osage 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); Clinical Pharmacology (12.3).) Use with Medications Known to Cause Hypoglycemia: In clinical trials of JANUVIA as monotherapy and JANUVIA as part of combination therapy with metformin or pioglitazone, rates of hypoglycemia reported with JANUVIA were similar to rates in patients taking placebo. The use of JANUVIA in combination with medications known to cause hypoglycemia, such as sulfonylureas or insulin, has not been adequately studied. 6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. 6.1 Clinical Trials Experience In controlled clinical studies as both monotherapy and combination therapy, the overall incidence of adverse reactions with JANUVIA was similar to that reported with placebo. Discontinuation of therapy due to clinical adverse reactions was also similar to placebo. Two placebo-controlled m
'"/>




Page: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32
Related medicine technology :

1. VeroScience Late-Breaking Abstract on Cycloset (A Quick Release Formulation of Bromocriptine Mesylate) Accepted for Poster Presentation at American Diabetes Association 67th Scientific Sessions
2. Pilot Phase 3 Results of NovaCardias KW-3902 for Acute Congestive Heart Failure Presented at Late-Breaking Session of Heart Failure Congress 2007
3. Breaking Multi-Center Study: Masimo SET Pulse Oximetry Technology Shown to Significantly Lower Instances of Severe Retinopathy of Prematurity in Extremely Low Birth Weight Infants
4. Bentley Late Breaking Abstract Accepted for Poster Presentation at American Diabetes Association Scientific Sessions
5. Cougar Biotechnology Presents Positive CB7630 Clinical Data at AACR Annual Meeting Late-Breaking Clinical Trials Session
6. Everest Data on Short- and Long-Term Use of Otsukas Investigational Novel Treatment, Tolvaptan, Published in Journal of the American Medical Association and Featured in ACCs Late Breaking Clinical Trials
7. Lupus Foundation of America Statement on Results for Clinical Study of CellCept Released by Aspreva Pharmaceutical Company
8. 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
9. Amlodipine and Olmesartan Study Results Released;Late Breaker Presented at American Society of Hypertension Twenty-Second Annual Scientific Meeting (ASH 2007)
10. Amlodipine and Olmesartan Study Results Released; Late Breaker Presented at American Society of Hypertension Twenty-Second Annual Scientific Meeting (ASH 2007)
11. New Anti-Rejection Medication 6-Month Results for Heart Transplant Recipients to Be Released at International Heart and Lung Transplant Meeting