BUDESONIDE tablet, film coated, extended release

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

Golden State Medical Supply, Inc.

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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 obs

Резиме производа:

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 51407-824-30. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

BUDESONIDE- BUDESONIDE TABLET, FILM COATED, EXTENDED RELEASE
GOLDEN STATE MEDICAL SUPPLY, INC.
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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