Product Description*

Monotherapy or combination therapy with metformin, sulfonylurea, insulin (with or without metformin), PPART agonist, metformin plus sulfonylurea or metformin plus PPARY agonist 100 mg once daily. Patients with renal impairment Mild renal impairment (eGFR >60 to <90 mL/min1.73 m2) to moderate renal impairment (eGFR >30 to <60 mL/min/1.73 m2): No dosage adjustment is required. Moderate renal impairment (eGFR >30 to <45 mL/min/1.73 m2): 50 mg once daily. Severe renal impairment (eGFR >15 to <30 mL/min/1.73 m2) or ESRD (eGFR <15 mL/min/1.73 m2) requiring hemodialysis or peritoneal dialysis: 25 mg once daily. May be administered without regards to the timing of dialysis. Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of therapy & periodically thereafter.

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