Active substanceTrimetazidineTrimetazidine
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  • Dosage form: & nbspfilm-coated tablets
    Composition:
    One film coated tablet The shell contains:
    active substance: trimetazidine dihydrochloride 20 mg;
    Excipients: lactose monohydrate - 81.00 mg, povidone - 3.00 mg, crospovidone - 3.00 mg, magnesium stearate - 1.00 mg, polyvinyl alcohol 1.80 mg, macrogol (polyethylene glycol) 0.90 mg, talcum powder - 0.70 mg,titanium dioxide - 0.20 mg, dye crimson [Ponso 4R] - 0.18 mg, dye sunset yellow - 0.01 mg, aluminum varnish - 0.71 mg.
    Description:The tablets are biconvex, covered with a film membrane of red 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 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 adenosine triphosphate and phosphocreatine. In conditions of acidosis normalizes the functioning of membrane ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, normalizes the intracellular content of potassium ions. Reduces intracellular acidosis and increased phosphate content, due to myocardial ischemia and reperfusion.It prevents the damaging action of free radicals, preserves the integrity of cellular membranes, prevents activation of neutrophils in the ischemic area, increases the electric potential decreases the yield of creatine from the cells and the severity of ischemic myocardial injury.

    When the frequency of attacks of angina reduces (decreases nitrate consumption) after 2 weeks of treatment increases exercise capacity, reduced blood pressure drops. Improves hearing and results of vestibular samples in patients with pathology of ENT organs, reduces dizziness and tinnitus. In vascular pathology, the eye restores the functional activity of the retina.
    Pharmacokinetics:

    After taking 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. The connection with plasma proteins is 16%. Easily penetrates through the histohematological barriers. The half-life is 4.5-5 hours. It is excreted 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); severe liver dysfunction; pregnancy; lactation period; age to 18 years (efficacy and safety not established). Due to the presence of lactose in the formulation, it is contraindicated in congenital lactose intolerance, with lactase deficiency, with glucose-galactose malabsorption.

    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:

    Allergic reactions (skin itching). Rarely: headache, a feeling of strong palpitations; from the gastrointestinal tract - weak dyspeptic phenomena (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!

    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 a car and perform work that requires a high rate of psychomotor reactions.

    Form release / dosage:Film coated tablets a shell of 20 mg.
    Packaging:

    10 tablets in a contour cell packaging. 1,2,3, 4, 5 or 6 contour cell packings together with instructions for use put in a pack of cardboard.

    100 tablets per jar polymer, each jar along with instructions for use put 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 expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-009880/09
    Date of registration:04.12.2009
    The owner of the registration certificate:ALSI Pharma, ZAO ALSI Pharma, ZAO Russia
    Manufacturer: & nbsp
    Information update date: & nbsp24.10.2015
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