UCERIS- budesonide tablet, extended release

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Santarus Inc.

INN (Nome Internazionale):

BUDESONIDE

Composizione:

BUDESONIDE 9 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

UCERIS® extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. UCERIS is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of UCERIS. Anaphylactic reactions have occurred with other budesonide formulations [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 0.5 times and 0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. Maternal toxicity was observed in both rats and rabbits at these dose levels (see Data ). Based on animal da

Dettagli prodotto:

UCERIS® (budesonide) extended-release tablets 9 mg are white, round, biconvex tablets and debossed with “MX9”. They are supplied as follows: NDC 68012-309-30 Bottles of 30 tablets 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]. Keep container tightly closed. Protect from light and moisture.

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

UCERIS- BUDESONIDE TABLET, EXTENDED RELEASE
SANTARUS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
UCERIS SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR UCERIS.
UCERIS (BUDESONIDE) EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
UCERIS (budesonide) is a glucocorticosteroid indicated for the
induction of remission in patients with active, mild to
moderate ulcerative colitis. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage for the induction of remission in adult
patients with active, mild to moderate ulcerative colitis is
one 9 mg tablet to be taken once daily in the morning with or without
food for up to 8 weeks. (2.1)
DOSAGE FORMS AND STRENGTHS
Extended-release tablets: 9 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to budesonide or any of the ingredients in
UCERIS tablets (4)
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥2%) are headache, nausea,
decreased blood cortisol, upper abdominal pain,
fatigue, flatulence, abdominal distension, acne, urinary tract
infection, arthralgia, and constipation. (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
•
USE IN SPECIFIC POPULATIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 4/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Mild to Moderate Ulcerative Colitis
2.2 CYP3A4 Inhibitors
®
Hypercorticism and adrenal suppression: Since UCERIS is a
glucocorticosteroid, follow general warnings concerning
glucocorticoids. (5.1)
Transferring patients from systemic glucocorticoids: Risk of impaired
adrenal function when transferring from
glucocorticoid treatment with higher systemic effects to
glucocorticoid treatment with lower systemic effects, such as
UCERIS. Taper patients slowl