Gluclazide SR

Gliclazide

Non-insulin-dependent diabetes (type 2) in adults, in association w/ dietary measures & exercise, when these measures alone are not sufficient.

Initially 30 mg daily (½ tab), may be increased to 60, 90 or 120 mg daily in successive steps w/ at least 1-mth interval between each increment if blood glucose is not adequately controlled. Max: 120 mg daily. Patient whose blood glucose has not reduced after 2 wk Dose may be increased at end of 2nd wk. Switching from gliclazide 80 mg 1 tab of gliclazide 80 mg is comparable to 1 PR tab 30 mg (½ tab), from another oral antidiabetic medicinal product Initially 30 mg daily, adjusted to suit blood glucose response.

Should be taken with food: Take as single intake at breakfast time. Swallow w/o crushing/chewing.

Hypersensitivity to gliclazide, other sulfonylureas or sulfonamides. Insulin-dependent diabetes (type 1). Diabetic pre-coma & coma, diabetic ketoacidosis. Concomitant use w/ miconazole. Severe renal or hepatic insufficiency. Lactation.

Hypoglycaemia which is more likely to occur during low caloric diets, following prolonged or strenuous exercise, alcohol intake, use of combination of hypoglycemic agents; due to factors eg, malnutrition, irregular mealtimes, skipping meals, fasting or dietary changes, imbalance between physical exercise & carbohydrate intake, overdosage, thyroid disorders, hypopituitarism & adrenal insufficiency. St John's wort prep, fever, trauma, infection or surgery may affect blood glucose control. Patients w/ G6PD deficiency. Ensure following dietary advice & taking regular physical exercise. Monitor blood glucose & measure glycated Hb levels. Concomitant use w/ fluoroquinolones. Not to be taken by patients w/ galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Caution in driving or operating machinery especially at beginning of treatment. Renal & hepatic insufficiency. Severe renal failure. Avoid use during pregnancy. Childn & adolescents. Elderly.

Hypoglycemia; GI disturbances including abdominal pain, nausea, vomiting, dyspepsia, diarrhea & constipation.

Increased hypoglycemic effect w/ miconazole (systemic/oromucosal); phenylbutazone (systemic). Increased hypoglycemic reaction w/ alcohol. Potentiated blood glucose-lowering effect w/ other antidiabetics (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. Diabetogenic effect of danazol. Increased blood glucose levels w/ chlorpromazine (high doses); glucocorticoids (systemic & local: IA, cutaneous & rectal) & tetracosactrin; ritodrine, salbutamol, terbutaline (IV). Decreased exposure w/ St. John's wort. Risk of dysglycemia w/ fluoroquinolones. May potentiate anticoagulation of anticoagulant therapy eg, warfarin.

Antidiabetic Agents

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

Rx