Generic Name and Formulations:
Canagliflozin 100mg, 300mg; tabs.
Janssen Pharmaceuticals, Inc.
Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Not for treating type 1 diabetes or diabetic ketoacidosis.
Take before first meal of the day. Initially 100mg once daily; if tolerated and with eGFR ≥60mL/min/1.73m2, and need additional glycemic control; may increase to 300mg once daily. Moderate renal impairment (eGFR 45–<60mL/min/1.73m2): 100mg once daily; if eGFR <45mL/min/1.73m2: do not initiate. Concomitant UGT inducers in patients with eGFR ≥60mL/min/1.73m2: consider increase to 300mg once daily; if eGFR 45–<60mL/min/1.73m2: consider other antihyperglycemics.
<18yrs: not established.
Severe renal impairment (eGFR <30mL/min/1.73m2), ESRD, or on dialysis.
Increased risk of lower limb amputations; monitor for infection, new pain or tenderness, sores or ulcers in lower limbs, and discontinue if occur. Consider risk factors for amputation (eg, prior amputation, peripheral vascular disease, neuropathy, diabetic foot ulcers) before initiation. Correct volume depletion before starting therapy. Monitor for symptomatic hypotension in renal impairment, elderly, low systolic BP, concomitant diuretics or drugs that interfere with the RAA system (eg, ACEIs, ARBs). Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Evaluate renal function prior to starting and monitor periodically thereafter; more frequently if eGFR <60mL/min/1.73m2. Risk of acute kidney injury in hypovolemia, chronic renal insufficiency, CHF, and concomitant drugs (eg, diuretics, ACEIs, ARBs, NSAIDs). Consider temporarily discontinuing in reduced oral intake or fluid losses; monitor for acute kidney injury; discontinue and treat if occurs. Monitor K+ levels in patients with renal impairment or predisposed to hyperkalemia. Discontinue if hypersensitivity reactions occur; monitor until resolved. Consider bone fracture risks before initiation. Monitor for genital mycotic infections, UTIs, increases in LDL-C; treat if needed. Severe hepatic impairment: not recommended. Pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.
Antagonized by UGT inducers (eg, rifampin, phenytoin, phenobarbital, ritonavir): see Adults dose. Concomitant digoxin: monitor. Consider a lower dose of concomitant insulin/insulin secretagogue to reduce risk of hypoglycemia. May cause false (+) urine glucose tests or unreliable measurements of 1,5-AG assay; use alternative methods to monitor glycemic control.
Sodium-glucose co-transporter 2 (SGLT2) inhibitor.
Female genital mycotic infections, UTIs (may be serious), increased urination; lower limb amputation, hypotension, ketoacidosis (may be fatal), acute kidney injury, hyperkalemia, hypoglycemia, increases in LDL-C, bone fractures, urosepsis, pyelonephritis.
Tabs—30, 90, 100 (10x10 blister cards), 500
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