Tanglin Epalrestat Capsules

1. Indications and Usage
Diabetic Complications: Indicated for the improvement of symptoms (such as neurogenic symptoms and visual disturbances) associated with diabetic neuropathy.
Chronic Inflammation: Indicated for the treatment of chronic skeletal inflammation and associated symptoms (e.g., pain, swelling, joint deformity).
2. Dosage and Administration
Standard Dose: The recommended dose is 50 mg (one capsule) three times daily, taken orally before meals.
Titration: If the therapeutic effect is insufficient, the dose may be increased to 100 mg three times daily, but the maximum recommended daily dose is 300 mg.
Missed Dose: If a dose is missed, it should be taken as soon as remembered. If it is close to the next dose, skip the missed dose.
3. Mechanism of Action
Aldose Reductase Inhibition: Epalrestat is a selective and competitive inhibitor of the enzyme aldose reductase.
Sorbitol Accumulation: By inhibiting aldose reductase, it prevents the accumulation of sorbitol in diabetic tissues (nerves, retina, lens), thereby alleviating osmotic stress and delaying the progression of diabetic microvascular complications.
4. Safety and Warnings
Liver Function: Epalrestat may cause or exacerbate liver dysfunction. Liver function tests (AST, ALT, ALP, etc.) should be performed periodically.
Hypersensitivity: Do not use in patients with known hypersensitivity to epalrestat or other aldose reductase inhibitors.
Renal Impairment: Use with caution in patients with severe renal impairment, as drug accumulation may occur.
Pregnancy: Safety and efficacy in pregnancy have not been established; use only if the potential benefit justifies the risk.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Elevated liver enzymes (AST, ALT), nausea, abdominal pain, and diarrhea.
Liver Dysfunction: Cases of jaundice and liver enzyme elevation have been reported.
Other Adverse Effects: Rash, pruritus, dizziness, and insomnia have been reported.
Clinical Findings: Clinical trials have demonstrated improvement in diabetic neurologic symptoms and chronic joint inflammation markers.
6. Drug Interactions
Alcohol: Concomitant use with alcohol may enhance liver dysfunction; caution is advised.
Other Hepatotoxic Drugs: Concomitant use with other drugs known to cause liver dysfunction may increase the risk of hepatotoxicity.
Anticoagulants: May potentiate the effects of oral anticoagulants; monitoring of coagulation parameters is advised.
7. Pharmaceutical Information
Active Ingredient: Epalrestat.
Strengths: Typically available as 50 mg capsules.
Appearance: White or off-white hard capsules.
Storage: Store in a cool, dry place, protected from light and moisture.