BUDESONIDE capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Padagis US LLC

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 sub

Product samenvatting:

Budesonide 3 mg delayed-release capsules are hard gelatin capsules with an opaque light grey body and an opaque pink cap, coded with ENTOCORT EC 3 mg on the capsule and are supplied as follows: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Keep container tightly closed.

Autorisatie-status:

New Drug Application

Productkenmerken

BUDESONIDE- BUDESONIDE CAPSULE
PADAGIS US LLC
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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:
•
•
DOSAGE AND ADMINISTRATION
Administration Instructions (2.1):
•
•
•
•
Recommended Dosage:
_Mild to moderate active Crohn’s disease (2.2):_
•
•
_Maintenance of clinical remission of mild to moderate Crohn’s
disease (2.3):_
•
•
Hepatic Impairment:
•
DOSAGE FORMS AND STRENGTHS
Delayed-release Capsules: 3 mg (3)
CONTRAINDICATIONS
Hypersensitivity to budesonide or any of the ingredients in budesonide
delayed-release capsules. (4)
WARNINGS AND PRECAUTIONS
•
•
•
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)
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.
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.
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 prov