BUDESONIDE capsule, coated pellets

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Northstar Rx LLC.

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

Budesonide delayed-release capsules (enteric coated) 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 (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)]. 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

Sommarju tal-prodott:

Budesonide Delayed-Release Capsules (Enteric Coated) 3 mg are white to off-white, free flowing pellets, filled in size '1' hard gelatin capsules having opaque light-orange colored cap printed with "720" in black ink and opaque white body and are supplied as follows: NDC 16714-829-01 in bottle of 100 capsules Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

BUDESONIDE - BUDESONIDE CAPSULE, COATED PELLETS
NORTHSTAR RX LLC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUDESONIDE DELAYED-
RELEASE CAPSULES (ENTERIC COATED) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR BUDESONIDE DELAYED-RELEASE CAPSULES (ENTERIC COATED).
BUDESONIDE DELAYED-RELEASE CAPSULES (ENTERIC COATED), FOR ORAL USE
INITIAL U.S. APPROVAL:1997
INDICATIONS AND USAGE
Budesonide delayed-release capsules (enteric coated) are
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 capsules (enteric coated).
_Hepatic Impairment_
Consider reduci