BUDESONIDE tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Golden State Medical Supply

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 skele

Product summary:

Budesonide extended-release tablets 9 mg, are white, round, biconvex, film-coated tablets imprinted with “ WPI ” and “ 2510 ” on one side and plain on the other. Tablets are supplied in bottles of 30, NDC 51407-224-30. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUDESONIDE- BUDESONIDE TABLET, FILM COATED, EXTENDED RELEASE
GOLDEN STATE MEDICAL SUPPLY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
BUDESONIDE EXTENDED-RELEASE TABLETS.
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
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 if transferring to budesonide
extended-release tablets. ( 5.2)
Immunosuppression: Potential worsening of infections (e.g., existing
tuberculosis, fungal, bacterial, viral, or parasitic
infection; or ocular herpes simplex). Use with caution in patients
with these infections. More serious or even fatal
course of chickenpox or measles can occur in susceptible patients. (
5.3)
ADVERSE REACTIONS
Most common adverse reactions (incidence greater than or eq