Glucophage XR

Glucophage XR

metformin

Manufacturer:

PT. Merck Tbk
Concise Prescribing Info
Contents
Metformin HCl
Indications/Uses
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.
Dosage/Direction for Use
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.
Administration
Should be taken with food: If taken once daily, take w/ the evening meal. Swallow whole, do not chew/crush.
Contraindications
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. Acute alcohol intoxication, alcoholism. Elective major surgery. Severe renal failure or dysfunction (CrCl or GFR <30 mL/min); hepatic insufficiency.
Special Precautions
Lactic acidosis; poorly controlled diabetes, ketosis, prolonged fasting, excessive alcohol intake, severe infection, hypoxia-associated conditions; dehydration. Determine renal function prior to treatment & regularly thereafter. Increased risk of hypoxia & renal insufficiency in patients w/ heart failure. Regularly perform usual laboratory tests for diabetes monitoring. Overwt patients should continue energy-restricted diet. Discontinue therapy 48 hr prior to, during or 48 hr after use of IV iodinated contrast media & elective major surgery. Avoid consumption of alcohol and alcohol-containing medicinal product. Concomitant use w/ antihypertensives, diuretics, NSAIDs; combination w/ insulin & other oral antidiabetics eg, sulfonylureas or meglitinides. May affect ability to drive & use machines. Not recommended to initiate treatment in patients w/ CrCl or GFR <45 mL/min. Pregnancy. Not recommended during lactation. Not to be used in childn. 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/ acute alcohol intoxication, loop diuretics. Medicinal products w/ intrinsic hyperglycaemic activity eg, glucocorticoids, tetracosactides, B2-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, daclastavir, vandetanib. Altered efficacy & renal elimination w/ OCT1 & OCT2 inhibitors eg, crizotinib, olaparib. Iodinated contrast materials.
MIMS Class
ATC Classification
A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.
Presentation/Packing
Form
Glucophage XR tab 750 mg
Packing/Price
8 × 15's (Rp243,079/boks)
Form
Glucophage XR tab 1,000 mg
Packing/Price
12 × 10's (Rp345,600/boks)
Form
Glucophage XR tab 500 mg
Packing/Price
8 × 15's (Rp243,076/boks)
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