Description
Release form
capsules
Packing
60 pcs.
Pharmacological action
PHARMACOTHERAPEUTIC GROUP: anxiolytic agent (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 have been 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 impulse transmission. When directly acting on the GABA-A receptor by allosteric modulation, etifoxin binds predominantly to subunits of the 2 or 3 receptor of the study, it was shown that ethifoxin binds to the GABA-A receptor at sites other than 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.
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 drug 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.
Special instructions
If you experience skin or allergic reactions, as well as complications from the liver, you should stop taking the drug.
If you miss a dose, you should not double the dose at the next dose.
Due to the risk of drowsiness, you should avoid driving and operating during treatment, requiring increased attention, for example, the management of various mechanisms.
is NOT RECOMMENDED TO TAKE THE DRUG WITH ALCOHOLIC BEVERAGES.
DO NOT EXCEED THE PRESCRIBED DOCTOR.
Composition
1 capsule contains:
Ethifoxin hydrochloride 50 mg
Lactose monohydrate 119 mg
Talc 15 mg
Cellulose microcrystalline 10 mg
Silicon dioxide anhydrous 3 mg spdld 3 mg srdldrd 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
inside, 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
The following are adverse events (AEs) that were noted 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. Violations of the genitals and mammary gland Frequency not found: metrorrhagia in women, taking oral contraceptives. Disorders of the gastrointestinal tract Frequency not found: lymphocytic colitis. Drug interaction potentiates the action of drugs that depress the central nervous system, such as opioid analgesics, barbiturates, hypnotics, antihistamines, antipsychotics, etc. Also enhances the effects of alcohol. Overdose Symptoms: lethargy, excessive drowsiness. Treatment: if necessary, provide symptomatic treatment. There is no specific antidote. Storage conditions at temperatures from 15oC to 25oC. Keep out of the reach and sight of children! Shelf life 3 years. Deystvuyushtee substance Эtifoksin Dosage form capsules Possible product names STRESAM 0.05 N60 CAPS STRESAM 50mg Caps. X60 Stresam caps. 50mg N60 France STRESEZ CAPS. 50MG No. 60 Stresam capsules 50 mg, 60 pcs. Biocodex, France
