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Basic Drug Info
Drug Name:PENTASA
Manufacturer:Shire US Inc.
Other Info:

The following events have been identified during post-approval use of products which contain (or are metabolized to) mesalamine in clinical practice.

Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made.

These events have been chosen for inclusion due to a combination of seriousness, frequency of reporting, or potential causal connection to mesalamine:Gastrointestinal: Reports of hepatotoxicity, including elevated liver function tests (SGOT/AST, SGPT/ALT, GGT, LDH, alkaline phosphatase, bilirubin), jaundice, cholestatic jaundice, cirrhosis, and possible hepatocellular damage including liver necrosis and liver failure.

Some of these cases were fatal.

One case of Kawasaki-like syndrome which included hepatic function changes was also reported.


Clinical Trials:

Indications and Usage
PENTASA is indicated for the induction of remission and for the treatment of patients with mildly to moderately active ulcerative colitis.
Ulcerative Colitis -- Inflammation of the COLON that is predominantly confined to the MUCOSA. Its major symptoms include DIARRHEA, rectal BLEEDING, the passage of MUCUS, and ABDOMINAL PAIN.

Contraindications
PENTASA is contraindicated in patients who have demonstrated hypersensitivity to mesalamine, any other components of this medication, or salicylates.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.


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