BUDESONIDE capsule

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Carilion Materials Management

INN (Medzinárodný Name):

BUDESONIDE

Zloženie:

BUDESONIDE 3 mg

Spôsob podávania:

ORAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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. 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. Budesonide capsules (enteric coated) are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide capsules (enteric coated). Anaphylactic reactions have occurred [ ]. see Adverse Reactions (6.2) Budesonide was teratogenic and embryocidal in rabbits and rats. Budesonide produced fetal loss, decreased pup weights, and skeletal abnormalities at subcutaneous doses of 25 mcg/kg in rabbits (approximately 0.05 times the maximum recommended human dose on a body surface area basis) and 500 mcg/kg in rats (approximately 0.5 times the maximum recommended human dose

Prehľad produktov:

NDC:68151-4374-0 in a PACKAGE of 1 CAPSULES

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

BUDESONIDE- BUDESONIDE CAPSULE
CARILION MATERIALS MANAGEMENT
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR . INITIAL U.S. APPROVAL: 1997 BUDESONIDE CAPSULES
(ENTERIC COATED)BUDESONIDE CAPSULES
(ENTERIC COATED)
BUDESONIDE CAPSULES (ENTERIC COATED), FOR ORAL USE
INDICATIONS AND USAGE
Budesonide capsules (enteric coated) are a glucocorticosteroid
indicated for:
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•
DOSAGE AND ADMINISTRATION
•
•
DOSAGE FORMS AND STRENGTHS
Capsules: 3 mg ( ) 3
CONTRAINDICATIONS
Hypersensitivity to any of the ingredients in budesonide capsules
(enteric coated). ( ) 4
WARNINGS AND PRECAUTIONS
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•
•
ADVERSE REACTIONS
Most common adverse reactions (≥ 5%) are headache, respiratory
infection, nausea, back pain, dyspepsia, dizziness,
abdominal pain, flatulence, vomiting, fatigue, pain. ( ) 6.1
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACTMYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX)OR FDA AT 1-800-FDA-1088 ORwww.fda.gov/medwatch.
DRUG INTERACTIONS
•
USE IN SPECIFIC POPULATIONS
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 8/2014
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. ( ) 1.2
Mild to moderate active Crohn’s disease: 9 mg once daily in the
morning for up to 8 weeks. Repeated 8 week courses
of budesonide capsules (enteric coated) can be given for recurring
episodes of active disease. ( ) 2.1
Maintenance of clinical remission of mild to moderate Crohn’s
disease: 6 mg once daily for up to 3 months. Continued
treatment with budesonide capsules (enteric coated) 6 mg for more than
3 months has not been shown to provide
substantial clinical benefit. ( ) 2.2
Since budesonide capsules (enteric coated) are a glucocorticosteroid,
genera