sufficiency For patients with mild renal insufficiency (creatinine clearance (CrCl) greater than or equal to 50 mL/min, approximately corresponding to serum creatinine levels of less than or equal to 1.7 mg/dL in men and less than or equal to 1.5 mg/dL in women), no dosage adjustment for JANUVIA is required. For patients with moderate renal insufficiency (CrCl greater than 30 to less than 50 mL/min, approximately corresponding to serum creatinine levels of greater than 1.7 to less than or equal to 3.0 mg/dL in men and greater than 1.5 to less than or equal to 2.5 mg/dL in women), the dose of JANUVIA is 50 mg once daily. For patients with severe renal insufficiency (CrCl less than 30 mL/min, approximately corresponding to serum creatinine levels of greater than 3.0 mg/dL in men and greater than 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. (See Clinical Pharmacology (12.3).) 3 DOSAGE FORMS AND STRENGTHS -- 100 mg tablets are beige, round, film-coated tablets with "277" on one side. -- 50 mg tablets are light beige, round, film-coated tablets with "112" on one side. -- 25 mg tablets are pink, round, film-coated tablets with "221" on one side. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS Use in Patients with Renal Insufficiency: A dosage adjustment is recommended in patients with moderate or severe renal insufficiency and in patients with ESRD requiring hemodialysis or peritoneal dialysis. (See Dosage and Administration (2.2); Cl
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