Active substanceTrimetazidineTrimetazidine
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  • Dosage form: & nbspfilm coated tablets
    Composition:One tablet, film-coated shell, contains the current substance trimetazidine dihydrochloride 20,000 mg;
    Excipients: ludipress LCE (lactose monohydrate 94.7-98.3%, povidone 3-4%) 39.500 mg; lactose monohydrate 36,200 mg; creamcolloidal dioxide (aerosil) 1,500 mg; croscarmellose sodium 2,000 mg; magnesium stearate 0.800 mg;
    shell:hypromellose (hydroxypropylmethylcellulose) 3.306 mg, titanium dioxide 0.716 mg, talc 0.254 mg, macrogol-4000 (polyethyleneglycol 4000) 0.716 mg, dye azorubin [E122] 0.008 mg.
    Description:

    Round biconvex tablets, covered with a film coating of pink color. Core from white to almost white.

    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:

    Rimecor has an antihypoxic effect. Normalizes the energy metabolism of cells that have undergone hypoxia or ischemia. 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 slowing down of oxidation of fatty acids due to selective inhibition of long chain 3-ketoacyl-CoA-thiolase). Supported by myocardial contractility, prevents intracellular depletion of ATP and creatine phosphate.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, 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 ischemia zone, reduces the yield creatine phosphokinase from cells and the severity of myocardial ischemic damage.

    When angina pectoris reduces the frequency of attacks (decreases the daily requirement for nitrates), after two weeks of treatment, exercise tolerance increases. Limits sharp fluctuations in blood pressure. Reduces dizziness and noise in the ears of ischemic etiology, hearing and vestibular samples improve. In vascular pathology, the eye restores the functional activity of the retina.

    Pharmacokinetics:Suction
    After oral administration 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 20 mg of trimetazidine is about 55 ng / ml. The half-life is 4.5-5 hours.
    Distribution
    Easily penetrates through the histohematological barriers. Connection with blood plasma proteins -16%.
    Excretion
    It is excreted from the body by the kidneys (about 60% unchanged).
    Indications:Ischemic heart disease: prevention of attacks of stable angina (in complex therapy).
    Kohler-vestibular disorders of ischemic nature, such as dizziness, tinnitus, hearing impairment.
    Chorioretinal vascular disorders with ischemic component.
    Contraindications:

    Hypersensitivity to any component of the drug; severe renal failure (creatinine clearance less than 15 ml / min); severe dysfunction liver; pregnancy, lactation (breastfeeding); age under 18 years (effectiveness and safety not established); lactose intolerance, lactase deficiency or glucose-galactose malabsorption (the preparation contains lactose).

    Pregnancy and lactation:

    The drug is contraindicated in pregnancy due to the lack of clinical data on the safety of its use.In experimental studies, the teratogenic effect of trimetazidine has not been established.

    It is not known whether trimetazidine from breast milk. Therefore, if it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.

    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 course of treatment on the recommendation of a doctor.

    Side effects:The distribution of side effects by frequency is made in accordance with the following, gradation: very often - more than 1/10; often more than 1/100 and less than 1/10; infrequently - more than 1/1000 and less than 1/100; rarely - more than 1/10000 and less than 1/1000; very rarely - less than 1/10000, including individual messages.
    From the digestive system: often - abdominal pain, diarrhea, dyspepsia, nausea, vomiting.
    Co cardiovascular system: rarely - orthostatic hypotension, "tides" to the skin of the face.
    From the central nervous system: often - dizziness, headache; very rarely - extrapyramidal disorders (tremor, rigiden- tity, akinesia), reversible after drug discontinuation.
    From the skin and subcutaneous tissue: often - a rash, itching, hives.
    Other: often - asthenia.
    Overdose:

    Data on overdose cases are limited. In case of an overdose, symptomatic therapy should be given.

    Interaction:

    Drug interaction of the drug trimetazidine not described.

    Special instructions:

    Trimetazidine is not intended for relief of angina attacks.

    The drug is not indicated for the initial course of therapy for unstable angina or myocardial infarction. In the event of a change in the nature of the attacks of angina pectoris or their frequency, the treatment should be reviewed and adapted.

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

    The use of the drug, as a rule, does not affect the ability to drive a car and perform work that requires a high rate of mental and physical reactions, but the drug may cause dizziness and other side effects that may affect the above abilities.

    Form release / dosage:Tablets, film-coated, 20 mg.
    Packaging:

    10 or 30 tablets in a contour cell box made of a polyvinylchloride film and aluminum foil printed lacquered.

    1, 2, 3, 6 contour cell packs of 10 tablets or 1, 2 contourcell packs of 30 tablets together with instructions for use in a pack of cardboard.

    Storage conditions:

    In a dry, protected from light 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 expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000611
    Date of registration:10.06.2010
    The owner of the registration certificate:Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSCNizhny Novgorod Chemical and Pharmaceutical Plant, OJSC
    Manufacturer: & nbsp
    Information update date: & nbsp25.10.2015
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