BUDESONIDE- budesonide capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

American Health Packaging

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

BUDESONIDE Capsules is indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon. Pediatric use information is approved for Perrigo Pharma International DAC’s Entocort EC (budesonide) capsules. However, due to Perrigo Pharma International DAC’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. BUDESONIDE Capsules is 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 is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of Budesonide Capsules. 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 misca

Prehľad produktov:

BUDESONIDE Capsules, 3 mg are hard gelatin capsules size “0” light grey opaque body and pink opaque cap imprinted with black ink “AC” on cap and “520” on body filled with white to off white Pellets. BUDESONIDE Capsules, 3 mg are supplied as follows: Unit dose packages of 30 (5 x 6) NDC 60687-421-25 Store at 25°C (77°F); excursions permitted to 15-30°C (59- 86°F) [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

BUDESONIDE- BUDESONIDE CAPSULE
AMERICAN HEALTH PACKAGING
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUDESONIDE CAPSULES SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BUDESONIDE CAPSULES.
BUDESONIDE CAPSULES (ENTERIC COATED), FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
BUDESONIDE Capsules is a corticosteroid indicated for:
Treatment of mild to moderate active Crohn’s disease involving the
ileum and/or the ascending colon. ( 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.
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.
_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
Capsule s.
Hepatic Impairment:
Consider reducing the dosage to 3 mg once daily in adult patients with
moderate hepatic impairment (Child-Pugh Class
B). (2.4,5.1,8.6)
DOSAGE FORMS AND STRENGTHS
Capsules: 3 mg ( 3)
CONTRAINDICATIONS
Hypersensitivity to budesonide or any of the ingredients in BUDESONIDE
Capsules. ( 4)
WARNINGS AND PRECAUTIONS
Hypercorticism and Adrenal Axis Suppression: Follow general warnings
concerning corticosteroids; pediatrics and
patients with hepatic impairment may be at increased risk.
(2.4,5.1,8.4,8.6)
Symptoms of Steroid Withdrawal in Patients Transferred fro