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

Excipients: lactose (sugar milk), potato starch, giprolose (hydroxypropylcellulose Klucel), hypromellose, silicon dioxide colloid, magnesium stearate.

Sheath: Opadry II (85 Series) (polyvinyl alcohol, partially hydrolyzed, macrogol 3350, pebbles, E 171 Titanium dioxide, yellow iron oxide coloring E 172, the dye black iron oxide E 172, red iron oxide coloring E 172).

Description:

The tablets covered with a cover of pink color, round, biconcave. At the break of white 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:

The drug is antihypoxic, antianginal action. Normalizes the energy metabolism of cells exposed to hypoxia or ischemia (mainly cardiomyocytes and neurons in the brain), prevents a decrease in intracellular ATP content. Thus, the drug ensures the normal functioning of membrane ion channels, transmembrane transfer of potassium and sodium ions and preservation of cellular homeostasis. It slows the oxidation of fatty acids due to selective inhibition of the long-chain 3-ketoatsetil-CoA thiolase, which leads to an increase in glucose oxidation and recovery interface between glycolysis and oxidative decarboxylation, and, as shown, causes protect the myocardium from ischemia.Switching of fatty acid oxidation to glucose oxidation underlies antianginal action of t/ RTI & gt; In experimental animal studies, it has been shown that trimetazidine supports the energy heart metabolism and neurosensororgans during periods of ischemia; reduces the magnitude of intracellular acidosis and the degree of changes in the transmembrane ion flow that occurs with ischemia; bylowers the level of migration and infiltrationthe radionuclide of polynucleated neutrophils in ischemic and reperfusion tissues of the heart, reduces the size of myocardial damage; while it does not affect hemodynamics. In clinical studies it was shown that in patients with coronary heart disease (including angina), the drug increases the coronary reserve, thereby slowing the development of ischemia caused by physical exertion, starting from the 15th day of therapy; limits sharp fluctuations in blood pressure without any significant changes in heart rate. Trimetazidine improves the contractile function of the left ventricle in patients with ischemic dysfunction, facilitates angina pectoris.

Pharmacokinetics:

After taking the drug inside trimetazidine quickly absorbed. The maximum concentration (Cmah) is reached after 5 hours in blood plasma.

Clearance (CL) is reached after 60 hours. V_d is 4.8 l / kg, which implies good diffusion in the tissue. The connection with plasma proteins is low, about 16% (in vitro).

It is excreted from the body, mainly by the kidneys in unchanged form. The half-life (T1/2) - about 7 hours, in patients older than 65 years - about 12 hours Renal clearance of trimetazidine directly correlates with the clearance of creatinine, liver clearance decreases with age.

Indications:

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

- Chorioretinal vascular disorders;

- Cohleo-vestibular disorders of ischemic nature (tinnitus, hearing impairment, dizziness).

Contraindications:

- Hypersensitivity to any component of the drug;

- Renal failure (creatinine clearance less than 15 ml / min.);

- Pronounced violations of the liver;

- Pregnancy;

- The period of breastfeeding;

- Age under 18 years (efficiency and safety not established);

- Patients with lactase deficiency, galakzozemia, or glucose-galactose malabsorption syndrome.

Pregnancy and lactation:

The drug is contraindicated in pregnancy due to the lack of clinical data on the safety of its use. It is not known whether trimetazidine with breast milk. Therefore, if it is necessary to prescribe the drug during lactation, breastfeeding should be stopped. AT experimental research not established teratogenic action of trimetazidine.

Dosing and Administration:

Trimetazidine MV is prescribed 1 tablet 2 times a day during meals in the morning and in the evening. The duration of therapy is set individually.

Side effects:

Rarely - nausea, ptota, allergic reactions are possible.

Overdose:

At present, no cases of drug overdose have been reported.

Interaction:

There is no information.

Special instructions:

It is not used for relief of angina attacks and is not indicated for the initial course of therapy for unstable angina or myocardial infarction, as well as in preparation for hospitalization or in its first days.

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

Effect on the ability to drive transp. cf. and fur:

The use of the drug does not affect the ability to drive and perform work, requiring a high rate of mental and physical reactions.

Form release / dosage:

Tablets with modified release, film-coated, 35 mg.

Packaging:

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

1, 2 or 3 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C, Keep out of reach of children.

Shelf life:

2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-006550/09

Date of registration:17.08.2009

The owner of the registration certificate:VALENTA PHARM, PAO VALENTA PHARM, PAO Russia

Manufacturer: & nbsp

VALENTA PHARMACEUTICS, JSC Russia

Information update date: & nbsp25.10.2015

Illustrated instructions

Instructions

Trimetazidine MB (Trimetazidine MV)