Trimetazidine (Tablets, Capsules) Instructions for Use

Instructions
Dosage forms

ATC Code

C01EB15 (Trimetazidine)

Active Substance

Trimetazidine (Rec.INN registered by WHO)

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Drugs for the treatment of heart diseases; other drugs for the treatment of heart diseases

Pharmacological Action

An agent that normalizes the energy metabolism of cells subjected to hypoxia or ischemia. It prevents the decrease in intracellular ATP content, ensures the normal functioning of membrane ion channels, transmembrane transfer of potassium and sodium ions, and the preservation of cellular homeostasis.

Trimetazidine slows down the oxidation of fatty acids by selectively inhibiting long-chain 3-ketoacyl-CoA thiolase, which leads to an increase in glucose oxidation and restoration of the coupling between glycolysis and oxidative decarboxylation and has been shown to provide protection of the myocardium from ischemia. The switching of fatty acid oxidation to glucose oxidation underlies the antianginal action of trimetazidine.

Trimetazidine supports the energy metabolism of the heart and neurosensory organs during episodes of ischemia; reduces the degree of intracellular acidosis and the extent of changes in the transmembrane ion flow that occurs during ischemia; lowers the level of migration and infiltration of polymorphonuclear neutrophils in ischemic and reperfused heart tissues, reduces the size of myocardial damage; while not affecting hemodynamics.

Pharmacokinetics

Trimetazidine is rapidly and almost completely absorbed from the gastrointestinal tract. V_d is 4.8 L/kg. It easily passes through histohematic barriers. Plasma protein binding is about 16%.

T_1/2 is 4.5-5 hours. It is excreted by the kidneys, mainly unchanged.

Indications

Long-term therapy of coronary artery disease: prevention of attacks of stable angina pectoris as part of mono- or combination therapy.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
I20	Angina pectoris

ICD-11 code	Indication
BA40.Z	Angina pectoris, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer Trimetazidine orally with water during meals.

The recommended total daily dose is 40 mg to 70 mg.

Divide the total daily dose into two or three separate administrations.

For a twice-daily regimen, administer one 20 mg tablet every 12 hours.

For a thrice-daily regimen, administer one 20 mg tablet every 8 hours.

Adhere strictly to the dosing schedule prescribed by your physician.

The duration of therapy is determined individually based on the clinical response and should be long-term for the management of chronic stable angina pectoris.

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

In patients with moderate renal impairment (creatinine clearance 30-60 ml/min), use with caution; the need for dose adjustment should be evaluated.

This drug is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 ml/min).

Use with caution in patients over 75 years of age and in those with severe hepatic impairment.

Adverse Reactions

From the digestive system: frequently – abdominal pain, diarrhea, dyspepsia, nausea, vomiting; frequency unknown – constipation.

From the nervous system: frequently – dizziness, headache; infrequently – paresthesia; frequency unknown – symptoms of parkinsonism (tremor, akinesia, increased tone), instability in the Romberg position and unsteady gait, restless legs syndrome (usually reversible after discontinuation of therapy), insomnia, drowsiness.

From the hearing organ and labyrinthine disorders: frequency unknown – vertigo.

From the skin and subcutaneous tissues: frequently – skin rash, itching, urticaria; frequency unknown – acute severe cutaneous adverse reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) and acute generalized exanthematous pustulosis, which can be fatal.

Allergic reactions frequency unknown – angioedema.

From the cardiovascular system: rarely – palpitations, extrasystole, tachycardia, marked decrease in blood pressure, orthostatic hypotension (may be accompanied by general weakness, dizziness or loss of balance, especially when taken simultaneously with antihypertensive drugs), flushing.

From the hematopoietic system: frequency unknown – agranulocytosis, thrombocytopenia, thrombocytopenic purpura.

From the liver and biliary tract: frequency unknown – hepatitis.

Other: frequently – asthenia.

