Glucophage/Glucophage Forte/Glucophage XR

Metformin HCl

Type 2 DM particularly in overwt, when dietary management and exercise does not result in adequate control: 1st line therapy in overwt type 2 diabetic adult patients. Prevention of type 2 DM in patients w/ prediabetes & at least 1 additional risk factor in whom lifestyle modifications alone have not reached adequate glycemic control. Glucophage Monotherapy or in combination w/ other oral antidiabetics or w/ insulin. Monotherapy or in combination w/ insulin in childn from 10 yr & adolescent.

Glucophage/Glucophage Forte Adult Monotherapy or in combination w/ other oral antidiabetic agents Initially 500 mg or 850 mg bid-tid. Max of 3 g daily as 3 divided doses. Monotherapy in prediabetes 1,000-1,700 mg/day divided in 2 doses given during or after meals. Combination w/ insulin Initially 500 mg or 850 mg bid or tid, while insulin dosage is adjusted on the basis of blood glucose measurements. Childn 10 yr & adolescents Monotherapy or in combination w/ insulin 500 or 850 mg once daily. Max of 2 g daily as 2 or 3 divided doses. Glucophage XR Monotherapy & combination w/ oral antidiabetic agents Initially 500 or 750 mg once daily w/ the evening meal. May increase to 1 g as maintenance therapy for patients already treated w/ metformin. Dose adjustment based on blood glucose measurements is recommended after 10-15 days. A slow increase of dose may improve GI tolerability. Max recommended dose for 500 mg tab: 4 tab daily. Recommended dose of 750 mg tab: 2 tab once daily. If glycemic control is still not achieved on 2 tab of 750 mg once daily, may be increased to a max dose of 3 tab daily. Max recommended dose of 1 g: 2 tab daily. Combination w/ insulin Initially 500 mg or 750 mg once daily, while insulin dosage is adjusted on the basis of blood glucose measurements. Monotherapy for prediabetes 1,000-1,500 mg once daily. Moderate renal impairment stage 3 CrCl 30-59 mL/min or eGFR 30-59 mL/min/1.73 m² Starting dose: 500 mg or 850 mg daily. Max: 1,000 mg.

Should be taken with food: XR tab: Swallow whole, do not chew/crush. Must be taken daily w/o interruption w/ evening meal.

Hypersensitivity; any type of metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis; diabetic pre-coma; severe renal failure (CrCl <30 mL/min) or eGFR <30 mL/min/1.73 m²); acute conditions w/ the potential to alter renal function eg, dehydration, severe infection or shock, iodinated contrast materials in radiodiagnostic exam can lead to renal failure. Elective major surgery; acute or chronic disease which may cause tissue hypoxia eg, unstable CHF, resp failure, recent MI or shock, hepatic insufficiency acute alcohol intoxication, alcoholism. Discontinue 48 hr before the test in patients w/ CrCl <45 mL/min or eGFR <45 mL/min/1.73m² for IV administration or w/ CrCl <60 mL/min or eGFR <60 mL/min/1.73m² for intra-arterial administration. Discontinue 48 hr prior to elective major surgical interventions & may not be reinstituted until 48 hr afterwards.

Conditions where renal function may be acutely impaired eg, dehydration (severe or prolonged diarrhea or vomiting), when initiating antihypertensive or diuretic therapy & when starting therapy w/ NSAID. Risk of lactic acidosis. Regular monitoring of cardiac and renal function. Patient should continue following dietary advice. Regularly perform lab tests for diabetes. Combination w/ insulin, sulphonylureas or meglitinides. Periodic monitoring in patients w/ risk factor for vit B₁₂ deficiency. May reduce vit B₁₂ serum levels. Risk of hypoglycemia in combination w/ other antidiabetic agents in ability to drive or operate machinery. Avoid consumption of alcoholic beverage. Confirmation of diagnosis of type 2 DM before initiation of treatment in childn >10 yr & adolescent. Careful follow up in childn especially pre-pubscent childn. Pregnancy. Not recommended during lactation.

GI disorders eg, nausea, vomiting, diarrhea, abdominal pain and loss of appetite. Vit B₁₂ decrease/deficiency; Taste disturbance.

Patients w/ CrCl <45 mL/min or eGFR <45 mL/min/1.73 m² for IV administration or in patients w/ CrCl <45 mL/min or eGFR <60 mL/min/1.73 m² for intra-arterial administration of iodinated contrast materials, metformin must be discontinued 48 hr before the test. More frequent blood glucose monitoring may be required, especially at the beginning of treatment w/ medicinal products w/ intrinsic hyperglycemic activity [eg, glucocorticoids & tetracosactides (systemic & local routes), β₂ agonists, danazol, chlorpromazine at high dose (100 mg/day) & diuretics]. Increased risk of lactic acidosis w/ loop diuretics & in acute alcohol intoxication particularly in case of fasting or malnutrition, hepatic insufficiency. Reduced efficacy w/ OCT1 substrate/inhibitors (eg, verapamil). Increased GI absorption & efficacy w/ OCT1 inducers (eg, rifampicin). Decreased renal elimination & increased plasma conc w/ OCT2 substrates/inhibitors (eg, cimetidine, dolutegravir, crizotinib, olaparib, daclatasvir, vandetanib).

Antidiabetic Agents

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

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