Entocort_EC: profile and news

MADD questions magistrates DWI punishment Aug 9, 2005
But according to the official Entocort EC web site, the drug Stickney said he was under and used to treat Crohn's disease and intestinal disorder, is a non ... - WFAA (subscription),

Prometheus Announces FDA Approval for Additional Indication of ... May 10, 2005
Entocort EC is the only pharmacological product indicated for the treatment of mild to moderate Crohn's disease involving the ileum and/or the ascending colon ... - PharmaLive.com

FDA Approvals: Requip, Entocort EC, Triglide May 12, 2005
On April 29, the FDA approved a new indication for budesonide (Entocort EC capsules, made by Prometheus Laboratories, Inc.), allowing its use for up to three ... - Medscape (subscription)

Prometheus gets additional OK for Crohn's drug May 11, 2005
The FDA has approved Prometheus Laboratories' supplemental new drug application for the additional use of Entocort EC capsules in mild to moderate Crohn's ... - Pharmaceutical Business Review

FDA approves Prometheus drug application May 10, 2005
...announced Tuesday that the US Food & Drug Administration (FDA) has approved the supplemental new drug application for the use of Entocort EC capsules for the ... - San Diego Daily Transcript (subscription),

Other information

Indication
For the treatment of mild to moderate active Crohn's disease.

Pharmacology
Budesonide is a synthetic corticosteroid indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon. Budesonide is used in Crohn's disease to decrease the symptoms and inflammation associated with the disease, especially at times of flare up. Budesonide has a high topical glucocorticosteroid (GCS) activity and a substantial first pass elimination. The formulation contains granules which are coated to protect dissolution in gastric juice, but which dissolve at pH >5.5, ie, normally when the granules reach the duodenum. Thereafter, a matrix of ethylcellulose with budesonide controls the release of the drug into the intestinal lumen in a time-dependent manner.

Mechanism Of Action
The exact mechanism of action of budesonide in the treatment of Crohn's disease is not fully understood. However, being a glucocorticosteroid, budesonide has a high local anti-inflammatory effect.

Drug Category
Bronchodilator Agents; Anti-inflammatory Agents; Corticosteroids; ATC:A07EA06; ATC:D07AC09; ATC:R01AD05; ATC:R03BA02

Brand Names/Synonyms
Bidien; Budeson; Budesonide; Budesonide, Pharma; BudesonideÊ; Cortivent; Desonide; Desowen; Entocort; Entocort Ec; Micronyl; Preferid; Pulmicort; Pulmicort Nebuamp; Pulmicort Respules; Pulmicort Turbuhaler; Rhinocort; Rhinocort Aqua; Rhinocort Turbuhaler; Spirocort; Tridesilon

Dosage Forms
CAPSULE (SUSTAINED-RELEASE); METERED-DOSE (AEROSOL); SUSPENSION

Absorption
Complete

Interactions
Interactions for Budesonide:

Concomitant oral administration of ketoconazole (a known inhibitor of CYP3A4 activity in the liver and in the intestinal mucosa) caused an eight-fold increase of the systemic exposure to oral budesonide. If treatment with inhibitors of CYP3A4 activity (such as ketoconazole, intraconazole, ritonavir, indinavir, saquinavir, erythromycin, etc.) is indicated, reduction of the budesonide dose should be considered. After extensive intake of grapefruit juice (which inhibits CYP3A4 activity predominantly in the intestinal mucosa), the systemic exposure for oral budesonide increased about two times. As with other drugs primarily being metabolized through CYP3A4, ingestion of grapefruit or grapefruit juice should be avoided in connection with budesonide administration.

Chemical IUPAC Name
Not Available

Chemical Formula
C25H34O6

Half Life
2.0 and 3.6 hours

Drug Type
Approved Drug

# Accession No
APRD00442

CAS Registry Number
51333-22-3