Trimedin

White, circular, slightly biconvex, film-coated tablet, plain on both sides.
Each film-coated tablet contains: Trimetazidine Hydrochloride BP 35 mg (in modified release form).

Pharmacotherapeutic group: Other cardiac preparation.
Pharmacology: Pharmacodynamics: Trimetazidine inhibits β-oxidation of fatty acids by blocking long-chain 3-ketoacyl-CoA thiolase, which enhances glucose oxidation. In an ischaemic cell, energy obtained during glucose oxidation requires less oxygen consumption than in the β-oxidation process. Potentiation of glucose oxidation optimizes cellular energy processes, thereby maintaining proper energy metabolism during ischaemia.
Pharmacodynamic effects: In patients with ischaemic heart disease, trimetazidine acts as a metabolic agent, preserving the myocardial high-energy phosphate intracellular levels. Anti-ischaemic effects are achieved without concomitant haemodynamic effects.
Pharmacokinetics: Trimetazidine is rapidly and completely absorbed from the gastrointestinal tract. Plasma protein binding is low and the volume of distribution is 320 L. Four pathways of metabolism are known but metabolism is not extensive, with 51% of unchanged drug eliminated in urine. Elimination is rapid (t_½=6 h) and predominantly renal.

It is used in angina pectoris and in ischaemia of neurosensorial tissues as in Meniere's disease.

One tablet morning and evening, with meals. Trimetazidine can be combined with calcium channel blocker or beta blockers.
Or as prescribed by the physician.

No cases of occurrence of poisoning by trimetazidine owing to its overdose have been reported.

Hypersensitivity to Trimetazidine. Parkinson's disease, parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders. Severe renal impairment (creatinine clearance <30 mL/min).

Trimetazidine can cause or worsen parkinsonian symptoms (tremor, akinesia, hypertonia), which should be regularly investigated, especially in elderly patients. In doubtful cases, patients should be referred to a neurologist for appropriate investigations.
The occurrence of movement disorders such as parkinsonian symptoms, restless leg syndrome, tremors, gait instability should lead to definitive withdrawal of trimetazidine.
These cases have a low incidence and are usually reversible after treatment discontinuation. The majority of the patients recovered within 4 months after trimetazidine withdrawal. If parkinsonian symptoms persist more than 4 months after drug discontinuation, a neurologist opinion should be sought.
Falls may occur, related to gait instability or hypotension, in particular in patients taking antihypertensive treatment.
Caution should be exercised when prescribing trimetazidine to patients in whom an increased exposure is expected: Moderate renal impairment; Elderly patients older than 75 years old.

Pregnancy: There are no adequate data from the use of Trimetazidine in pregnant women. Animal studies are insufficient. The potential risk for humans is unknown. Trimetazidine should not be taken during pregnancy unless clearly necessary.
Lactation: It is unknown whether trimetazidine is excreted in human or animal breast milk. Since excretion in breast milk and a risk to the suckling child cannot be excluded, trimetazidine should not be used during breastfeeding.

The most commonly reported encountered side effects are gastric discomfort, nausea, headache, and vertigo. However, the side effects are mild and non specific.

No drug interactions have been reported so far, in particular no interactions have been reported between trimetazidine and beta blockers, calcium antagonists, nitrates, heparin, hypolipidaemic agents or digitalis.

Store at temperatures not exceeding 30°C.

Anti-Anginal Drugs

C01EB15 - trimetazidine ; Belongs to the class of other cardiac preparations.

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