Glyformet Extended Release Tablet

Reduction in the risk or delay of the onset of type 2 DM in adult, overwt patients w/ impaired glucose tolerance &/or impaired fasting glucose, &/or increased HbA1c who are at high risk for developing overt type 2 DM & still progressing towards type 2 DM despite implementation of intensive lifestyle change for 3-6 mth. Monotherapy or in combination w/ other oral antidiabetic agents, or w/ insulin for the treatment of type 2 DM in adults, 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) Initially 500 mg once daily, adjust dose on the basis of blood glucose measurements after 10-15 days. Max recommended dose: 2,000 mg once daily. Monotherapy in type 2 DM & combination w/ other oral antidiabetic agents Initially 500 mg once daily, adjust dose on the basis of blood glucose measurements after 10-15 days. Max recommended dose: 2,000 mg daily. Increase in increments of 500 mg every 10-15 days, up to a max of 2,000 mg once daily. Consider 1,000 mg bid w/ food for both doses if glycaemic control is not achieved on a 2,000 mg once-daily dosing regimen. Combination w/ insulin Initially 500 mg once daily, while adjust insulin dosage on the basis of blood glucose measurements. For patients already treated w/ metformin & insulin in combination therapy, dose equiv to metformin daily dose up to a max of 2,000 mg, while adjust insulin dosage on the basis of blood glucose measurements. Renal impairment GFR 60-89 mL/min Consider dose reduction in relation to declining renal function. Total max daily dose: 2,000 mg, 45-59 mL/min Start at most ½ of the max dose. Total max daily dose: 2,000 mg, 30-44 mL/min Start at most ½ of the max dose. Total max daily dose: 1,000 mg.

Should be taken with food: Take w/ the evening meal. Swallow whole, do not chew/crush.

Hypersensitivity. Any type of acute metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis). Diabetic pre-coma. 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. Severe renal failure (GFR <30 mL/min). Hepatic insufficiency, acute alcohol intoxication, alcoholism.

Lactic acidosis. Temporarily discontinue in case of dehydration; & in the presence of conditions that alter renal function. Initiate medicinal products that can acutely impair renal function (eg, antihypertensives, diuretics & NSAIDs) w/ caution in metformin-treated patients. Assess GFR before treatment initiation & regularly thereafter. Risk of hypoxia & renal insufficiency in patients w/ heart failure. Use w/ regular monitoring of cardiac & renal function in patients w/ stable chronic heart failure. Intravascular administration of iodinated contrast agents may lead to contrast induced nephropathy, resulting in metformin accumulation & increased risk of lactic acidosis. Discontinue treatment prior to or at the time of the imaging procedure & do not restart until at least 48 hr after, provided that renal function has been re-evaluated & found to be stable. Discontinue treatment at the time of surgery under general, spinal or epidural anaesth; 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. Continue diet w/ regular distribution of carbohydrate intake during the day for all patients; energy-restricted diet for overwt patients. Perform usual lab tests for diabetes monitoring regularly. Alert patients to the risk of hypoglycaemia when used in combination w/ other antidiabetic agents (eg, sulphonylureas, insulin, or meglitinides). Do not use metformin to treat impaired glycaemic control or diabetes in patient who is planning to become pregnant & during pregnancy. Not recommended during lactation. Not to be used in childn. Not recommended in elderly ≥75 yr.

GI disorders eg, nausea, vomiting, diarrhoea, abdominal pain & loss of appetite. Taste disturbance.

Not recommended w/ alcohol due to increased risk of lactic acidosis, particularly in case of fasting, malnutrition or hepatic impairment; iodinated contrast agents. May increase the risk of lactic acidosis w/ NSAIDs, including selective COX II inhibitors, ACE inhibitors, AIIA & diuretics, especially loop diuretics; close monitoring of renal function is necessary. Caution when used w/ medicinal products w/ intrinsic hyperglycaemic activity eg, glucocorticoids (systemic & local routes) & sympathomimetics; may require more frequent blood glucose monitoring, especially at the beginning of treatment. Reduced efficacy w/ inhibitors of OCT1 (eg, verapamil). Increased GI absorption & efficacy w/ inducers of OCT1 (eg, rifampicin). Decreased renal elimination & thus lead to increased plasma conc w/ inhibitors of OCT2 (eg, cimetidine, dolutegravir, ranolazine, trimethoprim, vandetanib, isavuconazole). Altered efficacy & renal elimination w/ inhibitors of both OCT1 & OCT2 (eg, crizotinib, olaparib).

Antidiabetic Agents

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

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