BUDESONIDE capsule, delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Major Pharmaceuticals

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Budesonide delayed-release capsules are indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon in patients 8 years of age and older.  Budesonide delayed-release capsules are indicated for the maintenance of clinical remission of mild to moderate Crohn’s disease involving the ileum and/or the ascending colon for up to 3 months in adults.  Budesonide delayed-release capsules are contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of budesonide delayed-release capsules. Serious hypersensitivity reactions, including anaphylaxis have occurred [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, administration of

Product summary:

Budesonide delayed-release capsules, 3 mg,  are supplied as hard gelatin capsules with an opaque light gray body imprinted “778” and an opaque maroon cap imprinted “AMNEAL” with black ink. They are available as follows:  Carton of 20 Capsules (10 capsules per blister pack x 2), NDC 0904-7166-10 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BUDESONIDE- BUDESONIDE CAPSULE, DELAYED RELEASE
MAJOR PHARMACEUTICALS
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BUDESONIDE DELAYED-
RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR BUDESONIDE
DELAYED-RELEASE CAPSULES.
BUDESONIDE DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Budesonide delayed-release capsules are a corticosteroid indicated
for:
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DOSAGE AND ADMINISTRATION
Administration Instructions (2.1):
•
•
•
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Recommended Dosage:
_Mild to moderate active Crohn’s disease (2.2):_
•
•
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Hepatic Impairment:
•
DOSAGE FORMS AND STRENGTHS
Delayed-Release Capsules: 3 mg (3)
CONTRAINDICATIONS
Hypersensitivity to budesonide or any of the ingredients in budesonide
delayed-release capsules. (4)
WARNINGS AND PRECAUTIONS
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Treatment of mild to moderate active Crohn’s disease involving the
ileum and/or the ascending colon,
in patients 8 years and older. (1.1)
Maintenance of clinical remission of mild to moderate Crohn’s
disease involving the ileum and/or the
ascending colon for up to 3 months in adults. (1.2)
Take once daily in the morning.
Swallow whole. Do not chew or crush.
For patients unable to swallow an intact capsule, open the capsules
and empty the granules onto one
tablespoonful of applesauce. Mix and consume the entire contents
within 30 minutes. Do not chew or
crush. Follow with 8 ounces of water.
Avoid consumption of grapefruit juice for the duration of therapy.
Adults: 9 mg once daily for up to 8 weeks; repeat 8 week treatment
courses for recurring episodes of
active disease.
Pediatrics 8 to 17 years who weigh more than 25 kg: 9 mg once daily
for up to 8 weeks, followed by 6
mg once daily in the morning for 2 weeks.
_Maintenance of clinical remission of mild to moderate Crohn’s
disease (2.3):_
Adults: 6 mg once daily for up to 3 months; taper to complete
cessation after 3 months. Continued
treatment for more than 3 months ha