UCERIS- budesonide aerosol, foam

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)

Available from:

Salix Pharmaceuticals, Inc.

INN (International Name):

BUDESONIDE

Composition:

BUDESONIDE 28 mg

Administration route:

RECTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

UCERIS rectal foam is indicated for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. UCERIS rectal foam is contraindicated in patients with a history of a known hypersensitivity to budesonide or any of the ingredients of UCERIS rectal foam. Reactions have included anaphylaxis [see Adverse Reactions (6.2)] . Risk Summary Limited published studies report on the use of budesonide in pregnant women; however, the data are insufficient to inform a drug-associated risk for major birth defects and miscarriage. There are clinical considerations (see Clinical Considerations) . In animal reproduction studies with pregnant rats and rabbits, subcutaneous administration of budesonide during organogenesis at doses 1.2 times and 0.12 times, respectively, the human intrarectal dose of 4 mg/day, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. Maternal toxicity was observed in both rats and rabbits at the

Product summary:

UCERIS rectal foam is supplied as a kit containing 2 aerosol canisters with 28 PVC applicators coated with paraffin lubricant for administration of the foam (NDC 65649-651-03). Each canister (NDC 65649-651-02) is labeled with a net weight of 33.4 g and contains 14 metered doses. Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Handling UCERIS rectal foam contains a flammable propellant. Do not have the canister burned after use and do not spray contents directly towards flames. DO NOT REFRIGERATE.

Authorization status:

New Drug Application

Summary of Product characteristics

UCERIS- BUDESONIDE AEROSOL, FOAM
SALIX PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
UCERIS RECTAL FOAM SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR UCERIS RECTAL FOAM.
UCERIS (BUDESONIDE) RECTAL FOAM
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
UCERIS rectal foam is a glucocorticosteroid indicated for the
induction of remission in patients with active mild to
moderate distal ulcerative colitis extending up to 40 cm from the anal
verge. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
UCERIS rectal foam contains 2 mg budesonide per metered dose. (3)
CONTRAINDICATIONS
Known hypersensitivity to budesonide or any of the ingredients in
UCERIS rectal foam. (4)
WARNINGS AND PRECAUTIONS
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•
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ADVERSE REACTIONS
Most common adverse reactions (≥ 2%) are decreased blood cortisol,
adrenal insufficiency, and nausea. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT SALIX PHARMACEUTICALS
AT 1-800-321-4576 OR FDA AT 1-
800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
CYP3A4 Inhibitors (e.g., ketoconazole, grapefruit juice): May cause
increased systemic corticosteroid effects; avoid
concomitant use. (7.1)
USE IN SPECIFIC POPULATIONS
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•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
®
The recommended dosage is 1 metered dose administered twice daily for
2 weeks followed by 1 metered dose
administered once daily for 4 weeks. (2.1)
For rectal administration only. (2.2)
Warm the canister in the hands while shaking it vigorously for 10 to
15 seconds prior to use. (2.2)
Hypercorticism and adrenal suppression: Follow general warnings
concerning glucocorticosteroids. (5.1)
Impaired Adrenal Function in Patients Transferred from Other
Glucocorticoids: Taper slowly from
glucocorticosteroids with high systemic effects; monitor for
withdrawal symptoms and unmasking of allergies
(rhinitis, eczema). (5.2)
In