Fengle Trimetazidine Hydrochloride Capsules

1. Indications and Usage
Angina Pectoris: Indicated for the preventive treatment of angina pectoris.
Vertigo and Tinnitus: Used as adjunctive therapy for the symptomatic treatment of vertigo and tinnitus.
2. Dosage and Administration
Standard Dose: The usual dosage for adults is 20 mg (one capsule) three times daily, taken during meals. The total daily dose should not exceed 60 mg.
Administration: Oral administration. The capsules should be swallowed with water during meals to ensure proper absorption and minimize gastrointestinal irritation.
3. Mechanism of Action
Metabolic Protection: Trimetazidine acts as a metabolic modulator, protecting cells from hypoxia or ischemia by inhibiting long-chain fatty acid oxidation and shifting energy metabolism toward glucose oxidation.
ATP Preservation: By preserving intracellular ATP levels, it maintains the function of ion pumps and transmembrane sodium-potassium currents, stabilizing the intracellular environment.
4. Safety and Warnings
Contraindications: Contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min) due to the risk of drug accumulation.
Movement Disorders: May cause or exacerbate movement disorders (e.g., tremor, parkinsonian syndrome). Discontinuation is necessary if these symptoms occur.
Not for Acute Attacks: Not indicated for the symptomatic treatment of acute angina attacks or the initial treatment of unstable angina or myocardial infarction.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Rare gastrointestinal discomfort (e.g., nausea, vomiting).
Neurological Effects: Dizziness, headache, and sleep disturbances may occur.
Clinical Findings: Clinical trials have demonstrated its efficacy in reducing the frequency of angina attacks and improving quality of life when used as adjunctive therapy.
6. Drug Interactions
Interaction Profile: No significant drug interactions have been observed in clinical studies.
Precautions: Caution is advised when combining with other medications metabolized by the liver or excreted renally.
7. Pharmaceutical Information
Active Ingredient: Trimetazidine Hydrochloride.
Strengths: Typically available as 20 mg capsules.
Appearance: White or off-white granular powder.
Storage: Protect from light and store in a sealed container.