Contraindications

Hypersensitivity to trimetazidine; Parkinson’s disease, symptoms of parkinsonism, tremor, restless legs syndrome and other related movement disorders; severe renal failure (creatinine clearance less than 30 ml/min); children and adolescents under 18 years of age; pregnancy, lactation (breastfeeding).

With caution

Patients with moderate renal impairment (creatinine clearance 30-60 ml/min), patients with severe hepatic impairment (10 to 15 points on the Child-Pugh scale); patients over 75 years of age.

Use in Pregnancy and Lactation

Trimetazidine is contraindicated for use during pregnancy and lactation (breastfeeding).

Use in Hepatic Impairment

Should be used with caution in patients with severe hepatic impairment (10 to 15 points on the Child-Pugh scale).

Use in Renal Impairment

Contraindicated in severe renal failure (creatinine clearance less than 30 ml/min). Should be used with caution in patients with moderate renal impairment (creatinine clearance 30-60 ml/min).

Pediatric Use

Contraindicated in children and adolescents under 18 years of age.

Geriatric Use

Should be used with caution in patients over 75 years of age.

Special Precautions

Not intended for relief of angina attacks and is not indicated for the initial course of therapy for unstable angina or myocardial infarction at the pre-hospital stage or in the first days of hospitalization.

Effect on ability to drive vehicles and operate machinery

During the use of trimetazidine, patients should exercise caution when driving vehicles and operating machinery, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Trimetazidine MR [Atoll LLC (Russia)]
Prolonged-release film-coated tablets, 35 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 180, 200, or 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon Pharm, LLC (Russia)

Dosage Form

Trimetazidine MB

Prolonged-release film-coated tablets, 35 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 180, 200, or 300 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release film-coated tablets from light pink to pink in color, round, biconvex in shape; on the cross-section, two layers are visible: a core of white or almost white color and a film coating.

	1 tab.
Trimetazidine dihydrochloride	35 mg

Excipients: hypromellose 93 mg, microcrystalline cellulose 178.9 mg, colloidal silicon dioxide 1.55 mg, magnesium stearate 1.55 mg.

Film coating composition: Opadry II 85F240012 pink 10 mg, including polyvinyl alcohol 4 mg, macrogol-3350 2.438 mg, iron oxide red dye 0.04 mg, iron oxide red dye 0.022 mg, talc 1.48 mg, titanium dioxide 2.02 mg.

10 pcs. – blister packs (aluminum/PVC) (1) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (2) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (3) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (4) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (5) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (6) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (10) – cardboard packs.
20 pcs. – blister packs (aluminum/PVC) (1) – cardboard packs.
20 pcs. – blister packs (aluminum/PVC) (2) – cardboard packs.
20 pcs. – blister packs (aluminum/PVC) (3) – cardboard packs.
20 pcs. – blister packs (aluminum/PVC) (4) – cardboard packs.
20 pcs. – blister packs (aluminum/PVC) (5) – cardboard packs.
20 pcs. – blister packs (aluminum/PVC) (6) – cardboard packs.
20 pcs. – blister packs (aluminum/PVC) (10) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (1) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (2) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (3) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (4) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (5) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (6) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Trimetazidine MR [Izvarino Pharma LLC (Russia)]
Modified-release film-coated tablets, 35 mg: 10, 30, 60, 120, and 180 pcs.

Marketing Authorization Holder

Izvarino Pharma LLC (Russia)

Dosage Form

Trimetazidine MB

Modified-release film-coated tablets, 35 mg: 10, 30, 60, 120, and 180 pcs.

Dosage Form, Packaging, and Composition

Modified-release film-coated tablets from pink to brownish-pink in color, with a score on one side, round, biconvex in shape. On the cross-section – a core from white or almost white to white with a yellowish tint.

