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

The recommended dosage for the induction of remission and the symptomatic treatment of mildly to moderately active ulcerative colitis is 1g (4 PENTASA (mesalamine) 250 mg capsules or 2 PENTASA (mesalamine) 500 mg capsules) 4 times a day for a total daily dosage of 4g. Treatment duration in controlled trials was up to 8 weeks.

PENTASA (mesalamine) controlled-release 250 mg capsules are supplied in bottles of 240 capsules (NDC 54092-189-81); and blister packs of 80 capsules (NDC 54092-189-80). Each green and blue capsule contains 250 mg of mesalamine in controlled-release beads. PENTASA (mesalamine) controlled-release capsules are identified with a pentagonal starburst logo and the number 2010 on the green portion and PENTASA (mesalamine) 250 mg on the blue portion of the capsules.

PENTASA (mesalamine) controlled-release 500 mg capsules are supplied in bottles of 120 capsules (NDC 54092-191-12); and blister packs of 80 capsules (NDC 54092-191-80). Each blue capsule contains 500 mg of mesalamine in controlled-release beads. PENTASA (mesalamine) controlled-release capsules are identified with a pentagonal starburst logo and PENTASA (mesalamine) 500 mg on the capsules.

Store at 25°C (77°F) excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Manufactured for Shire US Inc., 725 Chesterbrook Blvd., Wayne, PA 19087, USA Rev. 01/2007
FDA Rev date: 6/26/2007

Last reviewed on RxList: 7/27/2007
This monograph has been modified to include the generic and brand name in many instances.