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Adjunct to diet & exercise to improve glycaemic control in adults w/ type 2 DM when treatment w/ both empagliflozin & metformin is appropriate. Adults w/ type 2 DM & established CV disease to reduce the risk of CV death; should be used in conjunction w/ other measures to reduce CV risk in line w/ the current standard care.
1 tab twice a day. Individualized dose. Max daily dose: 25 mg/2,000 mg. Patient not adequately controlled on metformin alone or in combination w/ other products including insulin Empagliflozin 5 mg bid + metformin dose already being taken. Patient tolerating a total daily dose of empagliflozin 10 mg May be increased to empagliflozin 25 mg total daily dose. Patient already treated w/ empagliflozin Continue to take the same empagliflozin daily dose. Patient switching from separate tab of empagliflozin (10 mg or 25 mg total daily dose) & metformin Take the same daily dose of empagliflozin & metformin already being taken or the nearest therapeutically appropriate dose of metformin. Renal impairment eGFR 60-89 mL/min Max daily dose: 3,000 mg for metformin, 25 mg for empagliflozin; 45-59 mL/min Max daily dose: 2,000 mg for metformin, no dose adjustment required for empagliflozin; 30-44 mL/min Max daily dose: 1,000 mg for metformin, no dose adjustment required for empagliflozin.
Hypersensitivity to empagliflozin or metformin. Any type of acute metabolic acidosis (eg, lactic acidosis, diabetic ketoacidosis); diabetic pre-coma. Acute conditions w/ the potential to alter renal function eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agents; 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. Severe renal failure (CrCl <30 mL/min or eGFR <30 mL/min/1.73 m2). Not to be used in patients w/ type 1 diabetes. Risk of ketoacidosis while on treatment include patients on a very low carbohydrate diet, w/ an acute illness, pancreatic disorders suggesting insulin deficiency (eg, type 1 diabetes, history of pancreatitis or pancreatic surgery), insulin dose reduction (including insulin pump failure), alcohol abuse, severe dehydration, w/ history of ketoacidosis. Temporarily discontinue in clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or surgery). Assess GFR before treatment initiation & regularly thereafter. Patients for whom an empagflozin-induced drop in BP could pose a risk, eg, patients w/ known CV disease, on anti-hypertensive therapy w/ a history of hypotension or patients ≥75 yr. Interrupt treatment temporarily w/ complicated UTI or until fluid loss is corrected & monitor vol status & electrolytes. Discontinue at the time of surgery under general, spinal or epidural anesth; may be restarted no earlier than 48 hr following surgery or resumption of oral nutrition & provided that renal function has been re-evaluated & found to be stable. Avoid in pregnancy. Discontinue during lactation. Not recommended for childn <18 yr & elderly ≥85 yr. Metformin: Lactic acidosis. Discontinue prior to or at the time of the imaging procedure & not restarted until at least 48 hr after, provided that renal function has been re-evaluated & found to be stable.