BUDESONIDE (ENTERIC COATED)- budesonide capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Alvogen, Inc.

INN (International Name):

BUDESONIDE

Composition:

BUDESONIDE 3 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Budesonide capsules (enteric coated)  are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon. Pediatric use information is approved for Perrigo Pharma International DAC’s ENTOCORT EC (budesonide) capsules. However, due to Perrigo Pharma International DAC’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Budesonide capsules (enteric coated) are indicated for the 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. Budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of Budesonide capsules (enteric coated). Serious hypersensitivity reactions, including anaphylaxis have occurred  [see Adverse Reactions (6.2)]. Risk Summary Limited published studies report on the use of budesonide in pregnant women; however, the data are insuffici

Product summary:

Budesonide 3 mg capsules (enteric coated) are hard gelatin capsules with an opaque light grey body and an opaque pink cap, coded with NATCO 3 mg on the capsule and are supplied as follows:  NDC 47781-146-01   Bottles of 100 NDC 47781-146-02   Bottles of 20 NDC 47781-146-10   Bottles of 1000 NDC 47781-146-50   Bottles of 50 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [See USP Controlled Room Temperature]. Keep container tightly closed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUDESONIDE (ENTERIC COATED)- BUDESONIDE CAPSULE
ALVOGEN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUDESONIDE CAPSULES (ENTERIC COATED)
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BUDESONIDE CAPSULES (ENTERIC COATED).
BUDESONIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Indicationsand Usage, Treatment of Mild to Moderate Active Crohn’s
Disease (1.1) 4/2016
Dosage and Administration, Treatment of Mild to Moderate Active
Crohn’s Disease (2.1) 4/2016
INDICATIONS AND USAGE
Budesonide capsules (enteric coated) is a glucocorticosteroid
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.
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 capsules
(enteric coated).
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 any of the ingredients in Budesonide capsules
(enteric coated). (4)
WARNINGS AND PRECAUTIONS
H