Trimetazidine MB tabs 35mg #60

Instruction for use of Trimetazidine MB

To buy Trimetazidine MB just add it to your shopping cart

Trimetazidine MB is a drug with an antihypoxic effect, used to prevent attacks of stable angina pectoris.

Release form and composition

Dosage forms of release of Trimetazidine MB:
    prolonged-release film-coated tablets: from light pink to pink, round, biconvex; the core in cross section is white or almost white (10, 20 or 30 pcs. in blisters, in a cardboard box 1-6 or 10 packs; 10, 20, 30, 40, 50, 60 or 100 pcs. in polymer cans, in a cardboard box 1 can);
    coated / film-coated modified-release tablets: pink to brownish-pink, round, biconvex, scored on one side; core on a cross section - from almost white or white to white with a yellowish tinge (15 pcs. in blisters, in a cardboard box 2 or 4 packs; 10 pcs. in blisters, in a cardboard box 1-3 , 6, 12 or 18 packs; 20 pcs. In blisters, in a cardboard box 1-3 packs).
Composition of 1 extended-release tablet:
    active substance: trimetazidine dihydrochloride - 35 mg;
    additional components: magnesium stearate - 1.55 mg; colloidal silicon dioxide - 1.55 mg; hypromellose - 93 mg; microcrystalline cellulose - 178.9 mg;
    shell: Opadry II 85F240012 pink (macrogol-3350 - 2.438 mg; talc - 1.48 mg; polyvinyl alcohol - 4 mg; dye iron oxide red - 0.04 mg; dye iron oxide yellow - 0.022 mg; titanium dioxide - 2, 02 mg) - 10 mg.
Composition of 1 modified release tablet:
    active substance: trimetazidine dihydrochloride - 35 mg;
    additional components: colloidal silicon dioxide - 2 mg; anhydrous calcium hydrogen phosphate - 157 mg; hypromellose - 50 mg; magnesium stearate - 1.5 mg; crospovidone - 2.5 mg; talc - 2 mg;
    shell: Opadry II pink (85F34610) (polyvinyl alcohol - 40%; titanium dioxide - 24.24%; macrogol 3350 - 20.2%; talc - 14.8%; dye iron oxide yellow - 0.37%; dye oxide iron red - 0.36%; dye black iron oxide - 0.03%) - 8 mg.

Pharmacodynamics

Trimetazidine MB has an antihypoxic effect.
Directly affects the neurons of the brain and cardiomyocytes, optimizing their function and metabolism. The cytoprotective effect is due to the activation of oxidative decarboxylation, an increase in the energy potential and the rationalization of oxygen consumption (due to the inhibition of long-chain 3-ketoacyl-CoA thiolase, an increase in aerobic glycolysis and blockade of fatty acid oxidation is observed).
The main properties of trimetazidine:
    maintaining myocardial contractility, preventing intracellular depletion of creatine phosphate and adenosine triphosphoric acid;
    normalization of the functioning of ion channels of membranes under conditions of acidosis, preventing the accumulation of sodium and calcium ions in cardiomyocytes, normalizing the intracellular concentration of potassium ions;
    a decrease in intracellular acidosis and an increased content of phosphates, which is due to reperfusion and myocardial ischemia;
    preventing the damaging effects of free radicals, maintaining the integrity of cell membranes, preventing the activation of neutrophils in the ischemic zone, increasing the duration of the electric potential, reducing the release of creatine phosphokinase from cells and the severity of ischemic damage to the myocardium.
The substance has no direct effect on hemodynamic parameters.
The main effects of Trimetazidine MB in angina pectoris:
    limitation of fluctuations in blood pressure caused by physical activity, without significant changes in heart rate;
    an increase in coronary reserve, which leads to a slowdown in the onset of ischemia associated with exercise (starting from the 15th day of treatment);
    improvement of the contractile function of the left ventricle against the background of ischemic dysfunction;
    reducing the incidence of angina attacks and the need to take short-acting nitroglycerin.

Pharmacokinetics

After oral administration, trimetazidine is almost completely and rapidly absorbed in the gastrointestinal tract. Its bioavailability is 90%. The time to reach the maximum plasma concentration in the blood is approximately 5 hours. For more than 24 hours, the concentration of the substance in the blood plasma is maintained at a level exceeding and equal to 75% of the maximum concentration determined for 11 hours. When taken regularly, the equilibrium concentration is reached after 60 hours. Simultaneous food intake does not affect the bioavailability of trimetazidine.
The volume of distribution of the substance is 4.8 l / kg. Trimetazidine is characterized by a rather low degree of binding to blood plasma proteins - approximately 16%.
Excretion of the substance from the body occurs mainly by the kidneys (approximately 60% - unchanged). In healthy young volunteers, the half-life is 7 hours, in patients over the age of 65 - approximately 12 hours.
The clearance of trimetazidine is characterized to a greater extent by renal clearance, which directly correlates with creatinine clearance, and to a lesser extent - with hepatic clearance, which decreases with the age of the patient.
In patients from 75 years of age, an increase in the plasma concentration of trimetazidine in the blood is possible, which is associated with an age-related decrease in renal function. No safety features were found in this group of patients in comparison with the general population.
In patients with renal insufficiency, the plasma concentration of trimetazidine in the blood on average increased by 2.4 / 4 times (in patients with creatinine clearance of 30-60 or <30 ml / min, respectively) in comparison with volunteers with no impairment of renal function. No safety features were found in this group of patients in comparison with the general population.