	1 tab.
Trimetazidine dihydrochloride	35 mg

Excipients: anhydrous calcium hydrogen phosphate – 157 mg, hypromellose – 50 mg, colloidal silicon dioxide – 2 mg, crospovidone – 2.5 mg, talc – 2 mg, magnesium stearate – 1.5 mg.

Coating composition: Opadry II pink (85F34610) – 8 mg (polyvinyl alcohol – 40%, titanium dioxide – 24.24%, macrogol 3350 – 20.20%, talc – 14.80%, iron oxide yellow dye – 0.37%, iron oxide red dye – 0.36%, iron oxide black dye – 0.03%).

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.
10 pcs. – blister packs (12) – cardboard packs.
10 pcs. – blister packs (18) – cardboard packs.

Trimetazidine MR [Novosibkhimpharm, JSC (Russia)]
Modified-release film-coated tablets, 35 mg: 10, 20, or 30 pcs.

Marketing Authorization Holder

Novosibkhimpharm, JSC (Russia)

Manufactured By

Valenta Pharm, JSC (Russia)

Dosage Form

Trimetazidine MB

Modified-release film-coated tablets, 35 mg: 10, 20, or 30 pcs.

Dosage Form, Packaging, and Composition

Modified-release film-coated tablets	1 tab.
Trimetazidine dihydrochloride	35 mg

10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.

Trimetazidine MR [Remedia, LLC (Russia)]
Extended-release tablets, film-coated, 35 mg: 10, 20, 30, 40, or 60 pcs.

Marketing Authorization Holder

Remedia, LLC (Russia)

Manufactured By

Micro Labs Limited (India)

Dosage Form

Trimetazidine MB

Extended-release tablets, film-coated, 35 mg: 10, 20, 30, 40, or 60 pcs.

Dosage Form, Packaging, and Composition

Extended-release film-coated tablets light pink in color, round, biconvex; the appearance of the tablet on the cross-section: coating – light pink, core – white.

	1 tab.
Trimetazidine dihydrochloride	35 mg

Excipients: hypromellose – 73.83 mg, hypromellose K100LVP – 18 mg, lactose monohydrate – 27.17 mg, croscarmellose sodium – 8.5 mg, talc – 3 mg, magnesium stearate – 2.5 mg, colloidal silicon dioxide – 2 mg.

Coating composition hypromellose-15 cps – 4.31 mg, polysorbate 80 – 0.04 mg, titanium dioxide (E171) – 1.8 mg, talc – 1.8 mg, iron oxide red dye (E172) – 0.17 mg, propylene glycol – 0.68 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.

Trimetazidine MR [Tatkhimpharmpreparaty, JSC (Russia)]
Modified-release film-coated tablets, 35 mg: 30 or 60 pcs.

Marketing Authorization Holder

Tatkhimpharmpreparaty, JSC (Russia)

Dosage Form

Trimetazidine MB

Modified-release film-coated tablets, 35 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Modified-release film-coated tablets pink in color, round, biconvex; on the cross-section, two layers are visible: a core of white or almost white color and a pink coating; surface roughness of the tablets is allowed.

	1 tab.
Trimetazidine dihydrochloride	35 mg

Excipients: Kollidon SR [polyvinyl acetate – 80%, povidone – 19%, sodium lauryl sulfate – 0.8%, silicon dioxide – 0.2%] – 99 mg, microcrystalline cellulose – 61.8 mg, hypromellose (Methodel K 100 M) – 22 mg, colloidal silicon dioxide (aerosil) – 1.1 mg, magnesium stearate – 1.1 mg.

Coating composition Opadry II pink [polyvinyl alcohol – 2.64 mg, titanium dioxide – 1.6124 mg, macrogol – 1.3332 mg, talc – 0.9768 mg, carmine red dye – 0.025 mg, iron oxide yellow – 0.0099 mg, iron oxide black – 0.0027 mg] – 6.6 mg.

15 pcs. – blister packs (2) – cardboard packs.
15 pcs. – blister packs (4) – cardboard packs.

