BUDESONIDE capsule

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

APPCO PHARMA LLC

INN (International Adı):

BUDESONIDE

Kompozisyon:

BUDESONIDE 3 mg

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

BUDESONIDE- BUDESONIDE CAPSULE
APPCO PHARMA LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUDESONIDE CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUDESONIDE CAPSULES.
BUDESONIDE CAPSULES (ENTERIC COATED), FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Indications and Usage, Treatment of Mild to Moderate Active Crohn’s
Disease (1.1) 04/2016
Dosage and Administration, Treatment of Mild to Moderate Active
Crohn’s Disease (2.1) 04/2016
INDICATIONS AND USAGE
BUDESONIDE Capsules is a corticosteroid indicated for:
Treatment of mild to moderate active Crohn’s disease involving the
ileum and/or the ascending colon. (1.1)
Maintenance of clinical remission of mild to moderate Crohn’s
disease involving the ileum and/or the ascending colon
for up to 3 months in adults. (1.2)
DOSAGE AND ADMINISTRATION
Administration Instructions (2.1):
Take once daily in the morning
Swallow whole. Do not chew or crush.
Avoid consumption of grapefruit juice for the duration of therapy
Recommended Dosage:
_Mild to moderate active Crohn’s disease (2.2):_
Adults: 9 mg once daily for up to 8 weeks; repeat 8 week treatment
courses for recurring episodes of active disease.
_Maintenance of clinical remission of mild to moderate Crohn’s
disease (2.3)._
Adults: 6 mg once daily for up to 3 months; taper to complete
cessation after 3 months. Continued treatment for more
than 3 months has not been shown to provide substantial clinical
benefit.
When switching from oral prednisolone, begin tapering prednisolone
concomitantly with initiating BUDESONIDE
Capsule s.
Hepatic Impairment:
Consider reducing the dosage to 3 mg once daily in adult patients with
moderate hepatic impairment (Child-Pugh Class
B). (2.4,5.1, 8.6)
DOSAGE FORMS AND STRENGTHS
Capsules: 3 mg (3)
CONTRAINDICATIONS
Hypersensitivity to budesonide or any of the ingredients in BUDESONIDE
Capsules. (4)
WARNINGS AND PRECAUTIONS
Hypercorticism and Adrenal Axis Suppression: Follo