Expiration date: 09/2026

Pharmachologic effect: anxiolytic

Active substance: fabomotizole

Pharmacodynamics

Afobazol® - selective non-benzodiazepine anxiolytic. Acting on the ?1-receptors in nerve cells of the brain, GABA Afobazol® stabilizes / benzodiazepine receptors and restores their sensitivity to inhibition by endogenous mediators. Afobazol® also increases the bioenergy potential of nerve cells and protects them from damage (providing neuroprotection).

The drugs are sold mainly in the form of a combination of anxiolytic (anti-anxiety) and a light stimulus (activating) effects. Afobazol® reduces or eliminates anxiety (concern, foreboding, fear, irritability), tension (fearfulness, tearfulness, anxiety, inability to relax, insomnia, fear), anxiety, somatic symptoms (muscular, sensory, cardiovascular, respiratory, gastrointestinal -kishechnye symptoms), vegetative disorders (dry mouth, sweating, dizziness), cognitive disorders (difficulty concentrating, impaired memory). Especially shows the use of the drug in patients with predominantly asthenic personality traits as alarming suspiciousness, insecurity, increased vulnerability and emotional lability, tendency to emotional and stress reactions.

The effect of the drug develops 5-7 days of treatment. The maximum effect is achieved by the end of the 4th week of treatment and persists after the end of treatment an average of 2.1 weeks. Afobazol® causes muscular weakness, drowsiness and has no negative effects on concentration and memory. If its application is not formed drug dependence and withdrawal symptoms do not develop.

Pharmacokinetics

Suction

Following oral administration Afobazol® well and rapidly absorbed from the gastrointestinal tract. Cmax plasma - (0,13 ± 0,073) g / ml; Tmax - (0,85 ± 0,13) h.

Distribution

Afobazol® intensively distributed by well-vascularized organs, for it is characterized by a rapid transfer from the central pool (blood plasma) in the peripheral (highly vascularized organs and tissues).

Metabolism

Afobazol® exposed to the effect of the first passage through the liver, the main directions of the metabolism is the hydroxylation of the aromatic ring of the benzimidazole cycle and oxidation by a morpholino moiety.

Breeding

T1 / 2 of the drug Afobazol® ingestion of (0,82 ± 0,54) h. A short T1 / 2 due to intensive biotransformation of the drug and the rapid distribution of the plasma from the blood to the organs and tissues. The drug is excreted mainly as metabolites and some unchanged in the urine and feces.

Testimony

• Anxiety disorders in adults:
  
• Generalized anxiety disorder;
  
• Neurasthenia;
  
• Adjustment disorder;
  
• Various somatic diseases (asthma, irritable bowel syndrome, systemic lupus erythematosus, ischemic heart disease, hypertension, arrhythmias), including: dermatological, oncological;
  
• Treatment of sleep disorders associated with anxiety;
  
• Cardiopsychoneurosis;
  
• Premenstrual syndrome;
  
• Alcohol withdrawal syndrome;
  
• Relief of withdrawal when quitting smoking.
  

Contraindications

• idiosyncrasy of the drug;
  
• galactose intolerance, lactase deficiency or glucose-galactose malabsorption;
  
• pregnancy;
  
• lactation;
  
• children's age (18 years).
  

Side effects

Allergic reactions are possible.

Rarely - headache, which usually resolves on its own and does not require discontinuation of therapy.

Interaction

Afobazol® does not react with ethanol and does not affect the hypnotic effect of thiopental. It enhances the anticonvulsant effect of carbamazepine. It is strengthening the anxiolytic effect of diazepam.

Dosing and Administration

Inside, after a meal.

The optimal single dose - 10 mg daily - 30 mg for 3 doses distributed over the day. The duration of a course of the drug is 2-4 weeks.

If necessary, on doctor's advice, the daily dose can be increased to 60 mg, and the duration of the treatment and 3 months.

Overdose

Symptoms may develop sedation and increased sleepiness without manifestations of muscle relaxation (with a large overdose and toxicity).

Treatment: As introduced emergency n / a 20% solution of caffeine sodium benzoate and 1 ml 2-3 times a day.

Special instructions

Effects on ability to drive and use machines. The drug has no negative impact on the vehicle driving and performing potentially hazardous activities that require high concentration and speed of psychomotor reactions.

Release Form

Tablets of 5 mg or 10 mg. In blisters, 10, 20 or 25 pieces. The resin bank 30, 50, 100 or 120 units. Each bank or 3, 5 or 10 contour packs Table 10., Or 1, 2, 3, 4 or 6, contour packs Table 20., Or 2 or 4-outline packages of Table 25. a stack of cardboard.

Manufacturer

JSC "Pharmstandard". 305022, Kursk, st. 2nd Aggregate 1a / 18.

www.pharmstd.ru

Storage conditions

The temperature is not above 25 ° C.

Keep out of the reach of children.

Shelf-life: 3 years.

Do not use beyond the expiration date printed on the package.