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

    Composition per one tablet:

    active substance - trimetazidine dihydrochloride (in pereaccount for 100% of the substance) - 20 mg;

    Excipients: potato starch - 14 mg, calcium stearate - 1 mg, lactose monohydrate - to obtain a tablet weighing 98 mg (excluding shell);

    composition of the shell: hypromellose 2910 - 0.99 mg, polysorbate 80 - 0.25 mg, titanium dioxide -0.48 mg, talc-0.28 mg.

    Description:tablets are round, biconvex, covered with a film coating of 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 caused by an increase in the energy potential, activation of oxidative decarboxylation, and optimization of oxygen consumption (enhancement of aerobic glycolysis and blockade of fatty acid oxidation). Supports contractility of the myocardium prevents intracellular depletion of ATP and creatine phosphate. In conditions of acidosis it normalizes the functioning of ion channels of membranes, prevents the accumulation of calcium and sodium in cardiomyocytes, normalizes the intracellular content of potassium ions. Reduces intracellular acidosis and phosphate content, due to myocardial ischemia. Prevents the damaging effect of free radicals, preserves the integrity of cell membranes, prevents the activation of neutrophils in zone of ischemia, normalizes the duration of action potential and activity of creatine phosphokinase, reduces the severity of ischemic myocardial damage.

    When angina pectoris reduces the frequency of attacks (helps reduce nitrate intake), after 2 weeks of treatment provides increased tolerance to exercise, reduces sudden fluctuations in blood pressure (BP). Improves hearing and results of vestibular samples in patients, reduces dizziness and tinnitus. In vascular pathology, the eye restores the functional activity of the retina.

    Pharmacokinetics:When ingested quickly and almost completely absorbed in the gastrointestinal tract. The maximum concentration (after a single oral intake at a dose of 20 mg) is mg / ml, the time of achievement is 2 hours.
    Bioavailability is 90%. The volume of distribution is 4.8 l / kg. Binding to blood plasma proteins - 16 %. Easily passes through the histohematological barriers. It is excreted by the kidneys (about 60 % at unchanged form). The half-life is 4.5-5 h.
    Indications:

    - Ischemic heart disease: prevention of attacks of stable angina (as part of combination therapy);

    - chorioretinal disorders with ischemic component;

    - cochleovestibular disorders of ischemic nature, such as dizziness, noise in the ears, hearing loss.

    Contraindications:

    Hypersensitivity to any of the components of the drug, severe kidneyinsufficiency (creatinine clearance less than 15 ml / min), expressed liver function abnormalities, lactose intolerance, lactase deficiency, glucose-galactose malabsorption, pregnancy, lactation, age under 18 years (efficacy and safety not established).

    Pregnancy and lactation:Contraindicated in pregnancy. For the duration of treatment, breastfeeding should be discontinued.
    Dosing and Administration:The drug is taken orally during a meal 1 tablet 2-3 times a day. The daily dose is 40-60 mg. The duration of the course of treatment is according to the doctor's recommendation.
    Side effects:The frequency 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, "hot flashes" of blood to the skin of the face.

    Overdose:Data on overdose are limited. In case of an overdose, symptomatic therapy should be given.
    Interaction:The results of interaction of trimetazidine with other drugs have not been established.
    Special instructions:

    The drug is not intended to stop angina attacks, but also for the initial course of therapy for stable angina or myocardial infarction.

    Effect on the ability to drive transp. cf. and fur:The drug may cause dizziness. Care should be taken when driving vehicles and engaging in other potentially hazardous activities.
    Form release / dosage:Tablets, film-coated, 20 mg.
    Packaging:10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil. 3 contour mesh packages 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:

    2 of the year.

    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-000805
    Date of registration:03.10.2011
    The owner of the registration certificate:BELMEDPREPARATY, RUP BELMEDPREPARATY, RUP Republic of Belarus
    Manufacturer: & nbsp
    BELMEDPREPARATY, RUP Republic of Belarus
    Representation: & nbsp"Belmedpreparaty" RUP "Belmedpreparaty" RUP
    Information update date: & nbsp24.10.2015
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