In combination therapy in the symptomatic treatment of adult patients with stable angina, whose first-stage antianginal therapy is insufficient or not tolerated.
A medicine with a protective effect. Trimetazidine inhibits β-oxidation of fatty acids by blocking long-chain thiolase of 3-ketoacyl coenzyme A, which enhances Glucose oxidation. The energy obtained in the cell in the process of glucose oxidation, in comparison with the β-oxidation process, requires less oxygen consumption. The intensification of glucose oxidation leads to the improvement of energy processes occurring in hypoxic cells, which ensures the maintenance of intracellular homeostasis during ischemia. Trimetazidine achieves Cmax in the blood after about 5 hours after administration. Plasma proteins are approximately 16% bound. It is mostly excreted in the urine, mainly in unchanged form. T0,5 is 7 hours, in patients> 65 years increases to 12 hours.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. Known hypersensitivity to products containing soya or peanuts. Parkinson's disease, parkinsonism symptoms, tremors, restless leg syndrome and other related movement disorders. Severe renal impairment (creatinine clearance <30 ml / min).
Precautions:
Trimetazidine may cause or worsen parkinsonian symptoms (tremor, immobility, hypertonia), which should be systematically checked, especially in elderly patients. In cases of doubt, patients should be referred to a neurologist. When movement disorders occur, such as parkinsonism symptoms, restless legs syndrome, tremor or unstable gait, the preparation should be discontinued. In most patients, symptoms disappear within 4 months after discontinuation of trimetazidine. If the parkinsonian symptoms persist for more than 4 months after discontinuation, a neurologist assessment is required. Caution should be exercised when using trimetazidine in patients who may be expected to have an increased exposure, i.e. patients with moderate renal impairment or over 75 years. It is not recommended for severe liver problems. The preparation is not indicated for the treatment of angina attacks and as the initial treatment for unstable angina or myocardial infarction. The drug should not be used before hospitalization or during the first days of hospitalization. In the case of angina attack, the condition of the coronary arteries should be reassessed and the treatment adjusted accordingly (pharmacotherapy and revascularization, if necessary). The safety and efficacy of trimetazidine in children below 18 years have not been established. Due to the content of soy lecithin, patients with known allergies to soy or peanut should not use this preparation.
Pregnancy and lactation:
Avoid taking the drug during pregnancy and breastfeeding.
Side effects:
Common: pain and dizziness, abdominal pain, diarrhea, indigestion, nausea, vomiting, rash, pruritus, urticaria, asthenia. Rarely: palpitations, additional spasms, tachycardia, hypotension, orthostatic hypotension (which may be associated with malaise, dizziness or falls, especially in patients taking antihypertensive agents), redness of the face. Not known: parkinsonism (tremors, immobility, hypertonia), unsteady gait, restless legs syndrome, other associated movement disorders (usually transient after discontinuation of treatment), insomnia or somnolence, constipation, acute generalized pustular exanthema (AGEP), angioneurotic edema, agranulocytosis , thrombocytopenia, thrombocytopenic purpura, hepatitis. Trimetazidine may contribute to the deterioration of patients suffering from Parkinson's disease or the disease of scattered Lewy bodies.
Dosage:
Orally. Adults: 1 tabl. 2 times a day. In patients with moderate renal impairment (creatinine clearance 30-60 ml / min) the dose is 1 tablet.in the morning, during breakfast. In elderly patients, exposure to trimetazidine may be, the dose should be determined with caution.
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