Trimetazidine-Biocom MB modified-release pills 35mg, 120pcs

Composition

1 modified release coated tablet contains:

Active ingredient: of Trimetazidine dihydrochloride – 35,00 mg;

excipients: calcium hydrogen phosphate dihydrate – 79,93 mg, hypromellose (hydroxypropyl methylcellulose) – 57,40 mg, prosolv (siliconized microcrystalline cellulose) – 20,50 mg, potato starch – 3,07 mg, silicon dioxide colloid (Aerosil) – 2.05 mg, magnesium stearate – 2.05 mg;

the composition of the shell: hypromellose (hydroxypropyl methylcellulose) – 3,476 mg, macrogol (polyethylene glycol) – 0,524 mg, titanium dioxide E 171 – 0,976 mg dye iron oxide red E 172 – 0,024 mg.

Pharmacological properties

Pharmacotherapeutic group: anti-vehicle.

ATX code C 01 EB 15

Pharmacological properties

Pharmacodynamics

Trimetazidine has an antianginal, antihypoxic effect. Directly affecting cardiomyocytes and brain neurons, it 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 (increased aerobic glycolysis and blockade of fatty acid oxidation). Supports myocardial contractility, prevents a decrease in the intracellular content of ATP and phosphocreatinine. In conditions of acidosis, it normalizes the functioning of ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, and normalizes the intracellular content of potassium ions.

Reduces intracellular acidosis and phosphate concentrations due to myocardial ischemia and reperfusion. It prevents the damaging effect of free radicals, preserves the integrity of cell membranes, prevents neutrophil activation in the ischemic zone, increases the duration of the electrical potential, reduces the release of creatine phosphokinase from cells and the severity of ischemic myocardial damage.

When angina reduces the frequency of attacks (reduces the intake of nitrates), after 2 weeks of treatment increases tolerance to physical activity, decreases blood pressure drops. Hearing and vestibular test results are improved in patients, dizziness and tinnitus are reduced.

In vascular pathology, the eye restores the functional activity of the retina.

Pharmacokinetics

After oral use, trimetazidine is rapidly and almost completely absorbed from the gastrointestinal tract. Bioavailability – 90%. The time to reach the maximum concentration in blood plasma is 2 hours. The maximum concentration after a single dose of 35 mg of trimetazidine is about 55 ng / ml. Easily penetrates through histohematic barriers. The half-life (T 1/2) is 4.5-5 hours. Binding to plasma proteins is 16%. It is excreted from the body by the kidneys (about 60% unchanged).

Pharmacokinetics in special patient groups

Patients with impaired renal function

Trimetazidine exposure was increased on average 2.4 – fold in patients with moderate renal insufficiency (creatinine clearance 30-60 ml/min), and on average 4-fold in patients with severe renal insufficiency (creatinine clearance less than 30 ml/min) compared to patients with normal renal function.

No safety features were found in this patient population compared to the general population.

Elderly patients

Patients over 75 years of age may experience increased exposure to trimetazidine due to age-related decline in renal function.

Indications

Long-term therapy of coronary heart disease: prevention of stable angina attacks as part of mono-or combination therapy.

Use during pregnancy and lactation

There are no data on the use of Trimetazidine-Biocom MV in pregnant women. Animal studies have not revealed the presence of direct or indirect reproductive toxicity. Reproductive toxicity studies have not shown the effect of trimetazidine on the reproductive function of rats of both sexes. As a precautionary measure, it is not recommended to use the drug Trimetazidine-Biocom MV during pregnancy.

There are no data on the excretion of trimetazidine or its metabolites in breast milk. The risk to the newborn/child cannot be excluded. Do not use Trimetazidine-Biocom MV during breastfeeding.

Contraindications

-Hypersensitivity to any component of the drug;

– Parkinson’s disease, symptoms of Parkinsonism, tremor, restless legs syndrome and other related motor disorders;

– Severe renal failure (creatinine clearance below 30 ml / min);

– Age under 18 years (efficacy and safety have not been established).

With caution

-Severe hepatic insufficiency (clinical data are limited);

– Moderate renal insufficiency.

Side effects

Inside, while eating.

The recommended dosage regimen is 2 tablets (70 mg) per day, in 2 divided doses. Course of treatment according to the doctor’s recommendation.

Special patient groups

Patients with impaired renal function

In patients with moderate renal insufficiency (creatinine clearance 30-60 ml / min), the daily dose is 35 mg in the morning with breakfast.

Elderly patients

Patients over 75 years of age may experience increased exposure to trimetazidine due to age-related decline in renal function.

Dose selection in patients over 75 years of age should be carried out with caution.

How to take, course of use and dosage

Inside, while eating.

The recommended dosage regimen is 2 tablets (70 mg) per day, in 2 divided doses. Course of treatment according to the doctor’s recommendation.

Special patient groups

Patients with impaired renal function

In patients with moderate renal insufficiency (creatinine clearance 30-60 ml / min), the daily dose is 35 mg in the morning with breakfast.

Elderly patients

Patients over 75 years of age may experience increased exposure to trimetazidine due to age-related decline in renal function.

Dose selection in patients over 75 years of age should be carried out with caution.

Overdose

There is only limited information about trimetazidine overdose. In case of overdose, symptomatic therapy should be performed.

Special instructions

The drug is not intended for the relief of angina attacks and is not indicated for the initial course of treatment of unstable angina or myocardial infarction at the prehospital stage or in the first days of hospitalization.

If an angina attack develops, treatment should be reviewed and adapted (drug therapy or revascularization).

Trimetazidine-Biocom MV can cause or worsen the symptoms of Parkinsonism (tremor, akinesia, increased tone), so patients, especially the elderly, should be regularly monitored. In cases of doubt, patients should be referred to a neurologist for appropriate evaluation.

If motor disorders such as Parkinsonism symptoms, restless legs syndrome, tremor, instability in the Romberg position and “shaky” gait appear, Trimetazidine-Biocom MV should be permanently discontinued.

Such cases are rare and symptoms usually resolve after discontinuation of therapy: in most patients – within 4 months after discontinuation of the drug. If 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 “unsteadiness” of gait or a marked decrease in blood pressure, especially in patients taking antihypertensive drugs (see the section “Side effects”).

Caution should be exercised when prescribing Trimetazidine-Biocom MV to patients who may have increased exposure to it:

– With moderate renal insufficiency (see the sections “Pharmacological properties” and “Dosage and use”).

– In elderly patients over 75 years of age (see the section “Pharmacological properties”).

Influence on the ability to drive vehicles and perform work that requires a high rate of psychomotor reactions

Given the possibility of developing adverse reactions from the central nervous system when taking trimetazidine (see the section “Side effects”), caution should be exercised when driving vehicles and performing work that requires an increased rate of physical and mental reactions.

Form of production

Modified release coated tablets.

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C.

Keep out of reach of children.

Shelf

life is 3 years.

Do not use after the expiration date indicated on the package.

Active ingredient

Trimetazidine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets