ENTOCORT EC is indicated for:

• the treatment of mild to moderate active Crohn's disease involving the iluem and/or the ascending colon and
• 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.

The recommended adult dosage for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon is 9 mg taken once daily in the morning for up to 8 weeks. 

Repeated 8 week courses of ENTOCORT EC can be given for recurring episodes of active disease.

Following an 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled (CDAI <150), ENTOCORT EC 6 mg is recommended once daily for maintenance of clinical remission up to 3 months. If symptom control is still maintained at 3 months an attempt to taper to complete cessation is recommended. Continued treatment with ENTOCORT EC 6 mg for more than 3 months has not been shown to provide substantial clinical benefit.

Patients with mild to moderate active Crohn’s disease involving the ileum and/or ascending colon have been switched from oral prednisolone to ENTOCORT EC with no reported episodes of adrenal insufficiency. Since prednisolone should not be stopped abruptly, tapering should begin concomitantly with initiating ENTOCORT EC treatment.

Hepatic Insufficiency: Patients with moderate to severe liver disease should be monitored for increased signs and/or symptoms of hypercorticism. Reducing the dose of ENTOCORT EC capsules should be considered in these patients.

CYP3A4 inhibitors: If concomitant administration with ketoconazole, or any other CYP3A4 inhibitor, is indicated, patients should be closely monitored for increased signs and/or symptoms of hypercorticism. Reduction in the dose of ENTOCORT EC capsules should be considered. 

ENTOCORT EC capsules should be swallowed whole and not chewed or broken.

The most common adverse events reported were headache, respiratory infection, nausea, and symptoms of hypercorticism. Clinical studies have shown that the frequency of glucocorticosteroid-associated adverse events was 1 substantially reduced with ENTOCORT EC capsules compared with prednisolone at therapeutically equivalent doses.

See package insert for complete information.

ENTOCORT EC is contraindicated in patients with known hypersensitivity to budesonide.

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 glucocorticosteroids may have unwanted effects. Replacement of systemic glucocorticosteroids with ENTOCORT EC capsules may unmask allergies, eg, rhinitis and eczema, which were previously controlled by the systemic drug. When ENTOCORT EC capsules are used chronically, systemic glucocorticosteroid effects such as hypercorticism and adrenal suppression may occur. Reduced liver function affects the elimination of glucocorticosteroids, and increased systemic availability of oral budesonide has been demonstrated in patients with liver cirrhosis. 

See package insert for complete information.