Expiration date: 11/2026
Active substance: Etifoxine
The drug forms
Gelatine capsules, smooth, shiny, number 2, with a white body and a blue cap; contents of capsules - powder white or white with a slight yellowish tint.
Characteristic: Anxiolytic (tranquilizer).
Pharmachologic effect: sedative, anxiolytic.
Pharmacodynamics
Benzoxazine derivative possesses anxiolytic activity, less sedative effect.
Selectively affects the supramolecular chloride channels of the GABA-benzodiazepine-receptor complex hlorionofor inhibiting GABAergic transmission. It does not cause addiction and withdrawal symptoms.
Pharmacokinetics
Suction
After oral administration, the drug is rapidly absorbed from the gastrointestinal tract. Time to Cmax in the blood - 2-3 hours.
Distribution
It penetrates through the placental barrier.
Metabolism
Rapidly metabolized in the liver to form several metabolites. One of the metabolites - dietiletifoksin - is active.
Breeding
Excreted mainly in urine as metabolites, and small amounts of unchanged. T1 / 2 etifoxine - about 6 hours, T1 / 2 of the active metabolite - 20 hours.
Testimony
Eliminating anxiety, fear, inner tension, irritability, mood decline (including on the background of somatic diseases, especially cardiovascular nature).
Contraindications
- Hypersensitivity to the drug;
- state of shock;
- myasthenia gravis;
- severe liver function;
- severe renal impairment;
- childhood and adolescence to 18 years.
Pregnancy and breast-feeding
Use of the drug during pregnancy and lactation is contraindicated.
When pregnancy is detected during treatment with Stresam®, should consult a physician about further treatment.
Side effects
CNS: slight drowsiness, appearing in the first days of admission and usually disappear on their own in the course of treatment.
Allergic reactions: seldom - skin rash, urticaria, angioedema.
Interaction
Stresam® potentiates the effect of drugs which depress the central nervous system (including opioids, barbiturates, sleeping pills, antihistamines, antipsychotics).
Stresam® increases the impact of ethanol.
Dosing and Administration
Inside, squeezed a small amount of water, 1 caps. 3 times a day or 2 capsules. Two times a day. Treatments - usually from a few days to 4-6 weeks.
The dose and duration of treatment should be determined individually depending on the patient's condition.
Overdose
Symptoms: lethargy, excessive sleepiness.
Treatment: gastric lavage with water, symptomatic treatment. There is no specific antidote.
Special instructions
As part Stresam® lactose is present, it should be considered when administering the drug to patients with galactosemia, a syndrome of malabsorption of glucose and galactose, as well as in the case of lactase deficiency.
In the event of missed doses should not double the dose the next administration.
Prescribed by the doctor dose should not be exceeded.
It is not recommended to take the drug in the use of 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
Due to road management should avoid the risk of drowsiness and activities that require attention, such as the various control mechanisms.
Storage conditions
At a temperature of 15-25 ° C.
Keep out of the reach of children.
The shelf life: 3 years.
Do not use beyond the expiration date printed on the package.
