Предуктал® MB

General characteristics. Structure:

Active agent: trimetazidina of dihydrochloride of 35 mg.
Excipients: calcium hydrophosphate dihydrate of 80,90 mg, povidone of 8,70 mg, gipromelloza of 74,00 mg, magnesium stearate of 1,00 mg, silicon dioxide of colloid 0,40 mg, macrogoal-6000 of 0,1317 mg;
cover: the dry premix for a pink cover of N5361 consisting of titanium of dioxide of 0,6908 mg, dye ferrous oxide of red 0,0103 mg, a glitserola of 0,2191 mg, gipromelloza of 3,6414 mg, magnesium of stearate of 0,2191 mg, a macrogoal-6000 of 0,0876 mg.
Description: round, biconvex tablets, film coated, pink color. Color of a tablet on a break: white.

Pharmacological properties:

Pharmacodynamics. Trimetazidin prevents decrease in intracellular concentration of adenosinetriphosphate (ATP) by preservation of power metabolism of cells in a condition of a hypoxia. Thus, drug provides normal functioning of membrane ion channels, transmembrane transfer of potassium ions and sodium and preservation of a cellular homeostasis.
Trimetazidin inhibits oxidation of fatty acids at the expense of the selection inhibition of enzyme 3 ketoatsil-KOA-tiolazy (3-KAT) of a mitochondrial long-chain isoform of fatty acids that leads to strengthening of oxidation of glucose and acceleration of glycolysis with glucose oxidation, as causes protection of a myocardium against ischemia. Switching of power metabolism from oxidation of fatty acids on oxidation of glucose is the cornerstone of pharmacological properties of a trimetazidin.
It is experimentally confirmed what триметазидин has the following properties:
- supports power metabolism of heart and neurosensory fabrics during ischemia;
- reduces expressiveness of intracellular acidosis and the changes of a transmembrane ion flux arising at ischemia;
- lowers the level of migration and infiltration of polynuclear neutrophils in ischemic and reperfuzirovanny tissues of heart;
- reduces the amount of injury of a myocardium;
- does not make direct impact on hemodynamics indicators.
At patients with stenocardia триметазидин:
- increases a coronary reserve, thereby slowing down approach of the ischemia caused by an exercise stress since 15th day of therapy;
- limits the fluctuations of arterial pressure caused by an exercise stress without considerable changes of heart rate;
- considerably reduces the frequency of attacks of stenocardia and the need for reception of nitroglycerine of short action;
- improves sokratitelny function of a left ventricle at patients with ischemic dysfunction.
In clinical trial lasting 2 months it was shown that addition of tablets of a trimetazidin with the modified release in a dose of 35 mg to therapy atenololy in a dose of 50 mg in 12 hours after intake led to significant delay of approach of an ischemic depression of a segment of ST when carrying out loading tests.

Pharmacokinetics. After intake триметазидин it is quickly absorbed and reaches the maximum concentration in a blood plasma approximately in 5 hours.
Over 24 hours concentration in a blood plasma remains at the level exceeding 75% of the concentration defined in 11 hours. The equilibrium state is reached in 60 hours. Meal does not influence bioavailability of a trimetazidin.
The volume of distribution makes 4,8 l/kg that demonstrates good distribution of a trimetazidin in fabrics (extent of linkng with proteins of a blood plasma rather low, about 16% of in vitro).
Trimetazidin is brought generally by kidneys, mainly, in not changed look.
The elimination half-life at young healthy volunteers about 7 hours, at patients is more senior than 65 years - about 12 hours.
The renal clearance of a trimetazidin directly correlates with the clearance of creatinine (CC), the hepatic clearance decreases the patient with age.
It is shown that at patients of advanced age at reception of a daily dose 2 tablets of a trimetazidin in two steps, increase in exposure in a blood plasma does not result in any more expressed effects in comparison with placebo.

Indications to use:

Cardiology: long therapy of coronary heart disease: prevention of attacks of stable stenocardia as a part of mono - or a combination therapy.
LOR-diseases: treatment of vestibulo-cochlear disturbances of the ischemic nature, such as dizziness, sonitus, hearing disorder.
Ophthalmology: chorioretinal disturbances with ischemic components.

Route of administration and doses:

Pill should be taken entirely, without chewing, washing down with water. Inside, on 1 tablet 2 times a day, in the morning and in the evening, during food. Duration of treatment is defined by the doctor.

Features of use:

Предуктал® the MV is not intended for stopping of attacks of stenocardia and not shown for an initial course of therapy of unstable stenocardia or a myocardial infarction, and also by preparation for hospitalization or in its first days.
In case of development of an attack of stenocardia it is necessary to reconsider and adapt treatment (medicinal therapy or carrying out revascularization).
Influence on ability to drive the car and to perform the works demanding the high speed of psychomotor reactions
Предуктал® the MV slightly influences ability to control of motor transport and performance of work, demanding the increased speed of physical and mental reactions.
Due to the possible development of dizziness and other side effects it is necessary to be careful at control of vehicles and occupations other potentially dangerous types of activity demanding the increased concentration of attention and 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 (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); seldom (> 1/10000, <1/1000); very seldom (<1/10000), including, separate messages.
From the alimentary system
Often: abdominal pain, diarrhea, dyspepsia, nausea, vomiting.
General disturbances
Often: adynamy.
From the central nervous system
Often: dizziness, headache.
Very seldom: extrapyramidal symptoms (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:

It was not observed.

Contraindications:

Hypersensitivity to any of drug components.
Patients with the expressed renal failure (KK less than 15 ml/min.).
Due to the lack of enough clinical data purpose of drug is not recommended to patients up to 18 years.
With care: patients with the expressed liver failure (clinical data are limited).
Pregnancy and period of feeding by a breast
Researches on animals did not reveal teratogenic effect, however due to the lack of clinical data, it is not recommended to use the drug Preduktal® MV during pregnancy.
It is unknown whether gets триметазидин into breast milk. In need of use of the drug Preduktal® MV in the period of a lactation, breastfeeding needs to be stopped.

Overdose:

There is only very limited information on overdose of a trimetazidin. In case of overdose it is necessary to carry out symptomatic therapy.

Storage conditions:

Special storage conditions are not required. To store in places, unavailable to children. PERIOD OF VALIDITY
3 years. Not to apply after the expiry date specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets with the modified release, film coated, 35 mg.
On 30 tablets in the blister (PVC / Is scarlet). 2 blisters with the instruction on a medical use in a pack cardboard.
When packaging (packaging)/production at the Russian enterprise LLC Serdiks:
On 30 tablets in the blister (PVC / Is scarlet). 2 blisters with the instruction on a medical use in a pack cardboard.
Packaging for hospitals:
On 30 tablets in the blister (PVC / Is scarlet). On 3 or 6 blisters with the instruction on a medical use in a pack cardboard.
On 10 blisters on 30 tablets in the blister place in a pack cardboard (the pack is not marked). On 3 packs cardboard with instructions on a medical use in a box cardboard with control of the first opening.