Composition
One tablet contains afobazole (dry matter basis) 10 mg
Packaging
Tablets 10 mg. 20 tablets in a blister strip packaging.
3 contour packages together with instructions for medical use in the state and Russian languages are placed in a carton box.
Description
Tablets of white or white color with a creamy shade, flat-cylindrical shape with a bevel.
Indications
Afobazol® is used in adults with anxiety conditions:
- generalized anxiety disorders, neurasthenia, adjustment 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
- sleep disorders associated with anxiety
- cardiopsychoneurosis
- premenstrual syndrome
- alcohol withdrawal syndrome
- to alleviate smoking cessation symptoms
Shelf life - 2 years
Release Form
Tablets 10 mg. 20 tablets in a blister strip packaging.
3 contour packages together with instructions for medical use in the state and Russian languages are placed in a carton box.
Overdose
Symptoms: with a significant overdose and intoxication, a sedative effect and increased drowsiness may develop without manifestations of muscle relaxation.
Treatment: caffeine sodium benzoate 20% solution in ampoules of 1.0 ml 2-3 times a day subcutaneously is used as an emergency.
Pharmodynamics
Afobazol® is a 2-mercaptobenzimidazole derivative, a selective anxiolytic that does not belong to the class of benzodiazepine receptor agonists. Prevents the development of membrane-dependent changes in the GABA receptor.
Afobazol® has an anxiolytic effect with an activating component that is not accompanied by hypnosedative effects (the sedative effect is detected in Afobazol® in doses 40-50 times higher than the ED50 for anxiolytic action). The drug has no muscle relaxant properties, a negative effect on memory and attention indicators. With its use, drug dependence is not formed and withdrawal syndrome does not develop.
The action of the drug is realized mainly in the form of a combination of anxiolytic (anti-anxiety) and mild stimulating (activating) effects. Reduction or elimination of anxiety (concern, bad feelings, apprehension, irritability), tension (fearfulness, tearfulness, anxiety, inability to relax, insomnia, fear), and therefore somatic (muscle, sensory, cardiovascular, respiratory, gastrointestinal symptoms ), vegetative (dry mouth, sweating, dizziness), cognitive (difficulty concentrating, impaired memory) disorders are observed on days 5-7 of treatment with Afobazol®. The maximum effect is achieved by the end of 4 weeks of treatment and remains in the post-treatment period, on average 1-2 weeks. The use of the drug is especially shown in persons with predominantly asthenic personality traits in the form of anxious suspiciousness, uncertainty, increased vulnerability and emotional lability, a tendency to emotional stress reactions. Afobazol® is non-toxic.
Interaction
Afobazol® does not affect the narcotic effect of ethanol and the hypnotic effect of thiopental. It potentiates the anticonvulsant effect of carbamazepine. It increases the anxiolytic effect of diazepam.
Special instructions
The drug does not cause addiction, addiction, withdrawal syndrome. The peculiarities of the use of the drug Afobazol® in the elderly have not been identified.
Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms
The question of the possibility of driving vehicles and controlling potentially dangerous mechanisms should be resolved after assessing the patient's individual response to the drug.
Pharmacokinetics
After oral administration, Afobazol is well and quickly absorbed from the gastrointestinal tract. The maximum concentration of the drug in plasma (Cmax) is 0.130 + 0.073 μg / ml; time to reach maximum concentration (TCmax) - 0.85 0.13 h.
Afobazole undergoes the "first pass effect" through the liver, the main directions of metabolism are hydroxylation at the aromatic ring of the benzimidazole ring and oxidation at the morpholine fragment. Afobazole 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). The half-life of Afobazol when taken orally is 0.82 + 0.54 hours. The short half-life is due to the intensive biotransformation of the drug and the rapid distribution from blood plasma to organs and tissues.
The drug is excreted mainly in the form of metabolites and partially unchanged in the urine and feces. With prolonged administration, it does not accumulate in the body.
Contraindications
- individual intolerance to the drug
- pregnancy and lactation
- children and adolescents up to 18 years old
Side effects
- increased individual sensitivity to drug components
- allergic reactions
Mode of application
It is applied orally, after meals.
Optimally, a single dose of the drug is 10 mg, the daily dose is 30 mg, divided into 3 doses throughout the day. The duration of the course of the drug is 2-4 weeks.
If necessary, the daily dose of the drug can be increased to 60 mg, and the duration of treatment up to 3 months.
Manufacturer country - Russia - Pharmstandard-Leksredstva
Packaging Description - Blister strip packaging 60 pcs.
Excipients: potato starch, microcrystalline cellulose, milk sugar (lactose), povidone (kollidone 25), magnesium stearate
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