Stresam® [Etifoxine]

Pharmacological properties

in therapeutic doses of Etifoxine, the hydrochloride has anxiolytic properties and has a neurovegetative regulatory effect.

In vitro and in vivo animal studies have shown that the anxiolytic effect of Etifoxine is due to a double mechanism of action (direct and indirect) on GABA_Areceptor for increasing GABAergic transmission:

direct effect on the GABA receptor_A due to positive allosteric modulation by binding mainly to β₂- or β₃- subunits; studies show that the binding site of Etifoxine to GABA_Athe receptor is different from that of benzodiazepine binding;

indirect effect due to increased production of neurosteroids in the brain (by activating mitochondrial translocation of proteins), including allopregnanolone, which are positive allosteric modulators of GABA_Areceptor.

Clinical studies have not established any withdrawal effect and addiction potential (physical or psychological).

Pharmacokinetics Ethifoxin hydrochloride is well absorbed in the digestive tract. It is rapidly metabolized, does not bind to blood cells, its plasma levels decrease slowly in three phases. The drug and its main metabolite are excreted mainly in the urine. Ethifoxin hydrochloride crosses the placental barrier.

Indications

Psychosomatic manifestations of anxiety.

Application

The doctor determines the dose and duration of treatment individually, depending on the severity of the disease.

Adults are prescribed 3-4 capsules per day for 2-3 doses. Capsules are taken before meals with a little water.

The course of treatment is from 4 to 12 weeks.

Contraindications

Hypersensitivity to the components of the drug, shock, myasthenia gravis, severe violations of the liver and / or kidneys. During pregnancy and breastfeeding.

Side effects

Dizziness is sometimes noted, which may occur at the beginning of treatment and disappear on its own with prolonged treatment.

Classification of adverse reactions according to organ systems and frequency: very often (≥1 / 10), often (from ≥1 / 100 to 1/10), infrequently (from ≥1 / 1000 to 1/100), rarely (from ≥1 / 10,000 to 1/1000), very rarely (1/10 000), the frequency is unknown (it is impossible to estimate from the available data).

In each group, adverse events are presented in decreasing order of severity in frequency.

From the nervous system: rarely - slight drowsiness at the beginning of treatment, which disappears spontaneously in the process of its continuation.

From the skin and subcutaneous tissues: rarely - skin rashes: maculopapular rash, polymorphic erythema, pruritus, facial swelling.

On the part of the immune system: very rarely - urticaria, Quinckes edema, angiodermatitis; the frequency is unknown - anaphylactic shock, drug reaction with eosinophilia and symptoms of damage to various organ systems (MRESSO syndrome), Stevens-Johnson syndrome, leukocytoclastic vasculitis.

From the hepatobiliary system: frequency is unknown - liver damage: hepatitis, cytolytic hepatitis.

From the reproductive system and mammary glands: the frequency is unknown - intermenstrual bleeding in women taking oral contraceptives.

From the digestive tract: the frequency is unknown - lymphocytic colitis.

Reports of possible adverse reactions. Reports of possible adverse reactions identified after registration of the drug are important. This allows you to control the risk / benefit ratio of the drug. Health workers are asked to report any potential side effects through the national reporting system.

special instructions

In the event of termination of treatment with stresam, the patient does not have a withdrawal syndrome.

The use of alcohol and the use of other centrally acting drugs (haloperidol, diazepam, imipramine, etc.) are not recommended during treatment with Stresam.

In case of skin or allergic reactions, or severe liver disorders, treatment with ethifoxin should be stopped immediately.

The composition of the drug includes lactose, therefore, it is not recommended to prescribe the drug to patients with congenital galactosemia, glucose / galactose malabsorption syndrome or lactase deficiency.

Use during pregnancy and lactation. During pregnancy, the use of the drug is contraindicated.

If it is necessary to use the drug, breast-feeding must be stopped.

Children. The drug is not prescribed for children due to lack of sufficient clinical data.

The ability to influence the reaction rate when driving vehicles and working with mechanisms. Given the significant undesirable individual reactions (dizziness, drowsiness), the possibility of a temporary deterioration in the ability to drive vehicles and maintain potentially dangerous mechanisms during treatment with the drug is not ruled out.

Interactions

With the simultaneous use of stresam with drugs that depress the central nervous system (morphine derivatives (analgesics, antitussives and opioid substitution therapy for drug dependence), benzodiazepines, hypnotics, antipsychotics, histamine n1-receptor blockers, antidepressants, antihypertensive drugs of the central mechanism of action, baclore ), mutual potentiation of effects may occur.

Alcohol enhances the sedative effect of Stresam.

The simultaneous use of Stresam with alcohol or with drugs that depress the central nervous system (morphine derivatives (analgesics, antitussives and opioid substitution therapy for drug dependence), benzodiazepines, hypnotics, antipsychotics, N blockers₁histamine receptors, antidepressants, antihypertensive drugs of the central mechanism of action, baclofen, thalidomide), can cause a violation of the reaction rate, which, in turn, can be dangerous when driving vehicles or other mechanisms. It is not recommended to drink alcohol, drugs containing alcohol, and drugs that depress the central nervous system during treatment with the drug.

Overdose

It manifests itself as arterial hypotension. there is a risk of drowsiness. gastric lavage is recommended. if necessary, symptomatic treatment. no specific antidote exists.

Storage conditions

At temperatures up to 25 ° c out of the reach of children.