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Prometheus Highlights Record Performance in 2010
Date:3/1/2011

ation of budesonide granules, a glucocorticosteriod.  The granules are coated to protect dissolution in gastric juice, but dissolve at pH >5.5, normally when the granules reach the duodenum.  Thereafter, a matrix controls the release of the drug into the intestinal lumen in a time-dependent manner.  Eighty to ninety percent of Entocort EC does not enter the systemic circulation.  Entocort EC may reduce the incidence of some corticosteroid-associated side effects such as acne and moon face compared to prednisolone(2).

Important Safety InformationSince Entocort® EC (budesonide) Capsules is a glucocorticosteroid (GCS), general warnings about GCSs should be followed. GCSs can reduce the response of the hypothalamus-pituitaryadrenal axis to stress. Supplementation with a systemic GCS is recommended before surgery or other stress situations.

Adrenocortical function monitoring may be required in patients being transferred to Entocort EC from a systemic GCS, and the dose of the systemic GCS should be reduced cautiously.

Patients on drugs that suppress the immune system are more susceptible to infections, which may be more severe, and should avoid exposure to infections such as chicken pox or measles.

Caution should be taken in patients with tuberculosis, hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma or cataracts, or with a family history of diabetes or glaucoma, or with any other condition where GCSs may have unwanted effects.

Reduced liver function affects the elimination of GCSs, and increased systemic availability of oral budesonide has been observed in patients with liver cirrhosis. Patients with moderate to severe liver disease and patients who are concomitantly taking ketoconazole or any other CYP3A4 inhibitor should be closely monitored for increased signs and/or symptoms of hypercorticism. Reduction in the dose of Entocort EC should be considered in these patients. Patients sho
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SOURCE Prometheus Laboratories Inc.
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