Detailed Drug Information:

DRUG CLASS AND MECHANISM: Budesonide is a synthetic steroid of the glucocorticoid family. 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 Entocort EC, 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. The budesonide that is absorbed into the body travels 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 Entocort EC in October of 2001.

PREPARATIONS: Capsules: 3mg

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).

DOSING: Budesonide usually is taken once daily for up to eight weeks.

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

PREGNANCY: Glucocorticoids taken orally that are similar to budesonide have been shown to cause fetal abnormalities in animals. It is not known if there is an increased risk of malformation in children born to mothers exposed to budesonide during pregnancy.

NURSING MOTHERS: Glucocorticosteroids are secreted in human 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. The amount of budesonide secreted in breast milk has not been determined.

SIDE EFFECTS: Budesonide generally is well tolerated. The most common side effects are headache (1 in 5 patients), respiratory infection (1 in 10 patients), nausea (1 in 10 patients), and symptoms or signs of too much corticosteroid. In the latter case, acne occurs in about 1 in 6 patients, easy bruising in 1 in 6 patients, moon (rounded) faces in 1 in 10 patients, and swollen ankles in 1 in 14 patients.

High doses of glucocorticoids may decrease the formation and increase the breakdown of bone. Higher doses also may suppress the body's ability to make its own natural glucocorticoid, cortisol. It is possible that these effects are shared by budesonide. People with suppressed production of cortisol (which can be tested for by the doctor) need increased amounts of glucocorticoids, probably by the oral or intravenous route during periods of high physical stress.