Served

Active material: Etifoxine
When ATH: N05BX03
CCF: Tranquillizer (anxiolytic)
ICD-10 codes (testimony): F40, F48.0
Manufacturer: BIOCODEX (France)

Pharmaceutical form, composition and packaging

Capsules gelatin, smooth, bright, №2, with a white body and a blue cap; contents of capsules – powder white or white with weak yellowish Sheen colors.

1 caps.
etifoxine50 mg

Excipients: lactose monohydrate, talc, microcrystalline cellulose, Colloidal anhydrous silica, magnesium stearate.

The composition of the shell: Titanium dioxide, gelatin, indigokarmin.

12 PC. – blisters (2) – packs cardboard.
20 PC. – blisters (3) – packs cardboard.

 

Pharmacological action

Anxiolytic (tranquillizer). Benzoxazine derivative, It has anxiolytic activity, less sedative effect.

Selectively affects the chlorinated channels supramolekuljarnogo GABA-benzodiazepine-chloro-ионофор receptor complex, by stimulating GABA-ergicheskuju transfer. It is addictive and syndrome “cancel”.

 

Pharmacokinetics

Absorption

After oral administration, the drug is rapidly absorbed from the gastrointestinal tract. The time to reach Cmax in the blood is 2-3 no.

Distribution

It penetrates through the placental barrier.

Metabolism

Rapidly metabolized in the liver prior to the formation of several metabolites. One of the metabolites – dietiletifoksin – It is active.

Deduction

Write mainly with urine in the form of metabolites, as well as in small quantities in an unmodified form. T1/2 each ampoule contains etiphocsine is about 6 no, T1/2 aktivnogo metabolite – 20 no.

 

Testimony

— eliminate anxiety, fear, internal stress, increased irritability, reduce mood (incl. against the background of systemic diseases, particularly cardiovascular nature).

 

Dosage regimen

 

The drug is taken orally by 1 capsule 3 times / day, or 2 capsules 2 times / day, with a little water. The course of treatment usually lasts from a few days to 4-6 weeks.

Dose and duration of treatment should be determined individually, depending on the condition of the patient.

 

Side effect

CNS: slight drowsiness, appearing in the early days of admission and typically disappearing yourself during treatment.

Allergic reactions: rarely – skin rashes, hives, angioedema.

 

Contraindications

- State of shock;

- Myasthenia;

- Severe liver;

- Severe renal dysfunction;

- Childhood and adolescence up 18 years;

- Hypersensitivity to the drug.

 

Pregnancy and lactation

Use of the drug during pregnancy and lactation is contraindicated.

Upon detection of pregnancy during treatment with Strezam®, should consult with a physician about continued treatment.

 

Cautions

Consisting of Strezama® lactose is present, that should be taken into account when appointing drug patients with galaktozemiej, malabsorption syndrome, glucose and galactose, as well as in the case of lactase deficiency.

In case of skipping the dose should not double the dose the next admission.

The doctor prescribed dose should not exceed.

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

Use in Pediatrics

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

Effects on ability to drive vehicles and management mechanisms

In connection with the risk of drowsiness should avoid vehicles and control activities, requiring greater attention, eg, control various mechanisms.

 

Overdose

Symptoms: slackness, hypersomnia.

Treatment: gastric lavage with plenty of water, symptomatic treatment. The specific antidote is absent.

 

Drug Interactions

Strezam® potenziruet effect preparations, CNS depressants (incl. Opioid analgesics, ʙarʙituratov, sleeping pills, antihistamines, neuroleptics).

Strezam® increases the impact of ethanol.

 

Conditions of supply of pharmacies

The drug is released under the prescription.

 

Conditions and terms

The drug should be stored out of reach of children at temperature from 15 ° to 25 ° C. Shelf life – 3 year.

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