ENTOCORT EC- budesonide capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Budesonide (UNII: Q3OKS62Q6X) (Budesonide - UNII:Q3OKS62Q6X)

Available from:

Padagis US LLC

INN (International Name):

Budesonide

Composition:

Budesonide 3 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ENTOCORT EC is 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. ENTOCORT EC is 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. ENTOCORT EC is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of ENTOCORT EC. 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 subcutaneous budesonide during organogenesis at doses approximately 0.5 times or 0.05 times, respecti

Product summary:

ENTOCORT EC 3 mg delayed-release capsules are hard gelatin capsules with an opaque light grey body and an opaque pink cap, coded with ENTOCORT EC 3 mg on the capsule and are supplied as follows: NDC 0574–9850–10         Bottles of 100 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Keep container tightly closed.

Authorization status:

New Drug Application

Summary of Product characteristics

ENTOCORT EC- BUDESONIDE CAPSULE
PADAGIS US LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ENTOCORT EC SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ENTOCORT EC.
ENTOCORT EC (BUDESONIDE) DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
ENTOCORT EC is a corticosteroid indicated for:
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DOSAGE AND ADMINISTRATION
Administration Instructions (2.1): (2)
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Recommended Dosage: (2)
_Mild to moderate active Crohn’s disease (2.2):_ (2)
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_Maintenance of clinical remission of mild to moderate Crohn’s
disease (2.3)_ (2)
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Hepatic Impairment: (2)
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DOSAGE FORMS AND STRENGTHS
Delayed-Release Capsules: 3 mg (3)
CONTRAINDICATIONS
Hypersensitivity to budesonide or any of the ingredients in ENTOCORT
EC. (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.
Adults: 6 mg once daily for up to 3 months; taper to complete
cessation after 3 months. Continued
treatment for more than 3 months has not been shown to provide
substantial clinical benefit.
When switching from oral pre