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References

  1. Lichtenstein AG, Abreu MT, Cohen R, et al. American Gastroenterological Association technical review on corticosteroids, immunomodulators, and infliximab in inflammmatory bowel disease. Gastroenterology. 2006;130(3):940-987.
  2. Crohn’s and Colitis Foundation of America. About Crohn’s disease. http://www.ccfa.org/info/about/crohns. Accessed October 12, 2007.
  3. Lee D, Kam L. Crohn’s disease. Medicine Net Web site. http://www.medicinenet.com/crohns_disease/article.htm. Accessed September 24, 2007.
  4. eHealth MD. Crohn’s disease. http://www.ehealthmd.com/library/ crohnsdisease/CD_symtoms.html. Accessed October 12, 2007.
  5. MedicineNet.com. How is Crohn’s disease treated? http://www.medicinenet.com/crohns_disease/page6/htm. Updated July, 20, 2007. Accessed September 27, 2007.
  6. National Digestive Diseases Information Clearinghouse. Crohn’s disease. http://digestive.niddk.nih.gov/ddiseases/pubs/crohns/ index.htm#treat. Accessed October 12, 2007.
  7. Allan RN. Crohn’s disease of the small intestine—ileum and right colon. In: Allan RN, Rhodes JM, Hanauer SB, eds. Inflammatory Bowel Diseases. New York, NY: Churchill Livingstone; 1997:589-595.
  8. ENTOCORT EC [package insert]. Wilmington, DE: AstraZeneca; 2005.
  9. Sandborn WJ, Löfberg R, Feagan BG, Hanauer SB, Campieri M, Greenberg GR. Budesonide for maintenance of remission in patients with Crohn’s disease in medically induced remission: a predetermined pooled analysis of four randomized, double-blind, placebo-controlled trials. Am J Gastroenterol. 2005;100(8):1780-1787.
  10. Campieri M, Ferguson A, Doe W, Persson T, Nilsson L-G; Global Budesonide Study Group. Oral budesonide is as effective as oral prednisolone in active Crohn’s disease. Gut. 1997;41(2):209-214.
  11. Thomsen OØ, Cortot A, Jewell D, et al; International Budesonide-Mesalamine Study Group. A comparison of budesonide and mesalamine for active Crohn’s disease. N Engl J Med. 1998;339(6):370-374.
 
Entocort EC Budesonide Capsules

It's important to take ENTOCORT EC exactly as it is prescribed. That way, it has a better chance of working the way it's supposed to. Follow all of your doctor’s recommendations and return for regular checkups. Please read the accompanying important Prescribing Information and discuss it with your doctor. If you have any questions or concerns or want to learn more about ENTOCORT EC, talk to your doctor.

Read this information carefully before you begin treatment. Read the information you get whenever you get more prescription medicine. There may be new information.

*For Crohn’s disease involving the ileum and/or ascending colon, ENTOCORT EC is indicated for the treatment of mild to moderate active disease (up to 8 weeks with repeated 8-week courses as necessary) and the maintenance of clinical remission of mild to moderate disease for up to an additional 3 months.

Important Safety Information

Do not take ENTOCORT EC® if you have had an allergic reaction to ENTOCORT EC or any of its ingredients. Patients who take ENTOCORT EC may require supplemental treatment with a systemic steroid if they are undergoing surgery or are subject to other stress situations. If you are switching to ENTOCORT EC from a systemic steroid (such as prednisone), carefully follow your doctor's instructions. This will help you avoid health risks that may be linked with stopping the use of systemic steroids.

The most common side effects of ENTOCORT EC are headaches, infection in your air passages (respiratory infection), nausea, and symptoms of hypercorticism (too much steroids in your body). Symptoms of hypercorticism may include an increase in the size of the face and neck, acne and bruising. Most symptoms of too much steroids in your body occur less often with ENTOCORT EC than with other corticosteroids.

Medicines that suppress the immune system, such as ENTOCORT EC, can make you more susceptible to infections. Patients who take ENTOCORT EC should avoid contact with people with infections, including chicken pox and measles.

While you are taking ENTOCORT EC, do not drink grapefruit juice regularly. Grapefruit juice can increase the amount of ENTOCORT EC in your blood. Other juices, like orange juice or apple juice, do not have this effect.

Call your physician right away if you notice itching, skin rash, fever, swelling of your face and neck, or trouble breathing while you are taking ENTOCORT EC. These may be signs that you are allergic to the medicine and you may need emergency help.