Duhe Metformin Hydrochloride and Gliclazide Tablets

1. Indications and Usage
Type 2 Diabetes: Primarily indicated for the treatment of type 2 diabetes, particularly in patients with vascular complications.
Combination Therapy: It is used when diet, exercise, and monotherapy with either metformin or gliclazide alone are insufficient to control blood glucose.
2. Dosage and Administration
Starting Dose: The usual starting dose is 80 mg gliclazide/250 mg metformin 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 gliclazide daily.
Special Populations: For elderly patients, the dose should be appropriately reduced.
3. Mechanism of Action
Metformin Component: Decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.
Gliclazide Component: Stimulates pancreatic beta cells to secrete insulin by closing ATP-sensitive potassium channels, restoring the first-phase insulin secretion peak.
Microvascular Protection: Gliclazide inhibits platelet aggregation and adhesion, helping to prevent diabetic microvascular complications.
4. Safety and Warnings
Lactic Acidosis: A rare but serious complication associated with metformin. Risk increases with renal impairment, sepsis, dehydration, or hepatic dysfunction.
Hypoglycemia: Gliclazide may cause hypoglycemia, especially in elderly, malnourished, or renal-impaired patients.
Renal Function: Renal function must be assessed prior to initiation and regularly thereafter. Use is contraindicated in significant renal impairment.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Gastrointestinal symptoms (diarrhea, nausea, vomiting, abdominal pain) are common due to metformin. Hypoglycemia, dizziness, and headache are associated with gliclazide.
Other Adverse Effects: Rare cases of hepatic dysfunction, allergic skin reactions (rash, pruritus), and hematologic abnormalities (anemia, leukopenia) have been reported.
6. Drug Interactions
Alcohol: Intake should be limited due to the increased risk of lactic acidosis and hypoglycemia.
Cationic Drugs: Drugs eliminated by renal tubular secretion (e.g., amiloride, digoxin, morphine) may compete with metformin.
Hypoglycemic Potentiators: Concurrent use with NSAIDs (especially salicylates), sulfonamide antibiotics, and beta-blockers may increase the risk of hypoglycemia.
Hyperglycemic Agents: Corticosteroids, thiazides, and phenytoin may diminish the antidiabetic effect.
7. Pharmaceutical Information
Active Ingredients: Metformin Hydrochloride and Gliclazide.
Strengths: Commonly available as 80 mg/250 mg tablets.
Appearance: Film-coated tablets, white to off-white.
Storage: Store below 25°C in a dry place.