Stresam, capsules 50 mg, 60 pcs.

Composition

1 capsule contains:

Etifoxin Hydrochloride 50 mg

Lactose monohydrate 119 mg

Talcum powder 15 mg

Microcrystalline cellulose 10 mg

Colloidal anhydrous silicon dioxide 3 mg

Magnesium Stearate 3 mg

Capsule shell composition:

• Titanium Dioxide

• gelatin

indigo carmine DESCRIPTION: smooth shiny gelatin capsules No.2 with a white body and a blue cap. Contents – white or white powder with a slight yellowish tinge of color.

Pharmacological action

PHARMACOTHERAPY GROUP:

an anxiolytic agent (a tranquilizer).

ATX CODE: N05BX03

PHARMACOLOGICAL PROPERTIES

Etifoxine hydrochloride belongs to the benzoxazine derivatives.

As an anxiolytic agent, etifoxin has an autonomous regulatory effect. In vitro and in vivo studies in rats and mice have shown that the anxiolytic activity of etifoxin is due to the dual mechanism of its action (direct and indirect) on GABA-A receptors, which improves GABA-ergic impulse transmission.

When directly exposed to the GABA-A receptor by allosteric modulation, etifoxin binds predominantly to the β2 or β3 receptor subunits; studies have shown that etifoxin binds to the GABA-A receptor at sites other than the benzodiazepine binding site. The indirect effect is achieved by increasing the synthesis of neurosteroids (by activating 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 gastrointestinal tract and rapidly metabolized in the liver to form several metabolites. One of the metabolites (diethylethyphoxine) is active and has a half-life of about 20 hours.

Penetrates 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 mainly excreted in the urine in the form of metabolites, as well as in unchanged form in small amounts. It is also excreted in the bile.

Indications

• Elimination of anxiety,
• increased irritability,
• fear,
• internal tension,
• decreased mood (including against the background of somatic diseases, especially of a cardiovascular nature).

Use during pregnancy and lactation

The use of the drug during pregnancy and lactation is contraindicated.

If pregnancy is detected during treatment with Stresam, you should consult your doctor about continuing treatment.

Contraindications

Hypersensitivity to the active ingredient or other component of the drug, shock, myasthenia gravis, severe liver and/or kidney function disorders. Due to the presence of lactose in the composition of the drug, the drug should not be used for galactosemia, glucose and galactose malabsorption syndrome, as well as in the case of lactase deficiency.

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

Side effects

Adverse events (AES) reported with this medication are listed below, according to classification by organ-system classes and frequency of occurrence (“rare”: ≥1/10 000 and:

<1/10 000) in descending order of frequency.

Nervous system disorders

Rare: slight drowsiness that appears in the first days of treatment and usually disappears on its own during treatment.

Skin and subcutaneous tissue disorders

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

Very rare: allergic reactions: urticaria, angioedema.

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

Liver and biliary tract

disorders Frequency not established: hepatitis, cytolytic hepatitis.

Genital and breast disorders

Frequency not established: metrorrhagia in women taking oral contraceptives.

Gastrointestinal disorders

Frequency not established: lymphocytic colitis.

Interaction

potentiates the action of drugs that depress the central nervous system, such as opioid analgesics, barbiturates, sleeping pills, antihistamines, neuroleptics, etc. It also increases the effects of alcohol.

How to take, course of administration and dosage

inside, with a small amount of water.

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

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

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

Overdose

Symptoms: lethargy, excessive sleepiness.

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

Special instructions

If you skip taking the drug, do not double the dose at the next dose.

The dose prescribed by the doctor should not be exceeded.

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

The composition of Stresam contains lactose, which should be taken into account when prescribing the drug to patients with galactosemia, glucose and galactose malabsorption syndrome, as well as in the case of lactase deficiency.

Use in pediatrics

It is not recommended to use the drug in children and adolescents under the age of 18 years.

Influence on the ability to drive motor vehicles and manage mechanisms

Due to the risk of drowsiness, avoid driving vehicles and activities that require increased attention, such as driving various mechanisms.

Form of production

Capsules

Storage conditions

At a temperature of 15-25 °C

Shelf life

3 years

Active ingredient

Etifoxin

Conditions of release from pharmacies

By prescription

Dosage form

of capsule

Weight

Weight: 35 gr.