Triducard^® (Tablets) Instructions for Use

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Contact Information

SEVERNAYA ZVEZDA NAO (Russia)

ATC Code

C01EB15 (Trimetazidine)

Active Substance

Trimetazidine (Rec.INN registered by WHO)

Dosage Form

Triducard®

Modified-release, film-coated tablets 35 mg: 30, 60, 90, 120, 180, or 300 pcs.

Dosage Form, Packaging, and Composition

Modified-release, film-coated tablets pink, round, biconvex.

Excipients: hypromellose (Metocel K 4M Premium EP) – 54 mg, microcrystalline cellulose – 118 mg, colloidal silicon dioxide (aerosil) – 1 mg, magnesium stearate – 1 mg.

Shell composition hypromellose – 4.628 mg, talc – 0.357 mg, titanium dioxide – 1.002 mg, macrogol (polyethylene oxide 4000) – 1.002 mg, dye azorubine (acid red 2C for pharmaceutical purposes) – 0.011 mg.

10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
30 pcs. – blister packs (1) – cardboard packs.
30 pcs. – blister packs (2) – cardboard packs.
30 pcs. – blister packs (3) – cardboard packs.
30 pcs. – blister packs (4) – cardboard packs.
30 pcs. – blister packs (6) – cardboard packs.
30 pcs. – blister packs (10) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
120 pcs. – polymer jars (1) – cardboard packs.
180 pcs. – polymer jars (1) – cardboard packs.
300 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer bottles (1) – cardboard packs.
60 pcs. – polymer bottles (1) – cardboard packs.
90 pcs. – polymer bottles (1) – cardboard packs.
120 pcs. – polymer bottles (1) – cardboard packs.
180 pcs. – polymer bottles (1) – cardboard packs.
300 pcs. – polymer bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Drug improving metabolism of the myocardium and neurosensory organs under ischemic conditions

Pharmacotherapeutic Group

Antihypoxant

Pharmacological Action

Trimetazidine has antianginal, antihypoxic action.

By directly affecting cardiomyocytes and brain neurons, it optimizes their metabolism and function. The cytoprotective effect is due to an increase in energy potential, activation of oxidative decarboxylation, and rationalization of oxygen consumption (enhancement of aerobic glycolysis and blockade of fatty acid oxidation). It maintains myocardial contractility, prevents a decrease in intracellular ATP and phosphocreatinine content. Under conditions of acidosis, it normalizes the functioning of ion channels, prevents the accumulation of calcium and sodium in cardiomyocytes, and normalizes the intracellular content of potassium ions. It reduces intracellular acidosis and phosphate concentration caused by myocardial ischemia and reperfusion. It prevents the damaging effect of free radicals, preserves the integrity of cell membranes, prevents neutrophil activation in the ischemic zone, increases the duration of the electrical potential, reduces the release of CPK from cells and the severity of ischemic myocardial damage.

In angina, it reduces the frequency of attacks (nitrate consumption decreases), after 2 weeks of treatment, exercise tolerance increases, and blood pressure fluctuations decrease.

It improves hearing and the results of vestibular tests in patients, reduces dizziness and tinnitus.

In vascular pathology of the eye, it restores the functional activity of the retina.

Pharmacokinetics

Absorption and distribution

After oral administration, Trimetazidine is rapidly and almost completely absorbed from the gastrointestinal tract. Bioavailability – 90%. Time to reach C_max in blood plasma – 5 hours. C_max after a single dose of 35 mg trimetazidine – about 55 ng/ml.

Easily passes through histohematic barriers. Plasma protein binding – 16%.

Elimination

T_1/2 – about 7 hours, in patients over 65 years – about 12 hours. It is excreted by the kidneys (about 60% unchanged).

Indications

• Coronary artery disease: prevention of angina attacks (as part of combination therapy);
• Chorioretinal vascular disorders;
• Dizziness of vascular origin;
• Cochleovestibular disorders of ischemic nature (tinnitus, hearing impairment).

ICD codes

Dosage Regimen

Take the drug orally, with meals.

Swallow the tablets whole; do not crush or chew them.

The standard adult dosage is one 35 mg tablet twice daily, equivalent to a total daily dose of 70 mg.

Administer one tablet in the morning and one tablet in the evening to maintain consistent plasma concentrations.

Adhere strictly to the twice-daily dosing schedule for optimal therapeutic effect.

This regimen applies to all indications, including angina prophylaxis, cochleovestibular disorders, and chorioretinal vascular disorders.

The duration of treatment is determined by the physician based on the underlying condition and clinical response.

Do not discontinue therapy without consulting your doctor.

Do not use this medication for the acute relief of an angina attack.

For patients with moderate renal impairment (creatinine clearance 30-60 ml/min), monitor renal function periodically during long-term treatment.

The drug is contraindicated in patients with severe renal impairment (creatinine clearance below 15 ml/min).

The maximum recommended daily dose is 70 mg; do not exceed this amount.

If a dose is missed, take it as soon as remembered unless it is nearly time for the next dose; in that case, continue with the regular schedule.

Adverse Reactions

Allergic reactions skin itching.

From the digestive system rarely – gastralgia, nausea, vomiting.

From the cardiovascular system rarely – headache, sensation of strong heartbeat.

Contraindications

• Renal failure (creatinine clearance below 15 ml/min);
• Severe liver dysfunction;
• Pregnancy;
• Breastfeeding period;
• Age under 18 years (efficacy and safety not established);
• Hypersensitivity to any component of the drug.

Use in Pregnancy and Lactation

Triducard^® is contraindicated for use during pregnancy and breastfeeding.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction.

Use in Renal Impairment

Contraindicated in renal failure (creatinine clearance below 15 ml/min).

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Special Precautions

The drug is not intended for relieving angina attacks!

In case of an angina attack, treatment should be reviewed and adapted (drug therapy or revascularization).

Effect on ability to drive vehicles and mechanisms

The use of the drug does not affect the ability to drive a car and perform work requiring high speed of mental and physical reactions.

Overdose

Currently, no cases of Triducard^® overdose have been reported.

Drug Interactions

No information on drug interactions of Triducard^® is available.

Storage Conditions

The drug should be stored in a dry, light-protected place, out of the reach of children, at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.