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:

1. http://www.anmat.gov.ar/farmacovigilancia/Informe_june_2012_en
2. MADRAC April 2013 Newsletter
3. http://www.medicines.ie/medicine/2583/SPC