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

Excipients: Mannitol -17.00 mg, microcrystalline cellulose-13.50 mg, corn starch - 27.00 mg, magnesium stearate-1.50 mg, talc-0.50 mg, silicon dioxide colloid - 0.50 mg.

Shell composition: gipromesellosis 3.188 mg, talc 0.157 mg, propylene glycol 0.533 mg, iron oxide yellow oxide 0.107 mg.

Description:Round biconvex, smooth on both sides of the tablet, covered with a film coating of yellow color. On the cross section, the nucleus is white or almost white in 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 caused by an increase in the energy potential, activation of oxidative decarboxylation, and rationalization of oxygen consumption (increased aerobic glycolysis and fat oxidation blockade, acids). Supports contractility of the myocardium, prevents the decrease in intracellular content of 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 phosphate content due to myocardial ischemia and reperfusion. Prevents the damaging effect of free radicals, preserves integrity cell membranes, prevents the activation of neutrophils in the ischemia 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. The hearing and results of vestibular samples in patients improve, dizziness and tinnitus decrease.

In vascular pathology, the eye restores 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 - 2 hours (maximum concentration after a single dose of 20 mg of trimetazidine about 55 ng / ml). Easily penetrates through the histohematological barriers.The half-life (T1/2) is 4.5-5 hours. Connection with blood plasma proteins - 16%. It is excreted from the body by the kidneys (about 60% unchanged).

Indications:

- Ischemic heart disease: prevention of angina attacks (in complex therapy);

- Chorioretinal vascular disorders

- Cochleo-vestibular disorders of ischemic nature (tinnitus, hearing impairment, dizziness).

Contraindications:

- Hypersensitivity to any component of the drug;

- Renal failure (creatinine clearance below 15 ml / min);

- Pronounced violations of the liver;

- Pregnancy;

- The period of breastfeeding;

- Age to 18 years (effectiveness and safety not established).

Pregnancy and lactation:

Trimetazidine is contraindicated in pregnancy due to the lack of clinical data on the safety of its use.

Until now, it remains unidentified whether trimetazidine excreted with breast milk. If it is necessary to use the drug Trimetazidine it is recommended to stop breastfeeding. The experience of clinical use of trimetazidine in relation to patients of childhood is currently absent.

Dosing and Administration:

A drug Trimetazidine take inside, while eating 1 tablet 3 times a day. The maximum daily dose is 60 mg.

The course of treatment on the recommendation of a doctor.

Side effects:

The incidence of side effects is given in the following gradation: very often (> 1/10); often (> 1/100, <1/10); infrequently (> 1/1000, <1/100); rarely (> 1/10000, <1/1000); very rarely (<1/10000), including, individual messages.

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

Common violations - often: asthenia.

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

From the skin - often: skin rash, itching, urticaria.

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

Overdose:

Currently, information on cases of drug overdose is limited. If necessary, conduct symptomatic therapy.

Interaction:No information.

Special instructions:

The drug is not intended for relief of angina attacks. The drug is not indicated for the initial course of therapy for unstable angina or myocardial infarction.In patients with coronary heart disease there is a significant decrease in the daily requirement for nitrates.

Effect on the ability to drive transp. cf. and fur:The use of Trimetazidine does not significantly affect the ability to drive vehicles, mechanisms, and performance of work requiring a high rate of mental and physical reactions, so care must be taken when driving vehicles and mechanisms.

Form release / dosage:

Film coated tablets 20 mg.

Packaging:

For 10 tablets in a blister of PVC / aluminum foil.

3 or 6 blisters are placed in a cardboard box along with the instruction for * application.

Storage conditions:

In a dry, the dark 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 expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N012158 / 01

Date of registration:10.08.2011

The owner of the registration certificate:Okasa Farma Pvt. Ltd.Okasa Farma Pvt. Ltd.

Manufacturer: & nbsp

Okasa Farma Pvt. Ltd. India

Representation: & nbspOkasa Farma Pvt. Ltd.Okasa Farma Pvt. Ltd.

Information update date: & nbsp24.10.2015

Illustrated instructions

Instructions

Trimetazidine (Trimetazidine)