Trimetazidine MV-Akrikhin [Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)]
Extended-release film-coated tablets, 35 mg: 30 or 60 pcs.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Trimetazidine MB-Akrikhin

Extended-release film-coated tablets, 35 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Extended-release film-coated tablets light pink in color, round, biconvex; the tablet is white or almost white in color at the break.

	1 tab.
Trimetazidine dihydrochloride	35 mg

Excipients: calcium hydrogen phosphate dihydrate, hyprolose (hydroxypropylcellulose), povidone (type K30) (polyvinylpyrrolidone), colloidal silicon dioxide, magnesium stearate.

Film coating composition ready-made mixture Opadry II 33G24509 Pink (hypromellose, titanium dioxide, lactose monohydrate, macrogol (polyethylene glycol 3000), triacetin (glycerol triacetate), iron oxide yellow dye, iron oxide red dye, iron oxide black dye).

6 pcs. – blister packs (10) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (6) – cardboard packs.

Trimetazidine SR Renewal [Obnovlenie Pfc, JSC (Russia)]
Prolonged-release film-coated tablets, 35 mg: 28, 30, 56, or 60 pcs.

Marketing Authorization Holder

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Trimetazidine MB Renewal

Prolonged-release film-coated tablets, 35 mg: 28, 30, 56, or 60 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release film-coated tablets from light pink to dark pink in color, round, biconvex; on the cross-section, the core is white or almost white.

	1 tab.
Trimetazidine dihydrochloride	35 mg

Excipients: calcium hydrogen phosphate dihydrate, hypromellose, povidone K30, magnesium stearate, colloidal silicon dioxide (aerosil), macrogol 6000.

Shell composition Opadry^® 03N240001 pink [hypromellose, titanium dioxide, glycerol, magnesium stearate, macrogol 6000, iron oxide red dye].

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
14 pcs. – contour cell packaging (2) – cardboard packs.
14 pcs. – contour cell packaging (4) – cardboard packs.
15 pcs. – contour cell packaging (2) – cardboard packs.
15 pcs. – contour cell packaging (4) – cardboard packs.

Trimetazidine SR-Teva [Teva Pharmaceutical Industries, Ltd. (Israel)]
Prolonged-release film-coated tablets, 35 mg: 20, 60, or 120 pcs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Merckle, GmbH (Germany)

Dosage Form

Trimetazidine MB-Teva

Prolonged-release film-coated tablets, 35 mg: 20, 60, or 120 pcs.

Dosage Form, Packaging, and Composition

Prolonged-release film-coated tablets pink in color, round, biconvex; on the cross-section – the core is white or almost white.

	1 tab.
Trimetazidine dihydrochloride	35 mg

Excipients: hypromellose – 90 mg, calcium hydrogen phosphate dihydrate – 141 mg, magnesium stearate – 3 mg, colloidal silicon dioxide – 1 mg.

Shell composition aqueous pink gloss – 7 mg (hypromellose – 60%, stearic acid – 5%, macrogol 6000 – 3%, glycerol – 5%, titanium dioxide – 26.75%, iron oxide red dye – 0.25%).

10 pcs. – blisters (2) – cardboard packs^×.
10 pcs. – blisters (6) – cardboard packs^×.
10 pcs. – blisters (12) – cardboard packs^×.

^× protective stickers may additionally be applied.

Trimetazidine-AKOS MR [Biocom, JSC (Russia)]
Modified-release tablets, coated, 35 mg: 10, 20, 30, 40, 50, 60 or 120 pcs.

Marketing Authorization Holder

Biocom, JSC (Russia)

Dosage Form

Trimetazidine-AKOS MR

Modified-release tablets, coated, 35 mg: 10, 20, 30, 40, 50, 60 or 120 pcs.

Dosage Form, Packaging, and Composition

Modified-release tablets, coated pink in color, round, biconvex.

