Properties
What is it?
Trade name of the preparation: BIFREN. International Nonproprietary Name: Phenibut. Dosage form: Capsules. Main physical-chemical properties: White hard gelatin capsules. Contents of capsules - white or almost white powder. The presence of pressed columns or lumps that disintegrate upon pressing is allowed. Composition of the medicinal product: 1 capsule contains: Active substance: Phenibut 250 mg. Excipients: Microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, talc; Capsule shell: Gelatin, titanium dioxide (E 171). Dosage form. Capsules Pharmacotherapeutic group: Psychostimulants and nootropics. See blog: BIFREN – for effective management of stress and anxiety Pharmacological properties Pharmacodynamics BIFREN is a derivative of γ-aminobutyric acid and phenylethylamine. Its antihypoxic and antiamnesic effects are dominant. It has tranquilizing properties, stimulates memory and learning ability, increases physical performance; eliminates psycho-emotional tension, anxiety, fear, and improves sleep; prolongs and enhances the action of hypnotic, narcotic, neuroleptic, and anticonvulsant drugs. It does not affect choline- and adreno-receptors. The preparation prolongs the latent period of nystagmus and reduces its duration and severity, and also has an antiepileptic effect. It significantly reduces the manifestations of asthenia and vasovegetative symptoms, including headache, feeling of heaviness in the head, sleep disturbance, irritability, emotional lability, and increases mental performance. Unlike tranquilizers, under the influence of BIFREN, psychological indicators (attention, memory, speed and accuracy of sensorimotor reactions) improve. In patients with asthenia and emotional lability, from the first days of treatment with the preparation, their well-being improves, interest and initiative increase, motivation for active activity increases without sedative effect or excitation. It has been established that phenibut improves brain bioenergetics. Pharmacokinetics The preparation is well absorbed after oral administration and penetrates well into all tissues of the body, and well crosses the blood-brain barrier. Distribution in the liver and kidneys is close to uniform, while in the brain and blood it is lower than uniform. A noticeable amount of administered phenibut is detected in the urine after 3 hours, while the concentration of the preparation in brain tissue does not decrease, it is detected in the brain even after 6 hours. On the second day, phenibut can only be detected in the urine; it is found in the urine for another 2 days after administration, although the amount detected is only 5% of the administered dose. The highest binding of phenibut occurs in the liver (80%), it is non-specific. No accumulation is observed with repeated administration. Indications for use. Asthenic and anxiety-neurotic conditions (emotional lability, memory impairment, decreased concentration of attention), restlessness, fear, agitation, obsessive-compulsive neurosis; in children - stuttering, enuresis, tics; in elderly people - insomnia, nocturnal restlessness. Prevention of stressful conditions, before operations or painful diagnostic procedures. As an adjunct in the treatment of abstinence syndrome in alcoholism. It is also prescribed for Meniere's disease, dizziness associated with vestibular apparatus dysfunction, as well as for the prevention of motion sickness. Method of administration and dosage. Take orally before meals, with water. For asthenic and anxiety-neurotic conditions in adults: 250-500 mg 3 times a day. The highest single doses are: in adults - 750 mg, in elderly patients - 500 mg. The course of treatment is 2-3 weeks. If necessary, the course of treatment can be extended to 4-6 weeks. In children over 11 years old - 250 mg 3 times a day; in children over 14 years old - adult doses. To eliminate dizziness during the exacerbation of infectious vestibular apparatus dysfunction and Meniere's disease: BIFREN is prescribed 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, and then 250 mg once a day for 5 days. In case of a relatively mild course of the disease, BIFREN is taken 250 mg twice a day for 5-7 days, and then 250 mg once a day for 7-10 days. To eliminate dizziness in vascular and traumatic vestibular apparatus dysfunction: BIFREN is prescribed 250 mg 3 times a day for 12 days. For the prevention of motion sickness: 250-500 mg is prescribed once, one hour before the expected start of travel, or upon the appearance of the first symptoms. The effect of BIFREN is enhanced with increasing dose. In the presence of pronounced manifestations (vomiting, nausea), the administration of the preparation is less effective even at doses of 750-1000 mg. For the relief of alcoholic abstinence syndrome: BIFREN is prescribed 250-500 mg 3 times a day and 750 mg at night during the first days of treatment, with a gradual reduction in the daily dose to the usual adult dose. If one or more doses are missed, continue taking at the previously prescribed doses. If necessary or if well-being deteriorates, the patient should consult a doctor. Side effects. Nervous system: drowsiness (at the beginning of treatment), headache and dizziness (at doses over 2 g per day, the severity of side effects decreases with dose reduction). Gastrointestinal tract: nausea (at the beginning of treatment), vomiting, diarrhea, pain in the epigastric region. Liver and biliary tract: hepatotoxicity (with prolonged intake of high doses). Immune system: allergic reactions, including rash, itching, urticaria, skin redness. Mental disorders: emotional lability, sleep disturbance (these side effects may occur in children when the medicinal product is used in violation of the instructions for use). Contraindications. Hypersensitivity to the components of the preparation. Acute renal failure. Age up to 11 years. Overdose. BIFREN is a low-toxicity compound; only with prolonged intake of daily doses of 7-14 g can it be hepatotoxic (eosinophilia and fatty liver dystrophy were observed). Symptoms: drowsiness, nausea, vomiting, possible development of arterial hypotension, acute renal failure. Treatment: gastric lavage. Therapy is symptomatic. In case of complications (arterial hypotension, renal failure), supportive and symptomatic measures are taken. Precautions. Caution should be exercised in patients with gastrointestinal tract pathology due to the irritating effect of BIFREN. Lower doses are prescribed for these patients. With prolonged use, blood cell count and liver function test indicators are monitored. Use during pregnancy or lactation. The use of BIFREN during pregnancy or breastfeeding is contraindicated, as there is insufficient data on the use of the preparation during these periods. Children. The preparation can be used in children over 11 years of age. Peculiarities of the effect of the medicinal product on the ability to drive vehicles or operate potentially dangerous mechanisms. Patients who develop drowsiness, dizziness, or other central nervous system disorders during treatment with the preparation should refrain from driving vehicles or operating other mechanisms. Interaction with other medicinal products. BIFREN can be combined with psychotropic drugs, with a reduction in the doses of BIFREN or other drugs used with it. BIFREN enhances and prolongs the action of hypnotic, narcotic, neuroleptic anticonvulsant drugs. Dosage form. 10 capsules in a blister; 2 blisters in a cardboard box. Storage conditions. Store in the original packaging at a temperature not exceeding 25°C. Keep out of reach of children. Shelf life. 2 years Do not use after the expiry date. Conditions for dispensing from pharmacies. Pharmaceutical product group III, available without a prescription.