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

    For 1 tablet:

    Active substance: trimetazidine dihydrochloride 35 mg;

    Excipients (core): hypromellose - 93.0 mg, microcrystalline cellulose - 178.9 mg, silicon dioxide colloid - 1.55 mg, magnesium stearate - 1.55 mg.

    Auxiliary substances (shell): Opaprai II 85F240012 Pink: polyvinyl alcohol 4.0 mg, macrogol 3350 2.438 mg, iron dye red oxide 0.04 mg, iron oxide yellow oxide 0.022 mg, talc 1.48 mg, titanium dioxide 2.02 mg mg.

    Description:

    Tablets biconcave form, covered with a film coat cream-pink color. In the cross section, two layers are visible, the inner layer (core) is white or white with a yellowish hue of 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.

    By directly affecting cardiomyocytes and neurons of the brain, the drug 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 glycolysis and fat oxidation blockade).

    Trimetazidine supports myocardial contractility, prevents the reduction of intracellular levels of adenosine triphosphate (ATP) and phosphocreatinine. In conditions of acidosis normalizes the functioning of ion channels of membranes, prevents the accumulation of calcium and sodium ions in cardiomyocytes, normalizes the intracellular content of potassium ions.

    Reduces intracellular acidosis and increased 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 (CK) from cells and the severity of myocardial ischemic damage Trimetazidine reduces the frequency of angina attacks, reduces the need for nitrates, after 2 weeks of use increases exercise tolerance, and sharp fluctuations in blood pressure (BP) decrease. Reduces dizziness and noise in the ears of ischemic etiology. In vascular pathology, the eye restores the functional activity of the retina.

    Pharmacokinetics:

    After taking the drug inside trimetazidine quickly and almost completely absorbed in the gastrointestinal tract. Bioavailability - 90%. The time to reach the maximum concentration in blood plasma is 3-5 hours. The stable state is reached after 60 hours. The volume of distribution is 4.8 l / kg. Connection with blood plasma proteins - 16%. Trimetazidine is excreted from the body mainly by the kidneys (about 60% - unchanged). The half-life is about 7 hours, in patients older than 65 years - about 12 hours. Renal clearance of trimetazidine directly correlates with creatinine clearance (CC), the liver clearance decreases with age. Easily penetrates through the histohematological barriers.

    Indications:

    Ischemic heart disease: prevention of angina attacks (in complex therapy).

    Cochleovestibular disorders of ischemic nature, such as dizziness, tinnitus, hearing impairment.

    Chorioretinal vascular disorders.

    Contraindications:

    - Pincreased sensitivity to any component of the drug;

    - renal failure (CC less than 15 ml / min);

    - severe liver dysfunction;

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

    Pregnancy and lactation:

    Studies in animals have not revealed teratogenic erosioneffect, however, in connection with the lack of clinical data on the safety of the drug during pregnancy, the risk of developing fetal malformations can not be ruled out. The use of the drug during pregnancy is contraindicated.

    It is not known whether ANTISTEN MB is excreted in breast milk.If it is necessary to use the drug ANTISTEN MB during lactation, the question of stopping breastfeeding should be solved.

    Dosing and Administration:

    Inside, during a meal.

    Antisthenes MV appoint 1 tablet 2 times a day (morning and evening).

    The course of treatment is recommended by a doctor.

    Side effects:

    The frequency is 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, indigestion, nausea, vomiting.

    From the side of the cardiovascular system: rarely - orthostatic hypotension, "hot flashes" to the skin of the face.

    From the central nervous system: often - dizziness, headache; very rarely - extrapyramidal disorders (tremor, rigidity, akinesia), reversible after drug withdrawal.

    From the skin and subcutaneous fat: often - skin rash, itching, hives.

    Other: often - asthenia.

    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!

    The drug is not indicated for the initial course of therapy for unstable angina or myocardial infarction.

    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:

    The drug ANTISTEN MB does not significantly affect the ability to drive vehicles and perform other jobs that require a high rate of psychomotor reactions.

    Form release / dosage:Tablets of prolonged action, film-coated 35 mg.
    Packaging:

    For 10, 20, 30 tablets are placed in a contour mesh box made of a polyvinylchloride film and aluminum foil printed lacquered.

    According to 10, 20, 30, 40, 50, 60 or 100 tabletsaboutplace in contacteyenepolymeric for medicines. One container or 1, 2, 3, 4, 5, 6, or 10 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

    Storage conditions:

    Store in a dry, dark 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-008140/10
    Date of registration:16.08.2010 / 10.11.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:OZONE, LLC OZONE, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp06.09.2017
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