Fabomotisol (Fabomotizole)

Pharmacodynamics Pharmacokinetics Indications Carefully Contraindications Dosing and Administration Side effects
Read on
Clinical and pharmacological group: & nbsp

Anxiolytics

Included in the formulation
  • Afobazol®
    pills inwards 
    OTISIFARM, OJSC     Russia
    • АТХ:

    N.05.B.X   Other anxiolytics

    N.05.B.X.04   Fabomotisol

    Pharmacodynamics:

    CSelective non-benzodiazepine anxiolytic. Acting on sigma-1 receptors in nerve cells of the brain, it stabilizes GABA / benzodiazepine receptors and restores their sensitivity to endogenous mediators of inhibition. Increases the bioenergetic potential of nerve cells and protects them from damage (has a neuroprotective effect).

    The effect of the drug is realized mainly in the form of a combination of anxiolytic (anti-anxiety) and light stimulating (activating) effects. Reduces or eliminates feelings of anxiety (anxiety, bad forebodings, fears, irritability), tension (fearfulness, tearfulness, anxiety, inability to relax, insomnia, fear), somatic manifestations of anxiety (muscular, sensory, cardiovascular, respiratory, gastrointestinal symptoms), vegetative disorders (dry mouth, sweating, dizziness), cognitive disorders (difficulty concentrating, weakened memory). Particularly shown is the use of the drug in individuals with predominantly asthenic personality traits in the form of anxious suspiciousness, uncertainty,increased vulnerability and emotional lability, a tendency to emotional-stressful reactions.

    Pharmacokinetics:

    After oral administration, it is absorbed well and quickly from the digestive tract. Maximum concentration in plasma - (0.13 ± 0.073) μg / ml; time to reach maximum concentration (0.85 ± 0.13) h.

    Intensively distributed over well-vascularized organs, it is characterized by rapid transfer from the central pool (blood plasma) to the peripheral (highly vascularized organs and tissues).

    Exposed to the effect of the first passage through the liver, the main directions of metabolism are hydroxylation on the aromatic ring of the benzimidazole ring and oxidation by the morpholino fragment.

    Half-life when administered orally (0.82 ± 0.54) h. Short half-life is caused by intensive biotransformation of the drug and rapid distribution from the blood plasma to the organs and tissues. The drug is excreted mainly in the form of metabolites and partially unchanged in urine and feces. With prolonged use, it does not accumulate in the body.

    Indications:

    Relief of withdrawal syndrome with quitting smoking.Alarming conditions in adults with the following conditions and diseases: generalized anxiety disorders; neurasthenia; adaptation disorders; various somatic diseases (bronchial 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 abstinence syndrome.

    ICD-10

    V.F10-F19.F17.3   Mental and behavioral disorders caused by the use of tobacco - the abstinence state

    V.F10-F19.F13.4   Mental and behavioral disorders caused by the use of sedatives and hypnotics - abstinence with delirium

    V.F10-F19.F13.3   Mental and behavioral disorders caused by the use of sedatives and hypnotics - the abstinence state

    V.F40-F48.F41.9   Anxiety disorder, unspecified

    V.F40-F48.F41.2   Mixed anxiety and depressive disorder

    V.F40-F48.F41.1   Generalized anxiety disorder

    V.F40-F48.F48.0   Neurasthenia

    XIV.N80-N98.N94.3   Premenstrual tension syndrome

    Contraindications:

    Hypersensitivity, intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption, pregnancy;

    lactation period; children's age (under 18 years).

    Carefully:

    Elderly age, liver and kidney disease.

    Pregnancy and lactation:

    The category of recommendations for the FDA - D.

    Contraindicated in pregnancy and lactation.

    Dosing and Administration:

    Inside after meal.

    The optimal single dose of the drug - 10 mg, daily - 30 mg divided into 3 doses during the day. The duration of the course use of the drug is 2-4 of the week.

    If necessary, on the recommendation of the doctor, the daily dose of the drug can be increased to 60 mg, and the duration of treatment is up to 3 months.

    Side effects:

    Allergic reactions are possible.

    Rarely - a headache, which usually passes by itself and does not require the withdrawal of the drug.

    Overdose:

    Symptoms: it is possible to develop a sedative effect and increased drowsiness without manifestations of muscle relaxation (with a significant overdose and intoxication).

    Treatment: as a first aid, subcutaneously 20% solution of caffeine sodium benzoate per 1 ml 2-3 times a day.

    Interaction:

    Does not interact with ethanol and does not affect the hypnotic effect of thiopental. Enhances the anticonvulsant effect of carbamazepine. It causes an increase in the anxiolytic effect of diazepam.

    Special instructions:

    The effect of the drug develops on the 5th-7th day of treatment. The maximum effect is achieved by the end of the 4th week of treatment and remains after the end of treatment on average 1-2 weeks. Does not cause muscle weakness, drowsiness and does not have a negative effect on concentration and memory. When it is used, there is no drug dependence and no withdrawal syndrome develops.

    Instructions
    Up