Name:
Dapten tab. 500 mg in kont. cell unitary enterprise No. 10×2
Description:
Tablets of white or almost white color, flat-cylindrical shape, with a chamfer and a risk mark. The main active ingredient Mebicar Release form Tablets Dosage 500 mg Pharmacodynamics The active substance of the drug Dapten 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. The active substance is chemically inert, does not interact with acids, alkalis, oxidizing and reducing agents, various drugs and food components. The drug acts on the activity of 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. The drug Dapten 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 it 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 Dapten 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 Take orally, regardless of food intake, drinking plenty of water. The line on Dapten tablets is intended solely to facilitate taking one tablet (by breaking the tablet into two halves), and not to divide the tablet into two doses. Adults take 1 tablet (300 mg or 500 mg) 2-3 times a day. The maximum single dose is 3 g, the highest daily dose is 10 g. The duration of the course of treatment 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 the drug Dapten in children and adolescents under the age of 18 years are not available. Use during pregnancy and lactation The active substance penetrates well into all tissues and body fluids. Due to the lack of adequately controlled clinical studies of the use of the drug during pregnancy and breastfeeding, it is not recommended to prescribe the drug. Influence on the ability to drive vehicles and work with mechanisms The drug can cause a decrease in blood pressure and weakness, which may affect the ability to drive and operate machinery. Precautions There have been isolated reports of cases of acute hypersensitivity reactions (hypersensitivity). Interaction with other drugsDapten drug can be combined with neuroleptics, tranquilizers (benzodiazepines), hypnotics, antidepressants and psychostimulants. Contraindications Hypersensitivity to the active substance or to any other component that is part of the drug. Composition Each tablet contains: Active ingredient: tetramethyltetraazabicyclooctanedione – 500 mg; Excipients: calcium stearate, povidone. 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 measures are carried out, including gastric lavage, and symptomatic therapy. The specific antidote is not known. Adverse reactions Dapten, like all medicines, can cause side effects, which may not affect everyone. The assessment of side effects is based on the following data on the frequency of occurrence: very often (?10), often (?1/100 to <1/10), infrequently (?1/1000 to <1/100), rarely (?1/10000 up to <1/1000), very rarely (<1/10000), the frequency is unknown (cannot be estimated from the available data). Immune system disorders: unknown - hypersensitivity (hypersensitivity). Nervous system disorders: rarely - dizziness; unknown - headache. From the side of the cardiovascular system: rarely - a decrease in blood pressure. Disorders from the gastrointestinal tract: rarely - dyspeptic disorders (expressed as a feeling of bitterness in the mouth, nausea, vomiting, abdominal pain, diarrhea). Skin and subcutaneous tissue disorders: 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: rarely - 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) are not a reason for discontinuing the drug. Blood pressure and body temperature normalize after the end of the course of treatment. Storage conditions In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children. Buy Dapten tablets 500 mg No. 10x2 Price for Dapten tablets 500 mg No. 10x2 Instructions for use for Dapten tablets 500 mg No. 10x2
INN | MEBICAR |
---|---|
The code | 114 364 |
Barcode | 4 812 608 008 670 |
Active substance | Mebicar |
Manufacturer | Lekpharm SOOO, Belarus |
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