Stresam, 50 mg capsules 60 pcs

Pharmacotherapeutic group:

Anxiolytic medicine (tranquilizer).

ATX 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, which improves GABAergic impulse transmission.

In direct action on the GABA-A receptor by allosteric modulation, ethifoxine binds predominantly to 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 (through 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 etifoxin) is active and has a half-life of about 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

Active ingredient

Composition

1 capsule contains:

Ethifoxine hydrochloride 50 mg

Lactose monohydrate 119 mg

Talc 15 mg

Microcrystalline cellulose 10 mg

/p>

Colloidal anhydrous silica 3 mg

Magnesium stearate 3 mg

Capsule shell composition:

titanium dioxide

gelatin

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.

Perhaps 1 capsule 3 times a day, or 2 capsules 2 times a day is usually 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

Potentiates the effect of drugs that depress the CNS, such as opioid analgesics, barbiturates, sleeping pills, antihistamines, neuroleptics, etc. Also enhances the effect of alcohol.

Special Instructions

If you miss a dose, do not double the dose the next time you take this medication.

The dose prescribed by the doctor should not be exceeded.

It is not recommended to take the drug while drinking alcoholic beverages.

Lactose is present in Strezam, which must be considered when prescribing in patients with galactosemia, glucose and galactose malabsorption syndrome, and lactase deficiency.

Pediatric use

The drug is not recommended for children and adolescents under 18 years of age.

Impact on driving and operating machinery

Because of the risk of drowsiness, driving and activities requiring increased attention, such as operating machinery, should be avoided.

Contraindications

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

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”:

<1/10,000) in decreasing order of frequency.

Nervous system disorders

Rarely: slight somnolence, appearing in the first days of administration and usually disappearing on its own during treatment.

Skin and subcutaneous tissue disorders

Rarely: skin reactions: maculopapular rash, erythema multiforme, itching, facial swelling.

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

Symptoms: lethargy, excessive sleepiness.

Treatment: gastric lavage with plenty of water, symptomatic treatment. There is no specific antidote.

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.