Generic Name and Formulations:
Budesonide (micronized) 3mg; e-c granules in caps.
Treatment of mild-to-moderate active Crohn's disease of the ileum and/or ascending colon in patients ≥8yrs of age and maintenance of clinical remission for up to 3 months in adults.
Swallow whole. Treatment: 9mg once daily in the AM for up to 8 wks; may repeat an 8-week course. Maintenance of remission: 6mg once daily for up to 3 months. Taper other systemic steroids when transferring to budesonide. Moderate hepatic impairment: consider 3mg once daily. Severe hepatic impairment: avoid.
<8yrs: not established. Treatment: 8–17yrs (>25kg): 9mg once daily in the AM for up to 8 wks, then 6mg once daily for 2 wks.
Systemic fungal, viral, or mycobacterial infections. Hypertension. Diabetes. Osteoporosis. Peptic ulcer. Glaucoma. Cataracts. If exposed to chickenpox or measles, consider prophylactic passive immune therapy. Supplement with systemic steroid in surgery and stress. Caution when transferring from steroids with high systemic availability. Moderate hepatic impairment: monitor for hypercorticism and consider reducing the dose. Elderly. Pregnancy. Nursing mothers: not recommended.
Avoid grapefruit juice. Systemic effects potentiated by CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine); avoid.
Headache, respiratory infection, nausea, back pain, dyspepsia, dizziness, abdominal pain, flatulence, vomiting, fatigue, pain; hypercorticism.
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