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SITAGLIPTIN

JANUVIA 50MG FILM-COATED TABLET

50mg Film-Coated Tablet

Indication*

Monotherapy: Adjunct to diet & exercise to improve glycemic control in patients with type 2 DM. Combination therapy: PPRAY agonist (eg, thiazolidinediones) or metformin as initial therapy or when the single agent alone, with diet & exercise does not provide adequate glycemic control. Combination with a sulfonylurea; Patients with type 2 DM to improve glycemic control when treatment with single agent alone, with diet & exercise, dose not provide adequate glycemic control. Combination with metformin & a sulfonylurea or metformin & PPARY agonist: Patients with type 2 DM to improve glycemic control when dual therapy with these agents, does not provide adequate glycemic control. Combination with insulin: Adjunct to diet & exercise to improve glycemic control in combination with insulin (with or without metformin).

Directions for Use*

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.

Administration*

May be taken with or without food.

*written indications, directions, and administration are updated as of March 05, 2024 and may not be accurate with the actual product purchased. Please read the details in the packaging.

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