Triductan (trimetazidine) coated tablets 20 mg. №60

Description

Triductan (trimetazidine) coated tablets 20 mg. №60

Composition

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 4R)) E 124), “yellow west” (E 110).

Dosage form

Film-coated tablets.

Main physical and chemical properties: round tablets with a biconvex surface, covered with a red film coating.

Pharmacotherapeutic group

Cardiac drugs.
ATC code C01E B15.

Pharmacological properties

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.

Indication

For the symptomatic treatment of adult patients with stable angina in case of insufficient efficacy or intolerance of first-line antianginal drugs.

Contraindication

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).
The use of Triductan coated tablets 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 coated tablets 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
  Elderly patients are more sensitive to the action 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.

Children

The safety and efficacy of trimetazidine in children have not been established. No data available.

Overdose

The amount of data on trimetazidine overdose is limited.
Treatment is symptomatic.

Side effects:

• 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.