budesonide (Entocort EC, Uceris)

• Budesonide is a synthetic (man-made) steroid of the glucocorticoid family that is used for treating Crohn's disease.

What brand names are available for budesonide?

• Entocort EC and Uceris are brand names for budesonide in the US.

• 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.
• Budesonide also is used for the induction of remission in patients with active, mild to moderate ulcerative colitis.
• Budesonide rectal foam is used for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anus.

The most common side effects of budesonide are:

• Headache
• Upper respiratory tract infection
• Nausea
• Diarrhea
• Abdominal pain
• Back pain
• Dizziness
• Fatigue
• Indigestion
• Vomiting
• Flatulence (intestinal gas, farting)
• Arthralgia
• Constipation
• Abdominal distension
• Acne
• Urinary tract infections (UTIs)
• Viral infections
• Low potassium
• Fatigue

Excessive corticosteroid use causes:

• Acne
• Easy bruising
• Moon (rounded) face
•  Buffalo hump
• Excessive hair growth
• Swollen ankles

Serious side effects of budesonide include:

• Adrenal suppression
• Suppression of the immune system
• Infections
• Intracranial hypertension
• Serious allergic reactions

• 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.
• The recommended dose for the spray is 1 spray administered twice daily for 2 weeks followed by 1 spray once daily for 4 weeks.

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.

• 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.
• 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.

What preparations of budesonide (Entocort EC, Uceris) are available?

• Capsules: 3 mg
• Tablets (Extended Release): 9 mg
• Rectal foam: 2 mg per spray

How should I keep budesonide (Entocort EC, Uceris) stored?

• Capsules should be stored between 15 C and 30 C (59 F and 86 F)

How does budesonide (Entocort EC, Uceris) work?

• 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.

When was budesonide (Entocort EC, Uceris) approved by the FDA?

• The FDA approved budesonide in October of 2001.