UCERIS RECTAL FOAM Rx
Generic Name and Formulations:
Budesonide 2mg; per metered dose; emulsion.
Valeant Pharmaceuticals, Inc
Indications for UCERIS RECTAL FOAM:
Induction of remission in patients with active, mild-to-moderate distal ulcerative colitis extending up to 40cm from the anal verge.
For rectal use only. Empty bowels prior to administration. Apply 1 metered dose twice daily (AM & PM) for 2 weeks, then 1 metered dose once daily (PM) for 4 weeks.
Not for oral use. Active or quiescent tuberculosis, untreated fungal, bacterial, systemic viral or parasitic infections or ocular herpes simplex. If exposed to chickenpox or measles, consider immune globulin or antiviral therapies. Supplement with systemic glucocorticosteroid in surgery or other stress situations. Caution when transferring from steroids with high systemic effects; monitor. May unmask allergies previously controlled by systemic corticosteroids. Hypertension. Diabetes. Osteoporosis. Peptic ulcer. Glaucoma. Cataracts. Temporarily discontinue prior to colonoscopy bowel preparation. Moderate-to-severe hepatic impairment (Child-Pugh Class B or C): monitor for hypercorticism; consider discontinuing if occurs. Flammable. Elderly. Pregnancy (Cat.C). Nursing mothers.
May be potentiated by concomitant CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, grapefruit juice); avoid.
Decreased blood cortisol, adrenal insufficiency, nausea; hypercorticism, adrenal suppression, immunosuppression, increased susceptibility to infection.
Canister—1 (14 doses); Kit—1 (2 canisters w. 28 applicators)