BUDESONIDE capsule

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Par Pharmaceutical Inc.

INN (इंटरनेशनल नाम):

BUDESONIDE

रचना:

BUDESONIDE 3 mg

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

प्राधिकरण का दर्जा:

New Drug Application Authorized Generic

उत्पाद विशेषताएं

BUDESONIDE- BUDESONIDE CAPSULE
PAR PHARMACEUTICAL INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUDESONIDE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR BUDESONIDE.
BUDESONIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
_Budesonide is a glucocorticosteroid indicated for:_
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Capsules: 3 mg (3)
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients in budesonide. (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (≥ 5%) are headache, respiratory
infection, nausea, back pain, dyspepsia, dizziness,
abdominal pain, flatulence, vomiting, fatigue, pain. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA AT
1-800-236-9933 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 12/2011
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. (1.2)
Mild to moderate active Crohn’s disease: 9 mg once daily in the
morning for up to 8 weeks. Repeated 8 week courses
of budesonide can be given for recurring episodes of active disease.
(2.1)
Maintenance of clinical remission of mild to moderate Crohn’s
disease: 6 mg once daily for up to 3 months. Continued
treatment with budesonide 6 mg for more than 3 months has not been
shown to provide substantial clinical benefit.
(2.2)
Hypercorticism and adrenal suppression: Since budesonide is a
glucocorticosteroid, general warnings concerning
glucocorticoids should be followed. (5.1)
Transferring patients from systemic glucocorticosteroid therapy: Care
is needed in patients who are transferred from
glucocorticosteroid treatme