August 27, 2016
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Asacol HD

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Asacol HD




PATIENT INFORMATION

  • Instruct patients to swallow the Asacol HD 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 HD they should discontinue their previous oral mesalamine therapy and follow the dosing instructions for Asacol HD. Inform patients that they should not substitute one Asacol HD tablet with two Asacol 400 mg tablets [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY].
  • 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 HD 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 HD contains dibutyl phthalate, which caused malformations and adverse effects on the male reproductive system in animal studies. Dibutyl phthalate is excreted in human milk.

Last reviewed on RxList: 4/25/2016
This monograph has been modified to include the generic and brand name in many instances.

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