BUDESONIDE capsule, coated pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

BUDESONIDE

Composition:

BUDESONIDE 3 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 68382-720-06 in bottle of 30 capsules with child-resistant closure NDC 68382-720-16 in bottle of 90 capsules with child-resistant closure NDC 68382-720-01 in bottle of 100 capsules with child-resistant closure NDC 68382-720-05 in bottle of 500 capsules NDC 68382-720-10 in bottle of 1,000 capsules NDC 68382-720-77 in unit-dose blister carton of 100 (10 x 10) unit-dose capsules Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUDESONIDE- BUDESONIDE CAPSULE, COATED PELLETS
ZYDUS PHARMACEUTICALS USA INC.
----------
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_
Co