Trimectal MB tabs 35mg #120

Instruction for Trimectal MB

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Trimectal MB is an antihypoxic agent.

Release form and composition

Dosage form Trimectal MB - film-coated tablets with modified release: round, biconvex, almost white or white with a yellowish tinge color (10, 20 and 30 pcs. In blisters, in a cardboard box 3 or 6 packs of 10 tablets or 2, 3, 5 or 6 packs of 20 tablets, or 1, 2 or 4 packs of 30 tablets; 60 pcs. in polyethylene cans, in a cardboard box 1 can).
Composition of 1 tablet:
    active substance: trimetazidine dihydrochloride - 35 mg;
    additional components: magnesium stearate - 2.5 mg, calcium hydrogen phosphate dihydrate - 73.8 mg, colloidal silicon dioxide - 1.2 mg, Kollidon SR (polyvinyl acetate - 80%, povidone - 19%, sodium lauryl sulfate - 0.8%, silicon dioxide - 0.2%) - 137.5 mg;
    composition of the film shell: macrogol 4000 (polyethylene glycol 4000), titanium dioxide, hypromellose and talc, or macrogol 4000 (polyethylene glycol 4000), talc, titanium dioxide and dry mixture for a film coating containing hypromellose.

Pharmacodynamics

Trimetazidine - an active component of Trimectal MB - a substance that has an antihypoxic effect, optimizes the metabolism and function of cardiomyocytes and brain neurons, exerting a direct influence on them. The cytoprotective property of the drug is due to the ability to increase the energy potential, activate oxidative decarboxylation and rationalize oxygen consumption (enhance aerobic glycolysis and block fatty acid oxidation). Trimetazidine is capable of inhibiting fatty acid oxidation due to the enzyme 3-ketoacyl-CoA-thiolase of mitochondrial long-chain fatty acid isoform, as a result of which glucose oxidation is enhanced, glycolysis with glucose oxidation is accelerated, which determines the protection of the myocardium from ischemia.
The pharmacological properties of the drug are based on switching energy metabolism from fatty acid oxidation to glucose oxidation. Trimetazidine prevents a decrease in the content of phosphocreatine and the intracellular level of adenosine triphosphoric acid (ATP), maintains myocardial contractility. Under conditions of acidosis, it prevents the accumulation of sodium and calcium ions in cardiomyocytes, normalizes the functioning of membrane ion channels and the intracellular content of potassium ions.
Trimectal MB reduces the increased content of phosphates and reduces intracellular acidosis caused by reperfusion and myocardial ischemia. It increases the duration of the electrical potential, preserves the integrity of cell membranes, prevents the damaging action of free radicals and the activation of neutrophils in the ischemic zone, reduces the severity of ischemic damage to the myocardium and the release of creatine phosphokinase (CPK) from cells.
Trimetazidine reduces the severity of tinnitus and dizziness. In case of vascular pathologies, it improves the functional activity of the retina.
In the course of experimental studies, it was found that trimetazidine:
    reduces the size of myocardial damage;
    reduces intracellular acidosis and the severity of changes in the transmembrane ion flux that occur during ischemia;
    reduces the level of migration and infiltration of polynuclear neutrophils in reperfused and ischemic heart tissues;
    supports the energy metabolism of the heart and neurosensory tissues during ischemia;
    does not directly affect hemodynamic parameters.
Clinical trials have confirmed the efficacy and safety of trimetazidine in patients with stable angina pectoris, including as part of combination therapy with insufficient efficacy of other antianginal drugs.
In patients with angina pectoris, trimetazidine:
    reduces the frequency of angina attacks;
    significantly reduces the need to take short-acting nitroglycerin;
    reduces fluctuations in blood pressure during exercise (without significant changes in heart rate);
    increases the coronary reserve, which slows down the onset of exercise-induced ischemia (starting from the 15th day of therapy);
    improves the contractile function of the left ventricle in patients with ischemic dysfunction.

Pharmacokinetics

After oral administration, trimetazidine is absorbed quickly and almost completely in the gastrointestinal tract. The maximum concentration in the blood reaches 5 hours after ingestion. It is characterized by high bioavailability - 90%. After 24 hours, the plasma concentration of trimetazidine remains at the level determined after 11 hours and is 75%. The equilibrium state is reached after 60 hours. Food does not affect the absorption and bioavailability of the drug.
The Vd (volume of distribution) of trimetazidine is 4.8 l / kg, which suggests a good diffusion of its distribution in tissues. In vitro, the connection with blood plasma proteins is about 16%.
It is excreted mainly by the kidneys, and in unchanged form - about 60%. T½ (half-life) is 7 hours in adult patients, about 12 hours in patients over the age of 65 years.
Hepatic clearance of trimetazidine decreases with age, renal clearance directly correlates with creatinine clearance.
The drug penetrates the histohematogenous barriers.
In patients over 75 years of age, due to age-related decline in renal function, an increase in the plasma concentration of trimetazidine is possible.
In patients with moderate renal insufficiency (creatinine clearance from 30 to 60 ml / min), the concentration of the drug in the blood plasma can be increased 2.4 times, in patients with severe renal insufficiency (creatinine clearance <30 ml / min) - approximately 4 times compared with patients with normal renal function. No specific features regarding the safety of the drug were found in this group of patients.

Indications for use

Trimectal MB is prescribed to patients with coronary heart disease to prevent attacks of stable angina pectoris (as a monopreparation or as part of combination therapy).

