BUDESONIDE capsule, delayed release

Pajjiż: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Mylan Pharmaceuticals Inc.

INN (Isem Internazzjonali):

BUDESONIDE

Kompożizzjoni:

BUDESONIDE 3 mg

Rotta amministrattiva:

ORAL

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

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 reproduction studies with pregnant rats and rabbits, administration of subcutaneous bu

Sommarju tal-prodott:

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 0378-7155-01 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.

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

BUDESONIDE- BUDESONIDE CAPSULE, DELAYED RELEASE
MYLAN PHARMACEUTICALS INC.
----------
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 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.
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 month