Adult: As conventional tab: Initially, 40-80 mg daily; may increase as necessary until adequate control is achieved. Max: 320 mg daily. Doses >160 mg daily are given in 2 divided doses. As modified-release tab: Initially, 30 mg daily; may increase in increments of 30 mg at intervals of at least 1 month (or after 2 weeks if no decrease in blood glucose is observed). Max: 120 mg daily. The 80 mg conventional tab is comparable to the 30 mg modified-release tab. Switch may be done with close blood glucose monitoring.
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.
This drug may impair concentration or cause transient visual disturbance due to hypoglycaemia, if affected, do not drive or operate machinery.
Monitor blood glucose, HbA1c (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.
Symptoms: Hypoglycaemia. Management: For moderate symptoms of hypoglycaemia, without any loss of consciousness or neurological signs: Consider carbohydrate intake, dose adjustment, or change of diet. In case of hypoglycaemic coma, administer a rapid IV inj of 50 mL of concentrated glucose solution (20-30%), followed by continuous infusion of a more dilute glucose solution (10%) at a rate that will maintain blood glucose levels above 1 g/L. Close monitoring is recommended.
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). Potentially Fatal: Increased hypoglycaemic effect with possible onset of hypoglycaemic symptoms, or even coma with miconazole.
Increased hypoglycaemic effect with alcohol; avoid concomitant use. Decreased exposure with St. John’s wort.
Description: Gliclazide is an antidiabetic sulfonylurea. It decreases blood glucose levels by increasing insulin sensitivity at peripheral target sites, stimulating insulin release from the β-cells of the islets of Langerhans, and reducing glucose output from the liver. It has haemovascular properties in which it decreases microthrombosis by an action on vascular endothelial fibrinolytic activity with an increase in tissue plasminogen activator (t-PA) activity, and by partial inhibition of platelet aggregation and adhesion. Duration: 24 hours (modified-release tab). Pharmacokinetics: Absorption: Rapidly absorbed from the gastrointestinal tract (conventional tab); slow and complete (modified-release tab). Bioavailability: 97% (modified-release tab). Time to peak plasma concentration: 4-6 hours (conventional tab); approx 6 hours (modified-release tab). Distribution: Distributed to the intracellular fluids. Crosses the placenta. Volume of distribution: 20-40 L. Plasma protein binding: Approx 94-95%. Metabolism: Extensively metabolised in the liver by CYP2C9 and CYP2C19 isoenzymes to inactive metabolites. Excretion: Mainly via urine (60-70%, <1% as unchanged drug); faeces (10-20%). Elimination half-life: 10.4 hours (conventional tab); 12-20 hours (modified-release tab).
A10BB09 - gliclazide ; Belongs to the class of sulfonylureas. Used in the treatment of diabetes.
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