Contraindications

    renal failure of severe severity (creatinine clearance <30 ml / min);
    symptoms of parkinsonism or Parkinson's disease (restless legs syndrome, tremors, and other associated movement disorders);
    age under 18;
    pregnancy and lactation;
    hypersensitivity to any component of the drug.
Trimectal MB should be used with caution in the treatment of patients over 75 years of age, patients with moderate renal and severe hepatic impairment.

Instructions for the use of Trimectal MB: method and dosage

Coated tablets Trimectal MB are taken orally, without chewing, with water, optimally during meals.
Adult patients are prescribed 1 tablet 2 times a day - in the morning and in the evening.
The maximum daily dose is 70 mg.
For patients with moderate renal failure, Trimectal MB 35 mg tablets are prescribed 1 pc. Once a day. The drug should be taken in the morning with breakfast.
For patients over the age of 75 years, the dose is selected with caution.
The doctor determines the duration of therapy individually.

Side effects

    on the part of the cardiovascular system: rarely (from> 1/10 000 to <1/1000) - hot flushes to the skin of the face, palpitations, marked decrease in blood pressure, tachycardia, extrasystole, orthostatic hypotension (possible loss of balance, dizziness, general weakness), especially with the combined use of antihypertensive drugs;
    from the digestive system: often (from> 1/100 to <1/10) - dyspepsia, abdominal pain, nausea, diarrhea, vomiting; the frequency is unknown (according to the available data, it is not possible to establish the frequency) - constipation;
    from the central nervous system: often - headache, dizziness; frequency unknown - sleep disturbances (drowsiness / insomnia), unsteadiness of gait, instability in the Romberg position, symptoms of parkinsonism (akinesia, tremor, increased tone), restless legs syndrome and other movement disorders;
    from the liver and biliary tract: frequency unknown - hepatitis;
    on the part of the hematopoietic organs: the frequency is unknown - thrombocytopenia, agranulocytosis, thrombocytopenic purpura;
    on the part of the skin: often - skin rashes, itching, urticaria; frequency unknown - Quincke's edema, acute generalized exanthematous pustulosis;
    general disorders: often - asthenia.

Overdose

Overdose cases have not been reported to date.
Recommended therapy for overdose is symptomatic.

Special instructions

Trimectal MB is not intended for relieving angina attacks. Should not be used for the initial course of unstable angina pectoris and myocardial infarction at the prehospital stage and in the first days of hospitalization.
If an attack of angina pectoris occurs against the background of the use of the drug, it is necessary to consult a doctor to revise and adapt the therapy regimen.
Trimetazidine can cause or worsen the existing symptoms of parkinsonism, therefore, patients, especially the elderly, should be monitored during treatment. In doubtful cases, consultation with a neurologist is required. Patients should be warned about the need for a complete cancellation of Trimectal CF in case of such disorders as restless legs syndrome, instability in the Romberg position, tremors, unsteadiness of gait, symptoms of parkinsonism. Such cases are rare and these disorders usually resolve after stopping trimetazidine, usually within 4 months. If symptoms persist for more than 4 months, consultation with a neurologist is required. Due to unsteadiness of gait and instability in the Romberg position, as well as with a pronounced decrease in blood pressure, cases of falling are possible, especially in patients receiving antihypertensive drugs.
Due to the peculiarity of the dosage form of Trimectal MB, the tablet framework may not dissolve in the intestine and be excreted in the feces, this phenomenon does not affect the effectiveness of trimetazidine.

Influence on the ability to drive vehicles and complex mechanisms

According to the instructions, Trimectal MB can cause side effects from the central nervous system, therefore, vehicle drivers and patients employed in potentially hazardous industries (requiring increased attention and speed of reactions) should be careful during the period of therapy.

Application during pregnancy and lactation

There are no data on the safety of using Trimectal MB during pregnancy. Animal studies did not reveal the presence of direct or indirect reproductive toxicity, as well as the effect of trimetazidine on the reproductive function of rats of both sexes. However, it is not recommended to prescribe the drug during pregnancy as a precautionary measure.
There is no information on the excretion of trimetazidine and its metabolites into breast milk. However, the risk to a breastfed baby cannot be completely excluded, therefore, Trimectal MB should not be used in lactating women.

Childhood use

Trimectal MB is contraindicated in patients under 18 years of age.

With impaired renal function

Trimectal MB should be used with caution in the treatment of patients with moderate renal failure (creatinine clearance 30-60 ml / min). The drug is contraindicated in severe renal failure (creatinine clearance <30 ml / min).

For violations of liver function

Trimectal MB should be used with caution in the treatment of patients with severe hepatic impairment.

Use in the elderly

Trimectal MB should be used with caution in the treatment of patients over 75 years of age.

Drug interactions

Trimetazidine increases the anti-ischemic effect of other antianginal drugs used simultaneously. No other drug interactions have been reported.

Terms and conditions of storage

Store no more than 3 years in a dark place at temperatures up to 25 ° C. Keep out of the reach of children.

Reviews about Trimectal MB

This drug, as a rule, is prescribed as part of a combination therapy, therefore, it is rather difficult to assess the degree of its effectiveness and positive effect on the human body. Nevertheless, positive reviews about Trimectal MB are common. Patients note a decrease in blood pressure fluctuations, the severity of tinnitus, nausea and dizziness.
Of the shortcomings, many note mild side effects at the beginning of the course of treatment (such as flushing of the skin of the face).

Terms of sell

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