BUDESONIDE capsule

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

BUDESONIDE (UNII: Q3OKS62Q6X) (BUDESONIDE - UNII:Q3OKS62Q6X)

Предлага се от:

Mylan Institutional Inc.

INN (Международно Name):

BUDESONIDE

Композиция:

BUDESONIDE 3 mg

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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

Каталог на резюме:

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.]

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

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