BUDESONIDE tablet, film coated, extended release

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Mylan Pharmaceuticals Inc.

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Budesonide extended-release tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Budesonide extended-release tablets are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide extended-release tablets. Anaphylactic reactions have occurred with other budesonide formulations [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, subcutaneous administration of budesonide during organogenesis at doses 0.5 times and 0.05 times, respectively, the maximum recommended human dose, resulted in increased fetal loss, decreased pup weights, and skeletal abnormalities. Maternal toxicity was observed in both rats and rabbits at

leaflet_short:

Budesonide Extended-Release Tablets are available containing 9 mg of budesonide, USP. The 9 mg tablets are white, film-coated, round, unscored tablets with M over BE9 imprinted in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4500-93 bottles of 30 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Keep container tightly closed. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

BUDESONIDE- BUDESONIDE TABLET, FILM COATED, EXTENDED RELEASE
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUDESONIDE EXTENDED-RELEASE
TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
BUDESONIDE EXTENDED-RELEASE
TABLETS.
BUDESONIDE EXTENDED-RELEASE TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Budesonide extended-release tablets are a glucocorticosteroid
indicated for the induction of remission in patients with
active, mild to moderate ulcerative colitis. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage for the induction of remission in adult
patients with active, mild to moderate ulcerative colitis is
one 9 mg tablet to be taken once daily in the morning with or without
food for up to 8 weeks. (2.1)
DOSAGE FORMS AND STRENGTHS
•
CONTRAINDICATIONS
•
WARNINGS AND PRECAUTIONS
•
•
•
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 2%) are headache, nausea,
decreased blood cortisol, upper abdominal pain,
fatigue, flatulence, abdominal distension, acne, urinary tract
infection, arthralgia, and constipation. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-RX) OR FDA AT
1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
•
USE IN SPECIFIC POPULATIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 4/2020
Extended-release tablets: 9 mg (3)
Known hypersensitivity to budesonide or any of the ingredients in
budesonide extended-release tablets (4)
Hypercorticism and adrenal suppression: Since budesonide
extended-release tablets are a glucocorticosteroid, follow
general warnings concerning glucocorticoids. (5.1)
Transferring patients from systemic glucocorticoids: Risk of impaired
adrenal function when transferring from
glucocorticoid treatment with higher systemic effects to
glucocorticoid treatment with lower systemic effects, such as
budesonide extended-release