Active substanceTrimetazidineTrimetazidine
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  • Dosage form: & nbspfilm-coated tablets
    Composition:One tablet, film-coated, contains:
    active substance: trimetazidine dihydrochloride 20 mg
    Excipients: cellulose microcrystalline 20.0 mg, mannitol 44.5 mg, copolyvidone 4.0 mg, silicon dioxide colloid 0.5 mg, magnesium stearate 1.0 mg, hypromellose 2.3 mg, macrogol 6000 (polyethylene glycol) 0.23 mg, dye - iron oxide red (E 172) 0.1 mg, titanium dioxide (E 171) 0.49 mg.
    Description:Round, biconvex tablets, covered with a film membrane of red-brown 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 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 intracellular depletion of ATP and phosphocreatinine. Under conditions of acidosis, normalizes the functioning of ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, normalizes the intracellular content of the calium ions. Reduces intracellular acidosis and phosphate content due to 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, prolongs the duration of the electrical potential, reduces the yield of creatine phosphokinase from cells and the severity of myocardial ischemic damage.

    When angina reduces the frequency of attacks (reduces the consumption of nitrates), after 2 weeks of treatment increases exercise tolerance, blood pressure drops decrease without any significant changes in heart rhythms. 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 oral administration trimetazidine quickly absorbed, CmOh is reached in less than 2 hours and is 55 ng / ml after a single dose of 20 mg. With repeated application, the equilibrium state is reached after 24-36 hours and remains stable until the end of the course of therapy.

    Easily passes through the histohematological barriers. Binding to plasma proteins is low, about 16% in vitro.

    It is excreted from the body, mainly by the kidneys (60%) unchanged. T1/2 - 4,5 - 5 hours.

    Indications:

    - long-term therapy of ischemic heart disease: prevention of angina attacks (monotherapy or as part of combination therapy);

    - treatment of cochlear-vestibular disorders of ischemic nature (such as: dizziness, tinnitus, hearing impairment);

    - chorioretinal vascular disorders with ischemic component.

    Contraindications:

    - hypersensitivity to the drug;

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

    - severe liver dysfunction;

    - pregnancy;

    - breast-feeding;

    - age to 18 years (efficacy and safety not established).

    Pregnancy and lactation:

    Contraindicated in pregnancy due to lack of clinical data on the safety of its use.

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

    In experimental studies, the teratogenic effect of trimetazidine has not been established.

    Dosing and Administration:

    The drug is taken with food. Assign a dose of 40-60 mg / day. Multiplicity of administration 2-3 times a day. The duration of therapy is set individually, depending on the clinical situation.

    Side effects:

    From the digestive system: rarely - nausea, vomiting.

    Allergic reactions: skin rash, itching and other manifestations are possible.

    Overdose:

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

    Interaction:

    At present, the cases of drug interaction are not described.

    Special instructions:

    It is not used to stop angina attacks!

    Against the background of treatment with a drug in a patient 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 mental and physical reactions.

    Form release / dosage:

    The tablets covered with a film cover of 20 mg.

    Packaging:

    For 10 tablets in a blister of PVC / A1-foil.

    3 or 6 blisters together with instructions for use in a cardboard box.

    Storage conditions:

    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:LSR-000825/08
    Date of registration:18.02.2008
    The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel
    Manufacturer: & nbsp
    Representation: & nbspTeva Teva Israel
    Information update date: & nbsp25.10.2015
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