Pentasa (Mesalamine) - Indications and Dosage

INDICATIONS AND USAGE

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

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

PENTASA 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 controlled-release capsules are identified with a pentagonal starburst logo and the number 2010 on the green portion and PENTASA 250 mg on the blue portion of the capsules.

PENTASA 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 controlled-release capsules are identified with a pentagonal starburst logo and PENTASA 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 189 0107 007A Rev. 07/2004

© 2004 Shire US Inc. XXXXXXXX

Licensed U.S. Patent Nos. B1 4,496,553 and 4,980,173. Licensed from Ferring A/S, Denmark