Not to be used for treatment of patients w/ type 1 diabetes. Discontinue & prompt treatment including antibiotics & surgical debridement should be instituted if Fournier's gangrene occurs. Stop immediately 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 anti-hypertensive 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). Caution in patients w/ low β-cell function reserve (eg, type 2 diabetes w/ low C-peptide or latent autoimmune diabetes in adults (LADA) or w/ history of pancreatitis), patients w/ conditions that lead to restricted food intake or severe dehydration, for whom insulin doses are reduced & patients w/ increased insulin requirements due to acute medical illness, surgery or alcohol abuse. UTIs; 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 amputation (primarily of the toe) has been observed in long-term, clinical studies in type 2 DM w/ SGLT2 inhibitors. +ve for glucose in urine. Not recommended in monitoring glycaemic control w/ 1,5-anhydroglucitol (1,5-AG) assay due to unreliable measurements in patients taking SGLT2 inhibitors. 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. 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 clinical studies in patients w/ hepatic impairment & NYHA class IV. Not recommended during 2nd & 3rd trimesters of pregnancy. Should not be used during lactation. Safety & efficacy for treatment of heart failure or CKD in childn <18 yr have not yet been established. No data is available for childn <10 yr. Elderly (≥65 yr) may be at greater risk for vol depletion.
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