Gliclazide

Should be taken with food.

Hypersensitivity to gliclazide, other sulfonylureas or sulfonamides. Type 1 diabetes mellitus, diabetic coma and pre-coma, diabetic ketoacidosis. Severe hepatic or renal impairment. Pregnancy and lactation. Concomitant use with miconazole.

Patient with risk factors for hypoglycaemia (e.g. malnourished, severe or poorly compensated endocrine disorders, severe vascular disease), G6PD-deficiency, porphyria, stress-related states (e.g. severe trauma, fever, infection, surgery). Mild to moderate hepatic or renal impairment. Elderly. Patient Counselling This drug may impair concentration or cause transient visual disturbance due to hypoglycaemia, if affected, do not drive or operate machinery. Monitoring Parameters Monitor blood glucose, HbA_1c (at least twice yearly in patients with stable glycaemic control; quarterly in patients not meeting therapy goals or with changes in treatment), renal and hepatic functions (baseline in all patients then periodically thereafter in patients with mild to moderate impairment). Assess for signs and symptoms of hypoglycaemia.

Significant: Hypoglycaemia. Rarely, serious skin and hypersensitivity reactions (e.g. rash, pruritus, erythema, urticaria, angioedema, maculopapular rash, bullous reactions [e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis], drug rash with eosinophilia and systemic symptoms [DRESS]). Blood and lymphatic system disorders: Rarely, reversible anaemia, leucopenia, thrombocytopenia, agranulocytosis. Eye disorders: Rarely, transient visual disturbances. Gastrointestinal disorders: Constipation, diarrhoea, nausea, vomiting, epigastric discomfort, abdominal pain, heartburn, dyspepsia. Hepatobiliary disorders: Rarely, jaundice, cholestasis, hepatitis. Investigations: Rarely, increased serum creatinine, alkaline phosphatase, ALT, AST, BUN, bilirubin. Nervous system disorders: Headache.

Increased hypoglycaemic effect with phenylbutazone. Concomitant use with β-blockers, fluconazole, ACE inhibitors (e.g. captopril, enalapril), H₂-receptor antagonists, MAOIs, sulfonamides, clarithromycin, NSAIDs and other antidiabetic agents (e.g. insulins, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, metformin, acarbose, thiazolidinediones) may potentiate the blood glucose lowering effect of gliclazide. Danazol, chlorpromazine (at doses >100 mg daily), glucocorticoids, tetracosactrin, ritodrine, salbutamol, terbutaline, barbiturates, estrogens, and progestogens may reduce blood sugar control with gliclazide by causing increased blood glucose levels. Increased risk of dysglycaemia with fluoroquinolones. May increase the effect of anticoagulants (e.g. warfarin).

Antidiabetic Agents

A10BB09 - gliclazide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.