Finished product reference

Gliclazide

Tablet · Oral · 80 mg

List code
1523
Pharmacologic class
Oral antidiabetic; sulfonylurea (second generation)

What it is and how it works

Gliclazide binds to the sulfonylurea receptor (SUR1) on pancreatic beta cells, closing ATP-sensitive potassium channels, depolarising the cell and stimulating insulin secretion. It requires functioning beta cells and also has haemovascular effects such as reduced platelet adhesiveness.

Indications

Type 2 diabetes mellitus in adults when diet, exercise and weight reduction alone are insufficient, as monotherapy or in combination with other antidiabetic agents including insulin.

Dosage and administration (summary)

Oral; standard tablets initially 40–80 mg daily, adjusted according to response up to 320 mg daily (doses above 160 mg divided into two); modified-release tablets 30–120 mg once daily with breakfast.

Contraindications

Type 1 diabetes, diabetic ketoacidosis or precoma, severe renal or hepatic impairment, concomitant miconazole, breastfeeding, and hypersensitivity to sulfonylureas or sulfonamides.

Warnings and precautions

Hypoglycaemia may occur, particularly in the elderly, with irregular meals, alcohol, renal or hepatic impairment, or with interacting drugs, and may be prolonged. Haemolytic anaemia can occur in G6PD deficiency, and weight gain is common; patients should be educated about recognising and treating hypoglycaemia.

Pregnancy

Not recommended in pregnancy; insulin is preferred for glycaemic control.

Storage and supply

Store below 30 °C, protected from moisture.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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