Stresam (Etifoxine hydrochloride)

pharmachologic effect

Anxiolytic (tranquilizer).
Etifoxine hydrochloride belongs to benzoxazine derivatives. As an anxiolytic agent, etifoxine has an autonomous regulatory effect. In vitro and in vivo studies in rats and mice showed that the anxiolytic activity of etifoxine is due to the dual mechanism of its action (direct and indirect) on GABA-A receptors, which improves GABAergic impulse transmission.

When acting directly on the GABA-A receptor through allosteric modulation, etifoxine binds predominantly to the β2- or β3-receptor subunits; studies have shown that etifoxine binds to the GABA-A receptor at sites different from the binding site of benzodiazepines. The indirect effect is achieved by increasing the synthesis of neurosteroids (via activation of mitochondrial translocator protein), such as allopregnanolone, which is also a positive aplosteric modulator of the GABA-A receptor.

Pharmacokinetics

Suction

After oral administration, the drug is quickly absorbed from the gastrointestinal tract. The time to reach Cmax in the blood is 2-3 hours.

Distribution

Penetrates through the placental barrier.

Metabolism

Rapidly metabolized in the liver to the formation of several metabolites. One of the metabolites, diethylethifoxine, is active.

Removal

T1/2 of etifoxine is about 6 hours, T1/2 of the active metabolite is 20 hours. It is excreted mainly in the urine in the form of metabolites and in small quantities unchanged; also excreted in bile.

Special instructions for the use of the drug Stresam

The drug is not prescribed to children under 15 years of age due to the lack of sufficient clinical data. If treatment with Strezam is stopped, withdrawal syndrome does not occur. Stresam does not affect the speed of psychomotor reactions, but taking into account the significant variability of individual reactions to the drug, the possibility of a temporary deterioration during treatment in the ability to drive vehicles and work with potentially dangerous mechanisms cannot be ruled out. It is not recommended to drink alcohol or use other psychotropic substances (haloperidol, diazepam, imipramine, etc.) during treatment with Strezam.

Side effects

Determination of the frequency of adverse events (AEs) observed while taking this drug: rare (≥1/10,000 and <1/1000), very rare (<1/10,000) in descending order of frequency.

From the nervous system:

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

From the skin and subcutaneous tissue:

rarely - maculopapular rash, erythema multiforme, itching, facial swelling.

Allergic reactions:

very rarely - urticaria, Quincke's edema; frequency not established - anaphylactic shock, drug-induced hypersensitivity syndrome with eosinophilia, Stevens-Johnson syndrome, leukocytoclastic vasculitis.

From the liver and biliary tract:

frequency not established - hepatitis, cytolytic hepatitis.

From the genital organs and breast:

frequency not established - metrorrhagia in women taking oral contraceptives.

From the digestive system:

frequency not established - lymphocytic colitis.

Capsules Stresam (Biocodex) - reviews

Swity

I suffer from depression and anxiety-neurotic disorders; after an accident a year ago, I suffered a serious injury to the head and spine. Astheno-neurotic states follow and, accordingly, psychosomatics rush. I always slept with Gidazepam... but then the moment came again, terrible stress, it blew me away. She explained to the psychotherapist that there was a vacuum in my head and, in general, panic attacks against the background of my neuroses... and she said that gidazepam makes me sleepy and it doesn’t help much. She switched me to Stresam... In general, the first pill lifted my spirits and made me more confident, well, I feel the drugs very quickly. Then I continued to drink it and felt the anxiety go away... somewhere far away I felt these attacks of noo very, very far away... the condition was even.. on the 5th day I began to become Aggressive.. I became very tough, then pain appeared in the thoracic region and on the left side body...then I felt a vacuum, I heard it from the side, I slept from 23.00 to 7.00 steadily. I didn’t notice any interruptions in my heart... but on the 8th, 9th, 10th day of taking it, I just started dying... what was happening to me... I was terrified. I just fell and stumbled... not that I was slowing down, but just stupidly, I became like crazy... a very terrible state. Today, after 10 days, I switched to Gidazepam... because severe dizziness began. The drug Strezam is good for relieving panic and anxiety... but the rest and the side effects made me feel so terrible.

Larisa

I took strezam - terrible heartburn after taking the capsule, especially at night

nikarenat

https://otzovik.com/review_4821023.html

The drug was prescribed to me by a neurologist, whom I see with complaints of constant headache. Vascular medications bring temporary relief, so the neurologist decided to use Stresam, which was supposed to normalize sleep and reduce general anxiety.

1 day of taking 1 tablet/3 times a day. I didn’t feel any shelves, and, accordingly, no effect either. But mine got better within the first day of taking it. It is a fact.

2 days of use in the same dosage. The dosage will be the same for the entire course of treatment. A slight anxiety appeared, which was expressed in restlessness, a desire to constantly do something.

3rd day of use: already after the morning pill I began to feel unusual anxiety, which was expressed in irritability, tremors of the arms and legs.

Day 4 of admission: from the very morning the irritation was so strong that I was ready to leave the house just to go somewhere. It was difficult to communicate normally with loved ones; everything was terribly annoying. The tremors became continuous. Tachycardia appeared.

