Afobazol® (Aphobazol®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceFabomotisolFabomotisol
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  • Afobazol®
    pills inwards 
    OTISIFARM, OJSC     Russia
    • Dosage form: & nbsppills
    Composition:

    1 tablet contains:

    active substance: fabomotisol (phabomotisol dihydrochloride) 5 mg and 10 mg;

    Excipients: starch potato 48 mg, cellulose microcrystalline 40 mg (for dosages of 5 mg) and 35 mg (for a dosage of 10 mg), lactose monohydrate 48.5 mg, povidone medium molecular weight (polyvinylpyrrolidone medium molecular weight medical, collidone 25) 7 mg, magnesium stearate 1.5 mg.

    Description:

    Tablets are white or white with a creamy shade of color, flat-cylindrical with a bevel.

    Pharmacotherapeutic group:Anxiolytic agent (tranquilizer)
    ATX: & nbsp

    N.05.B.X   Other anxiolytics

    N.05.B.X.04   Fabomotisol

    Pharmacodynamics:

    Afobazol® is a selective non-benzodiazepine anxiolytic.

    Acting on sigma-1 receptors in nerve cells of the brain, Afobazol® stabilizes GABA / benzodiazepine receptors and restores their sensitivity to endogenous mediators of inhibition. Afobazol® also increases the bioenergetic potential of neurons and has a neuroprotective effect: restores and protects nerve cells.

    The effect of the drug is realized mainly in the form of a combination of anxiolytic (anti-anxiety) and light stimulating (activating) effects.

    Afobazol® reduces or eliminates feelings of anxiety (concern, bad pre- feelings, fears), irritability, tension (fearfulness, tearfulness, anxiety, inability to relax, insomnia, fear), depressed mood, somatic manifestations of anxiety (muscle, sensory, cardiovascular, respiratory, gastrointestinal symptoms), vegetative disorders (dryness in mouth, sweating, dizziness), cognitive disorders (difficulty concentrating, weakened memory), incl. arising from stress disorders (adaptation disorders). Particularly shown is the use of the drug in people with mostly asthenic personality traits in the form of anxious suspicion, uncertainty, increased vulnerability and emotional lability, a tendency to emotional-stressful reactions. The effect of the drug develops on the 5th-7th day of treatment. The maximum effect is achieved by the end of 4 weeks of treatment and remains after the end of treatment on average 1-2 weeks.

    Afobazol® does not cause muscle weakness, drowsiness and does not have a negative effect on concentration of attention and memory. When it is used, addiction, drug dependence is not formed and the "cancellation" syndrome does not develop.

    Pharmacokinetics:

    After oral administration Afobazol® is absorbed well and quickly from the gastrointestinal tract.

    The maximum concentration of the drug in plasma (CmOh) - 0.130 ± 0.073 μg / ml; the time to reach the maximum concentration (TmOh ) - 0.85 ± 0.13 hours.

    Metabolism: Afobazol® undergoes the "first pass effect" through the liver, the main directions of metabolism are hydroxylation on the aromatic ring of the benzimidazole ring and oxidation by the morpholino fragment.

    Afobazol® is 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).

    Half-life Afobazol® for oral administration is 0.82 + 0.54 hours. A short elimination half-life is due to 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:

    Afobazol® is used in adults with anxiety conditions: generalized anxiousdisorders, neurasthenia, adaptation disorders, in patients with various somatic diseases (bronchial asthma, irritable bowel syndrome, systemic lupus erythematosus, ischemic heart disease, hypertension, arrhythmias), dermatological, oncological and other diseases. In the treatment of sleep disorders associated with anxiety, neurocirculatory dystonia, premenstrual syndrome, alcohol withdrawal syndrome, for relief, the "cancellation" syndrome with quitting smoking.

    Contraindications:

    Individual intolerance to the drug.

    Intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption.

    Pregnancy, lactation.

    Children under 18 years.

    Pregnancy and lactation:

    The use of the drug Afobazol® is contraindicated in pregnancy. If you need to use the drug during lactation, breastfeeding should be discontinued.

    Dosing and Administration:

    Is applied inside, after eating.

    Optimal single doses - 10 mg; per diem - 30 mg, distributed on 3 admission during the day. Duration of the course use of the drug is 2-4 weeks.

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

    Allergic reactions are possible.

    Rarely is a headache, which usually goes away on its own and does not require the withdrawal of the drug.
    Overdose:With a significant overdose and intoxication, it is possible to develop a sedative effect and increased drowsiness without manifestations of muscle relaxation.
    As an emergency, caffeine 20% solution in ampoules of 1.0 ml 2-3 times a day subcutaneously.
    Interaction:

    Afobazol® 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.

    Effect on the ability to drive transp. cf. and fur:

    The drug does not adversely affect the driving of motor vehicles and the performance of potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:Tablets of 5 mg or 10 mg.

    Packaging:

    For 10, 20, 25 or 30 tablets in a contour mesh package.

    For 30, 50, 100 or 120 tablets in cans of polymeric.

    Each jar or 3, 5 or 10 contour packs of 10 tablets, or 1, 2, 3, 4 or 6 contour packs of 20 tablets, or 2 or 4 contour packs of 25 tablets, or 1,2,3 or 4 contour packs packs of 30 tablets together with instructions for use are placed in a pack of cardboard.

    Storage conditions:

    Store at a temperature not exceeding 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

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

    Terms of leave from pharmacies:Without recipe
    Registration number:LS-000861
    Date of registration:23.07.2010 / 28.06.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.11.2017
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