Glucophage XR

Glucophage XR

metformin

Manufacturer:

Merck

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Metformin HCl
Indications/Uses
Reduction in risk or delay of onset of type 2 DM in adults, overwt patients w/ impaired glucose & fasting tolerance &/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 w/ insulin for type 2 DM in adults when dietary management & exercise alone does not result in adequate glycaemic control. Reduction of diabetic complications in overwt type 2 diabetic patients treated w/ IR metformin as 1st-line therapy after diet failure.
Dosage/Direction for Use
Adult w/ normal renal function (GFR ≥90 mL/min) Initially 1 500-mg tab once daily, adjusted based on blood glucose measurements after 10-15 days. Dosage may be increased every 10-15 days, up to max: 4 500-mg or 2 750-mg or 2 1,000-mg tab daily. Patient already treated w/ metformin Initially same daily dose of metformin IR tab. Transfer from another oral antidiabetic agent Discontinue the other agent & initiate as indicated. Combination w/ insulin 500 or 750 mg daily, adjust insulin dose based on blood glucose measurements. Patient w/ renal impairment (GFR 45-89 mL/min) Max: 2,000 mg daily, (GFR 30-44 mL/min) Max: 1,000 mg daily.
Administration
Should be taken with food: Take w/ the evening meal. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Any type of acute metabolic acidosis eg, lactic acidosis, diabetic ketoacidosis. Diabetic pre-coma. Acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock. Disease which may cause tissue hypoxia eg, decompensated heart or resp failure, recent MI. Acute alcohol intoxication, alcoholism. Severely reduced renal function (GFR <30 mL/min), hepatic insufficiency.
Special Precautions
Discontinue use 48 hr prior to & at the time of surgery w/ general, spinal or epidural anaesth; intravascular administration of iodinated contrast agents. Increased risk of lactic acidosis. Regularly monitor use in patients w/ stable chronic heart failure. Overwt patients should continue energy-restricted diet. Combination w/ insulin or other oral antidiabetics. Monitor renal function & temporarily discontinue use in presence of conditions that alter renal function. May be considered if clinically needed during pregnancy & in periconceptional phase as addition or alternative to insulin. Not recommended during lactation. Not to be used in childn. Not recommended in elderly ≥75 yr.
Adverse Reactions
GI disorders eg, nausea, vomiting, diarrhoea, abdominal pain, loss of appetite. Taste disturbance.
Drug Interactions
Increased risk of lactic acidosis w/ alcohol intoxication; NSAIDs including selective COX-2 inhibitors, ACE inhibitors, AIIA, diuretics especially loop diuretics. Reduced efficacy w/ organic cation transporters (OCT)1 inhibitors eg, verapamil. Increased GI absorption & efficacy w/ OCT1 inducers eg, rifampicin. Increased plasma conc w/ OCT2 inhibitors eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole. Altered efficacy & renal elimination w/ OCT1 & OCT2 inhibitors eg, crizotinib, olaparib. Iodinated contrast agents. Drugs w/ intrinsic hyperglycaemic activity eg, systemic & local glucocorticoids, sympathomimetics.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.
Presentation/Packing
Form
Glucophage XR tab 1,000 mg
Packing/Price
60's
Form
Glucophage XR tab 500 mg
Packing/Price
60's
Form
Glucophage XR tab 750 mg
Packing/Price
60's
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