PREGNANCY AND BREASTFEEDING SAFETY:
- 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.
STORAGE: Capsules should be stored between 15 C to 30 C (59 F to 86 F)
- 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 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.
Reference: FDA Prescribing Information
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