Discontinue use if diabetic ketoacidosis is suspected or diagnosed; Fournier's gangrene is suspected. Not to be used in patients w/ type 1 DM. Interrupt treatment & monitor ketones in patients who are hospitalised for major surgical procedures or acute serious medical illness. Consider temporary interruption of treatment when treating pyelonephritis or urosepsis. Patients for whom a dapagliflozin-induced drop in BP could pose a risk eg, patients on antihypertensive therapy w/ history of hypotension or elderly. Experience in NYHA class IV is limited. No experience for CKD in patients w/o diabetes who do not have albuminuria. Not been studied in CKD in patients w/ polycystic kidney disease, glomerulonephritis w/ flares (lupus nephritis or ANCA-associated vasculitis), ongoing or recent requirements of cytotoxic, immunosuppressive or other immunomodulating renal therapy, or in patients who received organ transplant. Carefully monitor vol status (eg, physical exam, BP measurements, lab tests including hematocrit & electrolytes) in case of intercurrent conditions that may lead to vol depletion (eg, GI illness). Temporary interruption of treatment is recommended for patients who develop vol depletion until corrected. Counsel patients w/ diabetes on routine preventative foot care. +ve test for glucose in urine. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not recommended to be initiated in patients w/ eGFR <15 mL/min/1.73 m
2. Glucose-lowering efficacy is reduced in patients w/ GFR <45 mL/min/1.73 m
2 & is likely absent in patients w/ severe renal impairment. Increased exposure in patients w/ severe hepatic impairment. Not recommended during 2nd & 3rd trimesters of pregnancy. Discontinue use once pregnancy is detected. Not to be used during lactation. Greater risk for vol depletion in elderly. Safety & efficacy of dapagliflozin in childn <18 yr has not yet been established.
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