Description
Latin name
Stresam
Release form
Capsules
Packaging
In a package of 24 capsules.
Pharmacological action
PHARMACOTHERAPEUTIC GROUP: anxiolytic drug (tranquilizer).
ATC CODE: N05BX03
PHARMACOLOGICAL PROPERTIES
Ethifoxin hydrochloride belongs to benzoxazine derivatives.
As an anxiolytic agent, etifoxin has an autonomous regulatory effect. In in vitro and in vivo studies in rats and mice, it was shown that the anxiolytic activity of etifoxin is due to the double mechanism of its action (direct and indirect) on GABA-A receptors, which improves GABA-ergic momentum transmission. When directly acting on the GABA-A receptor by allosteric modulation, etifoxin binds predominantly to subunits of the 2 or 3 receptor, studies have shown that etifoxin binds to the GABA-A receptor in different from the binding site of benzodiazepines. Indirect action is provided by increasing the synthesis of neurosteroids (by activating the mitochondrial translocation protein), such as allopregnanolone, which is also a positive allosteric modulator of the GABA-A receptor.
PHARMACOKINETICS: rapidly absorbed from the digestive tract, rapidly metabolized in the liver to form several metabolites. One of the metabolites (diethylephytoxin) is active and its half-life is about 20 hours.
Crosses the placental barrier.
The time to reach the maximum concentration in the blood is 2-3 hours, the half-life is about 6 hours.
It is excreted mainly with urine in the form of metabolites, as well as unchanged in small quantities. Also excreted with bile.
Indications
Treatment of psychosomatic manifestations of anxiety.
Contraindications
Hypersensitivity to the active ingredient or other component of the drug, shock conditions, myasthenia gravis, severe impaired liver and / or kidney function. Due to the presence of lactose in the preparation, the preparation should not be used for galactosemia, glucose and galactose malabsorption syndrome, as well as in case of lactase deficiency.
Not recommended for use under the age of 18 years.
Use during pregnancy and lactation
It is not recommended to use the drug during pregnancy. If pregnancy is detected while taking the drug, you should consult your doctor about continuing treatment.
It is not recommended to use the drug while breastfeeding.
Composition
1 capsule contains:
Ethifoxin hydrochloride 50 mg
Lactose monohydrate 119 mg
Talc 15 mg
Cellulose microcrystalline 10 mg
Silicon dioxide anhydrous 3 mg sldldrd 3 mg srdlrd indigo carmine
DESCRIPTION: smooth shiny gelatin capsules No. 2 with a white body and a blue cap. Content – white or white powder with a slight yellowish tint.
Dosage and administration of
by mouth, with a small amount of water.
The dose of the drug is determined by the doctor, individually, depending on the patient’s condition.
Typically, 1 capsule 3 times daily, or 2 capsules 2 times daily. (150-200 mg / day)
Duration of treatment – from several days to 4-6 weeks, depending on the patient’s condition.
Side effects of
The following are adverse events (AEs) observed when taking this drug, according to the classification of systemic organ classes and frequencies of occurrence ( rare : 1/10 000 and <1/1000, very rare : <1/10 000) in decreasing order of frequency. Disturbances from the nervous system Rarely: slight drowsiness that appears in the first days of admission and usually disappears on its own during treatment. Disorders of the skin and subcutaneous tissue Rarely: skin reactions: maculopapular rash, erythema multiforme, pruritus, facial edema. Very rare: allergic reactions: urticaria, Quincke’s edema. Frequency not found: anaphylactic shock, drug-induced hypersensitivity syndrome with eosinophilia, Stevens-Johnson syndrome, leukocytoclastic vasculitis. Disorders of the liver and biliary tract Frequency not found: hepatitis, cytolytic hepatitis. Genital and breast disorders Frequency not found: metrorrhagia in women taking oral contraceptives. Disorders of the gastrointestinal tract Frequency not found: lymphocytic colitis. The drug interaction of potentiates the action of CNS depressants, such as opioid analgesics, barbiturates, sleeping pills, antihistamines, neuroleptics, etc. It also enhances the effects of alcohol. Overdose Symptoms: lethargy, excessive drowsiness. Treatment: if necessary, provide symptomatic treatment. There is no specific antidote. Storage conditions for at temperatures from 15 ° C to 25 ° C. Keep out of the reach of children! The Expiration of is 3 years. Terms of delivery from pharmacies Prescription dosage form dosage form capsules Biocodex, France
