Active substanceTrimetazidineTrimetazidine
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  • Dosage form: & nbspmodified release tablets coated with a coating
    Composition:1 modified release tablet coated with a coating contains:
    active substance: trimetazidine dihydrochloride 35.00 mg;
    Excipients: calcium hydrophosphate dihydrate - 15.35 mg, hypromellose (hydroxypropylmethylcellulose) - 135,50 mg, povidone (polyvinylpyrrolidone low molecular weight) - 2.05 mg, silicon dioxide colloid (aerosil) - 2.05 mg, magnesium stearate - 2.05 mg;
    composition of the shell: hypromellose 9.00 mg, macragol (polyethylene glycol) - 1.40 mg, titanium dioxide E171 - 2.50 mg, ferric oxide red oxide E172 - 0.10 mg.
    Description:

    The tablets covered with a cover of pink color, round, biconcave.

    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:

    Trimetazidine 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 of cells and the severity of myocardial ischemic damage.
    When the frequency of attacks of angina reduces (decreases nitrate consumption) after 2 weeks of treatment increases exercise capacity, reduced blood pressure drops. The hearing and results of vestibular samples in patients improve, dizziness and tinnitus decrease.
    In vascular pathology, the eye restores the functional activity of the retina.
    Pharmacokinetics:

    After taking the drug inside trimetazidine quickly and almost completely absorbed from 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 penetrates through the histohematological barriers. The half-life (T1/2) is 4.5-5 hours. Connection with blood plasma proteins - 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;

    Vertigo 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!

    Against the background of drug treatment in patients with coronary heart disease there is a significant decrease in the daily requirement for nitrates.

    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, coated shell, 35 mg each.

    Packaging:

    10 tablets per contour cell packaging from PVC film and aluminum foil.

    By 1, 2, 3, 4, 5 or 6 contour cell packs together with instructions for use in cardboard pack.

    Storage conditions:In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.
    Shelf life:3 years.

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

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000026
    Date of registration:29.03.2007
    The owner of the registration certificate:BIOKOM, CJSC BIOKOM, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp25.10.2015
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