BUDESONIDE tablet, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. 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 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 a

Product summary:

Budesonide extended-release tablets 9 mg are white, round, biconvex tablets and debossed with “MX9”. They are supplied as follows: NDC 63629-9093-01  Bottles of 30 tablets Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

BUDESONIDE- BUDESONIDE TABLET, EXTENDED RELEASE
BRYANT RANCH PREPACK
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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
Extended-release tablets: 9 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to budesonide or any of the ingredients in
budesonide extended-release tablets (4)
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 OCEANSIDE
PHARMACEUTICALS AT 1-800-
321-4576 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
USE IN SPECIFIC POPULATIONS
•
•
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 2/2023
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 tablets. Taper patients
slowly from systemic
corticosteroids i