Stresam, 50 mg capsules 24 pcs

Pharmacotherapeutic group:

an anxiolytic agent (tranquilizer).

TAC CODE: N05BX03

Pharmacological properties

Ethifoxine hydrochloride belongs to benzoxazine derivatives.

As an anxiolytic agent, ethifoxine has an autonomous regulatory effect. In in vitro and in vivo studies in rats and mice it was shown that the anxiolytic activity of ethifoxine is due to its dual mechanism of action (direct and mediated) on GABA-A receptors, improving GABAergic impulse transmission.

In direct action on the GABA-A receptor by allosteric modulation, ethifoxine binds preferentially to the β2 or β3 receptor subunits; studies have shown that ethifoxine binds to the GABA-A receptor at sites other than the benzodiazepine binding site. Indirect action is provided by increasing the synthesis of neurosteroids (via activation of the mitochondrial translocator protein,) such as allopregnanolone, which is also a positive allosteric modulator of the GABA-A receptor.

PHARMACOKINETICS:

It is rapidly absorbed from the GI tract and is rapidly metabolized in the liver to form several metabolites. One of the metabolites (diethyl ethifoxine) is active and has a half-life of approximately 20 hours.

It penetrates the placental barrier.

The time to reach maximum concentration in the blood is 2-3 hours, the elimination half-life is about 6 hours.

Extracted mainly in the urine as metabolites, and also in unchanged form in small amounts. It is also excreted with bile.

Indications

Attenuation of anxiety, fear, inner tension, increased irritability, decreased mood (including against the background of somatic diseases, especially cardiovascular nature).

Active ingredient

Composition

1 capsule contains:

Ethifoxine hydrochloride 50 mg

Lactose monohydrate 119 mg

Talc 15 mg

Microcrystalline cellulose 10 mg

Microcrystalline cellulose 10 mg/p>

Colloidal anhydrous silica 3 mg

Magnesium stearate 3 mg

Capsule shell composition:

titanium dioxide

gelatin

indigo carmine

DESCRIPTION:

Smooth shiny gelatin capsules #2 with a white body and blue cap. The contents are a powder of white or white with a slight yellowish tinge.

How to take, the dosage

Orally, with a small amount of water.

The dose of the drug is determined by the doctor, individually, depending on the condition of the patient.

Preferably 1 capsule 3 times a day, or 2 capsules 2 times a day is prescribed. (150-200 mg/day)

The duration of treatment is from a few days to 4-6 weeks, depending on the condition of the patient.

Interaction

Special Instructions

Lactose is present in Strezam, which should be considered when prescribing the drug to patients with galactosemia, glucose and galactose malabsorption syndrome and in case of lactase deficiency.

If the drug is missed, the dose should not be doubled at the next dose. The dose prescribed by the doctor should not be exceeded. It is not recommended to take the drug while drinking alcoholic beverages. It is not recommended to use the drug in children and adolescents under 18 years of age.

Impact on the ability to drive vehicles and operate machinery:

Due to the risk of drowsiness, driving and activities requiring increased attention, such as operating various mechanisms, should be avoided.

Contraindications

Hypersensitivity to the active ingredient or another component of the medicinal product, shock states, myasthenia gravis, severe hepatic and/or renal dysfunction. Due to the presence of lactose in the drug, the drug should not be used in case of galactosemia, glucose and galactose malabsorption syndrome, as well as in case of lactase deficiency.

It is not recommended for use under 18 years of age.

Side effects

Listed below are the adverse events (AEs) reported with this medication according to system-organ classifications and frequency of occurrence (“rare”: ≥1/10,000 and < 1/1000, “very rare”):

Nervous system disorders

Rare: Minor somnolence, appearing in the first few days of administration and usually disappearing on its own during treatment.

Skin and subcutaneous tissue disorders

Rarely: skin reactions: maculopapular rash, erythema multiforme, pruritus, facial edema.

very rarely: allergic reactions: urticaria, Quincke’s edema.

Frequency not determined: anaphylactic shock, drug-induced hypersensitivity syndrome with eosinophilia, Stevens-Johnson syndrome, leukocytoclastic vasculitis.

Hepatic and biliary tract disorders

Frequency not determined: hepatitis, cytolytic hepatitis.

Genital and mammary disorders

Frequency not known: metrorrhagia in women taking oral contraceptives.

Gastrointestinal disorders

Frequency not established: lymphocytic colitis.

Overdose

Pregnancy use

The use of the drug is contraindicated in pregnancy and during breast-feeding.

If pregnancy is detected during treatment with the drug Strezam, it is necessary to consult a physician about continuing treatment.