Indications for use

Trimetazidine MB is prescribed as monotherapy or in combination with other drugs for long-term therapy of coronary heart disease as a prophylaxis for attacks of stable angina pectoris.

Contraindications

Absolute:
    severe renal impairment (in patients with creatinine clearance <30 ml / min);
    tremor, parkinsonism symptoms, Parkinson's disease, restless legs syndrome;
    age under 18;
    pregnancy and breastfeeding period;
    individual intolerance to any component of the drug.
Relative (Trimetazidine MB should be administered under medical supervision):
    moderate renal failure (in patients with creatinine clearance of 30-60 ml / min);
    age from 75 years.

Instructions for use: method and dosage

Trimetazidine MB is taken orally, without chewing, whole, washed down with water, preferably with meals.
Recommended dosage regimen: 2 times a day (morning and evening), 1 tablet (maximum).
The duration of the course is determined by the doctor individually.
Patients with moderate renal insufficiency, including elderly patients (with creatinine clearance of 30-60 ml / min), Trimetazidine MB 35 mg tablets should be taken 1 time per day in the morning. It is necessary to select a dose for patients over 75 years of age with extreme caution.

Side effects

Possible adverse reactions (> 10% - very often;> 1% and <10% - often;> 0.1% and <1% - infrequently;> 0.01% and <0.1% - rarely; <0, 01%, including individual messages - very rarely; with an unspecified frequency - in cases where it is not possible to estimate the frequency of occurrence of the violation):
    nervous system: often - dizziness, headache; with an unknown frequency - symptoms of parkinsonism (manifested in the form of tremor, akinesia, increased tone), unsteadiness of gait and instability in the Romberg position, restless legs syndrome and other disorders of the musculoskeletal system (usually reversible), sleep disturbances (manifested in the form of insomnia , drowsiness);
    digestive system: often - nausea, abdominal pain, dyspepsia, diarrhea, vomiting; with an unknown frequency - hepatitis, constipation;
    cardiovascular system: rarely - a pronounced decrease in blood pressure, tachycardia, palpitations, flushing to the skin of the face, extrasystole, orthostatic hypotension, which can occur with general weakness, loss of balance or dizziness, especially when combined with drugs with hypotensive action ;
    hematopoietic organs: with an unknown frequency - thrombocytopenia, agranulocytosis, thrombocytopenic purpura;
    skin: often - itching, skin rash, urticaria; with an unknown frequency - acute generalized exanthematous pustulosis;
    allergic reactions: with an unknown frequency - Quincke's edema;
    others: often - asthenia.

Overdose

There is only limited information about trimetazidine overdose. If necessary, symptomatic treatment is carried out.

Special instructions

Trimetazidine MB is not intended for relieving angina attacks. Also, the drug should not be used for the initial course of therapy for unstable angina pectoris or myocardial infarction before / in the first days of hospitalization. In cases of an attack of angina pectoris, it is necessary to review and adapt therapy (use of drugs or a revascularization procedure).
While taking Trimetazidine MB, the appearance / aggravation of symptoms of parkinsonism (akinesia, tremor, increased tone) is possible, and therefore, regular monitoring of patients, especially the elderly, is indicated. In doubtful cases, patients should be referred for an appropriate examination to a neurologist.
If symptoms of parkinsonism, restless legs syndrome, tremor, instability in the Romberg position, unsteadiness of gait and other movement disorders appear, Trimetazidine MB should be finally canceled. Such cases are rare, symptoms usually disappear after discontinuation of therapy (most often within 4 months after discontinuation of Trimetazidine MB; if symptoms persist for longer than a specified period, you should consult a neurologist).

Application during pregnancy and lactation

According to the instructions, Trimetazidine MB is not prescribed to women during pregnancy / breastfeeding, which is due to the lack of data confirming its safety.

Childhood use

Patients under the age of 18 are contraindicated in therapy, due to the lack of data confirming the safety of the drug.

With impaired renal function

Renal dysfunction:
    creatinine clearance 30-60 ml / min: taking Trimetazidine MB requires caution;
    creatinine clearance <30 ml / min: therapy is contraindicated.

Use in the elderly

Before prescribing Trimetazidine MB to patients aged 75 years and older, it is necessary to assess the benefit / risk ratio, therapy should be carried out with caution.

Drug interactions

There are no data on the interaction of Trimetazidine MB with other drugs / substances.

Terms and conditions of storage

Store in a dark place at temperatures up to 25 ° C. Keep out of the reach of children.
Shelf life is 3 years.

Reviews

According to a few reviews, Trimetazidine MB is an effective agent used to prevent attacks of stable angina pectoris.

Terms of sell

You don't need a prescription to buy Trimetazidine MB.