Instruction for use: Adaptol (Tetramethyltetraazabicyclooctandionum)

Trade name of the drug – Adaptol

International name of the drug: Tetramethyltetraazabicyclooctandionum

Dosage Form: capsules

ATC
N05BX Anxiolytics other

Pharmacotherapeutic group: Anxiolytic (tranquilizer) [Anxiolytics]

The nosological classification (ICD-10)

F17.3 Abstinent condition caused by tobacco use
F40.9 Phobic anxiety disorder, unspecified
F41.9 Anxiety disorder, unspecified
F48.9 Neurotic disorder, unspecified
F60.3 Emotionally unstable personality disorder
R07.2 Pain in the heart
R45.4 Irritability and anger
T42.4 Poisoning by benzodiazepines
T43.3 Poisoning antipsychotic and neuroleptic drugs
Y47.1 Adverse effects in therapeutic use of benzodiazepines
Y49.5 Adverse effects in therapeutic use other antipsychotic and neuroleptic drugs

Composition:
Tablets 1 tab.
active substance: Tetramethyltetraazabicyclooctandionum 500 mg
Excipients: methyl cellulose - 3.3 mg; calcium stearate - 1.7 mg

Description:
Round pills white or nearly white.

pharmachologic effect - Mode of action - anxiolytic.

Pharmacological Properties
Pharmacodynamics.

The active substance Adaptol - Tetramethyltetraazabicyclooctandionum - the chemical structure is close to the natural metabolites of an organism. Its molecule consists of two fragments of methylated urea comprising the bicyclic structure.

Adaptol effect on the activity of structures within the limbic-reticular complex, in particular emotiogenic hypothalamus area, and has an effect on all 4 major neurotransmitter systems - GABA, cholinergic, serotonergic and adrenergic, helping them balance and integration, but not renders peripheral adrenoceptor blocking action. It eliminates or reduces anxiety, anxiety, fear, internal emotional pressure and irritability. The calming effect is not accompanied by muscle relaxation and impaired motor coordination. It does not reduce the mental and motor activity, so Adaptol can be used during the work day or school. It does not create an elevated mood, feelings of euphoria. Hypnotic effect does not possess, but enhances the effect of hypnotics and normalize during sleep when violations. Adaptol eases or relieves nicotine withdrawal symptoms.

Also it provides soothing nootropic effect. Adaptol improves cognitive function, attention and mental performance, symptoms without stimulating productive psychopathological disorders - delirium, abnormal emotional activity.

Pharmacokinetics.
The drug was well (77-80%) absorbed from the gastrointestinal tract by up to 40% of the dose is bound by red blood cells. Rest does not bind to plasma proteins and the plasma is in a free state, so the active ingredient is distributed throughout the body smoothly and freely overcomes cell membranes. Cmax active ingredient in the blood is reached after 0.5 hours after administration and a high level is maintained for 3-4 hours, then gradually decreases. 55-70% of the dose excreted in the urine and the rest - with the feces as unchanged during the day.

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

Indications

neuroses and neurosis-like state (irritability, emotional instability, anxiety, fear);
improving the portability of neuroleptics and tranquilizers in order to eliminate them caused somatic-vegetative and neurological side effects;
cardialgia various origins (not associated with coronary heart disease);
nicotine abstinence (in the complex therapy to reduce the craving for smoking tobacco).

Contraindications

• hypersensitivity to the drug;
• pregnancy;
• lactation;
• Children up to age 18 years

Dosage and Administration
Inside, regardless of meals, 500 mg 2-3 times a day. The maximum single dose is 3 grams daily - 10 g Duration of treatment - from several days to 2-3 months.

In the treatment as a means of reducing the craving for tobacco smoking, - at 500-1000 mg three times a day for 5-6 weeks.

Side effect of Adaptol
Rarely - dizziness, drop in blood pressure, diarrhea disorders, allergic reactions (skin rashes, itching) after taking high doses: bronchospasm, decrease in body temperature, weakness. By lowering blood pressure and / or body temperature (body temperature may drop by 1-1,5 ° C) are not receiving the drug should be stopped. Blood pressure and body temperature return to normal on their own. In the event of allergic reactions, use of the drug should be discontinued.

Overdose

Toxicity is very low. The typical clinical picture is no overdose. Manifestations of severe poisoning are not logged in. The following symptoms may occur: weakness, hypotension, dizziness.

Treatment: in cases of suspected overdose, symptomatic treatment, including gastric lavage.

Interaction with other medicinal products.

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

SPECIAL INSTRUCTIONS

Habituation, dependence (mental and physical) and withdrawal are not set to Adaptol.

Effects on ability to drive or to perform work requiring higher rate of physical and mental reactions. The drug can cause a drop in blood pressure and weakness, which may adversely affect the ability to drive and maintain mechanisms. Caution must be exercised.

Release Form
Tablets, 500 mg. According to Table 10. in blisters made of PVC foil and aluminum foil. 2 blisters in a pack made of cardboard.
Storage conditions of Adaptol drug
In a dry place at a temperature no higher than 25 ° C.
Shelf life
4 years. Do not use beyond the expiration date printed on the package.
Conditions of supply of pharmacies
On prescription.