Active substanceTrimetazidineTrimetazidine
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  • Dosage form: & nbspmodified release tablets coated with a film sheath
    Composition:

    Each tablet of prolonged action, film-coated, contains:

    active substance - trimetazidine dihydrochloride 35 mg;

    Excipients - hypromellose 73.83 mg, hypromellose K 100 LVP18 mg, lactose monohydrate 27.17 mg, croscarmellose sodium 8.5 mg, talc 3 mg, magnesium stearate 2.5 mg, silicon dioxide colloid 2 mg;

    shell composition - Hypromellose-15 thousand.4.31 mg, polysorbate-80 0.04 mg, titanium dioxide (E171) 1.8 mg, talc 1.8 mg, iron dye red oxide (E172) 0.17 mg, propylene glycol 0.68 mg.

    Description:

    Round, biconvex tablets, covered with a film coat, light pink color. Type of tablet on a cross-section: the shell - light pink color, a kernel - 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:

    Has 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 fatty acid oxidation blockade due to inhibition of long chain 3-ketoatsil-co-thiolase). Supports contractility of the myocardium, prevents intracellular depletion of adenosine triphosphate (ATP) and creatine phosphate. In conditions of acidosis normalizes the functioning of ion channels of membranes, prevents the accumulation of Ca2 + and Na + in cardiomyocytes, normalizes the intracellular concentration of K +.

    Reduces intracellularityacidosis and phosphorus concentrationatheroma 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, increases the duration of electricityreduces the potential for yield of creatine phosphokinase (CK) from cells and severity of ischemic myocardial damage.

    When angina pectoris reduces the frequency of attacks (decreases the need for nitrates), after 2 weeks of treatment, exercise tolerance increases, sharp fluctuations in blood pressure decrease. Reduces dizziness and noise in the ears of ischemic etiology. In vascular pathology, the eye restores the functional activity of the retina.

    Pharmacokinetics:Quickly and almost completely absorbed in the gastrointestinal tract. Bioavailability is 90%. Time to reach the maximum concentration in the blood plasma (TCam) - 5.4 hours. The volume of distribution is 4.8 l / kg. The intake of food does not affect the pharmacokinetics of trimetazidine. It easily passes through the histohematetic barriers.The connection with plasma proteins is low. The half-life period (T1 / 2) is 6 hours, in patients older than 65 years - T1 / 2 about 12 hours. It is excreted by the kidneys (about 60% - unchanged).
    The renal clearance of trimetazidine directly correlates with the creatinine clearance, the hepatic clearance decreases with age.
    In elderly patients with a daily dose of 2 tablets a day in two divided doses, an increase in plasma exposure does not lead to any pronounced effect.
    Indications:

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

    - Cochleo-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 insufficiency (creatinine clearance less than 15 ml / min), pronounced impaired liver function, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, pregnancy, breastfeeding, age under 18 years (efficacy and safety not established).

    Pregnancy and lactation:The drug is contraindicated in pregnancy.It is not known whether trimetazidine with breast milk, so if necessary drug during lactation should stop breastfeeding. Teratogenic effects in animal studies have not been established.

    Dosing and Administration:

    Inside, one tablet 2 times a day (morning and evening), while eating. The course of treatment on the recommendation of a doctor.

    Side effects:

    The incidence of side effects is given in the following gradation: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000,

    <1/1000); very rarely (<1/10000), including individual messages.

    From the digestive system

    Often: abdominal pain, diarrhea, indigestion, nausea, vomiting.

    Common violations

    Often: asthenia.

    From the central nervous system

    Often: dizziness, headache; very rarely: extrapyramidal symptoms (tremor, rigidity, akinesia), reversible after drug withdrawal.

    From the skin

    Often: skin rash, itching, hives.

    From the side of the cardiovascular system

    Rarely: orthostatic hypotension, "tides" of blood to the skin of the face

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

    Drug interaction is not currently described.

    Special instructions:

    The drug is not intended for relief of angina attacks and is not indicated for the initial course of therapy for unstable angina or myocardial infarction, as well as for preparation for hospitalization in its first days. In the case of an attack of angina pectoris, the treatment should be reviewed and adapted. If you skip one or more doses of the drug, you can not take a higher dose to the next dose!

    Effect on the ability to drive transp. cf. and fur:During the treatment period, care should be taken when driving vehicles and engaging in other potentially hazardous activities.
    Form release / dosage:

    Tablets of prolonged action, film-coated 35 mg.

    Packaging:

    10 tablets per blister, made of PVC film and aluminum foil.

    By 1,2, 3, 4, 6 blisters together with instructions for use are placed in a cardboard box.

    Storage conditions:

    In dry, dark place at a temperature of no higher than 30 ° 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:LP-001086
    Date of registration:03.11.2011
    The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India
    Manufacturer: & nbsp
    Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India
    Information update date: & nbsp24.10.2015
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