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


  • PENTASA is contraindicated in patients with a hypersensitivity to mesalamine, any other components in this medication, or salicylates.
  • Caution should be exercised if PENTASA is administered to patients with impaired hepatic function.
  • 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.
  • Patients with pre-existing skin conditions such as atopic dermatitis and atopic eczema have reported more severe photosensitivity reactions.
  • Caution should be exercised if PENTASA is administered to patients with impaired 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.
  • Use of mesalamine may lead to spuriously elevated test results when measuring urinary normetanephrine by liquid chromatography with electrochemical detection, because of the similarity in the chromatograms of normetanephrine and mesalamine’s main metabolite, N-acetylaminosalicylic acid (N-Ac-5-ASA). An alternative, selective assay for normetanephrine should be considered.
  • 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.

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