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

Excipients: calcium hydrogen phosphate dihydrate 34.6 mg; giprolose (hydroxypropylcellulose) 6.0 mg; hypromellose (hydroxypropylmethylcellulose) 64.0 mg; copovidone(plasdon es-630) 4.2 mg; silicon dioxide colloid (aerosil) 6.4 mg; magnesium stearate 0.8 mg; cellulose microcrystalline 59.0 mg;

composition of the shell: Selobout AQ-01673 7.0 mg of [hypromellose (hydroxypropylmethylcellulose) 2.8 mg; Macrogol 400 (polyethylene glycol 400) 0.7 mg; Macrogol - 6000 (polyethylene glycol - 6000) 0.7 mg; Aluminum lacquer based on the dye crimson (Ponce 4 R) 0.7 mg; titanium dioxide 2.1 mg].

Description:The tablets covered with a film cover of pink color, round, biconcave. Insignificant roughness is allowed. On the cross-section, two layers are visible: the inner layer is almost white.

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:

Trimetazidine has an antihypoxic effect with stable angina. Directly affecting the cardiomyocytes and neurons of the brain, it optimizes their metabolism and function. The cytoprotective effect is caused by 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 contractility of the myocardium, prevents the reduction of intracellular content of adenosine triphosphate (ATP) and creatine phosphate. In conditions of acidosis normalizes the functioning of membrane ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, normalizes the intracellular content of potassium ions. Reduces intracellular acidosis and phosphate content due to myocardial ischemia and reperfusion. It prevents the damaging action of free radicals, preserves the integrity of cellular membranes, prevents activation of neutrophils in the ischemic area, increases the electric potential decreases the yield of creatine from the cells and the severity of ischemic myocardial injury.

Trimetazidine reduces the incidence of angina attacks (nitrate intake decreases), tolerance increases after 2 weeks of exercise, and sudden fluctuations in blood pressure decrease. Reduces dizziness and tinnitus.

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

Pharmacokinetics:

After taking the drug inside trimetazidine quickly and almost completely absorbed from the gastrointestinal tract. Bioavailability is 90%. Time to reach the maximum concentration in blood plasma is 5 hours. The equilibrium state is reached after 60 hours. The volume of distribution is 4.8 l / kg, which implies good diffusion of distribution in tissues. Connection with blood plasma proteins - 16%. Easily penetrates through the histohematological barriers. The half-life (T1 / 2) is about 7 hours, in patients older than 65 years - about 12 hours. It is excreted from the body kidneys (about 60% unchanged).

Renal clearance of trimetazidine directly correlates with the clearance of creatinine (CC), the hepatic clearance decreases with age.

Indications:

- Ischemic heart disease: prevention of attacks of stable angina (as part of combination therapy);

- chorioretinal disorders with ischemic component;

- Vestibulo-cochlear violations of ischemic nature, such as dizziness, tinnitus, hearing loss.

Contraindications:

Hypersensitivity to any component of the drug;

severe renal failure (CC below 15 ml / min);

severe liver dysfunction;

pregnancy;

the period of breastfeeding;

age to 18 years (efficacy and safety not established).

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 you need to use the drug during lactation should stop breastfeeding.

Dosing and Administration:

Inside, with food.

Deprenorm® MB take 1 tablet 2 times a day (morning and evening). The course of treatment is recommended by a doctor.

Side effects:

The frequency of side effects noted when taking trimetazidine is given 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); rarely (more than 1/10000, less than 1/1000); very rarely (less than 1/10000), including individual messages.

From the digestive system

Often: abdominal pain, diarrhea, indigestion, nausea, vomiting.

From the central nervous system Often: dizziness, headache, asthenia.

Very rarely: extrapyramidal disorders (tremor, rigidity, akinesia), reversible after discontinuation of the drug.

From the skin

Often: skin rash, itching, hives.

From the side of the cardiovascular system

Rarely: orthostatic hypotension, "hot flashes" of blood to the skin of the face.

Overdose:

Data on overdose cases are limited. In case of an overdose, symptomatic therapy should be given.

Interaction:

There is no information.

Special instructions:

Deprenorm® MB is not intended for relief of angina attacks, for the initial course of therapy for stable angina or myocardial infarction.

In the case of an attack of angina pectoris, the treatment should be reviewed and adapted.

Effect on the ability to drive transp. cf. and fur:The use of the drug does not affect the ability to drive a vehicle and perform work that requires an increased speed of psychomotor reactions.

Form release / dosage:

Tablets of prolonged action, film-coated, 35 mg.

Packaging:

For 10 or 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

According to 1, 2, 3, 6 contour cell packs of 10 tablets or 1, 2, 3, 4 contour cell packs of 30 tablets together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LS-001706

Date of registration:09.02.2011

Expiration Date:Unlimited

The owner of the registration certificate:CANONFARMA PRODUCTION, CJSC CANONFARMA PRODUCTION, CJSC Russia

Manufacturer: & nbsp

CANONFARMA PRODUCTION, CJSC Russia

Information update date: & nbsp24.03.2017

Illustrated instructions

Instructions

Deprenorm® MB (Deprenorm® MV)