For symptomatic treatment of adult patients with stable angina, with insufficient efficacy or intolerance to first-line antianginal drugs.
active substance: trimetazidine;
1 tablet contains trimetazidine dihydrochloride 20 mg;
Excipients: corn starch, mannitol (E 421), polyvinylpyrrolidone, talc, magnesium stearate, coating for coating Opadry II Red (talc, polyethylene glycol, indigo carmine (E 132), polyvinyl alcohol, titanium dioxide (E 171), po E 124), “yellow west” (E 110).
Main physical and chemical properties: round tablets with a biconvex surface, covered with a red film coating.
By maintaining energy metabolism in cells suffering from hypoxia or ischemia, trimetazidine prevents a decrease in intracellular ATP levels, thereby ensuring the proper functioning of ion pumps and transmembrane sodium-potassium flow while maintaining cellular homeostasis.
Trimetazidine inhibits β-oxidation of fatty acids by blocking long-chain 3-ketoacyl CoA thiolase (3-CAT), which increases glucose oxidation. In cells under ischemia, the process of obtaining energy by oxidation of glucose requires less oxygen compared to the process of obtaining energy by β-oxidation of fatty acids. Enhancing the process of glucose oxidation optimizes energy processes in cells and, accordingly, supports energy metabolism in ischemic conditions.
Special groups of patients.
Elderly patients. Elderly patients may have an increase in trimetazidine levels due to age-related decline in renal function.
Renal dysfunction. The concentration of trimetazidine in the blood increases in patients with moderate renal insufficiency (creatinine clearance 30-60 ml / min) and in patients with severe renal insufficiency (creatinine clearance <30 ml / min).
For the symptomatic treatment of adult patients with stable angina in case of insufficient efficacy or intolerance of first-line antianginal drugs.
Hypersensitivity to trimetazidine or to any of the components of the drug.
Parkinson’s disease, symptoms of parkinsonism, tremor, restless legs syndrome and other movement disorders related to the above.
Severe renal insufficiency (creatinine clearance <30 ml / min).
Interaction with other medicinal products and other forms of interaction
Interaction of Triductan with other drugs that would cause adverse effects has not been described.
The use of Triductan in combination with nitrates, β-blockers or calcium antagonists provides an additional therapeutic effect in patients with angina.
Trimetazidine can be prescribed in combination with heparin, vitamin K antagonists (without potentiating their action), as well as with ACE inhibitors, oral lipid-lowering drugs, acetylsalicylic acid.
Method of application and dosage
Triductan should be administered orally 1 tablet 3 times a day with meals.
After 3 months of treatment, the results of treatment should be evaluated and in the absence of effect, trimetazidine should be discontinued.
Special groups of patients.
Patients with impaired renal function.
Patients with moderate renal impairment (creatinine clearance 30-60 ml / min) are recommended to take 1 tablet 2 times a day: morning and evening with meals.
Elderly patients are more sensitive to the effects of trimetazidine due to age-related decline in renal function. For patients with moderate renal impairment (creatinine clearance 30-60 ml / min), the recommended dose is 1 tablet 2 times a day: morning and evening with meals.
For elderly patients, the dose should be titrated with caution.
The amount of data on trimetazidine overdose is limited.
Treatment is symptomatic.
Adverse reactions identified as side effects that may be related to the use of trimetazidine are listed with a certain frequency: very common (≥1 / 10); common (≥1 / 100, <1/10); uncommon (≥1 / 1000, <1/100); rare (≥1 / 10000, <1/1000); very rare (<1 / 10,000); frequency unknown (cannot be determined from the available information):
- From the nervous system: often – headache, dizziness; frequency unknown – possible symptoms of parkinsonism (tremor, akinesia, muscle hypertonia), gait instability, restless legs syndrome and other movement disorders related to the above, which are reversible after discontinuation of the drug; sleep disorders (insomnia, drowsiness).
- Cardiac disorders: rarely – palpitations, extrasystole, tachycardia.
- From the vessels: rarely – arterial hypotension, orthostatic hypotension, which may be associated with malaise, dizziness or fall (particularly in patients taking antihypertensive drugs), flushing.
- From the digestive tract: often – abdominal pain, dyspepsia, diarrhea, nausea, vomiting; frequency unknown – constipation.
- From the hepatobiliary system: frequency unknown – hepatitis.
- From the skin and subcutaneous tissue: often – rash, itching, urticaria; frequency unknown – acute generalized exanthematous pustular rash, angioneurotic edema.
- From the blood and lymphatic system: frequency unknown – agranulocytosis, thrombocytopenia, thrombocytopenic purpura.
- General disorders: often – asthenia.
Keep out of reach of children in the original packaging at a temperature not exceeding 25 ° C.