Glucophage/Glucophage XR

Glucophage/Glucophage XR

metformin

Manufacturer:

Merck

Distributor:

Apex Pharma Marketing
Concise Prescribing Info
Contents
Metformin HCl
Indications/Uses
Glucophage Monotherapy or in combination w/ other oral antidiabetics or insulin in adults. Monotherapy or in combination w/ insulin in childn ≥10 yr & adolescent. Reduction of diabetic complications in overwt type 2 diabetic adult patients treated w/ metformin as 1st-line therapy after diet failure. Glucophage XR Monotherapy or in combination w/ other oral antidiabetics or insulin in type 2 DM in adult, overwt patients w/ impaired glucose tolerance &/or impaired fasting glucose who are at high risk for developing overt type 2 DM & not suitable for lifestyle modifications or when dietary management & exercise alone does not result in adequate glycaemic control.
Dosage/Direction for Use
Glucophage Adult w/ normal renal function (GFR ≥90 mL/min) Monotherapy & combination w/ other oral antidiabetics Starting dose: 500 mg or 850 mg bd-tds, may be adjusted after 10-15 days. Max: 3 g daily. Combination w/ insulin Starting dose: 500 mg or 850 mg bd-tds, adjust insulin dosage according to blood glucose measurements. Renal impairment GFR 60-89 mL/min Max total daily dose: 3,000 mg, 45-59 mL/min Max total daily dose: 2,000 mg, 30-44 mL/min Max total daily dose: 1,000 mg. Monotherapy & combination w/ insulin Childn ≥10 yr & adolescent Starting dose: 500 mg bd, may be adjusted after 10-15 days. Max: 2 g daily. Glucophage XR Adult w/ normal renal function (GFR ≥90 mL/min) Reduction in the risk or delay of the onset of type 2 DM Initially 500 mg once daily, may be adjusted after 10-15 days. Max: 2,000 mg once daily. Monotherapy & combination w/ other oral antidiabetics 500-mg tab: 500 mg once daily. Dosage may be increased in increments of 500 mg every 10-15 days, up to 2,000 mg once daily. If glycaemic control is not achieved on 2,000 mg once daily, consider 1,000 mg bd, may be switched to standard metformin tab to a max of 3,000 mg daily if glycaemic control is still not achieved. 750-mg tab: Dose should be equiv to the daily dose of metformin tab (ER or IR) up to a max of 1,500 mg, may be adjusted after 10-15 days. Recommended dose: 2 tab once daily. If glycaemic control is not achieved on 2,000 mg once daily, consider 1,000 mg bd, may be switched to standard metformin tab to a max of 3,000 mg daily. 1,000-mg tab: 1 tab once daily. Max: 2 tab daily. If glycaemic control is not achieved, may be switched to standard metformin tab to a max of 3,000 mg daily. Transfer from another oral antidiabetic agent Discontinue the other agent & initiate 500 mg before switching to 750 mg or 1,000 mg. Combination w/ insulin Starting dose: 500 mg once daily, while insulin dosage is adjusted on the basis of blood glucose measurements. Renal impairment GFR 45-89 mL/min Max total daily dose: 2,000 mg, 30-44 mL/min Max total daily dose: 1,000 mg.
Administration
Should be taken with food: Take w/ the evening meal. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Acute metabolic acidosis (eg, lactic acidosis, diabetic keteoacidosis). Diabetic pre-coma. Severe renal failure (GFR <30 mL/min). Acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock. Disease which may cause tissue hypoxia eg, decompensated heart failure, resp failure, recent MI, shock. Elective major surgery. Hepatic insufficiency; acute alcohol intoxication, alcoholism.
Special Precautions
Lactic acidosis may occur in diabetic patients w/ worsening renal function, cardioresp illness or sepsis; excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting & hypoxia-associated conditions. Temporarily discontinue use in case of dehydration. Assess GFR before initiating therapy & regularly thereafter. Regularly monitor cardiac & renal function in patients w/ stable chronic heart failure (metformin is contraindicated in acute & unstable heart failure). Discontinue therapy if conditions characterized by hypoxemia occur. Hypoglycemia. Intravascular administration of iodinated contrast agents. Discontinue therapy 48 hr before elective surgery under general, spinal or peridural anaesth. Energy-restricted diet should be continued in overwt patients. Combination w/ insulin or other oral antidiabetics (eg, sulfonylureas or meglitinides) & ethanol. Regularly perform usual laboratory tests for diabetes monitoring. Monitor vit B12 serum levels annually. May affect ability to drive or use machines due to risk of hypoglycaemia when used in combination w/ other antidiabetics. Impaired hepatic function. Pregnancy & lactation. Childn. Elderly ≥75 yr.
Adverse Reactions
GI disorders eg, nausea, vomiting, diarrhoea, abdominal pain & appetite loss. Vit B12 deficiency; taste disturbance.
Drug Interactions
Increased risk of lactic acidosis in alcohol intoxication particularly in case of fasting, malnutrition or hepatic impairment. Discontinue use w/ iodinated contrast agents. Increased risk of lactic acidosis w/ NSAIDs including selective COX-2 inhibitors, ACE inhibitors, angiotensin II receptor antagonists & diuretics especially loop diuretics. Medicinal products w/ intrinsic hyperglycaemic activity (eg, local & systemic glucocorticoids & tetracosactides), β2-agonists, danazol, chlorpromazine (at high dosages of 100 mg daily), diuretics. Efficacy may be reduced by organic cation transporters (OCT)1 inhibitors (eg, verapamil). GI absorption & efficacy may be increased by OCT1 inducers (eg, rifampicin). Renal elimination may be decreased by OCT2 inhibitors (eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole). Efficacy & renal elimination may be altered by both OCT1 & OCT2 inhibitors (eg, crizotinib, olaparib).
MIMS Class
Antidiabetic Agents
ATC Classification
A10BA02 - metformin ; Belongs to the class of biguanides. Used in the treatment of diabetes.
Presentation/Packing
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Glucophage FC tab 1,000 mg
Packing/Price
60's
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Glucophage FC tab 850 mg
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100's
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Glucophage XR tab 1,000 mg
Packing/Price
60's
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Glucophage XR tab 500 mg
Packing/Price
60's
Form
Glucophage XR tab 750 mg
Packing/Price
60's
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