Instruction for use: Strezam

Trade name of the drug – Strezam

International nonproprietary name: Etifoxine

The name of the active substance in Latin: Strezam

Dosage Form: 50 mg capsule

Chemical name: ethylamino-2-methyl-4-phenyl-4-chloro-6-4N-3.1-benzoxazine hydrochloride

Composition:1 capsule contains:
Etifoxine hydrochloride 50 mg
Lactose monohydrate 119 mg
Talc 15 mg
Microcrystalline cellulose 10 mg
Colloidal anhydrous silica 3 mg
Magnesium stearate 3 mg
The composition of the capsule shell:
titanium
dioxide
gelatin
indigo carmine

Description: smooth shiny gelatin capsules ¹2 with a white body and a blue cap. Content - a powder white or white with a slight yellowish tint.
Pharmacotherapeutic group:antianxiety drug (tranquilizer).

ATX Code N05BX

Pharmacological Properties

Pharmacodynamics.

The benzoxazine derivative possesses anxiolytic activity, less sedative effect. It does not cause addiction and withdrawal symptoms. Selectively affects the SG-channels (chloride channels) supramolecular GABA-benzodiazepine-receptor complex hlorionofor inhibiting GABAergic transmission.

Pharmacokinetics.

Strezam rapidly absorbed from the gastrointestinal tract, it is rapidly metabolized in the liver to form several metabolites. One of the metabolites (diethyl etifoxine) is active and its half-life is about 20 hours. It penetrates through the placental barrier.
The time to reach maximum blood concentration - 2.3 hours, the half - about 6 hours.
Excreted mainly in urine as metabolites, and in the unchanged form in small amounts. It is also excreted in the bile.

Indications
It is used to eliminate anxiety, fear, inner tension, irritability, mood reduction, including background of systemic diseases, especially cardiovascular nature.

Contraindications
shock condition, myasthenia gravis, severe violations of the liver and / or kidney disease, hypersensitivity. Not recommended for use under the age of 18 years.

Use of the drug during pregnancy and lactation.
it is not recommended to use the drug Strezam during pregnancy. When pregnancy is detected during treatment, consult your doctor about follow-up treatment. Do not use the drug while breastfeeding.

Dosing and Administration

Strezam inside, with a small amount of water.
Dose determined by the physician individually, depending on the patient.
Usually assigned 1 capsule three times a day, or two capsules two times daily. (150-200 mg / day)
Treatment duration - from several days to 4-6 weeks, depending on the patient.

Side effects of Strezam
slight drowsiness, appearing in the first days of admission and usually disappear on their own in the course of treatment; rarely possible skin rashes and allergic reactions such as urticaria and angioedema.

Overdose of Strezam

symptoms: lethargy, excessive sleepiness. Treatment: gastric lavage with water, symptomatic treatment. There is no specific antidote.

Interaction Strezam with other drugs
Strezam potentiates the effect of drugs which depress the central nervous system, such as opioids, barbiturates, opiates, antihistamines, antipsychotics, and others. Also it enhances the effects of alcohol.

Special instructions
Due to the presence of lactose in the composition of the drug Strezam, the drug must not be used for galactosemia, malabsorption syndrome glucose and galactose, as well as in the case of lactase deficiency.
When you miss taking the drug should not double the dose the next administration.
Due to the risk of drowsiness, it should be avoided during treatment and road management activities requiring increased attention, for example, different control mechanisms.

It is not recommended to take the drug in conjunction with alcohol.Do not exceed the dose prescribed by your doctor.

Product: capsules; 12 capsules per blister PVC / aluminum blisters 2 with instructions for use in cardboard packs; 20 capsules or blisters in PVC / aluminum blisters 3 with instructions for use in cardboard packs.

Storage conditions: at a temperature of 15 ° C to 25 ° C. Keep out of the reach of children!

Shelf life: 3 years.

Conditions of supply of pharmacies by prescription.