Afobazol tab.

Dosage form

pills

Manufacturer

Pharmstandard, Russia

Structure

1 tablet contains:

active substance: fabomotizol (fabomotizole dihydrochloride) - 10 mg.

auxiliary substances: potato starch - 48 mg, microcrystalline cellulose - 35 mg, lactose monohydrate - 48.5 mg, medium molecular weight povidone (medium molecular weight polyvinylpyrrolidone, Kollidon 25) - 7 mg, magnesium stearate - 1.5 mg.

pharmachologic effect

Pharmacodynamics

Afobazole is a selective non-benzodiazepine anxiolytic.

Acting on sigma-1 receptors in the nerve cells of the brain, Afobazol stabilizes GABA / benzodiazepine receptors and restores their sensitivity to endogenous mediators of inhibition.

Afobazole also 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 mild stimulating (activating) effects. Afobazole reduces or eliminates feelings of anxiety (concern, bad feelings, apprehension, irritability), tension (fearfulness, tearfulness, anxiety, inability to relax, insomnia, fear), somatic manifestations of anxiety (muscle, sensory, cardiovascular, respiratory, gastrointestinal intestinal symptoms), autonomic disturbances (dry mouth, sweating, dizziness), cognitive disorders (difficulty concentrating, impaired memory). 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,tendency to emotionally stressful reactions.

The effect of the drug develops on the 5-7th day of treatment.

The maximum effect is achieved by the end of 4 weeks of treatment and remains after the end of treatment for an average of 1-2 weeks.

Afobazole causes muscle weakness, drowsiness, and has no negative effect on concentration and memory.

When using it, drug dependence is not formed and the withdrawal syndrome does not develop.

Pharmacokinetics

After oral administration, Afobazol is well and rapidly absorbed from the gastrointestinal tract.

The maximum concentration of the drug in plasma (Cmax) is 0.130 + 0.073 μg / ml

the time to reach the maximum concentration (Tmax) - 0.85 + 0.13 hours.

Metabolism: Afobazol undergoes a first pass effect" through the liver, the main directions of metabolism are hydroxylation at the aromatic ring of the benzimidazole cycle 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.

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.

In the treatment of sleep disorders associated with anxiety, neurocirculatory dystonia, premenstrual syndrome, alcohol withdrawal syndrome, to alleviate the withdrawal syndrome in smoking cessation.

Contraindications

Individual intolerance to the drug Afobazol.

Galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Pregnancy, lactation.

Children under the age of 18.

Side effects

Allergic reactions are possible.

Rarely - headache, which usually goes away on its own and does not require discontinuation of the drug.

Interaction

Afobazol does not interact with ethanol and does not affect the hypnotic effect of thiopental.

Enhances the anticonvulsant effect of carbamazepine.

Increases the anxiolytic effect of diazepam.

How to take, course and dosage

It is applied orally, after meals.

The optimal single dose is 10 mg

daily allowance - 30 mg, divided into 3 doses during the day.

The duration of the course 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.

Overdose

With a significant overdose and intoxication, the development of a sedative effect and increased drowsiness is possible without manifestations of muscle relaxation.

As an emergency, caffeine 20% solution is used in ampoules of 1.0 ml 2-3 times a day subcutaneously.

Special instructions

The drug does not have a negative effect on driving vehicles and performing potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

Release form

Pills

Storage conditions

In a dry, dark place at a temperature not exceeding 25 ° C

Shelf life

2 years

Brand name

AFOBAZOLE

Active substance

Morpholinoethylthioethoxybenzimidazole

Terms of dispensing from pharmacies

Without recipe

Name ENG

AFOBAZOL

Clinical and pharmacological group

Anxiolytic (tranquilizer)

ATX code

Fabomotizole

Dosage

10mg

Structure

1 tablet contains: active ingredient: fabomotizol (fabomotizole dihydrochloride) - 10 mg auxiliary substances: potato starch - 48 mg, microcrystalline cellulose - 35 mg, lactose monohydrate - 48.5 mg, medium molecular weight povidone (polyvinylpyrrolidone 25 med. ) - 7 mg, magnesium stearate - 1.5 mg.

Indications

Anxiety in adults:

generalized anxiety disorders, neurasthenia, adjustment disorders

in patients with various somatic (bronchial asthma, irritable bowel syndrome, SLE, ischemic heart disease, arterial hypertension, arrhythmias), dermatological, oncological and other diseases

sleep disorders associated with anxiety

cardiopsychoneurosis

premenstrual tension syndrome

alcohol withdrawal syndrome

to alleviate smoking cessation symptoms.

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

Contraindications

pregnancy

,

lactation period (breastfeeding)

age up to 18 years

hypersensitivity to the components of Afobazole.

INN / Active ingredient

Fabomotizol

Specifications

Category

Sedatives

,

Antipsychotics

,

Neurological disorders

Scope of the medicinal product

General

Release form

Tablet

Manufacturer country

Russia

Package quantity, pcs

60

Vacation conditions

Without recipe

Brand name

OTCPharm

The amount of the dosage form in the primary package

30 pcs.

Primary packaging type

Blister

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Anxiolytic agent (tranquilizer)

Anatomical and therapeutic characteristics

N05BX Other Anxiolytics

Dosage form

Pills

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

fabomotizole (fabomotizole dihydrochloride) - 10 mg

Package weight, g

twenty

Mode of application

:

It is applied orally, after meals. < br> < br> Optimal single doses - 10 mg

daily allowance - 30 mg, divided into 3 doses during the day.

The duration of the course of use of the drug is 2-4 weeks. < br> < br> 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.

Information on technical characteristics, delivery set, country of manufacture "