PENTASA References

IMS National Prescription Data. December 1, 2007.
Nugent SG, Kumar D, Rampton DS, Evans DF. Intestinal luminal pH in inflammatory bowel disease: possible determinants and implications for therapy with aminosalicylates and other drugs. Gut. 2001;48:571-577.
Sinha A, Ball DJ, Connor AL, Nightingale J, Wilding IR. Intestinal performance of two mesalamine formulations in patients with active ulcerative colitis as assessed by gamma scintigraphy. Pract Gastroenterol. 2003;27:56-69.
Robinson M, Hanauer S, Hoop R, Zbrozek A, Wilkinson C. Mesalamine capsules enhance the quality of life for patients with ulcerative colitis. Aliment Pharmacol Ther. 1994;8:27-34.
DiPiro JT, Schade RR. Inflammatory bowel disease. In: DiPiro JT, Talbert RL, Yee GC, Matzke GR, Wells BG, Posey LM, eds. Pharmacotherapy: A Pathophysiologic Approach. 4th ed. Stamford, Conn: Appleton & Lange; 1999:571-585.
Cuffari C, Present DH, Bayless TM, Lichtenstein GR. Optimizing therapy in patients with pancolitis. Inflamm Bowel Dis. 2005;11:937-946.
Colazal^® (balsalazide disodium) full prescribing information, Salix Pharmaceuticals, 2005.
Kane S, Huo D, Aikens J, Hanauer S. Medication non-adherence and the outcomes of patients with quiescent ulcerative colits. Am J Med. 2003;114:39-43.
Hanauer S, Schwartz J, Robinson M, et al, and the Pentasa® Study Group. Mesalamine capsules for treatment of active ulcerative colitis: results of a controlled trial. Am J Gastroenterol. 1993;88:1188-1197.
Wilding IR. A scintigraphic study to evaluate what happens to Pentasa® and Asacol® in the human gut. Pract Gastroenterol. November 1999;(suppl):1-8.

Important Safety Information

PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.
PENTASA is generally well tolerated. In worldwide clinical trials (N>2100), the most common adverse events were diarrhea (3.4%), headache (2.0%), nausea (1.8%), abdominal pain (1.7%), dyspepsia (1.6%), vomiting (1.5%), and rash (1.0%). As with other mesalamine products, serious adverse events may occur. PENTASA is contraindicated in patients with a hypersensitivity to salicylates. Caution should be used in patients with impaired hepatic or renal function. Patients with pre-existing renal disease, increased BUN or serum creatinine, or proteinuria should be monitored during PENTASA therapy.