Not to be used in patients who have had any serious hypersensitivity reaction to DPP-4 inhibitor or SGLT2 inhibitor; for treatment of patients w/ type 1 diabetes. Severe hypersensitivity reactions including SJS. Discontinue treatment if serious hypersensitivity; pancreatitis; bullous pemphigoid; Fournier's gangrene is suspected; diabetic ketoacidosis is suspected or diagnosed. Avoid use in patients w/ NYHA class III, IV cardiac status. Temporary interrupt treatment in patients who develop vol depletion until depletion is corrected. Interrupt treatment & monitor ketones in patients who are hospitalised for major surgical procedures or acute serious medical illnesses. Acute pancreatitis symptoms ie, persistent, severe abdominal pain. Severe & disabling arthralgia. Bullous pemphigoid requiring hospitalization. Diabetic ketoacidosis. Increased risk of genital mycotic infections; hypoglycemia. Monitor patients w/ history of genital mycotic infections. Body wt loss. Increased cases of lower limb amputation (primarily of the toe). Perineal necrotising fasciitis (Fournier's gangrene); combination of symptoms of pain, tenderness, erythema, or genital or perineal swelling, w/ fever or malaise. Patients w/ NYHA class I, II cardiac status; history of pancreatitis; low β-cell function reserve (eg, type 2 diabetes w/ low C-peptide or latent autoimmune diabetes in adults); conditions that lead to restricted food intake or severe dehydration; for whom dapagliflozin-induced drop in BP could pose risk (eg, patients on antihypertensive therapy w/ history of hypotension or elderly); insulin doses are reduced & patients w/ increased insulin requirements due to acute medical illness, surgery or alcohol abuse. Report development of blisters or erosions. Carefully 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). Assess patients immediately for ketoacidosis if symptoms (eg, nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness) occur. Consider patient history that may predispose to ketoacidosis before initiating treatment. Combination w/ sulfonylurea or insulin. +ve glucose in urine. Severe hepatic impairment. Not recommended in patients w/ estimated GFR <45 mL/min/1.73 m
2. Not to be used during pregnancy & breast-feeding. Childn & adolescents <18 yr. Elderly (especially ≥70 yr).