Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)
Rising Pharmaceuticals, Inc.
BUDESONIDE
BUDESONIDE 3 mg
ORAL
PRESCRIPTION DRUG
BUDESONIDE Capsules is 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 is 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 is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of Budesonide Capsules. 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 insufficient to inform a drug-associated risk for major birth defects and miscarr
BUDESONIDE Capsules, 3 mg are hard gelatin capsules size “0” light grey opaque body and pink opaque cap imprinted with black ink “AC” on Cap and “520” on body filled with white to off white Pellets. BUDESONIDE Capsules, 3 mg are supplied as follows: NDC 64980-255-01 Bottles of 100 Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [See USP Controlled Room Temperature]. Keep container tightly closed.
Abbreviated New Drug Application
BUDESONIDE - BUDESONIDE CAPSULE RISING PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE BUDESONIDE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUDESONIDE CAPSULES. BUDESONIDE CAPSULES (ENTERIC COATED), FOR ORAL USE INITIAL U.S. APPROVAL: 1997 RECENT MAJOR CHANGES Indications and Usage, Treatment of Mild to Moderate Active Crohn’s Disease (1.1) 04/2016 Dosage and Administration, Treatment of Mild to Moderate Active Crohn’s Disease (2.1) 04/2016 INDICATIONS AND USAGE BUDESONIDE Capsules is 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 Capsule s. 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. (4) WARNINGS AND PRECAUTIONS Hypercorticism and Adrenal Axis Suppre Soma hati kamili