Generic Name and Formulations:
Budesonide 9mg; extended-release tablets.
Valeant Pharmaceuticals, Inc
Indications for UCERIS:
Induction of remission in patients with active, mild-to-moderate ulcerative colitis.
Swallow whole. 9mg once daily in the AM for up to 8 weeks.
Active or quiescent tuberculosis, untreated fungal, bacterial, systemic viral or parasitic infections. Supplement with systemic glucocorticosteroid in surgery or other stress situations. Caution when transferring from steroids with high systemic availability (monitor). May unmask allergies previously controlled by systemic corticosteroids. If exposed to chickenpox or measles, consider immune globulin or antiviral prophylactic therapies. Hypertension. Diabetes. Osteoporosis. Peptic ulcer. Glaucoma. Cataracts. Moderate-to-severe liver disease: monitor for hypercorticism; consider discontinuing. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.
May be potentiated by CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin); consider discontinuing. Avoid grapefruit or grapefruit juice. May be affected by gastric acid reducing agents (eg, PPIs, H2-blockers, antacids).
Headache, nausea, decreased blood cortisol, upper abdominal pain, fatigue, flatulence, abdominal distension, acne, urinary tract infection, arthralgia, constipation; hypercorticism, adrenal suppression, immunosuppression.