Discontinue if ketoacidosis; perineal necrotizing fasciitis (Fournier's gangrene) is suspected. Consider temporary discontinuation of treatment for at least 3 days prior to surgery in patients who undergo scheduled surgery; in clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or post surgery). Consider temporary treatment interruption in patients w/ complicated UTI including pyelonephritis & urosepsis. Not to be used in patients w/ type 1 diabetes. Not recommended for use to improve glycemic control in adults w/ type 2 DM & those w/o established CV disease or risk factors w/ eGFR <30 mL/min/1.73 m
2; patients w/ heart failure &/or CKD w/ eGFR <20 mL/min/1.73 m
2. Not recommended for treatment of CKD in patients w/ polycystic kidney disease or those requiring or w/ recent history of IV immunosuppressants or >45 mg prednisone or equiv for kidney disease. Patients on very low carbohydrate diet, w/ 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 & history of ketoacidosis; for whom empagliflozin-induced drop in BP could pose risk eg, patients w/ known CV disease, on antihypertensives w/ history of hypotension or patients ≥75 yr. Immediately assess patients for ketoacidosis if symptoms occur regardless of blood glucose level. Monitor ketones even in treatment interruption. Carefully monitor vol status (eg, physical exam, BP measurements, lab test including haematocrit) & electrolytes in case of conditions that may lead to fluid loss (eg, GI illness). Evaluate treated patients w/ pain or tenderness, erythema, genital or perineal swelling, fever, malaise for necrotizing fasciitis. Assess renal function prior to initiation & periodically during treatment ie, at least yrly. Not to be taken by patients w/ rare hereditary conditions of galactose intolerance eg, galactosaemia. Not to be taken w/ alcohol beverage. Renal impairment. Avoid use during pregnancy. Discontinue lactation during treatment. Childn <18 yr. Increased risk of vol depletion in patients ≥75 yr. Not recommended in elderly ≥85 yr.
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