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Entocort EC (Budesonide) - Indications and Dosage

 
 



INDICATIONS & USAGE

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.

DOSAGE & ADMINISTRATION

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.

DOSAGE FORMS & STRENGTHS SECTION

ENTOCORT EC 3 mg 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.

They are supplied as follows:

NDC 65483-702-10 Bottles of 100

STORAGE AND HANDLING SECTION

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature].

Keep container tightly closed.

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