Instruction for use: Adaptol

Dosage form: Tablets

Active substance: Tetramethyltetraazabicyclooctandione

ATX

N05BX Other anxiolytics

Pharmacological group:

Anxiolytics

The nosological classification (ICD-10)

F17.3 Abstinence due to tobacco use: Nicotinic abstinence; syndrome with smoking cessation

F40.9 Phobic anxiety disorder, unspecified:Obsessive fear; Anxiety neurosis; Neurosis of anxiety; Acute anxiety disorder; Syndrome of paroxysmal fear; State of fear; Phobias; Phobic disorders; Feeling of fear

F41.9 Anxiety disorder, unspecified: Neurotic disorders with anxiety syndrome; Severe anxiety; Neuro-like symptomatology; Neuro-like disorders; Neuro-like conditions; Neuroses with anxiety symptoms; Neuroses with a sense of anxiety; Acute situational and stress anxiety; Acute attack of anxiety; Severe Anxiety; Situational Anxiety Disorder; State of anxiety; Anxious and delusional component; Alarming state; Anxiety; Anxiety Disorders; Anxiety syndrome; Sense of anxiety; Alarm conditions; Chronic neurotic anxiety; Susto; Psychopathy with a predominance of anxiety and anxiety; Anxiety disorders in neurotic and neurosis-like states; Anxious neuroses; Anxious and delusional state; Acute situational stress alarm; Depressed mood with elements of anxiety

F48.9 Neurotic disorder, unspecified: Neurosis; Secondary neurotic symptom; Other neurotic conditions; Neurosis with increased irritability; Neuroses; Neuroses of all kinds; Neuroses with retardation; Neuroses of the heart; Neurotic disorders in alcoholism; Neurotic disorders with retardation; Neurotic disorders with anxiety syndrome; Neurotic reactions; Neurotic symptoms with alcoholism; Neurotic states; Neurotic syndrome; Neurotic disorder; Attack of neurological dysfunction; School neurosis; Emotional Stress

F60.3 Emotionally unstable personality disorder: Mood swings; Mental lability; Emotional fence; Emotional detachment; Mood Change; Lability of mood; Instability of emotional background; Mixed emotional disorders; The state of emotional stress; Emotional lability; Emotional tension; Emotional instability; Emotional instability; Mood disturbance; Mood disorders; Decreased mood; Deterioration of mood; Mood swings

R07.2 Pain in the heart: neuroses of the heart; Myocardial ischemic pain; Pain syndrome in myocardial infarction; cardialgia; cardioneurosis; Cardiac syndrome; Pain in cardiac patients; Cardialgia on background dyshormonal myocardial dystrophy; Functional cardialgia; Psevdostenokardiya; pericardial pain

R45.4 Irritability and anger: Neurosis with increased irritability; Outbursts of anger; Anger; Resentment; Increased irritability; Increased irritability of the nervous system; Irritability; Irritability in neuroses; Irritability in psychopathic disorders; Symptoms of irritability; Dysphoria

T42.4 Poisoning with benzodiazepines: Intoxication with hypnotics and tranquilizers; Overdose of benzodiazepines; Overdose of benzodiazepines; Side effects of tranquilizers of benzodiazepine series

T43.3 Antipsychotic and neuroleptic poisoning: Side effects of antipsychotics; Neuroleptic extrapyramidal syndrome; Extrapyramidal neuroleptic syndrome; Correction of side effects of antipsychotics; Correction of side effects of neuroleptics; Acute intoxication with antipsychotic drugs; Condition after acute intoxication with antipsychotic agents

Y47.1 Adverse reactions in the therapeutic use of benzodiazepines: Benzodiazepine dependence; Dependence on anxiolytics and hypnotics; Dependence on benzodiazepines

Y49.5 Adverse reactions in the therapeutic use of other antipsychotic and antipsychotics

Composition

Tablets - 1 table.

active substance: tetramethyltetraazabicyclooctanedione 500 mg

excipients: methyl cellulose - 3.3 mg; calcium stearate - 1.7 mg

Description of dosage form

Round flat cylindrical tablets of white or almost white color, with a facet and a risk.

