Producer: CJSC Pharmfirma Soteks Russia
Code of automatic telephone exchange: N05BX
Release form: Firm dosage forms. Capsules.
General characteristics. Structure:
Active ingredient: aminophenyl-butyric acid a hydrochloride - 25 mg or 50 mg, either 125 mg, or 250 mg.
Excipients: hypro rod, silicon dioxide colloid, lactose, magnesium stearate. Gelatinous solid capsules contain: for a dosage of 25 mg - water, gelatin, titanium dioxide (Е 171); for a dosage of 50 mg - water, gelatin, dye an azoruby (Е 122), dye diamond blue (Е 133), dye quinolinic yellow (Е 104), titanium dioxide (Е 171); for a dosage of 125 mg - water, gelatin, dye an azoruby (Е 122), dye diamond blue (Е 133), titanium dioxide (Е 171); for a dosage of 250 mg - water, gelatin, dye an azoruby (Е 122), dye diamond blue (Е 133), titanium dioxide (Е 171).
Description. A dosage of 25 mg - capsules firm gelatinous No. 3 of white color. A dosage of 50 mg - capsules firm gelatinous No. 3, the case of white color, a cover of blue color. A dosage of 125 mg - capsules firm gelatinous No. 2, the case of white color, a cover of blue color. A dosage of 250 mg - capsules firm gelatinous No. 0, the case of white color, a cover of dark blue color. Contents of capsules - mix of powder and/or granules of color, white or white with a yellowish shade.
Pharmacodynamics. Nootropic means, facilitates GAMK-oposredovannuyu transfer of nervous impulses in the central nervous system (direct impact on GAMK-ergichesky receptors). Tranquilizing action is combined with the activating effect.
Also possesses antiagregantny, antioxidant and some anticonvulsant action. Improves a functional condition of a brain due to normalization of his metabolism and influence on a brain blood stream (increases volume and linear speed, reduces vascular resistance, improves microcirculation, has antiagregantny effect). Extends stage of latency and shortens duration and expressiveness of a nystagmus. Does not influence on holino-and adrenoceptors. Reduces vazovegetativny symptoms (including a headache, heavy feeling in the head, sleep disorders, irritability, emotional lability). At course reception increases physical and intellectual effeciency (attention, memory, speed and accuracy of sensory-motor reactions). Reduces manifestations of an adynamy (improves health, increases interest and an initiative (motivation of activity)) without sedation or excitement.
Promotes decrease in feeling of alarm, tension and concern, normalizes a dream. Does not cause oppression of the central nervous system in people of advanced age, the muscular weakening after-effect most often is absent.
Pharmacokinetics. Absorption is high, well gets into all body tissues and through a blood-brain barrier (about 0,1% of the entered drug dose, and at persons of young and advanced age in much bigger degree get into tissues of a brain). It is evenly distributed in a liver and kidneys. It is metabolized in a liver - 80-95%, metabolites are pharmacological not active. Does not kumulirut. In 3 h it begins to be removed by kidneys, at the same time concentration in tissue of a brain does not decrease and found during 6 h. About 5% are removed by kidneys in not changed look, partially with bile.
Indications to use:
Sleeplessness and night alarm at elderly. Menyer's disease, dizzinesses connected with dysfunctions of a vestibular analyzer of various genesis; prevention of a motion desease at kinetoza. As a part of complex therapy of an alcoholic abstinence syndrome for stopping of psychopathological and somatovegetativny frustration.
Route of administration and doses:
Inside after food 2-3-week courses. To adults and children since 14 years on 250-500 mg 3 times a day (the maximum daily dose of 2500 mg). To children from 3rd to 8 years on 50-100 mg 3 times a day; from 8 to 14 years - on 250 mg 3 times a day; from 8 to 14 years – on 250 mg 3 times a day.
The single maximum dose at adults and children from 14 years makes 750 mg, at persons 60 years - 500 mg are more senior, children up to 8 years have 150 mg, from 8 to 14 years - 250 mg.
Features of use:
At prolonged use it is necessary to control periodically indicators of function of a liver and peripheral blood. It is necessary to abstain from potentially dangerous types of activity demanding the increased concentration of attention.
Interaction with other medicines:
Extends and strengthens action of hypnagogues, narcotic analgetics, neuroleptics, protivoparkinsonichesky and antiepileptic means.
Hypersensitivity, pregnancy, breastfeeding, children's age up to 3 years. With care: at an erozivnoyazvenny gastrointestinal tract disease, a liver failure.
Symptoms: the expressed drowsiness, nausea, vomiting, fatty dystrophy of a liver (reception more than 7 g), an eosinophilia, a lowering of arterial pressure, a renal failure. Treatment: gastric lavage, reception of absorbent carbon and performing symptomatic therapy.
List B. In the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 3 years. Not to use after the period of validity specified on packaging.
According to the recipe
Capsules of 25 mg, 50 mg, 125 mg, 250 mg.