BUDESONIDE capsule, delayed release

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Golden State Medical Supply, Inc.

INN (Nama Antarabangsa):

BUDESONIDE

Komposisi:

BUDESONIDE 3 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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) ]. 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 rep

Ringkasan produk:

Budesonide Delayed-Release Capsules are available containing 3 mg of budesonide, USP. The 3 mg capsules are hard-shell gelatin capsules with a red opaque cap and red opaque body filled with white to off-white enteric-coated pellets with no markings. The capsules are axially printed with MYLAN over 7155 in black ink on the cap and body. They are available as follows: NDC 60429-264-01 bottles of 100 capsules Store at 20º to 25ºC (68º to 77ºF). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Keep container tightly closed.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

BUDESONIDE- BUDESONIDE CAPSULE, DELAYED RELEASE
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
BUDESONIDE DELAYED-RELEASE CAPSULES. 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 pellets 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 t