Trimetazidine hydrochloride
Visa No.: 893110180524
Product: Vaspycar MR
API: Trimetazidine hydrochloride
Product Category: Cardiovascular & Metabolism
Version approved leaflet: 40681e/QLD - ĐK_02/12/2025
INDICATIONS
Indicated in adults as add-on/supportive therapy to existing treatment for the symptomatic treatment of patients with stable angina pectoris that is not adequately controlled, or in patients who are intolerant to other anti-anginal therapies.
DOSAGE AND ADMINISTRATION
Route of administration: Oral use.
Dosage: One 35 mg tablet per dose, twice daily, i.e. one dose in the morning and one dose in the evening, taken with meals. The effectiveness of treatment should be evaluated after 3 months, and trimetazidine should be discontinued if there is no therapeutic response.
Special populations
Renal impairment
In patients with moderate renal impairment (creatinine clearance 30–60 mL/min), the recommended dose is one 35 mg tablet in the morning, taken with breakfast.\
Elderly patients
In elderly patients, plasma concentrations of trimetazidine may be increased due to age-related decline in renal function. In elderly patients with moderate renal impairment (creatinine clearance 30–60 mL/min), the recommended dose is one 35 mg tablet in the morning, taken with breakfast. Dose adjustment in elderly patients should be performed with caution.Việc chỉnh liều ở các bệnh nhân cao tuổi cần được tiến hành thận trọng.
Pediatric population: The safety and efficacy of trimetazidine in children under 18 years of age have not been established. No data are currently available.
CONTRAINDICATIONS
- Hypersensitivity to trimetazidine or to any of the excipients.
- Parkinson’s disease, parkinsonian symptoms, tremor, restless legs syndrome, and other related movement disorders.
- Severe renal impairment (creatinine clearance < 30 mL/min).
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children
