Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)
Alvogen, 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)]. Risk Summary Limited published studies report on the use of budesonide in pregnant women; however, the data are insuffici
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.
Abbreviated New Drug Application
BUDESONIDE (ENTERIC COATED)- BUDESONIDE CAPSULE ALVOGEN, 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, 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 Lestu allt skjalið