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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.
PENTASA capsules may be swallowed whole, or alternatively, the capsule may be opened and the entire contents sprinkled onto applesauce or yogurt. The entire contents should be consumed immediately. The capsules and capsule contents must not be crushed or chewed.
Safety and efficacy of PENTASA in pediatric patients have not been established.
PENTASA controlled-release 250 mg capsules are supplied in bottles of 240 capsules (NDC 54092-189-81). 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 or S429 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). 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 or S429 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. Revised. Aug 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 8/27/2015
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