Pharmachologic effect

Mode of action - anxiolytic.

Pharmacodynamics

The active substance of Adaptol - tetramethyltetraazabicyclooctanedione - by chemical structure is close to the natural metabolites of the body. Its molecule consists of two methylated fragments of urea, which are part of the bicyclic structure.

Adaptol acts on the activity of the structures entering the limbic-reticular complex, in particular, on the emotionogenic zones of the hypothalamus, and also affects all the four major neurotransmitter systems - GABA-, choline-, serotonin- and adrenergic, promoting their balance and integration, but not has peripheral adrenoblocking action. Eliminates or alleviates anxiety, anxiety, fear, inner emotional tension and irritability. The soothing effect is not accompanied by muscle relaxation and impaired coordination of movements. It does not reduce mental and motor activity, therefore Adaptol can be used during a working day or school. Does not create an upbeat mood, a sense of euphoria. Sleeping effect does not have, but enhances the effect of hypnotics and normalizes sleep during its violations. Adaptol facilitates or removes nicotine abstinence.

In addition to soothing, nootropic effect. Adaptol improves cognitive functions, attention and mental performance, without stimulating the symptoms of productive psychopathological disorders - nonsense, pathological emotional activity.

Pharmacokinetics

The drug is well (77-80%) absorbed from the digestive tract, up to 40% of the dose is associated with erythrocytes. The remaining part does not bind to blood plasma proteins and is in the blood plasma in a free form, so the active substance is unrestrictedly distributed throughout the body and freely overcomes the cell membranes. Cmax of the active substance in the blood is reached after 0.5 h after administration of the drug and the high level persists for 3-4 hours, then gradually decreases. 55-70% of the accepted dose is excreted from the body with urine, the rest - with feces in unchanged form during the day.

Tetramethyltetraazabicyclooctanedione is not metabolized and does not accumulate in the body.

Indications of preparation Adaptol

neuroses and neurosis-like conditions (irritability, emotional instability, anxiety, fear);

improving the tolerability of neuroleptics and tranquilizers to eliminate the associated somatovegetative and neurological side effects;

cardialgia of different genesis (not associated with ischemic heart disease);

nicotinic abstinence (as part of complex therapy to reduce the craving for tobacco smoking).

Contraindications

hypersensitivity to the components of the drug;

pregnancy;

period of lactation;

children under 18 years of age

Side effects

Rarely - dizziness, lowering of blood pressure, dyspeptic disorders, allergic reactions (skin rashes, itching), after taking high doses: bronchospasm, lowering of body temperature, weakness. With lowering blood pressure and / or body temperature (body temperature may drop by 1-1.5 ° C), the drug should not be stopped. BP and body temperature are normalized independently. When allergic reactions occur, the drug should be discontinued.

Interaction

Adaptol can be combined with neuroleptics, tranquilizers (including benzodiazepines), hypnotics, antidepressants and psychostimulants.

Dosing and Administration

Inside, regardless of food intake, 500 mg 2-3 times a day. The maximum single dose is 3 g, the daily - 10 g. The duration of the course of treatment is from several days to 2-3 months.

In complex therapy as a means of reducing the craving for tobacco smoking - 500-1000 mg 3 times a day for 5-6 weeks.

Overdose

The toxicity of the drug is very low. A typical clinical picture of an overdose is missing. Serious poisoning is not registered. The following symptoms can be observed: weakness, hypotension, dizziness.

Treatment: for suspected overdose, symptomatic treatment is carried out, incl. gastric lavage.

Special instructions

Addiction, dependence (mental and physical) and withdrawal syndrome to Adaptol have not been established.

Influence on the ability to drive a car or perform work that requires an increased speed of physical and mental reactions. The drug may cause a decrease in blood pressure and weakness, which can adversely affect the ability to drive and maintain machinery. Care must be taken.

Release form

Tablets, 500 mg. For 10 tab. in a planar cell box made of PVC film and aluminum foil. 2 contour squares in a pack of cardboard.

Conditions of leave from pharmacies

On prescription.

Storage conditions of the drug Adaptol

In a dry place, at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life of the drug Adaptol

4 years.

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