Депренорм® MV

General characteristics. Structure:

Active agent of a trimetazidin dihydrochloride of 35,0 mg;
excipients: hydrophosphate calcium dihydrate of 34,6 mg; hypro rod (hydroxypropyl cellulose) of 6,0 mg; gipromelloz (gidroksipropilmetiltsellyuloz) of 64,0 mg; коповидон 4,2 mg; silicon dioxide colloid (aerosil) of 6,4 mg; magnesium stearate of 0,8 mg; cellulose of microcrystallic 59,0 mg;
structure of a cover: Selekoat of AQ-01673 7,0 mg [gipromelloz (gidroksipropilmetiltsellyuloz) of 2,8 mg; a macrogoal - 400 (polyethyleneglycol - 400) 0,7 mg; a macrogoal - 6000 (polyethyleneglycol - 6000) 0,7 mg; an aluminum varnish on the basis of dye crimson [Ponso 4 R] (Е 124) 0,7 mg; titanium dioxide of 2,1 mg].

Description:
Tablets, film coated pink color, round, biconvex. The insignificant roughness is allowed. On cross section – almost white color.

Pharmacological properties:

Pharmacodynamics. Trimetazidin has anti-hypoxemic effect at stable stenocardia. Directly influencing cardiomyocytes and neurons of a brain, 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). Maintains contractility of a myocardium, prevents decrease in intracellular content of adenosine triphosphoric acid (ATP) and creatine phosphate. In the conditions of acidosis normalizes functioning of membrane ion channels, interferes with accumulation of calcium and sodium in cardiomyocytes, normalizes the intracellular maintenance of potassium ions. Reduces the intracellular acidosis and 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 a kreatinfosfokinaza exit from cells and expressiveness of ischemic injuries of a myocardium.
Trimetazidin reduces the frequency of attacks of stenocardia (consumption of nitrates decreases), in 2 weeks of reception tolerance to an exercise stress increases, sharp fluctuations of arterial pressure decrease. Dizziness and a sonitus decreases.
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 from digestive tract. Bioavailability - 90%. Time of achievement of the maximum concentration in a blood plasma - 5 h. The equilibrium 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%. Easily gets through gistogematichesky barriers. The elimination half-life (T1/2) makes about 7 h, at patients 65 years - about 12 h are more senior. It is brought out of an organism by kidneys (about 60% in not changed look).
The renal clearance of a trimetazidin directly correlates with the clearance of creatinine (CC), the hepatic clearance decreases with age.

Indications to use:

Coronary heart disease: prevention of attacks of stable stenocardia (as a part of a combination therapy);
chorioretinal disturbances with an ischemic component;
vestibulo-cochlear disturbances of the ischemic nature, such as dizziness, sonitus, hearing disorder.

Route of administration and doses:

Inside, during food.
Депренорм® MB accept 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:

Депренорм® MB is not intended for stopping of attacks of stenocardia, for an initial course of therapy of stable stenocardia or a myocardial infarction.
In case of development of an attack of stenocardia it is necessary to reconsider and adapt treatment.

Use at pregnancy and during breastfeeding:
Drug is contraindicated at pregnancy due to the lack of clinical data on safety of its use.
It is unknown whether it is allocated триметазидин with breast milk. Therefore in need of use of drug in the period of a lactation it is necessary to stop breastfeeding.

Influence on ability to manage transport and to perform the works demanding the high speed of psychomotor reactions:
Use of drug does not influence ability to driving and performance of work, demanding the increased speed of psychomotor reactions.

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); often (more than 1/100, less than 1/10); infrequently (more than 1/1000, less than 1/100); seldom (more than 1/10000, less than 1/1000); very seldom (less than 1/10000), including, separate messages.
From the alimentary system
Often: abdominal pain, diarrhea, dyspepsia, nausea, vomiting.
From the central nervous system
Often: dizziness, headache, adynamy.
Very seldom: extrapyramidal frustration (a tremor, rigidity, an akineziya), reversible after drug withdrawal.
From integuments
Often: skin rash, itch, small tortoiseshell.
From cardiovascular system
Seldom: orthostatic hypotension, "inflows" of blood to face skin.

Interaction with other medicines:

There are no data.

Contraindications:

Hypersensitivity to any component of drug;
heavy renal failure (KK is lower than 15 ml/min.);
the expressed abnormal liver functions;
pregnancy;
breastfeeding period;
age up to 18 years (efficiency and safety are not established).

Overdose:

The overdoses given about cases are limited. In case of overdose it is necessary to carry out symptomatic therapy.

Storage conditions:

In the dry, protected from light place at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity: 3 years. Not to apply after a period of validity.

Issue conditions:

According to the recipe

Packaging:

Tablets of the prolonged action, film coated, 35 mg.
On 10 or 30 tablets in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished.
On 1, 2, 3, 6 blister strip packagings on 10 tablets or on 1, 2, 3, 4 blister strip packagings on 30 tablets together with the application instruction place in a pack from a cardboard.