BUDESONIDE (ENTERIC COATED)- budesonide capsule, delayed release pellets

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Budesonide (UNII: Q3OKS62Q6X) (Budesonide - UNII:Q3OKS62Q6X)

Available from:

Mayne Pharma Inc.

INN (International Name):

Budesonide

Composition:

Budesonide 3 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 in patients 8 years of age and older. 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)] . 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

Product summary:

Budesonide extended-release capsules (enteric coated) are size #1 hard gelatin capsules with a pink opaque cap and a white opaque body printed with and '0495' on both cap and body in black ink containing 3 mg of budesonide, USP. Capsules are supplied as follows: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep container tightly closed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUDESONIDE (ENTERIC COATED)- BUDESONIDE CAPSULE, DELAYED RELEASE
PELLETS
MAYNE PHARMA INC.
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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 EXTENDED-RELEASE CAPSULES (ENTERIC COATED), FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Dosage and Administration (2.1) 09/2018
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, 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
wate r.
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 co