Guankang Gliclazide Tablets (Ⅱ)

1. Indications and Usage
Type 2 Diabetes: Primarily indicated for the treatment of type 2 diabetes, particularly in patients with vascular complications.
2. Dosage and Administration
Starting Dose: The usual starting dose is 80 mg once or twice daily, taken before meals.
Titration: The dose should be gradually increased based on blood glucose response. The usual maintenance dose ranges from 80 mg to 240 mg daily.
Special Populations: For elderly patients, the dose should be appropriately reduced.
3. Mechanism of Action
Insulin Secretion: Gliclazide stimulates pancreatic beta cells to secrete insulin, restoring the first-phase insulin secretion peak and increasing the second phase.
Microvascular Protection: It inhibits platelet aggregation and adhesion, regulates endothelial fibrinolytic activity, and helps prevent diabetic microvascular complications.
4. Safety and Warnings
Hypoglycemia: The most common adverse reaction. Risk increases with irregular meals, alcohol intake, or renal impairment.
Contraindications: Contraindicated in patients with severe hepatic or renal impairment, type 1 diabetes, diabetic ketoacidosis, and during pregnancy or lactation.
Monitoring: Patients must be able to adhere to regular meal times.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Hypoglycemia (symptoms include headache, hunger, nausea, confusion, tremors) and gastrointestinal disturbances (nausea, abdominal pain).
Rare Adverse Reactions: Allergic skin reactions (rash, pruritus), hematologic changes (anemia, leukopenia, thrombocytopenia), and hepatic dysfunction (jaundice, elevated liver enzymes).
6. Drug Interactions
Hypoglycemic Potentiators: Concurrent use with alcohol, NSAIDs (especially salicylates), sulfonamide antibiotics, anticoagulants, beta-blockers, and MAO inhibitors may increase the risk of hypoglycemia.
Hyperglycemic Agents: Corticosteroids, thiazides, and phenytoin may diminish the antidiabetic effect.
7. Pharmaceutical Information
Active Ingredient: Gliclazide.