Since there was no way to see a doctor in the near future, I stopped the drug myself.

Within 5 days everything returned to its previous state, quite stable. And although anxiety has a place in my body, it is still not as pronounced as with this drug.

Later, in consultation with a psychiatrist, I heard that this drug can cause such side effects, as it has a mild anxiolytic effect.

Well, in general, the drug is good, it is prescribed often, and is not addictive. It all depends on your disease. Find a good doctor and be open about any unwanted side effects. I will recommend it, since there are no similar organisms or reactions to the drug.

Be healthy and don't worry!!!

Kulmandi

https://otzovik.com/review_4113400.html

They gave it at the neurosis clinic. There was terrible anxiety, panic attacks, neurosis. Oh, I don’t even know who and what it can help with... well, maybe those who need enough valerian. given 3 times a day, 2-3 capsules. after a week there was zero effect, and this despite the fact that in addition to it there was a bunch of other things that, according to the instructions, were supposed to enhance the effects. Many people in the department drank it. I interviewed almost everyone with anxiety or attacks, and no one could respond positively.

Anastasia Arefieva

https://med-otzyv.ru/lekarstva/160-s/91607-strezam#scomments

Terrible drug. It feels like the roof is moving. Terrible dizziness, feeling of swelling of the face and itching all over the body.

Mila Doch

https://vk.com/topic-92998487_36470300

Strezam had no effect on me, what I took, what not. I reached 7 tablets a day, I didn’t increase it further, I was afraid for my health

Kochev V.

https://protabletky.ru/strezam/#otzivi

It has become widespread for the treatment of anxiety among neurologists, and the worries among neurologists are not in vain - the drug helps extremely rarely. For many it is not suitable at all, for some intolerance - one of the drugs that is effective in less than half of patients. No match for proven means

Olga D.

https://protabletky.ru/strezam/#otzivi

Constant worry for nothing. Expecting trouble. I was forced to see a doctor. Strezam was prescribed to help the nervous system. Perhaps it helps someone, has a beneficial effect. Three days later we had to stop taking Strezam. Aggressive behavior was combined with screaming and inappropriate actions. We have Parkinson's disease. We take other medications. The doctor suggested that it was an unfavorable reaction of the body in combination. In the instructions I read about the reaction to the body of mice. I assumed that there were no tests of the drug's reaction in humans.

special instructions

If skin or allergic reactions occur, as well as complications from the liver, the drug should be discontinued.

If you miss a dose of the drug, you should not double the dose the next time you take it.

The dose prescribed by the doctor should not be exceeded.

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 18 years of age.

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Impact on the ability to drive vehicles and operate machinery

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

Strezam and beer

Strezam and beer are incompatible. A drug based on etifoxine hydrochloride. It is a tranquilizer that relaxes muscle tissue and has a sedative effect.

Ethanol consumed increases irritability and leads to sudden mood swings. The effects of the substances are opposite.

If the patient has a history of mental disorders, irritability, nervousness, drinking alcoholic beverages is contraindicated. The disease intensifies, drug therapy becomes ineffective.

Systemic allergic reactions often occur that threaten the life and health of the patient (anaphylactic shock, urticaria, Quincke's edema).

Release form, composition and packaging

Capsules

gelatin, size No. 2, smooth, shiny, with a white body and a blue lid; the contents of the capsules are white or white powder with a slight yellowish tint.

Excipients:

lactose monohydrate - 119 mg, talc - 15 mg, microcrystalline cellulose - 10 mg, colloidal anhydrous silicon dioxide - 3 mg, magnesium stearate - 3 mg.

Shell composition:

titanium dioxide, gelatin, indigo carmine.

12 pcs. - blisters (2) - cardboard packs. 20 pcs. - blisters (3) - cardboard packs.

Brief characteristics of the drug

This is a psychotropic sedative drug prescribed for psychosomatic manifestations of anxiety and anxious states. The tranquilizer suppresses and relieves attacks of anxiety, fear and emotional stress.

The drug is produced in the form of gelatin capsules with a yellowish powder. The active component of each tablet is etifoxine hydrochloride – 50 mg.

The composition also contains talc, colloidal anhydrous silicon dioxide, lactose monohydrate, microcrystalline cellulose, magnesium stearate.

Etifoxine is absorbed from the gastrointestinal tract. After 2-3 hours its maximum concentration is recorded. The main metabolism passes through the liver, and the drug is excreted through the kidneys. Only in rare cases does a small amount mix with bile.

Contraindications for use:

• problems with kidneys, liver;
• myasthenia gravis;
• lactose intolerance;
• hypersensitivity to the components of the composition.

Also, the medicine is prohibited for use in the treatment of minor patients and pregnant women.

The instructions for use say that the drug should be taken three times a day, 50 mg. Only a doctor can adjust the dosage. The course of treatment is 4-6 weeks, depending on the stage of development of the disease.

Self-medication or improper use can lead to the following adverse reactions:

• lymphocytic colitis;
• cytolytic hepatitis;
• slight drowsiness in the initial stages;
• metrorrhagia (when taking oral contraceptives);
• skin itching and rashes, swelling, allergies;
• leukocytoclastic vasculitis.