November 26, 2015
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  • Instruct patients to swallow the Asacol tablets whole, taking care not to break, cut, or chew the tablets, because the coating is an important part of the delayed-release formulation.
  • Inform patients that if they are switching from a previous oral mesalamine therapy to Asacol they should discontinue their previous oral mesalamine therapy and follow the dosing instructions for Asacol. Inform patients that they should not substitute two Asacol 400 mg tablets with one Asacol HD 800 mg tablet [see DOSAGE AND ADMINISTRATION].
  • Inform patients that intact, partially intact, and/or tablet shells have been reported in the stool. Instruct patients to contact their physician if this occurs repeatedly.
  • Instruct patients to protect Asacol tablets from moisture. Instruct patients to close the container tightly and to leave any desiccant pouches present in the bottle along with the tablets.
  • Advise women who are pregnant, breastfeeding, or of childbearing potential that Asacol contains dibutyl phthalate, which was associated with malformations and adverse effects on the male reproductive system in animal studies. Dibutyl phthalate is excreted in human milk.

Last reviewed on RxList: 6/8/2015
This monograph has been modified to include the generic and brand name in many instances.

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