Uceris Rectal Foam

— THERAPEUTIC CATEGORIES —
  • Colorectal disorders

Uceris Rectal Foam Generic Name & Formulations

General Description

Budesonide 2mg; per metered dose; emulsion.

Pharmacological Class

Glucocorticoid.

How Supplied

Canister—1 (14 doses); Kit—1 (2 canisters w. 28 applicators)

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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