BUDESONIDE tablet, film coated, extended release

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

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

Предлага се от:

Golden State Medical Supply, Inc.

Начин на приложение:

ORAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

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

Каталог на резюме:

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 51407-366-30 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.

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

BUDESONIDE- BUDESONIDE TABLET, FILM COATED, EXTENDED RELEASE
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
BUDESONIDE EXTENDED-RELEASE TABLETS, 9MG
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 ≥ 2%)