	1 tab.
Trimetazidine dihydrochloride	35 mg

Excipients: calcium hydrogen phosphate dihydrate, hypromellose (hydroxypropyl methylcellulose), prosolv (silicified microcrystalline cellulose), potato starch, colloidal silicon dioxide (aerosil), magnesium stearate.

Shell composition hypromellose (hydroxypropyl methylcellulose), macrogol (polyethylene glycol), titanium dioxide E171, iron oxide red dye E172.

10 pcs. – contour cell packaging (1) – cardboard packs.
10 pcs. – contour cell packaging (2) – cardboard packs.
10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (4) – cardboard packs.
10 pcs. – contour cell packaging (5) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
10 pcs. – contour cell packaging (12) – cardboard packs.

Trimetazidine-Biokom MR [Biocom, JSC (Russia)]
Modified-release tablets, coated, 35 mg: 10, 20, 30, 40, 50, 60 or 120 pcs.

Marketing Authorization Holder

Biocom, JSC (Russia)

Dosage Form

Trimetazidine-Biokom MR

Modified-release tablets, coated, 35 mg: 10, 20, 30, 40, 50, 60 or 120 pcs.

Dosage Form, Packaging, and Composition

Modified-release tablets, coated pink in color, round, biconvex.

	1 tab.
Trimetazidine dihydrochloride	35 mg

Excipients: calcium hydrogen phosphate dihydrate – 79.93 mg, hypromellose (hydroxypropyl methylcellulose) – 57.4 mg, prosolv (silicified microcrystalline cellulose) – 20.5 mg, potato starch – 3.07 mg, colloidal silicon dioxide (aerosil) – 2.05 mg, magnesium stearate – 2.05 mg.

Shell composition hypromellose (hydroxypropyl methylcellulose) – 3.476 mg, macrogol (polyethylene glycol) – 0.524 mg, titanium dioxide E171 – 0.976 mg, iron oxide red dye E172 – 0.024 mg.

Trimetazidine-Teva [Teva Pharmaceutical Industries, Ltd. (Israel)]
Film-coated tablets, 20 mg: 30 or 60 pcs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Merckle, GmbH (Germany)

Dosage Form

Trimetazidine-Teva

Film-coated tablets, 20 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets red-brown in color, round, biconvex.

	1 tab.
Trimetazidine dihydrochloride	20 mg

Excipients: microcrystalline cellulose (type 302) – 20 mg, mannitol – 43.5 mg, copovidone – 4 mg, colloidal silicon dioxide – 0.5 mg, magnesium stearate – 2 mg.

Shell composition hypromellose – 2.3 mg, macrogol 6000 – 0.23 mg, iron oxide red dye – 0.1 mg, titanium dioxide – 0.49 mg.

10 pcs. – blisters (3) – cardboard packs^×.
10 pcs. – blisters (6) – cardboard packs^×.

^× protective stickers may additionally be applied.

Trimetazidine-VERTEX [Vertex, JSC (Russia)]
Capsules 20 mg: 30 or 60 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Trimetazidine-VERTEX

Capsules 20 mg: 30 or 60 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin, size No. 3, with a white body and a green cap; capsule contents – powder or compacted mass of white or almost white color, disintegrating upon light pressure with a glass rod.

	1 caps.
Trimetazidine dihydrochloride	20 mg

Excipients: lactose monohydrate – 127.7 mg, corn starch – 0.8 mg, povidone K17 (low molecular weight polyvinylpyrrolidone) – 0.8 mg, calcium stearate – 0.7 mg.

Capsule body composition titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition titanium dioxide – 1%, iron oxide yellow dye (iron oxide) – 1.7143%, indigo carmine – 0.3%, gelatin – up to 100%.

10 pcs. – contour cell packaging (3) – cardboard packs.
10 pcs. – contour cell packaging (6) – cardboard packs.
20 pcs. – contour cell packaging (3) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.

Medixlife (Author)

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