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Late Breaking Data Released at ADA Showed that the Investigational,Use of Januvia and Metformin as Initial Combination Therapy,Provided Significant Glucose Lowering Efficacy over 54 Weeks in,Patients with Type 2 Diabetes

mma (PPAR-gamma) agonist (e.g., thiazolidinediones) when the single agent does not provide adequate glycemic control. (1.2) Important Limitations of Use: JANUVIA should not be used in patients with type 1 diabetes mellitus (type 1 diabetes) or for the treatment of diabetic ketoacidosis. (1.3) DOSAGE AND ADMINISTRATION The recommended dose of JANUVIA is 100 mg once daily as monotherapy or as combination therapy with metformin or a PPAR-gamma agonist (e.g., thiazolidinediones). (2.1) JANUVIA can be taken with or without food. (2.1) Dosage Adjustment in Patients With Moderate, Severe and End Stage Renal Disease (ESRD) (2.2) ---------------------------------------------------------------------- 50 mg once daily 25 mg once daily ---------------------------------------------------------------------- Moderate Severe and ESRD CrCl greater than or equal to 30 CrCl less than 30 mL/min to less than 50 mL/min -Serum Cr levels (mg/dL) -Serum Cr levels (mg/dL) Men: greater than 1.7 - Men: greater than 3.0; less than or equal to 3.0; Women: greater than 1.5 - Women: greater than 2.5; less than or equal to 2.5 or on dialysis ---------------------------------------------------------------------- DOSAGE FORMS AND STRENGTHS Tablets: 100 mg, 50 mg, and 25 mg (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS A dosage adjustment is recommended in patients with moderate renal insufficiency and in patients with severe renal insufficiency or with ESRD requiring hemodialysis or peritoneal dialysis. 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. (2.2, 5)
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