for alcohol withdrawal syndrome to relieve psychopathological and somatovegetative disorders.

Use during pregnancy and breastfeeding
It is not recommended to use the drug during pregnancy and breastfeeding due to the lack of experience of clinical use in this category of patients.
Experimental studies on animals have not revealed any mutagenic, teratogenic or embryotoxic effects of aminophenylbutyric acid.

Contraindications
- hypersensitivity to the active substance or auxiliary components of the drug;
- acute renal failure;
- pregnancy;
- breastfeeding period;
- children under 3 years of age;
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

With caution
For patients with erosive and ulcerative diseases of the gastrointestinal tract due to the irritating effect of aminophenylbutyric acid, it is recommended to prescribe smaller doses of the drug.

Side effects
Classification of the frequency of development of side effects according to the recommendations of the World Health Organization (WHO):
very common ≥ 1/10;
common from ≥ 1/100 to < 1/10;
uncommon from ≥ 1/1000 to < 1/100;
rare from ≥ 1/10000 to < 1/1000;
very rare < 1/10,000, including isolated reports;
frequency unknown – it is not possible to determine the frequency of occurrence based on the available data.
Gastrointestinal disorders:
frequency unknown – nausea (at the beginning of treatment).
Nervous system disorders:
frequency unknown – drowsiness, dizziness, headache.
Skin and subcutaneous tissue disorders:
rarely – allergic reactions (skin rash, itching).
Liver and biliary tract disorders:
frequency unknown – hepatotoxicity (with prolonged use of high doses).
If any of the side effects listed in the instructions for use worsen, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction
For the purpose of mutual potentiation, aminophenylbutyric acid may be combined with other psychotropic agents, reducing the doses of the drug and combined medications. The drug prolongs and enhances the effect of hypnotics, neuroleptics and antiparkinsonian drugs.

How to take, course of administration and dosage
Orally after meals, with water. Do not chew.
Asthenic and anxiety-neurotic conditions:
Adults: 250-500 mg 3 times a day. Highest single doses: for adults - 750 mg, for patients over 60 years old - 500 mg. If necessary, the daily dose is increased to 2.5 g (2500 mg). The course of treatment is 4-6 weeks.
Children: from 3 to 8 years old – 125 mg (1/2 tablet 250 mg) 2-3 times a day; from 8 to 14 years old – 250 mg 2-3 times a day; children over 14 years old – adult doses.
Stuttering, tics, enuresis in children:
From 3 to 8 years old – 125 mg (1/2 tablet 250 mg) 2-3 times a day; from 8 to 14 years old – 250 mg 2-3 times a day; children over 14 years old – adult doses.
Insomnia and night anxiety in the elderly:
250-500 mg 3 times a day.
To eliminate dizziness caused by dysfunction of the vestibular analyzer of infectious genesis (otogenic labyrinthitis) and Meniere's disease:
During an exacerbation, 750 mg is prescribed 3 times a day for 5-7 days; when the severity of vestibular disorders decreases, 250-500 mg is prescribed 3 times a day for 5-7 days, then 250 mg is prescribed 1 time per day for 5 days. In relatively mild cases, 250 mg is prescribed 2 times a day for 5-7 days, then 250 mg is prescribed once a day for 7-10 days.
To eliminate dizziness caused by dysfunctions of the vestibular analyzer of vascular and traumatic genesis:
Prescribed at 250 mg 3 times a day for 12 days.
To prevent motion sickness during motion sickness:
250-500 mg once an hour before the expected trip or when the first symptoms of motion sickness appear. The anti-motion sickness effect of aminophenylbutyric acid increases with increasing doses. When severe symptoms of seasickness occur (uncontrollable vomiting and others), taking aminophenylbutyric acid orally is ineffective even at a dose of 750-1000 mg.
As part of complex therapy for alcohol withdrawal syndrome in order to relieve 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 reduction in the daily dose to the usual one for adults.
Never take a double dose to make up for a missed dose.
In patients with renal and/or hepatic insufficiency, renal and/or hepatic function indicators should be monitored during long-term use.
In case of liver dysfunction, high doses of aminophenylbutyric acid may cause hepatotoxicity. Patients are prescribed less effective doses.

Overdose
Aminophenylbutyric acid is low toxic. There are no reports of overdose.
Symptoms
Drowsiness, nausea, vomiting, dizziness. With prolonged use of high doses, eosinophilia, decreased blood pressure, renal dysfunction, fatty liver disease (with intake of more than 7 g) may develop.
Treatment
Gastric lavage, symptomatic treatment, maintenance of vital functions. There is no specific antidote.

Description
Round, flat-cylindrical tablets from white to white with a slightly yellowish tint with a bevel and a score line.
Impact on the ability to drive vehicles and operate machinery
During treatment, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions, since some patients may experience central nervous system disorders such as drowsiness and dizziness (see section "Side effects").

Special instructions
With long-term use, it is necessary to monitor the cellular composition of the blood and liver function indicators.

Release form
Tablets 250 mg.
10 tablets in a blister pack made of polyvinyl chloride film and aluminum foil.
20 tablets in a high density polyethylene jar.
1, 2, 3, 4 or 6 blister packs of 10 tablets or one jar together with instructions for use in a cardboard box.

Storage conditions
Store in a place protected from light at a temperature not exceeding 25 °C.
Keep out of reach of children.