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ASACOL HD- mesalamine tablet, delayed release


Patient Information

Administration[seeDosage and Administration (2.1)]

  • Inform patients that if they are switching from a previous oral mesalamine therapy to Asacol HD to discontinue their previous oral mesalamine therapy and follow the dosing instructions for Asacol HD. One Asacol HD 800 mg tablet is not substitutable for two mesalamine delayed-release 400 mg oral products.
  • Inform patients to take Asacol HD tablets on an empty stomach, at least 1 hour before and 2 hours after a meal.
  • 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 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.

Renal Impairment

  • Inform patients that Asacol HD may decrease their renal function, especially if they have known renal impairment or are taking nephrotoxic drugs, and periodic monitoring of renal function will be performed while they are on therapy. Advise patients to complete all blood tests ordered by their physician[seeWarnings and Precautions (5.1)].

Mesalamine-Induced Acute Intolerance Syndrome

  • Instruct patients to report to their physician if they experience new or worsening symptoms of cramping, abdominal pain, bloody diarrhea, and sometimes fever, headache, and rash[seeWarnings and Precautions (5.2)].

Hypersensitivity Reactions

  • Inform patients of the signs and symptoms of hypersensitivity reactions, and advise them to seek immediate medical care should signs and symptoms occur[seeWarnings and Precautions (5.3)].

Hepatic Failure

  • Inform patients with known liver disease of the signs and symptoms of worsening liver function and advise them to report to their physician if they experience such signs or symptoms[seeWarnings and Precautions (5.4)].

Blood Disorders

  • Inform elderly patients and those taking azathioprine or 6-mercaptopurine of the risk for blood disorders and the need for periodic monitoring of complete blood cell counts and platelet counts while on therapy. Advise patients to complete all blood tests ordered by their physician[seeDrug Interactions (7.2),Use in Specific Populations (8.5)].

Distributed by:
Allergan USA, Inc.
Madison, NJ 07940

2018 Allergan. All rights reserved.

Patented. Seewww.allergan.com/patents

Asacol is a registered trademark of Medeva Pharma Suisse AG, licensed to Allergan Pharmaceuticals International Limited.



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