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Usual Dosing (Adults)

INDICATIONS AND USAGE: indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Recommended Dosing: The recommended dose of JANUVIA is 100 mg once daily. JANUVIA can be taken with or without food.

Renal Dosing

dialysis Patients with Renal Insufficiency:
For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥50 mL/min, approximately corresponding to serum creatinine levels of ≤1.7 mg/dL in men and ≤1.5 mg/dL in women), no dosage adjustment for JANUVIA is required.

For patients with moderate renal insufficiency (CrCl ≥30 to <50 mL/min, approximately corresponding to serum creatinine levels of >1.7 to ≤3.0 mg/dL in men and >1.5 to ≤2.5 mg/dL in women), the dose of JANUVIA is 50 mg once daily.

For patients with severe renal insufficiency (CrCl <30 mL/min, approximately corresponding to serum creatinine levels of >3.0 mg/dL in men and >2.5 mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of hemodialysis.

Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of JANUVIA and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula.

Creatinine clearance for males = [140-age (years)]× [body wt (kg)]
72 × [serum creatinine (mg/dL)]
Creatinine clearance for females = [140-age (years)]× [body wt (kg)]× 0.85
72 × [serum creatinine (mg/dL)]

Hemodialysis

dialysis For patients with severe renal insufficiency (CrCl <30 mL/min, approximately corresponding to serum creatinine levels of >3.0 mg/dL in men and >2.5 mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of JANUVIA is 25 mg once daily. JANUVIA may be administered without regard to the timing of hemodialysis.

Reference(s)

National Institutes of Health, U.S. National Library of Medicine, DailyMed Database.
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Sitagliptin