Not to be used for treatment of patients w/ type 1 diabetes. Discontinue use & institute prompt treatment including antibiotics & surgical debridement if Fournier's gangrene occurs. Immediately stop treatment if diabetic ketoacidosis is suspected or diagnosed. Interrupt treatment in patients who are hospitalised for major surgical procedures or acute serious medical illnesses; monitor blood ketone levels; restart treatment when ketone values are normal & patient's condition has stabilised. Temporary interruption of treatment is recommended for patients who develop vol depletion until the depletion is corrected. Exercise caution in patients for whom dapagliflozin-induced drop in BP could pose a risk (eg, patients on antihypertensive therapy w/ history of hypotension or elderly). Monitor vol status (eg, physical exam, BP measurements, lab tests including haematocrit & electrolytes) in case of intercurrent conditions that may lead to vol depletion (eg, GI illness). Urinary glucose excretion may be associated w/ increased risk of UTI; temporary interruption of therapy should be considered when treating pyelonephritis or urosepsis. Counsel patients w/ diabetes on routine preventative foot care; increase in cases of lower limb amputations (primarily of the toe) has been observed in long-term, clinical studies in type 2 DM w/ SGLT2 inhibitors. +ve for glucose in urine. Monitoring glycaemic control w/ 1,5-anhydroglucitol (1,5-AG) assay is not recommended. Do not use in patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Not recommended to initiate treatment in patients w/ eGFR <15 mL/min/1.73 m
2. Glucose-lowering efficacy is reduced in type 2 DM patients when eGFR is <45 mL/min/1.73 m
2 & is likely absent in patients w/ severe renal impairment. Increased exposure in patients w/ severe hepatic impairment. No experience w/ treatment of CKD in patients w/o diabetes who do not have albuminuria. Not studied for the treatment of 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 an organ transplant. Limited experience in patients w/ hepatic impairment & NYHA class IV. Not recommended during 2nd & 3rd trimesters of pregnancy. Discontinue treatment when pregnancy is detected. Should not be used during lactation. Safety & efficacy in childn <18 yr have not yet been established. Elderly (≥65 yr) may be at greater risk for vol depletion.
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