Metformin Stella

Metformin HCl

As monotherapy or in combination w/ other oral antidiabetic agents or insulin for treatment of type 2 DM, particularly in overwt patients, when dietary management & exercise alone does not result in adequate glycaemic control.

Adult w/ normal renal function Monotherapy & combination w/ other oral antidiabetic agents Initially 500 or 850 mg bd or tds. Adjust dose after 10-15 days based on blood glucose measurements. Max dose: 3 g daily, in 3 divided doses. Combination w/ insulin Initially 500 or 850 mg bd or tds, while insulin dose is adjusted based on blood glucose measurements. Renal impairment GFR 60-89 mL/min Max dose: 3 g daily divided into 2-3 daily doses, GFR 45-59 mL/min Max dose: 2 g daily divided into 2-3 daily doses, GFR 30-44 mL/min Max dose: 1 g daily divided into 2-3 daily doses. Childn & adolescent ≥10 yr Monotherapy & combination w/ insulin Initially 500 or 850 mg once daily. Adjust dose after 10-15 days based on blood glucose measurements. Max dose: 2 g daily, in 2 or 3 divided doses.

Should be taken with food.

Hypersensitivity. Acute metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis). 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 (especially acute disease, or worsening of chronic disease) eg, decompensated heart failure, resp failure, recent MI, shock. Hepatic insufficiency, acute alcohol intoxication, alcoholism.

Risk of lactic acidosis. Discontinue use temporarily in case of dehydration (eg, severe diarrhoea or vomiting, fever or reduced fluid intake); in the presence of conditions that alter renal function. Increased risk of hypoxia & renal insufficiency in patients w/ heart failure. Regularly monitor cardiac & renal function in patients w/ stable chronic heart failure. Assess GFR before treatment initiation & regularly thereafter. Regularly perform usual lab tests for diabetes monitoring. Discontinue metformin at the time of surgery under general, spinal or epidural anaesth; may be restarted after 48 hr following surgery or resumption of oral nutrition & provided that renal function has been re-evaluated & found to be stable. All patients should continue their diet w/ a regular distribution of carbohydrate intake during the day. Overwt patients should continue their energy-restricted diet. Concomitant use w/ medicinal products acutely impair renal function eg, antihypertensive, diuretics, NSAIDs; medicinal products causing lactic acidosis; insulin or other oral antidiabetics (eg, sulfonylureas or meglitinides); intravascular administration of iodinated contrast agents. Limited data on the use of metformin during pregnancy. Not recommended during pregnancy. Breast-feeding is not recommended during treatment. Caution in prescribing to childn 10-12 yr. Elderly.

Nausea, vomiting, diarrhoea, abdominal pain & loss of appetite; taste disturbance.

Increased risk of lactic acidosis w/ alcohol, iodinated contrast agents, NSAIDs (including selective COX II inhibitors), ACE inhibitors, AIIA, loop diuretics. Potential interaction w/ medicinal products w/ intrinsic hyperglycaemic activity eg, glucocorticoids & sympathomimetics. Reduced efficacy w/ OCT1 inhibitors (eg, verapamil). Increased GI absorption & efficacy w/ OCT1 inducers (eg, rifampicin). Decreased renal elimination & increased plasma conc 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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