Тримектал® MV

General characteristics. Structure:

Active ingredient: 0,035 g of a trimetazidin dihydrochloride.

Excipients: коллидон SR [polyvinyl acetate of 80%, povidone of 19%, sodium lauryl sulfate of 0,8%, silicon dioxide of 0,2%], hydrophosphate calcium dihydrate, silicon dioxide colloid (aerosil), magnesium stearate.

Film cover: gipromelloz (gidroksipropilmetiltsellyuloz), talc, titanium dioxide, macrogoal 4000 (poly(ethylene oxide) 4000 or polyethyleneglycol 4000) or cover film Advantia Prime 390009ZA09-white (gipromelloza, talc, titanium dioxide, macrogoal 4000).

Pharmacological properties:

Pharmacodynamics. Has anti-hypoxemic effect. Directly influencing cardiomyocytes and neurons of a brain, drug optimizes their metabolism and function. The cytoprotective effect is caused by increase in energy potential, activation of oxidizing decarboxylation and rationalization of consumption of oxygen (strengthening of aerobic glycolysis and blockade of oxidation of fatty acids).

Trimetazidin maintains contractility of a myocardium, prevents decrease in intracellular content of adenosine triphosphoric acid (ATP) and phosphocreatinine. In the conditions of acidosis normalizes functioning of ion channels of membranes, interferes with accumulation of calcium ions and sodium in cardiomyocytes, normalizes the intracellular maintenance of potassium ions.

Reduces the intracellular acidosis and the increased content of phosphates caused by ischemia of a myocardium and reperfusion. Interferes with the damaging action of free radicals, keeps integrity of cellular membranes, prevents activation of neutrophils in an ischemia zone, increases duration of electric potential, reduces an exit of a kreatinfosfokinaza (KFK) from cells and expressiveness of ischemic injuries of a myocardium.

Trimetazidin reduces the frequency of attacks of stenocardia, reduces the need for reception of nitrates, in 2 weeks of reception increases tolerance to an exercise stress, sharp fluctuations of the arterial pressure (AP) decrease. Reduces dizziness and a sonitus. At vascular pathology of eyes improves functional activity of a retina of an eye.

Pharmacokinetics. After administration of drug inside триметазидин it is quickly and almost completely absorbed in digestive tract. Bioavailability — 90%.

Time of achievement of the maximum concentration in a blood plasma — 3 h.

The stable state is reached in 60 h. The volume of distribution makes 4,8 l/kg that assumes good diffusion of distribution in fabrics.

Communication with proteins of a blood plasma - 16%.

Trimetazidin is brought from an organism generally by kidneys (about 60% - in not changed ви). The elimination half-life about 7 h, at patients is more senior than 65 years — about 12 h.

The renal clearance of a trimetazidin directly correlates with the clearance of creatinine (CC), the hepatic clearance decreases with age. Easily gets through gistogematichesky barriers.

Indications to use:

Cardiology: coronary heart disease, prevention of attacks of stenocardia (as a part of complex therapy).

Kokhleovestibulyarny disturbances of the ischemic nature, such as dizziness, sonitus, hearing disorder.

Ophthalmology: chorioretinal vascular disorders with ischemic components.

Route of administration and doses:

Inside, during meal. Тримектал® MV appoint on 1 tablet 2 times a day (in the morning and in the evening). A course of treatment — according to the recommendation of the doctor.

Features of use:

Not to apply to stopping of attacks of stenocardia.

Drug is not shown for an initial course of therapy of unstable stenocardia or a myocardial infarction. In case of development of an attack of stenocardia it is necessary to reconsider and adapt treatment.

Influence on control of vehicles and mechanisms. Тримектал® the MV does not influence ability to driving of transport and performance of work, demanding the increased speed of psychomotor reactions.

Use at pregnancy and during breastfeeding. Data on use of a trimetazidin for pregnant women are absent. As a precautionary measure it is not recommended to apply Trimektal® of MV during pregnancy. Data on allocation of a trimetazidin or its metabolites in breast milk are absent. The risk for the newborn/child cannot be excluded. It is not necessary to apply  Trimektal® of MV during breastfeeding.

Side effects:

Frequency of the side effects noted at reception of a trimetazidin is specified in the following gradation: very often (more than 1/10, that is more than 1 cases on 10 patients); often (more than 1/100 and less than 1/10); infrequently (more than 1/1000 and less than 1/100); seldom (more than 1/10000 and less than 1/1000); very seldom (less than 1/10000), including separate messages.

From the alimentary system: often - an abdominal pain, diarrhea, dyspepsia, nausea, vomiting.

From the central nervous system: often - dizziness, a headache, an adynamy; very seldom - extrapyramidal frustration (a tremor, rigidity, an akineziya), reversible after drug withdrawal.

From integuments and a hypodermic fatty tissue: often — skin rash, an itch, a small tortoiseshell.

From cardiovascular system: seldom - orthostatic hypotension, "inflows" of blood to face skin.

Interaction with other medicines:

In clinical trials of a trimetazidin it is shown that it promotes increase in anti-ischemic activity of other anti-anginal drugs, other interactions were not observed.

Contraindications:

- hypersensitivity to any component of drug;
- chronic renal failure (KK less than 15 ml/min.);
- the expressed abnormal liver functions;
- pregnancy;
- lactation period;
- age up to 18 years (efficiency and safety are not established).

Overdose:

Now about cases of overdose of drug it was not reported.

Storage conditions:

List B. In the dry place protected from light at a temperature not over 25 ºС. To store in the place, unavailable to children. Period of validity: 2 years. Not to use after a period of validity.

Issue conditions:

According to the recipe

Packaging:

Tablets with the modified release, film coated, 35 mg. On 10, 20 or 30 tablets in a blister strip packaging from a film of polyvinyl chloride and aluminum foil. On 60 tablets in banks polymeric. 3 or 6 blister strip packagings on 10 tablets, 2, 3, 5 or 6 planimetric cell packagings on 20 tablets or 1, 2 or 4 blister strip packagings on 30 tablets, or one bank together with the application instruction in a pack from a cardboard.