Active substanceTrimetazidineTrimetazidine
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  • Dosage form: & nbspfilm coated tablets
    Composition:

    Each film-coated tablet contains:

    as an active component: 20 mg of trimetazidine dihydrochloride

    Excipients: microcrystalline cellulose, lactose (milk sugar), magnesium stearate, potato starch, croscarmellose sodium (impellose), silicon dioxide colloid (aerosil);

    plaster coating: Opadrai II (Hypromellose (hydroxypropylmethylcellulose), lactose monohydrate or polydextrose, macrogol 4000 (polyethylene glycol 4000), titanium dioxide, aluminum lacquer based on the dye crimson [ponso 4 R], aluminum varnish based on the dye sunset sunset yellow).

    Description:

    The tablets covered with a covering, red color, round, biconcave form, on a cross-section are visible two layers: a cover of red color, a kernel - white or almost white color.

    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 antihypoxic effect.

    Directly affecting the cardiomyocytes and neurons of the brain, it optimizes their metabolism and function. The cytoprotective effect is caused by an increase in the energy potential, activation of oxidative decarboxylation and rationalization of oxygen consumption (enhancement of aerobic glycolysis and blockade of fatty acid oxidation). Supports contractility of the myocardium, prevents a decrease in the intracellular content of alenosine triphosphate and phosphocreatine.In conditions of acidosis normalizes the functioning of membrane ion channels, prevents the accumulation of calcium and sodium ions in cardiomyocytes, normalizes the intracellular content of potassium ions.

    Reduces intracellular acidosis and increased phosphate content, due to myocardial ischemia and reperfusion. It interferes with 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 ischemic myocardial damage. With angina reduces the frequency of attacks, after 2 weeks of treatment, tolerance to physical activity increases, blood pressure drops decrease. Reduces dizziness and tinnitus. In vascular pathology, the eye improves the functional activity of the retina.

    Pharmacokinetics:

    After oral administration 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 20 mg of trimetazidine is about 55 ng / ml. Connection with blood plasma proteins - 16%. Easily penetrates through the histohematological barriers. The half-life is 4.5-5 hours. It is excreted by the kidneys (about 60 % in unchanged form).

    Indications:

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

    Chorioretinal vascular disorders;

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

    Contraindications:

    Hypersensitivity to any component of the drug; deficiency of lactase; lactose intolerance; glucose-galactose malabsorption; renal failure (creatinine clearance below 15 ml / min.); severe liver dysfunction; pregnancy; lactation period; age to 18 years (efficacy and safety not established).

    Dosing and Administration:

    Inside, with food.

    The recommended dosage regimen is 1 tablet (20 mg) 2-3 times a day (40-60 mg per day). The duration of the course of therapy is as recommended by the doctor.

    Side effects:

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

    Overdose:

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

    Interaction:

    There is no information.

    Special instructions:

    Do not use to stop angina attacks! The drug is not indicated for the initial course of therapy for stable angina or myocardial infarction.

    In the case of an attack of angina pectoris, the therapy should be reviewed and adapted.

    Effect on the ability to drive transp. cf. and fur:The use of the drug does not affect the ability to drive a car and perform work that requires a high speed of psychomotor reactions.
    Form release / dosage:

    Tablets, film-coated, 20 mg.

    Packaging:For 10 and 15 tablets in a contour mesh package. 3 or 6 contour cell packs of 10 tablets, 2 or 4 contour packs of 15 tablets together with the instructions for use are placed in a pack of cardboard.
    Storage conditions:

    List B.

    In a dry, sheltered spot, at a temperature of no higher than 25 ° C. Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-003152/10
    Date of registration:13.04.2010
    The owner of the registration certificate:TATHIMFARMPREPARATY, JSC TATHIMFARMPREPARATY, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp25.10.2015
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