Product Description.:
S429 250 mg, logo and 2010
capsule , blue green , oblong oblong
Black ink
PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.
Important Safety Information
* As with other mesalamine products, serious adverse events may occur. PENTASA is contraindicated in patients with a hypersensitivity to mesalamine, any other components in this medication, or salicylates.
* Caution should be used in patients with impaired hepatic or renal function.
* Mesalamine has been associated with an acute intolerance syndrome 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.
* Reports of nephritic syndrome and interstitial nephritis associated with mesalamine therapy have been reported.
* Patients with pre-existing renal disease, increased BUN or serum creatinine, or proteinuria should be monitored during PENTASA therapy, especially during the initial phase of treatment. Mesalamine-induced nephrotoxicity should be suspected in patients developing renal dysfunction during treatment.
* 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%).
