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An Investigational Study Released at ADA Showed that Initial,Combination Therapy with Januvia (sitagliptin) and Metformin Led to,Improvement in Markers of Beta Cell Function in Patients with Type,2 Diabetes

-- 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) ADVERSE REACTIONS The most common adverse reactions, reported in greater than or equal to 5% of patients treated with JANUVIA and more commonly than in patients treated with placebo are: upper respiratory tract infection, nasopharyngitis, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Merck & Co., Inc. at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. USE IN SPECIFIC POPULATIONS Safety and effectiveness of JANUVIA in children under 18 years have not been established. (8.4) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 10/2006 FULL PRESCRIBING INFORMATION: CONTENTS* 1 INDICATIONS AND USAGE 1.1 Monotherapy 1.2 Combination Therapy 1.3 Important Limitations of Use 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing 2.2 Patients wit
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