Not to be used in patients w/ type 1 diabetes. Immediately assess for ketoacidosis if symptoms eg, nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness occur. Discontinue treatment if ketoacidosis, necrotizing fasciitis of the perineum (Fournier's gangrene), pancreatitis, bullous pemphigoid is suspected or in clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or surgery). Higher risk of ketoacidosis in 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 & history of ketoacidosis. Evaluate for necrotizing fasciitis in patients who present w/ pain or tenderness, erythema, swelling in the genital or perineal area, fever, malaise. Combination w/ sulphonylurea or insulin. Patients for whom an empagliflozin-induced decrease in BP could pose a risk eg, patients w/ known CV disease, on antihypertensive therapy w/ history of hypotension or patients ≥75 yr. Monitor carefully vol status (eg, physical exam, BP measurements, lab tests including haematocrit) & electrolytes in conditions that may lead to fluid loss (eg, GI illness). Complicated UTI including pyelonephritis & urosepsis. Cardiac failure (NYHA class I-IV). Positive test result for glucose in urine. Not to be used in patients w/ eGFR <60 mL/min/1.73 m
2 or CrCl <60 mL/min. Assess renal function prior to treatment initiation & periodically during treatment; & prior to initiation of any concomitant medicines that may have -ve impact on renal function. Avoid use during pregnancy. Discontinue breast feeding during treatment. Not recommended for use in childn <18 yr. Not recommended in elderly ≥85 yr.
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