Daily dose: ½-2 tab daily ie, from 30-120 mg taken orally as a single intake at breakfast. Recommended dose: Initially 30 mg daily, may be used as maintenance dose if blood glucose is effectively controlled. May be increased to 60, 90 or 120 mg daily in successive steps if blood glucose is not adequately controlled. The interval between each dose increment should be at least 1 mth. Max: 120 mg daily. Patients at risk of hypoglycaemia Daily starting dose: 30 mg.
Hypersensitivity to gliclazide, other sulfonylurea, sulphonamides. Type I diabetes; diabetic pre-coma & coma, diabetic ketoacidosis. Treatment w/ miconazole. Severe renal or hepatic insufficiency. Lactation.
Hypoglycaemia which may occur due to low-calorie diets, prolonged or strenuous exercise, alcohol intake, use w/ other hypoglycaemic agents, or presence of risk factors (eg, patient refuses or unable to cooperate, malnutrition, irregular mealtimes, skipping meals, periods of fasting or dietary changes, imbalance between physical exercise & carbohydrate intake, renal & severe hepatic insufficiency, overdose, thyroid disorders, hypopituitarism & adrenal insufficiency). Inform patient of the importance of following dietary advice, taking regular exercise & regular monitoring of blood glucose levels. Fever, trauma, infection or surgical intervention may affect blood glucose control. Measurement of glycated Hb levels (or fasting venous plasma glucose) is recommended; blood glucose self-monitoring may be useful. Patients w/ G6PD-deficiency. Porphyric patients. Not to be administered to patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May impair the ability to drive & use machines due to hypoglycaemia. Avoid use during pregnancy. Safety & efficacy in childn & adolescents have not been established.
Hypoglycaemia, GI disturbances (eg, abdominal pain, nausea, vomiting, dyspepsia, diarrhoea, constipation). Transient visual disturbances at start of treatment. As for other sulfonylureas: observed cases of erythrocytopenia, agranulocytosis, haemolytic anaemia, pancytopenia, allergic vasculitis, hyponatraemia, elevated liver enzymes, impairment of liver function (eg, cholestasis, jaundice) & hepatitis which led to life-threatening liver failure in isolated cases.
Drug Interactions
Increased risk of hypoglycaemia w/ miconazole, phenylbutazone, alcohol, other antidiabetic agents (eg, insulins, acarbose, metformin, thiazolidinediones, dipeptidyl peptidase-4 inhibitors, GLP-1 receptor agonists), β-blockers, fluconazole, ACE inhibitors (eg, captopril, enalapril), H2-receptor antagonists, MAOIs, sulfonamides, clarithromycin, NSAIDs. Increased blood glucose levels w/ danazol, chlorpromazine at high doses, glucocorticoids, ritodrine, salbutamol, terbutaline, St John's wort prep. Risk of dysglycaemia w/ fluoroquinolones. Potentiation of anticoagulant therapy (eg, warfarin).
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