Trimetazidine MB - instructions for use, dose, side effects, contraindications

Auxiliary substances (shell): Opapray II 85F240012 Pink - 10.0 mg, incl. polyvinyl alcohol 4.0 mg, macrogol-3350 2.438 mg, iron oxide red oxide 0.04 mg, iron oxide oxide yellow 0.022 mg, talc 1.48 mg, titanium dioxide 2.02 mg

Description:

Round, biconvex tablets coated with a film coat from light pink to pink. On the cross section, the nucleus is white or almost white in 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 the oxidative decarboxylation and rationalization of oxygen consumption (increase in glycolysis and blockade of fatty acid oxidation).

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 ischemic myocardial 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.

Pharmacokinetics:

After taking the drug inside trimetazidine quickly and almost completely absorbed in the gastrointestinal tract. Bioavailability is 90%. Eating does not affect the bioavailability of trimetazidine. The time to reach the maximum concentration in blood plasma is 3-6 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 of 8.4 h, in patients older than 65 years - about 12 h. Renal clearance of trimetazidine directly correlates with the clearance of creatinine (CC), the liver clearance decreases with age. Easily penetrates through the histohematological barriers.

Indications:

Ischemic heart disease: prevention of attacks of stable angina (as part of complex therapy).

Contraindications:

- hypersensitivity to any component of the drug;

- severe renal failure (creatinine clearance (CK) less than 30 ml / min);

- age under 18 years (effectiveness and safety not established);

- pregnancy and the period of breastfeeding;

- Parkinson's disease, symptoms of parkinsonism, tremor, restless legs syndrome and other associated motor disorders.

Carefully:

Patients with severe hepatic impairment (clinical data are limited), renal failure (QC greater than 30 mL / min.), Age over 75 years.

Pregnancy and lactation:

Data on the use of the drug Trimetazidine MB in pregnant women are absent. Studies in animals have not revealed the presence of direct or indirect reproductive toxicity.Studies of reproductive toxicity have shown no effect of trimetazidine on reproductive function in rats of both sexes. As a precaution, it is not recommended to use the drug Trimetazidine MB during pregnancy.

It is not known whether trimetazidine or its metabolites with breast milk. The risk to a newborn / child can not be ruled out. If you need to use the drug Trimetazidine MV during lactation, you should decide whether to stop breastfeeding.

Dosing and Administration:

Inside, during a meal.

Trimetazidine MV is prescribed 1 tablet 2 times a day (morning and evening).

Patients with impaired renal function

In patients with moderate renal impairment (creatinine clearance from 30 to 60 ml / min), the drug is prescribed 1 tablet per day during breakfast.

Elderly patients

In elderly patients, exposure to trimetazidine may be increased due to age-related impairment of renal function.

It is recommended to take 1 tablet 1 time per day.

The advantage of therapy should be evaluated after 3 months, in the absence of effect, therapy should be discontinued.

Side effects:

Undesirable reactions, defined as undesirable phenomena, at least having a possible bearing on the treatment with trimetazidine, are 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), unspecified frequency (frequency can not be calculated from available data).

From the digestive system:

Often - pain in the abdomen, diarrhea, indigestion, nausea, vomiting.

Unspecified frequency: constipation.

From the cardiovascular system:

Rarely: sensation of heartbeat, extrasystole, tachycardia, marked decrease in arterial pressure, orthostatic hypotension, which may be accompanied by general weakness, dizziness or loss of balance, especially when taking antihypertensive drugs, "tides" of blood to the skin of the face.

From the central nervous system:

Often: dizziness, headache.

Unspecified frequency: symptoms of parkinsonism (tremor, akinesia, tone increase), instability in Romberg position and gait unsteadiness, restless legs syndrome, other associated motor disorders, usually reversible after discontinuation of therapy; sleep disorders (insomnia, drowsiness).

From the skin and subcutaneous fat:

Often: skin rash, itching, hives.

Unspecified frequency: acute generalized exanthematous pustulosis, angioedema.

Other: often - asthenia.

From the side of the circulatory system:

Unspecified frequency: agranulocytosis, thrombocytopenia, thrombocytopenic purpura.

From the liver and bile ducts:

Unspecified frequency: hepatitis.

Overdose:

There is only limited information on the overdose of trimetazidine. In case of an overdose, symptomatic therapy should be given.

Interaction:

There is no information.

Special instructions:

Trimetazidine MB is not designed to stop angina attacks and is not indicated for the initial course of therapy for unstable angina or myocardial infarction at the prehospital stage or in the first days of hospitalization!

In the case of an angina attack, treatment should be reviewed and adapted (drug therapy or revascularization).

Trimetazidine MB can cause or worsen symptoms of parkinsonism (tremor, akinesia, tone increase), therefore, regular monitoring of patients, especially of the elderly, should be carried out. In doubtful cases, patients should be referred to a neurologist for an appropriate examination.

When motor disorders such as Parkinsonism symptoms, restless legs syndrome, tremor, Romberg pose instability and gait unsteadiness occur, Trimetazidine MB should be finally abolished.

Such cases are rare and symptoms usually pass after discontinuation of therapy: in most patients - within 4 months after discontinuation of the drug. If the symptoms of parkinsonism persist for more than 4 months after discontinuation of the drug, you should consult a neurologist.

There may be cases of falls associated with instability in the Romberg position and the "shakiness" of gait or arterial hypotension, especially in patients taking antihypertensive drugs (see "Side effect" section).

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:

Care should be taken when driving vehicles and performing work that requires an increased speed of physical and mental reactions (risk of dizziness and weakness).

Form release / dosage:

Tablets of prolonged actions coated with a film coating of 35 mg.

Packaging:

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

By 10, 20, 30, 40, 50, 60 or 100 tablets in cans of polymeric for medicines.

One jar or 1, 2, 3, 4, 5, 6, 10 contour mesh packages together with the instructions for use will be placed in a cardboard box (bundle).

In the case of production of the preparation at the production site of OOO Ozon, Russia, 10, 20, 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 10, 20, 30, 40, 50, 60 or 100 tablets in cans of polyethylene terephthalate.

One jar or 1, 2, 3, 4, 5, 6, 10 contour mesh packages together with the instructions for use will be placed in a cardboard box (bundle).

Storage conditions:

In the 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:LP-002301

Date of registration:08.11.2013

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

OZON PHARM, LLC Russia

Information update date: & nbsp24.10.2015

Illustrated instructions

Instructions

Trimetazidine MB (Trimetazidine SR)