Active substanceTrimetazidineTrimetazidine
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  • Dosage form: & nbspmodified release tablets coated with a film sheath
    Composition:

    One tablet with modified release, film-coated, contains active substance trimetazidine dihydrochloride 35 mg.

    Excipients: hypromellose (metocele K 4M Premium EP) 54 mg; cellulose microcrystalline - 118 mg; silicon dioxide colloid (aerosil) - 1 mg; magnesium stearate - 1 mg;

    Shell composition: hydroxypropylmethylcellulose (hypromellose) - 4,628 mg; talc - 0.357 mg; titanium dioxide - 1.002 mg; macrogol (polyethylene oxide 4000) - 1.002 mg; dye azorubin (acidic red 2C for pharmaceutical purposes) -0.011 mg.

    Description:

    Tablets covered with a film membrane pink color, round, biconvex.

    Pharmacotherapeutic group:antihypoxic agent
    ATX: & nbsp

    C.01.E.B   Other drugs for the treatment of heart disease

    C.01.E.B.15   Trimetazidine

    Pharmacodynamics:

    Timetazidine has an antianginal, antihypoxic effect. Directly affecting the cardiomyocytes and neurons of the brain, it optimizes their metabolism and function. The cytoprotective effect is due to an increase in the energy potential, activation of oxidative decarboxylation, and rationalization of oxygen consumption (enhancement of aerobic glycolysis and fat oxidation blockade). Supports contractility of the myocardium, prevents the decrease in intracellular content of ATP and phosphocreatinine. In the conditions of acidosis normalizes the functioning of ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, normalizes the intracellular content of potassium ions.Reduces intracellular acidosis and phosphate concentration, caused by myocardial ischemia and reperfusion. Prevents the damaging effect of free radicals, preserves the integrity of cell membranes, prevents the activation of neutrophils in the ischemic zone, prolongs the duration of the electrical potential, reduces the yield of creatine phosphokinase from cells and the severity of myocardial ischemic damage

    When angina pectoris reduces the frequency of attacks (reduces the consumption of nitrates), after 2 weeks of treatment, exercise tolerance increases, blood pressure drops decrease. Improves hearing and results of vestibular samples in patients, reduces dizziness and tinnitus.

    In vascular pathology, the eye restores the functional activity of the retina.

    Pharmacokinetics:After taking the drug inside trimetazidine quickly and almost completely absorbed in the gastrointestinal tract. Bioavailability is 90%. Time to reach the maximum concentration in blood plasma - 2 hours. The maximum concentration after a single dose of 35 mg of trimetazidine is about 55 ng / ml. Easily passes through gistohemematicheskie barieres. The half-life (T1 / 2) is 4.5-5 hours. The connection with plasma proteins is 16%. It is excreted from the body by the kidneys (about 60% - unchanged).

    Indications:

    - Ischemic heart disease: prevention of angina attacks (in complex therapy);

    - Chorioretinal vascular disorders;

    - Dizziness of vascular origin;

    - Cohleo-vestibular disorders of ischemic nature (tinnitus, hearing impairment).

    Contraindications:

    - Hypersensitivity to any component of the drug;

    - Renal failure (creatinine clearance below 15 ml / min);

    - Pronounced violations of the liver;

    - Pregnancy;

    - The period of breastfeeding;

    - Age to 18 years (effectiveness and safety not established).

    Dosing and Administration:

    Inside, with food.

    The recommended dosage regimen is 2 tablets (70 mg) per day, in 2 divided doses. The course of treatment on the recommendation of a doctor.

    Side effects:

    Allergic reactions (skin itching). Rarely from the gastrointestinal tract: gastralgia, nausea, vomiting; a headache, a strong palpitation.

    Overdose:

    At present, no cases of drug overdose have been reported.

    Interaction:

    There is no information.

    Special instructions:

    The drug is not designed to stop angina attacks!

    In the case of an angina attack, treatment should be reviewed and adapted (drug therapy or revascularization).

    Effect on the ability to drive transp. cf. and fur:

    The use of the drug does not affect the ability to drive and perform work that requires a high rate of mental and physical reactions.

    Form release / dosage:

    Tablets with modified release, film-coated, 35 mg.

    Packaging:

    For 10 or 30 tablets in a contour cell package.

    By 30, 60, 90, 120, 180, 300 in a can of polymer or a polymer bottle. Each jar or vial, 3, 6 contour cell packs of 10 tablets or 1,2,3,4,6,10 contour mesh packs of 30 tablets together with instructions for use are placed in a pack of cardboard.

    Storage conditions:

    AT dry, sheltered from the sun, at temperature not higher 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years. Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-002018/07
    Date of registration:09.08.2007
    The owner of the registration certificate:NORTH STAR, CJSC NORTH STAR, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp25.10.2015
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