Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)
Par Pharmaceutical Inc.
BUDESONIDE
BUDESONIDE 3 mg
PRESCRIPTION DRUG
New Drug Application Authorized Generic
BUDESONIDE- BUDESONIDE CAPSULE PAR PHARMACEUTICAL INC. ---------- 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:_ • • DOSAGE AND ADMINISTRATION • • DOSAGE FORMS AND STRENGTHS Capsules: 3 mg (3) CONTRAINDICATIONS Hypersensitivity to any of the ingredients in budesonide. (4) WARNINGS AND PRECAUTIONS • • • 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 • USE IN SPECIFIC POPULATIONS • 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 Прочетете целия документ