Xavier Trimetazidine Dihydrochloride Sustained‑release Tablets

1. Indications and Usage
Chronic Angina: Indicated as adjunctive therapy to prevent angina attacks in patients inadequately controlled by antianginal standard therapy alone.
2. Dosage and Administration
Standard Dose: The recommended dose is one tablet (35 mg) twice daily.
Administration: Should be taken during meals. For prolonged treatment, the dosage should be periodically re-evaluated by the physician.
Administration Method: Do not chew, crush, or split the tablet; swallow whole with water.
3. Mechanism of Action
Metabolic Modulator: Trimetazidine acts as a metabolic modulator, shifting cellular energy metabolism from fatty acid oxidation toward glucose oxidation.
Cytoprotection: This process helps preserve intracellular ATP levels under hypoxic or ischemic conditions, reducing calcium overload and maintaining cellular integrity.
4. Safety and Warnings
Movement Disorders: May cause or exacerbate movement disorders (e.g., tremor, parkinsonian syndrome). Discontinuation is necessary if these symptoms occur.
Renal Insufficiency: Contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min) due to risk of drug accumulation.
Special Populations: Safety in children, adolescents, and pregnant or breastfeeding women has not been established.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Gastrointestinal disorders (e.g., diarrhea, nausea, abdominal pain), dizziness, and headache.
Serious Adverse Reactions: Parkinsonian symptoms (tremors, akinesia), movement disorders, and rare cases of thrombotic thrombocytopenic purpura (TTP).
6. Drug Interactions
Warfarin: May potentiate the anticoagulant effect of warfarin, potentially increasing the INR. Close monitoring of anticoagulation parameters is required.
Renal Excretion Drugs: Caution is advised when co-administered with other drugs excreted renally in patients with moderate renal insufficiency.
7. Pharmaceutical Information
Active Ingredient: Trimetazidine Dihydrochloride.
Strengths: Typically available as 35 mg prolonged-release tablets.
Appearance: Light reddish-pink, biconvex, elongated oval shaped tablets.
Storage: Do not store above 30°C. Keep in the original package to protect from moisture.