budesonide, Entocort EC

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Pharmacy Author:

Omudhome Ogbru, PharmD

Omudhome Ogbru, PharmD

Dr. Ogbru received his Doctorate in Pharmacy from the University of the Pacific School of Pharmacy in 1995. He completed a Pharmacy Practice Residency at the University of Arizona/University Medical Center in 1996. He was a Professor of Pharmacy Practice and a Regional Clerkship Coordinator for the University of the Pacific School of Pharmacy from 1996-99.

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Medical and Pharmacy Editor:

Jay W. Marks, MD

Jay W. Marks, MD

Jay W. Marks, MD, is a board-certified internist and gastroenterologist. He graduated from Yale University School of Medicine and trained in internal medicine and gastroenterology at UCLA/Cedars-Sinai Medical Center in Los Angeles.

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GENERIC NAME: budesonide

BRAND NAME: Entocort EC

DRUG CLASS AND MECHANISM: Budesonide is a synthetic (man-made) steroid of the glucocorticoid family that is used for treating Crohn's disease. The naturally-occurring hormone whose actions budesonide mimics, is cortisol or hydrocortisone which is produced by the adrenal glands. Glucocorticoid steroids have potent anti-inflammatory actions. Crohn's disease is a chronic inflammatory bowel disease of unknown cause that results in diarrhea, crampy abdominal pain, fever and bleeding from the rectum. The active ingredient in Budesonide, is released from granules in the ileum of the small intestine and the right (proximal) colon, where the inflammation of Crohn's disease occurs. Budesonide acts directly by contact with the ileum and colon. Budesonide that is absorbed into the body travels first to the liver where it is broken-down and eliminated from the body. This prevents the majority of the absorbed drug from being distributed to the rest of the body. As a result, budesonide causes fewer severe side effects throughout the body than other corticosteroids. The FDA approved budesonide in October of 2001.

PRESCRIPTION: Yes

GENERIC AVAILABLE: Yes

PREPARATIONS: Capsules: 3 mg

STORAGE: Capsules should be stored between 15-30 C (59-86 F)

PRESCRIBED FOR: Budesonide is used for the treatment of mild-to-moderately-active Crohn's disease involving the ileum (the second half of the small intestine) and/or ascending colon (the beginning of the large intestine). It also is approved for maintaining remissions for up to three months.

DOSING: The recommended dose for active Crohn's disease is 9 mg once daily in the morning for up to 8 weeks. The 8 week course may be repeated for recurring episodes. The dose for maintenance of remission is 6 mg once daily for 3 months.

DRUG INTERACTIONS: Medicines which block the liver enzymes that break down budesonide may lead to higher blood concentrations and more side effects of budesonide. Such medications include ketoconazole (Nizoral), fluconazole (Diflucan), itraconazole (Sporanox), clarithromycin (Biaxin), erythromycin, verapamil (for example, Calan; Isoptin; Covera HS), diltiazem (for example, Cardizem; Dilacor), ritonavir (Norvir; Kaletra), indinavir (Crixivan), and saquinavir (Invirase, Fortovase). Grapefruit juice has a similar effect and should not be consumed by patients taking budesonide.

PREGNANCY: There are no adequate studies in pregnant women. Budesonide should only be used in pregnant women if the benefits outweigh the unknown risk. Use of budesonide during pregnancy may suppress the adrenal glands of the infant.

NURSING MOTHERS: Budesonide is secreted in human breast milk. Because of the potential for adverse reactions in nursing infants from any corticosteroid, a decision should be made whether to discontinue nursing or discontinue the budesonide.

SIDE EFFECTS: The most common side effects of budesonide are headache, respiratory tract infection, nausea, diarrhea, abdominal pain, back pain, dizziness, fatigue, and symptoms or signs of excessive steroid use. Excessive corticosteroid use causes acne, easy bruising, moon (rounded) faces, buffalo hump, excessive hair growth, and swollen ankles.

Report Problems to the Food and Drug Administration You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088. Need help identifying pills and medications? Use the pill identifier tool on RxList.