Generic Name:
Category: ANTI DIABETICS
Product Description
Gliclazide®, a second-generation sulfonylurea oral antidiabetic agent indicated for the management of Type 2 Diabetes Mellitus. It lowers blood glucose by stimulating insulin secretion from functional pancreatic β-cells and helps improve glycaemic control when diet, exercise, and weight reduction alone are insufficient.
Gliclazide® also possesses haemovascular benefits, including reducing platelet aggregation and improving microcirculation, which may contribute to lowering the risk of diabetic microvascular complications.
Indications
Gliclazide® is indicated for:
- Treatment of Type 2 Diabetes Mellitus in adults when dietary measures, physical activity, and weight reduction alone do not provide adequate glycaemic control.
- Use as monotherapy or in combination with other oral antidiabetic agents or insulin when appropriate.
- Improving glycaemic control to reduce the risk of diabetes-related complications.
Contraindications
Gliclazide® is contraindicated in patients with:
- Hypersensitivity to gliclazide, other sulfonylureas, sulfonamides, or any component of the formulation.
- Type 1 Diabetes Mellitus.
- Diabetic ketoacidosis, diabetic pre-coma, or diabetic coma.
- Severe renal impairment or severe hepatic impairment.
- Concomitant treatment with miconazole (systemic or oral gel), due to the increased risk of severe hypoglycaemia.
- Pregnancy and breastfeeding, unless the potential benefits outweigh the risks and insulin therapy is considered more appropriate.
Dosage and Administration
Gliclazide® should be taken orally with breakfast or the first main meal of the day. Tablets should be swallowed whole with water.
Adults
- Starting dose: 40–80 mg once daily.
- The dose may be increased gradually according to blood glucose response.
- Usual maintenance dose: 80–320 mg daily.
- Doses above 160 mg/day should be administered in two divided doses.
- Maximum daily dose: 320 mg.
Elderly Patients
- Start at the lowest effective dose and monitor closely due to the increased risk of hypoglycaemia.
Renal or Hepatic Impairment
- Use with caution in mild to moderate impairment.
- Contraindicated in severe renal or hepatic impairment.
Missed Dose
- If a dose is missed, take the next scheduled dose as prescribed.
- Do not take a double dose to make up for a missed dose.
Key Features
- Effective oral therapy for Type 2 Diabetes Mellitus
- Stimulates physiological insulin secretion
- Helps achieve and maintain optimal glycaemic control
- May reduce the risk of diabetic microvascular complications
- Once- or twice-daily dosing depending on the prescribed dose
- Suitable for use as monotherapy or in combination with other antidiabetic medications
- Supports long-term diabetes management when combined with healthy lifestyle measures