ASK DIS: Trimetazidine: update on indication and dose adjustment

Available product:

Tab Metazine 20mg

Tab Vasteral MR 35mg

The DCA will issue a directive to instruct all product registration holders to update their package inserts with the following information:

Indications

Trimetazidine is indicated in adults as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled by or intolerant to first-line antianginal therapies
removed the indication for otology and ophthalmology use

Contraindications

Trimetazidine is contraindicated in patients with Parkinson’s Disease or parkinsonian symptoms
Trimetazidine is contraindicated in patients with severe renal impairment (creatinine clearance <30ml/min)

Renal Impairement

In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 20mg twice daily, i.e., one in the morning and one in the evening during meals.
In patients with moderate renal impairment (creatinine clearance [30-60] ml/min), the recommended dose is 1 tablet of 35mg in the morning during breakfast

Elderly

Elderly patients (>75 years) may have increased trimetazidine exposure due to age-related decrease in renal function
Dose titration in elderly patients should be exercised with caution

Precautions

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.

References:

ASK DIS