Country: United States
Language: English
Source: NLM (National Library of Medicine)
BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)
Teva Pharmaceuticals USA, 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 pregnant women; however, the data are insufficient to inform a
Budesonide Capsules (Enteric Coated), 3 mg are available as elongated, two-piece hard gelatin capsules with dark peach opaque cap and white opaque body, filled with white to off-white pellets, imprinted with “TEVA 7445” in black ink, containing 3 mg budesonide, USP, packaged in bottles of 100 capsules (NDC: 0093-7445-01). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
BUDESONIDE (ENTERIC COATED)- BUDESONIDE CAPSULE, DELAYED RELEASE PELLETS TEVA PHARMACEUTICALS USA, 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 pat Read the complete document