ENTOCORT EC budesonide capsule

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

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

Inapatikana kutoka:

AstraZeneca Pharmaceuticals LP

INN (Jina la Kimataifa):

BUDESONIDE

Tungo:

BUDESONIDE 3 mg

Dawa ya aina:

PRESCRIPTION DRUG

Idhini hali ya:

New Drug Application

Tabia za bidhaa

ENTOCORT EC- BUDESONIDE CAPSULE
ASTRAZENECA PHARMACEUTICALS LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ENTOCORT EC SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR ENTOCORT EC.
ENTICORT® EC (BUDESONIDE) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
ENTOCORT EC is a glucocorticosteroid indicated for: (1)
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Capsules: 3 mg (3) (3)
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients in ENTOCORT EC. (4) (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) (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA AT
1–800–236–9933 OR FDA AT 1-800-FDA-
1088 OR WWW.FDA.GOV/MEDWATCH. (6)
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION AND MEDICATION GUIDE.
REVISED: 12/2011
®
Treamtment 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 ENTOCORT EC 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 ENTOCORT EC 6 mg for more than 3 months has not been
shown to provide substantial clinical
benefit. (2.2)
Hypercorticism and adrenal suppression: Since ENTOCORT EC is a
glucocorticosteroid, general warnings
concerning glucocorticoids should be followed. (5.1)
Transferring patients from systemic glucocorticosteroid therapy: Care
is needed in patients who ar