Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM. Reduce the risk of major adverse CV events (CV death, nonfatal MI & nonfatal stroke) in adults w/ type 2 DM & established CV disease.
Initially 100 mg once daily. Patient w/ eGFR ≥60 mL/min/1.73 m2 May be increased to 300 mg once daily if initial dose is tolerated. Moderate renal impairment (eGFR 45 to <60 mL/min/1.73 m2) Max: 100 mg once daily.
Not recommended in patients w/ type 1 DM or for the treatment of diabetic ketoacidosis. Risk of symptomatic hypotension; acute kidney injury; UTI; genital mycotic infections; bone fracture; dose-related increases in LDL-C. Assess & correct vol status in patients w/ vol depletion prior to initiating therapy. Assess renal function before treatment initiation & periodically thereafter. Monitor patients for ketoacidosis & temporarily discontinue in clinical situations known to predispose to ketoacidosis (eg, prolonged fasting due to acute illness or surgery). Rare reports of necrotizing fasciitis of the perineum (Fournier's gangrene). Reduce dose of insulin or insulin secretagogue when used as an add-on therapy. Discontinue use if hypersensitivity reactions occur. Monitor for signs & symptoms of infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs, & discontinue use if these complications occur. False positive urine glucose tests. Interference w/ 1,5-anhydroglucitol (1,5-AG) assay. Not recommended in pregnancy (2nd & 3rd trimester) & lactation. Childn <18 yr. Elderly ≥65 yr.
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