Pharmacological properties

Pharmacodynamics. Bifren is derivative γ-aminobutyric acid and a feniletilamin. Its anti-hypoxemic and anti-amnestic action is dominating. Has tranquilizing properties, stimulates memory and learning ability, increases physical effeciency; eliminates psychoemotional tension, uneasiness, fear and improves a dream; extends and strengthens effect of hypnotic drugs, narcotic, antipsychotic and anticonvulsants. Does not influence well-cared and adrenoceptors. Drug extends stage of latency and reduces duration and expressiveness of a nystagmus, has antiepileptic effect. Considerably reduces severity of an asthenia and vazovegetativny symptoms, including a headache, heavy feeling in the head, a sleep disorder, irritability, emotional lability, increases intellectual working capacity. Unlike tranquilizers, under the influence of medicine bifren psychological indicators (attention, memory, speed and accuracy of sensory-motor reactions) improve. At patients with an asthenia and at emotionally labile patients from the first days of therapy by medicine the health improves, interest and an initiative, motivation in vigorous activity without sedation or excitement increases. It is established that Phenibutum improves brain bio-energetics.

Pharmacokinetics. Drug is well soaked up after oral administration and well gets into all body tissues, well gets through GEB. Distribution in a liver and kidneys is close to uniform, and in a brain and blood — below uniform. In 3 h the noticeable amount of the entered Phenibutum is defined in urine, in the same time the concentration of medicine in tissue of a brain does not decrease, it is revealed in a brain in 6 h

Phenibutum can be defined Next day only in urine; it is found in urine in 2 days after reception, however the revealed quantity is only 5% of the entered dose.

Greatest binding of Phenibutum happens in a liver (80%), it is not specific.

At repeated introduction of cumulation it is noted p.

Indication

Asthenic and alarming and neurotic states (emotional lability, memory violation, decrease in concentration of attention), concern, fear, alarm, neurosis of persuasive states;

• at children — stutter, enuresis, tics; elderly people have insomnia, night concern.

Prevention of stressful states, before operations or painful diagnostic tests.

As supportive application during treatment of an abstinence syndrome at alcoholism.

is Appointed also at Menyer's disease, dizzinesses connected with dysfunction of a vestibular mechanism for motion desease prevention.

Use

is Applied inside before consumption of food, washing down with water.

At asthenic and alarming and neurotic states the adult: appoint 250–500 mg 3 times a day. The highest single doses: for adults — 750 mg, for patients of advanced age — 500 mg.

Course of treatment makes 2–3 weeks. In case of need it is possible to increase a course of treatment up to 4–6 weeks

to Children aged from 11 years — on 250 mg 3 times in day; to children aged from 14 years — doses for adults.

For elimination of dizziness at dysfunction of a vestibular mechanism of infectious genesis and Menyer's disease during aggravation: Bifren appoint 750 mg 3 times a day within 5–7 days, at reduction of expressiveness of vestibular frustration — on 250–500 mg 3 times a day within 5–7 days, and then on 250 mg of 1 times a day for 5 days. At rather easy course of diseases Bifren accept 250 mg 2 times a day within 5–7 days, and then — on 250 mg of 1 times a day within 7–10 days.

For elimination of dizziness at dysfunction of a vestibular mechanism of vascular and traumatic genesis: Bifren appoint 250 mg 3 times a day for 12 days.

For motion desease prevention: appoint in a dose 250–500 mg once for 1 h till the expected beginning of rolling or at emergence of the first symptoms.

Effect of the medicine Bifren amplifies at increase in a dose.

in the presence of the significant manifestations (vomiting, nausea) even in a dose of 750-1000 mg.

For knocking over of an alcoholic abstinence syndrome: Bifren in the first days of treatment appoint 250–500 mg 3 times a day and 750 mg to night, with gradual decrease in a daily dose to usual for adults.

, continue reception in earlier appointed doses. If necessary or at deterioration in health the patient should consult with the doctor.

Children. Drug can be used at children aged from 11 years.

Contraindication

Hypersensitivity to medicine components. opn. children's age up to 11 years.

Side effects

from nervous system: drowsiness (in an initiation of treatment), a headache and dizziness (in doses it is higher than 2 g/days, at a dose decline the expressiveness of side effect decreases).

from digestive system: nausea (in an initiation of treatment), vomiting, diarrhea, pain in epigastric area.

from a liver and biliary tract: hepatotoxicity (at prolonged use of high doses).

from the immune system: allergic reactions, including rash, an itch, urticaria, erubescence.

Disturbance of mentality: emotional lability, a sleep disorder (these side reactions can be observed at children at use of medicine not according to the instruction for application).

Special instructions

Should be careful the patient with pathology of a digestive tract because of irritable effect of medicine bifren. This patient appoint lower doses. At prolonged use control cellular composition of blood, indicators of functional hepatic trials.

Use during pregnancy or feeding by a breast. Use of the medicine Bifren during pregnancy or feeding by a breast contraindicated as there are no sufficient data concerning use of medicine during this period.

Ability to influence speed of response at control of vehicles or other mechanisms. Patients at whom during medicament treatment arise drowsiness, dizziness or other violations from central nervous system should abstain from control of vehicles or work with other mechanisms.

Interaction

Bifren can be combined with psychotropic medicines, reducing medicine doses bifren and the medicines applied with it.

and extends effect of hypnotic drugs, narcotic, antipsychotic and anticonvulsants.

Overdose

Bifren — low-toxic connection, only in a daily dose of 7-14 g at prolonged use it can be hepatotoxic (the eosinophilia and fat dystrophy of a liver were observed).

Symptoms: drowsiness, nausea, vomiting, development of arterial hypotension, OPN is possible.

Treatment: gastric lavage. Symptomatic therapy.

At complications (arterial hypotension, a renal failure) take auxiliary and symptomatic measures.

Storage conditions

In original packing at a temperature not above 25 °C.