BUDESONIDE capsule, delayed release

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Amneal Pharmaceuticals LLC

INN (Међународно име):

BUDESONIDE

Састав:

BUDESONIDE 3 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

Budesonide delayed-release capsules are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older.  Budesonide delayed-release capsules 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 delayed-release capsules are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide delayed-release 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 miscarriage. There are clinical considerations [see Clinical Considerations] . In animal reproduction studies with pregnant rats and rabbits, administration of

Резиме производа:

Budesonide delayed-release capsules, 3 mg,  are supplied as hard gelatin capsules with an opaque light gray body imprinted “778” and an opaque maroon cap imprinted “AMNEAL” with black ink. They are available as follows:  Bottles of 21:                          NDC 65162-778-49 Bottles of 100:                        NDC 65162-778-10 Bottles of 180:                        NDC 65162-778-18 Bottles of 300:                        NDC 65162-778-30 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

BUDESONIDE- BUDESONIDE CAPSULE, DELAYED RELEASE
AMNEAL PHARMACEUTICALS LLC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUDESONIDE DELAYED-
RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR BUDESONIDE
DELAYED-RELEASE CAPSULES.
BUDESONIDE DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Budesonide delayed-release capsules are a corticosteroid indicated
for:
Treatment of mild to moderate active Crohn’s disease involving the
ileum and/or the ascending colon,
in patients 8 years and older. (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.
For patients unable to swallow an intact capsule, open the capsules
and empty the granules onto one
tablespoonful of applesauce. Mix and consume the entire contents
within 30 minutes. Do not chew or
crush. Follow with 8 ounces of water.
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.
Pediatrics 8 to 17 years who weigh more than 25 kg: 9 mg once daily
for up to 8 weeks, followed by 6
mg once daily in the morning for 2 weeks.
_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 delayed-release capsules.
Hepatic Impairment:
Consider reducing the dosage to 3 mg once daily in adult patients