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INDICATION

PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.

IMPORTANT SAFETY INFORMATION

  • PENTASA is contraindicated in patients with a hypersensitivity to mesalamine, any other components in this medication, or salicylates.

IMPORTANT SAFETY INFORMATION (CONTINUED)

  • Mesalamine has been associated with an acute intolerance syndrome (3% of patients in clinical trials with mesalamine or sulfasalazine) that may be difficult to distinguish from a flare of inflammatory bowel disease. Symptoms include cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, and rash. If acute intolerance syndrome is suspected, prompt withdrawal is required.
  • Caution should be exercised if PENTASA is administered to patients with impaired hepatic or renal function. Single reports of nephrotic syndrome and interstitial nephritis associated with mesalamine therapy have been described in the foreign literature. There have been rare reports of interstitial nephritis in patients receiving PENTASA. Patients with preexisting renal disease, increased BUN or serum creatinine, or proteinuria should be carefully monitored, especially during the initial phase of treatment. Mesalamine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.
  • The most common adverse events in US clinical trials (N=451) were diarrhea (3.5%), headache (2.2%), nausea (3.1%), abdominal pain (1.1%), rash (1.3%), anorexia (1.1%), and nausea and vomiting (1.1%). In combined domestic and foreign 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%).
  • Safety and efficacy of PENTASA in pediatric patients have not been established.

Please see Full Prescribing Information for PENTASA (mesalamine).


References:

  1. Drugs at FDA, PENTASA Approval, May 1993.
  2. U.S. Food and Drug Administration. CDER: Approval letter July 8, 2004. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20049scs015ltr.pdf. Accessed on November 16, 2012.
  3. IMS: Total PENTASA TRx. July 1993 – August 2012.

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