UCERIS is a glucocorticosteroid indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis.
The recommended dosage of UCERIS is one 9-mg tablet to be taken once daily in the morning with or without food for up to 8 weeks.
UCERIS is contraindicated in patients with known hypersensitivity to budesonide or any of the ingredients of UCERIS.
Most common adverse reactions (incidence ≥2%) are headache, nausea, decreased blood cortisol, upper abdominal pain, fatigue, flatulence, abdominal distension, acne, urinary tract infection, arthralgia, and constipation.
Avoid Cytochrome P450 3A4 inhibitors (eg, ketoconazole, grapefruit juice). May cause increased systemic corticosteroid effects.
Hepatic impairment: Monitor patients for signs and/or symptoms of hypercorticism.
The Important Safety Information does not include all the information needed to use UCERIS safely and effectively. See Full Prescribing Information for additional information.
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Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Reference: Data on file, Santarus, Inc.