Strezam kaps. 50 mg No. 60

Pharmacological properties

Pharmacodynamics. in therapeutic doses of an etifoksin the hydrochloride has anxiolytic properties and makes neurovegetative regulatory impact.

Research in vitro and in Vivo on animals was shown that anxiolytic influence of an etifoksin is caused by the double mechanism of action (direct and indirect) on GAMK _A - a receptor for increase in GAMK-ergichesky transfer:

direct impact on a receptor of GAMK _A thanks to positive allosteric modulation by binding mainly with β ₂ — or β ₃ — podjedinitsa; researches show that the place of binding of an etifoksin on GAMK _A - a receptor differs from that binding of benzodiazepines;

indirect influence due to increase in production of neurosteroids in a brain (by activation of a mitochondrial translocation of proteins), including an allopregnanolona which are the GAMK _{A positive allosteric modulators} - a receptor.

any effect of cancellation and potential of dependence (physical or psychological).

Pharmacokinetics. Etifoksina a hydrochloride is well soaked up in a GIT. It is quickly metabolized, does not contact blood cells, its plasma levels decrease slowly in three phases. Drug and its main metabolite are removed mainly with urine. Etifoksina a hydrochloride gets through a placental barrier.

Indication

Psychosomatic manifestations of uneasiness.

by

individually, depending on disease severity.

Adult are appointed by 3–4 capsules a day for 2–3 receptions. Capsules accept to food, washing down with a small amount of water.

Course of treatment makes from 4 to 12 weeks

Contraindication

Hypersensitivity to medicament components, a state of shock, a myasthenia, heavy abnormal liver functions and/or kidneys. period of pregnancy and feeding by a breast.

Side effects

Sometimes note dizziness which can arise in an initiation of treatment and independently disappear at long-term treatment.

Classification of side reactions by the systems of bodies and frequency: very often (≥1/10), it is frequent (from ≥1/100 to 1/10), infrequently (from ≥1/1000 to 1/100), is rare (from ≥1/10 000 to 1/1000), is very rare (1/10,000), frequency is unknown (it is impossible to estimate on the available data).

In each group in decreasing order of weight on frequency.

from nervous system: seldom — easy drowsiness in an initiation of treatment which disappears spontaneously in the course of its continuation.

from skin and hypodermic fabrics: seldom — skin rashes: makulopapulezny rash, polymorphic erythema, itching, face edema.

from the immune system: very seldom — urticaria, a Quincke's edema, angiodermit; frequency is unknown — an acute anaphylaxis, medicamentous reaction with an eosinophilia and symptoms of defeat of various systems of bodies (MPECCO a syndrome), Stephens's syndrome — Johnson, a leykotsitoklastichesky vasculitis.

from a gepatobiliarny system: frequency is unknown — injuries of a liver: hepatitis, cytolytic hepatitis.

from a reproductive system and mammary glands: frequency is unknown — intermenstrual bleedings at the women accepting oral contraceptives.

from a GIT: frequency is unknown — lymphocytic colitis.

Message about possible side reactions. Messages about the possible side reactions revealed after medicine registration are important. It the risk/advantage of medicament allows to control ratios. Health workers are asked to report about any possible by-effects through national reporting system.

Special instructions

in case of the treatment termination strezamy the patient has no withdrawal.

does not recommend alcohol intake and use of other medicaments of the central action (a haloperidol, diazepam, Imipraminum, etc.) during treatment by Strezam.

in case of skin or allergic reactions, or heavy disturbances of a liver treatment etifoksiny should be stopped immediately.

lactose therefore it is not recommended to appoint medicament sick with a congenital galactosemia, a sprue of a glucose/galactose or deficiency of lactase is a part of drug.

Use during pregnancy and feeding by a breast. During pregnancy it is contraindicated to use drug.

In case of need medicament uses feeding by a breast needs to be stopped.

Children. Drug is not appointed to children due to the lack of sufficient clinical data.

Ability to influence speed of response at control of vehicles and work with mechanisms. Taking into account considerable undesirable individual reactions (dizziness, drowsiness) the probability of temporary deterioration in ability to run vehicles and to serve potentially dangerous mechanisms during medicament treatment is not excluded.

At simultaneous use of a strezam with the medicines oppressing central nervous system (morphine derivatives (analgetics, antibechics and opioid replacement therapy of medicament addiction), benzodiazepines, sleeping medicines, neuroleptics, blockers of n1-receptors of a histamine, antidepressants, antihypertensive medicaments of the central mechanism of action, Baclofenum, thalidomide), emergence of mutual potentiation of effects is possible

Interaction.

Alcohol strengthens sedative action of Strezam.

Simultaneous use of Strezam with alcohol or with the medicines oppressing central nervous system (morphine derivatives (analgetics, antibechics and opioid replacement therapy of medicament addiction), benzodiazepines, sleeping medicines, neuroleptics, blockers of N ₁ - histamine receptors, antidepressants, antihypertensive medicaments of the central mechanism of action, Baclofenum, thalidomide), disturbance of speed of reactions can cause that, in turn, can constitute danger at control of vehicles or other mechanisms. It is not recommended to take the alcohol, medicines containing alcohol, and medicines oppressing central nervous system during medicament treatment.

Overdose

Is shown by arterial hypotension. there is a risk of development of drowsiness. gastric lavage is recommended. in case of need — symptomatic treatment. specific antidote does not exist.

Storage conditions

At a temperature up to 25 °C out of children's reach.