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

Sheath: hypromellose E 5 - 0.70 mg, hypromellose E 15 - 0.86 mg, giprolose 0.60 mg, macrogol - 0.08 mg, aluminum varnish based on the dye of the crimson (Ponso 4R) - 0.11 mg, Crimson dye (Ponceau 4R) 0.05 mg.

Description:

The tablets covered with a film cover, red color, the round form, biconcave. At the break, 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:Has 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 intracellular depletion of adenosine triphosphate (ATP) and creatine phosphate.

In the conditions of acidosis normalizes the functioning of ion channels normalizes the intracellular content of potassium ions. Reduces intracellular acidosis and 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,increases the duration of the electrical potential, reduces the yield of creatine phosphokinase from cells and the severity of myocardial ischemic damage. When the frequency of attacks of angina reduces (decreases nitrate consumption) after 2 weeks of treatment increases exercise capacity, reduced blood pressure drops. Improves hearing and results of vestibular samples in patients, reduces dizziness and tinnitus. In vascular pathology, the eye restores the functional activity of the retina.

Pharmacokinetics:Quickly and almost completely absorbed by the intestinal mucosa. Bioavailability is 90%. Time to reach the maximum concentration in blood plasma - 2 hours. The maximum concentration (after a single oral intake of 20 mg of trimetazidine dihydrochloride) is about 55 ng / ml. The half-life is 4.5 - 5 hours. It easily passes through the histohematetic barriers. Connection with blood plasma proteins - 16%. It is excreted by the kidneys (about 60% - unchanged).

Indications:

Ischemic heart disease (IHD) prevention of attacks with stable angina pectoris (in complex therapy).Cochemo-vestibular disorders of ischemic nature, such as dizziness, tinnitus, hearing impairment. Chorioretinal vascular disorders with ischemic component.

Contraindications:

Increased sensitivity to the drug, severe renal impairment (creatinine clearance less than 15 mL / min.), Expressed human liver, pregnancy, lactation, age 18 years (effectiveness and safety are installed).

Pregnancy and lactation:

Pregnancy and the period of breastfeeding are contraindications to the use of the drug.

Dosing and Administration:

Inside, 1 tablet 2-3 times a day (40-60 mg). The course of treatment is recommended by a doctor.

In case of missed dose, the drug should be taken as soon as possible. If it's time to take the next dose, then the previous dose should be missed.

Do not take a double dose of the drug in order to replenish the missed dose.

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 redto less than 1/10000, including individual message.

Allergic reactions (skin itching) on the drug or any of its components.

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

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

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

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

Other: often - asthenia.

Overdose:

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

Interaction:

There is no information.

Special instructions:

Against the background of drug treatment in patients with coronary heart disease there is a significant decrease in the daily requirement for nitrates. The drug is not indicated for the initial course of therapy for unstable angina or myocardial infarction. In the case of a developed attack of angina pectoris should be reviewed and adapted treatment. The drug contains a scarlet dye, which can cause allergic reactions.

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

The drug may cause dizziness and other side effects that may affect the ability to drive vehicles and mechanisms.

Form release / dosage:Coated tablets, 20 mg.

Packaging:

For 60 tablets, film-coated 20 mg in a bottle of orange glass, sealed with a plastic stopper or 30 tablets, coated with a film coating of 20 mg in a blister of a PVC / A1-foil film. One bottle or two blisters for 30 tablets, film-coated 20 mg along with the instructionsandit is put into a cardboard box for use.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the date shown on the package.

Drugs should not be disposed of in sewers or in household waste containers. You should ask the pharmacist what to do with unnecessary medicines. This will help protect the environment.

Terms of leave from pharmacies:On prescription

Registration number:П N016031 / 01

Date of registration:29.10.2009

The owner of the registration certificate:Pabianicki Pharmaceutical Plant Polfa, JSCPabianicki Pharmaceutical Plant Polfa, JSC Poland

Manufacturer: & nbsp

PABIANICE PHARMACEUTICAL WORKS POLFA Poland

Representation: & nbspPABYNITSKY PHARMACEUTICAL FACTORY POLFA JSC PABYNITSKY PHARMACEUTICAL FACTORY POLFA JSC Poland

Information update date: & nbsp25.10.2015

Illustrated instructions

Instructions

Trimetaside (Trimetazide)