Metformin Stella

As monotherapy or in combination w/ other oral antidiabetic agents or insulin for the 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 (GFR ≥90 mL/min) 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. Adjust insulin dose based on blood glucose measurements. Renal impairment w/ GFR 60-89 mL/min Max dose: 3 g daily divided into 2-3 daily doses, 45-59 mL/min Max dose: 2 g daily divided into 2-3 daily doses, 30-44 mL/min Max dose: 1 g daily divided into 2-3 daily doses. Childn ≥10 yr & adolescent 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. Assess GFR before treatment initiation & regularly thereafter. Temporarily discontinue use in case of dehydration; in the presence of conditions that alter renal function. Patients w/ heart failure are more at risk of hypoxia & renal insufficiency. Regularly monitor cardiac & renal function in patients w/ stable chronic heart failure. Discontinue metformin prior to or at the time of imaging procedure & do not restart until at least 48 hr after, provided that renal function has been re-evaluated & found to be stable. Discontinue metformin at the time of surgery under general, spinal or epidural anaesth; may restart therapy no earlier than 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/ regular distribution of carbohydrate intake during the day. Overwt patients should continue their energy-restricted diet. Regularly perform usual lab tests for diabetes monitoring. May reduce vit B₁₂ serum levels. Periodically monitor vit B₁₂ serum levels in patients w/ risk factors for vit B₁₂ deficiency. Caution when used in combination w/ medicinal products that can acutely impair renal function (eg, antihypertensives, diuretics, NSAIDs); medicinal products that may cause lactic acidosis; iodinated contrast agents; insulin or other oral antidiabetics (eg, sulfonylureas, meglitinides). If clinically needed, consider use during pregnancy & in the periconceptional phase as addition or alternative to insulin. Breast-feeding is not recommended during treatment. Carefully follow up effect on growth & puberty in childn, especially prepubescent childn. Caution when prescribing to childn 10-12 yr. Adjust dose based on renal function in the elderly.

Nausea, vomiting, diarrhoea, abdominal pain, loss of appetite. Vit B₁₂ decrease/deficiency; taste disturbance.

Increased risk of lactic acidosis w/ alcohol, iodinated contrast agents, NSAIDs (including selective COX II inhibitors), ACE inhibitors, AIIAs, diuretics (especially loop diuretics). Potential interaction w/ medicinal products w/ intrinsic hyperglycaemic activity eg, glucocorticoids (systemic & local) & 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/ inhibitors of both OCT1 & OCT2 (eg, crizotinib, olaparib). Risk of hypoglycaemia w/ other antidiabetic agents (eg, sulfonylureas, insulin, meglitinides).

Antidiabetic Agents

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

P₁S₁S₃