NameAdapt. Release formCapsules. MHNT tetramethyltetraazabicyclooctanedione. FTGA anxiolytic agent (tranquilizer). Brief characteristics White/white hard gelatin capsules containing white or off-white powder are allowed in the form of compressed into a column, which crumbles when touched with a glass rod. Non-uniformity in particle size is allowed. Composition Active ingredient: mebicar. Each capsule contains 300 mg mebicar. Excipients: methylcellulose, calcium stearate. The composition of the capsules: gelatin, titanium dioxide (E171). Pharmacotherapeutic group and code atxPsychostimulants, drugs for the treatment of attention deficit hyperactivity disorder, nootropic drugs. Other psychostimulants and nootropics. ATX code: N06BX21. Pharmacological properties Pharmacodynamics The active substance of the drug Adaptol is close in chemical structure to the natural metabolites of the body – its molecule consists of two methylated urea fragments that are part of the bicyclic structure. Let’s easily dissolve in water and in many organic solvents. Adaptol does not interact with acids, alkalis, oxidizing and reducing agents, various drugs and food components. Adaptol acts on the activity of the structures included in the limbic-reticular complex, in particular, on the emotiogenic zones of the hypothalamus, and also has an effect on all 4 major neurotransmitter systems – GABA, choline, serotonin and adrenergic, but does not have a peripheral adrenonegative effect. Adaptol eliminates or reduces anxiety, anxiety, fear, internal emotional stress and irritability. The calming effect of the drug is not accompanied by muscle relaxation and impaired coordination of movements. The drug does not reduce mental and motor activity, so Adaptol can be used during the working day or study. The drug does not create high spirits, a feeling of euphoria. It does not have a hypnotic effect, but enhances the effect of hypnotics and improves the course of sleep in case of its disturbances. Pharmacokinetics The active substance of the drug Adaptol is well (77-80%) absorbed from the gastrointestinal tract, up to 40% of the dose taken is bound by erythrocytes. The rest does not bind to plasma proteins and is in the plasma in a free form, so the active substance is freely distributed throughout the body and freely overcomes cell membranes. The maximum concentration of the active substance in the blood is reached 0.5 hours after taking the drug and the high level persists for 3-4 hours, then gradually decreases. 55-70% of the dose taken is excreted from the body with urine, the rest – with feces unchanged during the day. The active substance of the drug is not metabolized and does not accumulate in the body. Indications for use Somatoform dysfunction of the autonomic nervous system and other neurotic disorders. Dosage and administration Adaptol is taken orally, regardless of food intake. Adults take 300-600 mg 2-3 times a day. The maximum single dose is 3 g, the highest daily dose is 10 g. The duration of the treatment course is from several days to 2-3 months. Elderly patients do not need to reduce the dose. Patients with hepatic insufficiency do not need to reduce the dose. Dose adjustments have not been studied in patients with renal insufficiency. In these patients, the drug should be administered with caution. Data on the safety and efficacy of Adaptol in children and adolescents under the age of 18 are not available. Side effectsAdaptol, like all medicines, can cause side effects that may not affect everyone. The frequency of side effects according to the MedDRA classification system (Medical Dictionary of Regulatory Terminology): Very common (≥1 / 10); Frequent (≥1/100 to <1/10); Uncommon (≥1/1000 to <1/100); Rare (≥1/10,000 to <1/1000); Very rare (<1/10,000); Unknown (cannot be determined from available data). Immune system disorders: unknown - hypersensitivity (hypersensitivity). Nervous system disorders: rare - dizziness; unknown - headache. Cardiovascular disorders: rare - hypotension. Gastrointestinal disorders: rare - dyspeptic disorders (expressed as a feeling of bitterness in the mouth, nausea, vomiting, abdominal pain, diarrhea). Skin and subcutaneous tissue disorders: rare - allergic reactions (angioneurotic edema, eyelid edema, facial edema, lip edema, tongue edema, rash, papular rash, itching, erythema, urticaria, skin edema), hyperhidrosis. In the event of an allergic reaction, the drug should be discontinued. Respiratory, thoracic and mediastinal disorders: unknown - bronchospastic reactions, bronchospasm attack. Renal and urinary disorders: unknown - polyuria, nocturia (frequent urination at night). General disorders and reactions at the injection site: rare - a decrease in body temperature, weakness; unknown - chest pain, swelling of the extremities, localized edema. Metabolic and nutritional disorders: unknown - loss of appetite. A decrease in blood pressure and / or a decrease in body temperature (body temperature may drop by 1-1.5 ° C) is not a reason for discontinuing the drug. Blood pressure and body temperature return to normal after the end of the course of treatment. In the event of adverse reactions, including those not listed in this leaflet, you must stop taking the drug and consult a doctor. Contraindications Hypersensitivity to the active substance or to excipients of the drug. Overdose The drug is low toxic. Two reports of cases of overdose have been received. A single dose of the drug in a suicide attempt at a dose of 30 g did not lead to the development of a lethal outcome. Treatment: in case of overdose, conventional detoxification methods are carried out, including gastric lavage, and symptomatic therapy. The specific antidote is not known. Precautions There have been isolated reports of cases of acute hypersensitivity reactions (hypersensitivity). The use of the drug during pregnancy and lactation The active substance penetrates well into all tissues and body fluids. Adequately controlled clinical studies of the use of the drug during pregnancy and lactation are not available, so prescribing the drug is not recommended. Influence on the ability to drive vehicles The drug may cause a decrease in blood pressure and weakness, which may affect the ability to drive and operate machinery. Drug interactionAdaptol can be combined with neuroleptics, tranquilizers (benzodiazepines), hypnotics, antidepressants and psychostimulants. Shelf life 3 years. Storage conditionsStore at a temperature not exceeding 25 °C. Release form: 10 capsules in a blister pack made of lacquered aluminum foil and polyvinyl chloride film. 2, 3 or 4 blisters (20, 30 or 40 capsules) in a carton box with enclosed instructions for use. Leave conditions By prescription. Manufacturer and owner of the registration certificateOlainfarm JSC Address: st. Rupnicu 5, Olaine, LV-2114, Latvia. Buy Adaptol capsules 300mg №10x2 Price for Adaptol capsules 300mg №10x2Instruction for use for Adaptol capsules 300mg №10x2
INN | MEBICAR |
---|---|
The code | 131 891 |
Barcode | 4 750 258 314 553 |
Dosage | 300 mg |
Active substance | Mebicar |
Manufacturer | Olainfarm, Latvia |
Importer | IOOO "Interfarmaks", Republic of Belarus, 223028, Minsk region, Minsk district, Zhdanovichsky s / s, ag. Zhdanovichi, st. Zvezdnaya, 19A-5, pom. 5-2 |
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