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Glucophage

Glucophage

metformin

Manufacturer:

Merck

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Metformin HCl
Indications/Uses
Monotherapy or in combination w/ other oral antidiabetic agents or w/ insulin for type 2 DM in adults when dietary management & exercise alone results in inadequate glycaemic control. May be used as monotherapy or in combination w/ insulin in childn >10 yr & adolescents. Reduction of diabetic complications in overwt type 2 diabetic adults treated w/ metformin as 1st-line therapy after diet failure.
Dosage/Direction for Use
Adult w/ normal renal function (GFR ≥90 mL/min) Monotherapy & combination w/ other oral antidiabetic agents Initially 500- or 850 mg bd-tds, adjusted based on blood glucose measurements after 10-15 days. Max: 3 g daily in 3 divided doses. Transfer from another oral antidiabetic agent Discontinue the other agent & initiate as indicated. Combination w/ insulin Initially 500- or 850 mg bd-tds, adjust insulin dose based on blood glucose measurements. Childn ≥10 yr & adolescent Monotherapy & combination w/ insulin Initially 500- or 850 mg once daily, adjusted based on blood glucose measurements after 10-15 days. Max: 2 g daily in 2 or 3 divided doses. Renal impairment GFR 60-89 mL/min Max: 3,000 mg daily in 2-3 divided doses, GFR 45-59 mL/min Max: 2,000 mg daily in 2-3 divided doses, GFR 30-44 mL/min Max: 1,000 mg daily in 2-3 divided doses.
Administration
Should be taken with food: Take during or after meals.
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 causing 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
Temporarily discontinue use if dehydration occurs; in presence of conditions altering renal function. Lactic acidosis. Patients w/ inadequately controlled diabetes, ketosis, prolonged fasting, conditions associated w/ hypoxia; stable chronic heart failure. May reduce vit B12 serum levels. Assess renal function prior to initiation & regularly thereafter. Regularly perform usual lab tests for diabetes monitoring. Overwt patients should continue energy-restricted diet. Discontinue use prior to, during or 48 hr after use of intravascular iodinated contrast agents & surgery under general, spinal or epidural anaesth. Hypoglycaemia w/ insulin or other antidiabetics eg, sulfonylureas, meglitinides. Concomitant use w/ antihypertensives, diuretics, NSAIDs. Pregnancy. Not recommended during lactation. Childn 10-12 yr. Elderly.
Adverse Reactions
GI disorders eg, nausea, vomiting, diarrhoea, abdominal pain, loss of appetite. Vit B12 decrease/deficiency; 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/ OCT1 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. More frequent blood glucose monitoring in 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 FC tab 1000 mg
Packing/Price
8 × 15's
Form
Glucophage FC tab 500 mg
Packing/Price
6 × 20's
Form
Glucophage FC tab 850 mg
Packing/Price
5 × 20's
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