Gluco -500/Gluco -850

Metformin HCl

Type 2 DM particularly in overwt patients w/ inadequate glycemic control after diet & exercise as monotherapy or in combination w/ other oral antidiabetic agents or w/ insulin in adults, adolescents & childn ≥10 yr.

Adult w/ normal renal function (GFR ≥90 mL/min) Monotherapy or combination w/ other oral antidiabetic agents or insulin Initially 500 mg or 850 mg bid or tid. May adjust dose after 10-15 days based on blood glucose measurements. Max: 3 g daily in 3 divided doses. Adolescents & childn ≥10 yr Initially 500 mg or 850 mg once daily. May adjust dose after 10-15 days based on blood glucose measurements. Max: 2 g daily in 2 or 3 divided doses. Renal impairment w/ GFR 60-89 mL/min Max: 3 g daily in 2-3 divided doses, 45-59 mL/min Max: 2 g daily in 2-3 divided doses, 30-44 mL/min Max: 1 g daily in 2-3 divided doses.

Should be taken with food.

Hypersensitivity. Any type of acute metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis). Diabetic precoma. Acute conditions w/ potential to alter renal function eg, dehydration, severe infection, shock. Disease which may cause tissue hypoxia especially acute disease or worsening of chronic disease eg, decompensated heart & resp failure, recent MI, shock. Severe renal failure (GFR <30 mL/min). Hepatic insufficiency, acute alcohol intoxication, alcoholism.

Discontinue treatment at the time of surgery under general, spinal or epidural anesth; prior to or at the time of imaging procedure & not restarted until at least 48 hr after. Temporarily discontinue in case of dehydration (severe diarrhea or vomiting, fever or reduced fluid intake); presence of conditions that alter renal function. Stop treatment in case of suspected symptoms of lactic acidosis. Increased risk of lactic acidosis in acute worsening of renal function. Excessive alcohol intake, hepatic insufficiency, inadequately controlled diabetes, ketosis, prolonged fasting & any conditions associated w/ hypoxia. Patients w/ heart failure. Regularly monitor cardiac & renal function in patients w/ stable chronic heart failure. Contrast induced nephropathy in intravascular administration of iodinated contrast agents. Assess GFR before treatment initiation & regularly thereafter. Regularly perform usual lab test for diabetes monitoring. Periodically monitor vit B₁₂ in patients w/ risk factors for vit B₁₂ deficiency. Concomitant use w/ medicinal products that can acutely impair renal function eg, antihypertensives, diuretics & NSAIDs. Combination w/ insulin or other oral antidiabetic (sulfonylureas or meglitinides). Breastfeeding is not recommended during treatment. Childn 10-12 yr.

GI disorders eg, nausea, vomiting, diarrhea, abdominal pain & appetite lost. Decreased/deficiency of vit B₁₂; taste disturbance.

Increased risk of lactic acidosis w/ alcohol; NSAIDs including selective COX-2 & ACE inhibitors, AIIA & diuretics especially loop diuretics. Concomitant use w/ iodinated contrast agents; glucocorticoids (systemic & local) & sympathomimetics. Reduced efficacy w/ organic cation transporters (OCT) 1 inhibitors eg, verapamil. Increased GI absorption & efficacy w/ OCT1 inducers eg, rifampicin. Decreased renal elimination w/ OCT2 inhibitors eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole. Altered efficacy & renal elimination w/ both OCT1 & OCT2 inhibitors eg, crizotinib, olaparib.

Antidiabetic Agents

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

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