1 capsule contains: Active substance: etifoxine hydrochloride 50 mg. Adjuvants: lactose monohydrate - 119 mg, talc - 15 mg, microcrystalline cellulose - 10 mg, silicon dioxide, anhydrous colloidal dioxide - 3 mg. Coat: titanium dioxide, gelatin, indigo carmine.
Anxiolytic (tranquilizer). Etifoxine hydrochloride belongs to benzoxazine derivatives. As an anxiolytic agent, etifoxine has an autonomous regulatory effect. In vitro and in vivo studies in rats and mice, it was shown that the etipoxin anxiolytic activity is due to its dual mechanism of action (direct and mediated) on GABA-A receptors, which improves GABA-ergic transmission of the impulse. With a direct effect on the GABA-A receptor by allosteric modulation, etifoxine binds predominantly to the β2 or β3 receptor subunits; Studies have shown that etifoxine binds to the GABA-A receptor at sites other than the benzodiazepine binding site. Indirect action is provided by increasing the synthesis of neurosteroids (by activating the mitochondrial protein translocator), such as allopregnanolone, which is also a positive aplosteric modulator of the GABA-A receptor.
Absorption: After oral administration, the drug is rapidly absorbed from the gastrointestinal tract. The time to reach Cmax in the blood is 2-3 hours. Distribution: It penetrates the placental barrier. Metabolism: It is rapidly metabolized in the liver to form several metabolites. One of the metabolites, diethylethoxoxin, is active. Excretion: T1 / 2 of etipoxin is about 6 hours, T1 / 2 of the active metabolite is 20 hours. It is eliminated mainly with urine as metabolites and in small quantities in unchanged form; also excreted in the bile.
Treatment of psychosomatic manifestations of anxiety.
Hypersensitivity to the components of the drug. Shock conditions. Miastenia. Severe abnormal liver function. Severe renal dysfunction. Due to the presence of lactose in the composition, the drug should not be used for galactosemia, glucose malabsorption syndrome and galactose, as well as in case of lactase deficiency.Children and adolescents up to 18 years.
The use of the drug in severe liver dysfunction is contraindicated
Use during pregnancy and lactation
The use of the drug during pregnancy and during breastfeeding is not recommended. When pregnancy occurs during the treatment with Stresam, the patient should consult with a doctor about the continuation of treatment.
Dosage and administration
The doctor determines the dose and duration of the course of treatment individually, depending on the patient's condition. The drug is prescribed Inside, as a rule, 50 mg (1 capsule) 3 times / day or 100 mg (2 caps) 2 times / day. The course of treatment usually ranges from several days to 4-6 weeks. Capsules washed down with a small amount of water.
Determination of the frequency of adverse events (AEs), noted when taking this drug is rare (≥1 / 10 000 and less than 1/1000), very rarely (less than 1/10 000) in decreasing order of frequency. On the nervous system rarely - slight drowsiness that appears in the first days of reception and usually disappearing independently during the treatment. On the side of the skin and subcutaneous tissue rarely - maculo-papular rash, erythema multiforme, itching, swelling of the face. Allergic reactions are very rare - urticaria, Kvinke swelling. Frequency not established - anaphylactic shock, drug-induced hypersensitivity syndrome with eosinophilia, Stevens-Johnson syndrome, leukocytoclastic vasculitis. Frequency of the liver and biliary tract is not installed - hepatitis, cytolytic hepatitis. in women taking oral contraceptives. The frequency of the digestive system has not been established - lymphocytic colitis.
Symptoms: lethargy, excessive drowsiness. Treatment: if necessary, symptomatic therapy is carried out. The specific antidote is absent.
Interaction with other drugs
Stresam potentiates the action of drugs that inhibit the central nervous system (including opioid analgesics, barbiturates, sleeping pills, antihistamines, antipsychotics). Stresam enhances the effects of ethanol.
If you experience skin or allergic reactions, as well as complications of the liver, the drug should not be taken. If you miss a drug intake, do not double the dose at the next dose. Pediatrics: It is not recommended to use the drug in children and adolescents under the age of 18. Influence on the ability to drive vehicles and control mechanisms: Due to the risk of sleepiness should be avoided and road management activities that require attention, such as the various control mechanisms.