Vero-Trimetazidine - instructions for use, dose, side effects, contraindications

Excipients to obtain a tablet of 100 mg: lactose monohydrate (sugar milk) - 38.8 mg, potato starch - 26.3 mg, microcrystalline cellulose - 4.7 mg, povidone (polyvinylpyrrolidone) - 4.7 mg,sodium carboxymethyl starch (primogel) - 3 mg, talc - 1 mg, silicon dioxide colloid (aerosil) - 0.5 mg, magnesium stearate - 1 mg;

composition of the shell: hypromellose (hydroxypropylmethylcellulose) - 2,126 mg, povidone (polyvinylpyrrolidone) - 1,331 mg, macrogol (polyethylene glycol 4000) - 0.462 mg, talc 0.61 mg, titanium dioxide 0.462 mg, azorubin dye 0.009 mg.

Description:

The tablets covered with a film cover, pink color, round, biconcave. Light marble is allowed. Tablets on a break of 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).

Has a cardioprotective effect. Supports contractility of the myocardium, prevents the reduction of intracellular content of adenosine triphosphate (ATP) and phosphocreatinine.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 increased phosphate content, due to myocardial ischemia and reperfusion. Prevents the damaging effect of free radicals, preserves the integrity of cell membranes, prevents the activation of neutrophils in the ischemic zone, prolongs the duration of the electrical potential, reduces the yield of creatine phosphokinase from cells and the severity of ischemic myocardial damage. When the frequency of attacks of angina reduces (decreases nitrate consumption) after 2 weeks of treatment increases exercise capacity, reduced blood pressure drops. Reduces dizziness and tinnitus. In vascular pathology, the eye improves the functional activity of the retina.

Pharmacokinetics:After taking 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. Connection with blood plasma proteins - 16%. Easily penetrates through the histohematological barriers. The half-life is 4.5-5 hours. It is excreted by the kidneys (about 60% - unchanged).

Indications:Ischemic heart disease (IHD), prevention of angina attacks (as part of complex therapy); chorioretinal disorders with ischemic component, vestibulo-cochlear disorders of ischemic etiology (dizziness, tinnitus, hearing impairment).

Contraindications:Hypersensitivity to trimetazidine and / or other components of the drug; age under 18 years (effectiveness and safety not established); renal failure (creatinine clearance below 15 ml / min); pronounced impaired liver function (due to lack of sufficient clinical experience); pregnancy; lactation period; hereditary intolerance to galactose, insufficiency of lactase, glucose-galactose malabsorption (for a given dosage form containing lactose).

Pregnancy and lactation:

Contraindicated in pregnancy. For the duration of treatment, breastfeeding should be discontinued.

Dosing and Administration:

Inside, with food.

The recommended dosing regimen is 20 mg (1 tablet) 2-3 times a day. The duration of treatment is determined by the doctor.

Side effects:

Frequency: very often - more than 1/10; often more than 1/100 and less than 1/10; infrequently - more than 1/1000 and-less than 1/100; rarely - more than 1/10000 and less than 1/1000; very rarely - less than 1/10000, including individual messages.

From the digestive system: often abdominal pain, diarrhea, dyspepsia, nausea,vomiting.

From the cardiovascular system: rarely - orthostatic hypotension, "hot flashes" to the skin of the face.

From the nervous system: often - dizziness, headache; very rarely - extrapyramidal disorders (tremor, rigidity, akinesia), reversible after drug withdrawal.

From the skin and subcutaneous tissue: often - skin rash, itching, hives.

Other: often - asthenia.

Overdose:At present, no cases of drug overdose have been reported.

Interaction:The drug interaction of trimetazidine is not described.

Special instructions:Do not use to stop angina attacks!

Against the background of drug treatment in patients with IHD, there is a significant decrease in the daily requirement for nitrates.

Effect on the ability to drive transp. cf. and fur:

The drug has no significant effect on the ability to drive vehicles and perform other works that require a high rate of psychomotor reactions.

Form release / dosage:Tablets, film-coated, 20 mg.

Packaging:For 10 tablets in a planar cell package. 30 tablets in a can of polymeric materials. Each bank or 3 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:At a temperature not higher than 30 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N002624 / 01

Date of registration:02.06.2008 / 02.10.2015

Expiration Date:Unlimited

The owner of the registration certificate:VEROPHARM SA VEROPHARM SA Russia

Manufacturer: & nbsp

VEROPHARM SA Russia

Information update date: & nbsp02.02.2017

Illustrated instructions

Instructions

Vero-Trimetazidine (Vero-Trimetazidine)