Glucophage XR

Metformin HCl

Reduce risk or delay of onset of type 2 DM in adults, overwt patients w/ impaired glucose tolerance &/or fasting glucose &/or increased HbA1c who are at high risk for developing overt type 2 DM & still progressing towards type 2 DM despite implementing intensive lifestyle change for 3-6 mth. Monotherapy or in combination w/ other oral antidiabetic agents or insulin for type 2 DM in adults when dietary management & exercise alone does not result in adequate glycaemic control.

Adult w/ normal renal function (GFR ≥90 mL/min) Reduction in the risk or delay of the onset of type 2 DM Initially one 500-mg tab once daily w/ evening meal. After 10-15 days, adjust dose based on blood glucose measurements. Max: 2,000 mg once daily. Monotherapy Initially 1 tab of 500 mg once daily, may be adjusted based on blood glucose measurements after 10-15 days. Max: 2,000 mg once daily. If glycaemic control is not achieved on 2,000 mg once daily, consider Glucophage XR 1,000 mg twice daily. If glycaemic control is still not achieved, may be switched to metformin tab IR up to max: 3,000 mg daily. Patient already treated w/ metformin Initially same daily dose of metformin IR tab. Transfer from another oral antidiabetic agent Discontinue other agent & initiate as indicated. Combination w/ insulin Initially 500 once daily, adjust insulin based on blood glucose measurements. Patient w/ CrCl or GFR 45-59 mL/min Initially 500 mg or 750 mg once daily. Max: 1,000 mg daily, CrCl or GFR 30-44 mL/min Max: 1,000 mg daily.

Should be taken with food: If taken once daily, take w/ the evening meal. Swallow whole, do not chew/crush.

Hypersensitivity. Metabolic acidosis eg, lactic acidosis, diabetic ketoacidosis. Diabetic pre-coma. Acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agents. Disease causing tissue hypoxia eg, unstable CHF, resp failure, recent MI or shock. Acute alcohol intoxication, alcoholism. Elective major surgery. Severe renal failure or dysfunction (CrCl or GFR <30 mL/min); hepatic insufficiency.

Discontinue therapy 48 hr prior to, during or 48 hr after use of iodinated contrast materials & elective major surgery. Temporarily discontinue use in presence of conditions that alter renal function. Lactic acidosis; poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, severe infection, hypoxia-associated conditions; dehydration. Initiation of antihypertensive therapy or diuretic therapy & when starting therapy w/ NSAIDs. Patients w/ heart failure are more at risk of hypoxia & renal insufficiency. Regular monitoring of cardiac & renal function in patients w/ stable chronic heart failure. Contraindicated in acute & unstable heart failure. Overwt patients should continue energy-restricted diet. Regularly perform usual lab tests for diabetes monitoring. Reduced vit B₁₂ serum levels; should be monitor periodically in patients w/ risk factors for vit B₁₂ deficiency. Combination w/ insulin or other oral antidiabetics (eg, sulfonylureas or meglitinides). Determine CrCl or GFR prior to treatment & regularly thereafter. May impair ability to drive or operate machinery. Pregnancy. Not recommended during breastfeeding. Not to be used in childn. Not recommended in elderly ≥75 yr.

GI disorders eg, nausea, vomiting, diarrhoea, abdominal pain, loss of appetite. Vit B₁₂ decrease/deficiency; taste disturbance.

Increased risk of lactic acidosis w/ acute alcohol intoxication, loop diuretics. Medicinal products w/ intrinsic hyperglycaemic activity eg, glucocorticoids, tetracosactides, β₂-agonists, danazol, chlorpromazine, diuretics. Reduced efficacy w/ OCT1 substrates/inhibitors eg, verapamil. Increased GI absorption & efficacy w/ OCT1 inducers eg, rifampicin. Increased plasma conc w/ OCT2 substrates/inhibitors eg, cimetidine, dolutegravir, crizotinib, olaparib, daclatasvir, vandetanib. Altered efficacy & renal elimination w/ OCT1 & OCT2 inhibitors eg, crizotinib, olaparib.

Antidiabetic Agents

A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.

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