budesonide, Entocort EC, Uceris extended release tablets

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GENERIC NAME: budesonide

BRAND NAME: Entocort EC, Uceris extended release tablets

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; Tablets (Extended Release): 9 mg

STORAGE: Capsules should be stored between 15C to 30 C (59 F to 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 is approved for maintaining remissions for up to three months. It is also used for induction of remission in patients with active, mild to moderate ulcerative colitis.

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. The recommended dosage for the induction of remission in adult patients with active, mild to moderate ulcerative colitis is one 9 mg extended release tablet to be taken once daily in the morning for up to 8 weeks.

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.




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