Држава: Сједињене Америчке Државе
Језик: Енглески
Извор: NLM (National Library of Medicine)
BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)
Mylan Institutional Inc.
BUDESONIDE
BUDESONIDE 3 mg
ORAL
PRESCRIPTION DRUG
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) ]. Limited published studies report on the use of budesonide in preg
Budesonide Capsules (enteric coated) are available containing 3 mg of budesonide, USP. The 3 mg capsule is a hard-shell gelatin capsule with a red opaque cap and red opaque body filled with white to off-white enteric-coated pellets with no markings. The capsule is axially printed with MYLAN over 7155 in black ink on both the cap and body. They are available as follows: NDC 51079-020-03 – Unit dose blister packages of 30 (5 cards of 6 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
BUDESONIDE- BUDESONIDE CAPSULE MYLAN INSTITUTIONAL INC. ---------- 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 (ENTERIC COATED), FOR ORAL USE INITIAL U.S. APPROVAL: 1997 INDICATIONS AND USAGE Budesonide capsules (enteric coated) are 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 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 budesonide or any of the ingredients in budesonide capsules (enteric coated). ( 4) WARNINGS AND PRECAUTIONS Hypercorticism and Adrenal Axis Suppression: Follow general warnings concerning corticosteroids; pediatrics and patients with hepatic impairment may be at i Прочитајте комплетан документ