Trimetazidine - instructions for use, doses, side effects, contraindications

Excipients: giprolose (hydroxypropyl cellulose) 0.7 mg, corn starch 16 mg, silicon dioxide colloid (aerosil) 3.13 mg, lactose monohydrate (milk sugar) 89.47 mg, magnesium stearate 0.7 mg.

composition of film shell: celiac AQ-01673 - 6 mg: hypromellose (hydroxypropylmethylcellulose) 2.4 mg, macrogol-400 (polyethylene glycol-400) 0.6 mg, macrogol-6000 (polyethylene glycol-6000) 0.6 mg, dye crimson [Ponso 4 R] 0.6 mg, titanium dioxide 1.8 mg.

Description:

The tablets are round biconvex, covered with a film membrane, pink; On a cross-section - white or almost 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:

Trimetazidine has an antihypoxic effect. Directly affecting the cardiomyocytes and neurons of the brain, it optimizes their metabolism and function. The cytoprotective effect is due to an increase in the energy potential, activation of oxidative decarboxylation, and rationalization of oxygen consumption (enhancement of aerobic glycolysis and fat oxidation blockade). Supports contractility of the myocardium, prevents the reduction of intracellular adenosine triphosphate and creatine phosphate. In conditions of acidosis normalizes the functioning of membrane ion channels, prevents the accumulation of calcium and sodium ions in cardiomyocytes, normalizes the intracellular content of potassium ions.Reduces intracellular acidosis and increased 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.

With stable angina trimetazidine reduces the frequency of attacks (reduces the consumption of nitrates), after 2 weeks of treatment, exercise tolerance increases, sharp fluctuations in blood pressure decrease. Reduces dizziness and tinnitus. In vascular pathology, the eye improves the functional activity of the retina.

Pharmacokinetics:

After oral administration trimetazidine quickly and almost completely absorbed in the gastrointestinal tract. Bioavailability is 90%. Time to reach the maximum concentration in blood plasma - 2 hours. The maximum concentration after a single dose of 20 mg of trimetazidine is about 55 ng / ml. The connection with plasma proteins is 16%. The volume of distribution is 4.8 l / kg.Easily passes through the histohematological barriers. The half-life is 4.5-5 hours. It is excreted by the 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;

- cochlear-vestibular disorders of ischemic nature, such as dizziness, tinnitus, hearing impairment.

Contraindications:

Hypersensitivity to any component of the drug; deficiency of lactase; lactose intolerance; glucose-galactose malabsorption; severe renal failure (creatinine clearance below 15 ml / min.); severe liver dysfunction; pregnancy; lactation period; age to 18 years (efficacy and safety not established).

Pregnancy and lactation:

The drug is contraindicated during pregnancy and during breastfeeding.

Dosing and Administration:

Inside, with food.

The recommended dosing regimen is 1 tablet (20 mg) 2-3 times a day (40-60 mg / day).The duration of the course of therapy is as recommended by the 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.

Common violations

Often: asthenia.

From the central nervous system Often: dizziness, headache.

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:

The drug is not intended for relief of angina attacks, for the initial course of therapy of 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:

Care must be taken when driving vehicles and engaging in other potentially hazardous activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Tablets, film-coated, 20 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-001096

Date of registration:26.07.2011

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

Manufacturer: & nbsp

CANONFARMA PRODUCTION, CJSC Russia

Information update date: & nbsp24.10.2015

Illustrated instructions

Instructions

Trimetazidine (Trimetazidine)