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Active ingredients
Aminophenylbutyric acid
Release form
Pills
Composition
Each tablet contains: active ingredient: Phenibut hydrochloride (Phenibut) - 250 mg. Excipients: lactose monohydrate, povidone K-25, calcium stearate, potato starch.
Pharmacological effect
Tranquilizer, gamma-aminobutyric acid derivative (GABA) and phenylethylamine. Does not affect cholino and adrenoreceptors. It eliminates tension, anxiety, fear, improves sleep. The drug shortens the duration and severity of nystagmus. It has anticonvulsant action. Phenibut reduces the manifestations of asthenia and vasic-vegetative symptoms, including headache, feeling of heaviness in the head, irritability, emotional lability, increases mental performance. Attention, memory, speed and accuracy of sensory motor reactions under the influence of Phenibut are improved. It is established that when Phenibut is used for traumatic brain injury, the number of mitochondria in the cells located hearth lesion. Phenibut also has an antioxidant effect.
Pharmacokinetics
The absorption of the drug is high, it penetrates well into all tissues of the body and through the blood-brain barrier (BBB). About 0.1% of the injected dose of the drug penetrates into the brain tissue, and in young and old people to a much greater extent. Evenly distributed in the liver and kidneys. Metabolized in the liver -80-95%, metabolites are not pharmacologically active. Not cumulated. After 3 hours, it begins to be excreted by the kidneys, while the concentration in the brain tissue does not decrease and is found in the brain for an additional 6 hours. About 5% is excreted by the kidneys unchanged, partly with bile.
Indications
Asthenic and anxiety-neurotic states, anxiety, fear, obsessive-compulsive disorder, psychopathy. Stuttering and tics in children, enuresis. Retention of urine on the background of myelodysplasias. Insomnia and nightmares in the elderly. Prevention of anxiety states that arise before surgical interventions and painful diagnostic studies (sedation). Meniere's disease, dizziness associated with dysfunctions of the vestibular analyzer of various origins (including with otogenic labyrinthitis, vascular and traumatic disorders).prevention of kinetozakh. Primary open-angle glaucoma (as part of combination therapy). As an auxiliary therapy in the treatment of alcoholism (for stopping psychopathological and somatovegetative disorders with withdrawal syndrome). Treatment of precririous and delirious conditions in alcoholism (in combination with conventional detoxification agents).
Contraindications
Hypersensitivity to the components of the drug, liver failure, pregnancy, lactation. With care: erosive and ulcerative lesions of the gastrointestinal tract.
Precautionary measures
It is used with caution in patients with a state of alcohol withdrawal with convulsions in history, as well as in patients with severe traumatic brain injury.
Use during pregnancy and lactation
During pregnancy and lactation Phenibut can be used, but only with a ratio of benefits and risks for mother and child.
Dosage and administration
Inside, after eating. Adults appoint 250-500 mg 3 times a day. The maximum single dose in adults - 750 mg, in patients over 60 years old - 500 mg. The course of treatment is 2-3 weeks. If necessary, the course can be extended to 4-6 weeks. The duration of the course of treatment is determined by the doctor taking into account the peculiarities of the disease, tolerance of the drug and the effect achieved. Children aged 8 to 14 years - 250 mg 3 times a day. Children older than 14 years are prescribed doses for adults. For stopping of alcohol withdrawal syndrome in the first days of treatment - 250-500 mg 3 times a day and 750 mg - at night, with a gradual decrease in the daily dose to the usual for adults. With the disease and Meniere's syndrome in the period of exacerbation - 750 mg 3 times a day for 5-7 days, while reducing the severity of vestibular disorders - 250-500 mg 3 times a day for 5-7 days and then - 250 mg 1 time per day for 5 days. With a mild course of the disease - 250 mg 2 times a day for 5-7 days, followed by a dose reduction to 250 mg 1 time per day for 7-10 days. For the treatment of dizziness with dysfunctions of the vestibular analyzer of vascular and traumatic genesis - 250 mg 3 times a day for 12 days. For the prevention of motion sickness - 250-500 mg once for 1 hour before the intended journey (the effect is dose-dependent). Phenibut is ineffective in the development of pronounced phenomena of motion sickness (“indomitable” vomiting, dizziness, and other symptoms).In patients with impaired liver function, high doses of phenibut can cause a hepatotoxic effect. Patients in this group are assigned smaller doses of the drug under the control of liver function. There are no data on the adverse effects of phenibut on patients with impaired renal function when taking therapeutic doses.
Side effects
The classification of undesirable side reactions according to the frequency of development is very often (≥1 / 10). often (≥ 1/100 to less than 1/10). infrequently (≥ 1/1000 to less than 1/100). rarely (≥ 1/10 000 to less than 1/1000). very rarely (less than 1/10 000). * - frequency of manifestation is not known (it is impossible to determine by available data). Violations of the nervous system * Drowsiness (at the beginning of treatment), increased irritability, agitation, anxiety, dizziness, headache. Violations of the gastrointestinal tract * nausea (in treatment). Disorders of the skin and subcutaneous tissues rarely - allergic reactions (skin rash, itching). Disorders of the liver and biliary tract * with prolonged use of high doses - hepatotoxicity.
Overdose
Increased symptoms of side effects: severe drowsiness, nausea, vomiting, fatty liver (taking more than 7 g), eosinophilia, lowering blood pressure, impaired renal function. First aid - gastric lavage, taking activated charcoal and conducting symptomatic therapy.
Interaction with other drugs
In order to mutually potentiate, Phenibut can be combined with other psychotropic drugs, reducing the doses of Phenibut and the drugs that are combined with it. Lengthens and strengthens the effect of hypnotic drugs, narcotic, neuroleptic and anticonvulsant drugs, alcohol. There is evidence of an increase in the action of antiparkinsonian drugs under the influence of the drug Fenibut.
special instructions
Phenibut is used with caution in erosive and ulcerative lesions of the gastrointestinal tract, liver failure. With long-term use of Phenibut, it is necessary to monitor indicators of liver function and peripheral blood picture. refrain from potentially hazardous activities requiring increased attention and high-speed psychomotor reactions.