Uceris Rectal Foam Generic Name & Formulations
Legal Class
Rx
General Description
Budesonide 2mg; per metered dose; emulsion.
Pharmacological Class
Glucocorticoid.
How Supplied
Canister—1 (14 doses); Kit—1 (2 canisters w. 28 applicators)
Manufacturer
Generic Availability
NO
Mechanism of Action
Budesonide has glucocorticosteroid (GCS) activity.
Uceris Rectal Foam Indications
Indications
Induction of remission in patients with active, mild to moderate distal ulcerative colitis extending up to 40cm from the anal verge.
Uceris Rectal Foam Dosage and Administration
Adult
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.
Children
Not established.
Uceris Rectal Foam Contraindications
Not Applicable
Uceris Rectal Foam Boxed Warnings
Not Applicable
Uceris Rectal Foam Warnings/Precautions
Warnings/Precautions
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: monitor for hypercorticism; consider discontinuing if occurs. Flammable. Elderly. Pregnancy. Nursing mothers.
Uceris Rectal Foam Pharmacokinetics
See Literature
Uceris Rectal Foam Interactions
Interactions
May be potentiated by concomitant CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, cyclosporine, grapefruit juice); avoid.
Uceris Rectal Foam Adverse Reactions
Adverse Reactions
Decreased blood cortisol, adrenal insufficiency, nausea; hypercorticism, adrenal suppression, immunosuppression, increased susceptibility to infection.
Uceris Rectal Foam Clinical Trials
See Literature
Uceris Rectal Foam Note
Not Applicable
Uceris Rectal Foam Patient Counseling
See Literature
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