Should not be used in patients w/ type 1 DM. Increased diuresis may lead to modest BP decrease; caution in patients for whom a dapagliflozin-induced drop in BP could pose a risk. Carefully monitor vol status & electrolytes in cases of intercurrent conditions leading to vol depletion (eg, GI illness); temporary interruption of treatment for patients who develop vol depletion is recommended until depletion is corrected. Reports of acute kidney injury; diabetic ketoacidosis; post-marketing cases of Fournier's gangrene. Discontinue immediately if diabetic ketoacidosis is suspected or diagnosed. Interrupt treatment in patients who are hospitalised for major surgical procedures or acute serious medical illness; monitoring of ketones is recommended in these patients. Discontinue use & prompt treatment should be instituted if Fournier's gangrene is suspected. Urinary glucose excretion may be associated w/ increased risk of UTI; temporary treatment interruption should be considered when treating pyelonephritis or urosepsis. Limited experience in NYHA class IV. Patients w/ infiltrative cardiomyopathy have not been studied. No experience in the treatment of CKD in patients w/o diabetes who do not have albuminuria. Increased cases of lower limb amputations in long-term, clinical studies in type 2 DM w/ another SGLT2 inhibitor; counsel patients w/ DM on routine preventative foot care. +ve test for glucose in urine. Should not be taken by patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not recommended in patients w/ GFR <25 mL/min. Reduced glucose-lowering efficacy in patients w/ GFR <45 mL/min; likely absent in patients w/ severe renal impairment. Increased dapagliflozin exposure in patients w/ severe hepatic impairment. Not recommended during 2nd & 3rd trimesters of pregnancy. Discontinue treatment once pregnancy is detected. Should not be used while breast-feeding. Safety & efficacy have not been established in childn <18 yr. Greater risk for vol depletion & renal impairment in elderly patients.
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