Entocort EC

Entocort EC

INDICATIONS

Mild to Moderate Active Crohn's Disease

ENTOCORT EC is indicated for the treatment of mild to moderate active Crohn's disease involving the ileum and/or the ascending colon.

Maintenance of Clinical Remission of Mild to Moderate Crohn's Disease

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.

DOSAGE AND ADMINISTRATION

Mild to Moderate Active Crohn's Disease

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 orally 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.

Maintenance of Clinical Remission of Mild to Moderate Crohn's Disease

Following an 8 week course(s) of treatment for active disease and once the patient's symptoms are controlled (CDAI less than 150), ENTOCORT EC 6 mg orally 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.

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. Grapefruit juice, which is known to inhibit CYP3A4, should also be avoided when taking ENTOCORT EC. In these cases, reduction in the dose of ENTOCORT EC capsules should be considered [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

Dosage Forms And Strengths

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.

Storage And Handling

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 and are supplied as follows:

NDC 65483-702-10 Bottles of 100 17

Store at 25°C (77°F); excursions permitted to 15-30°C (5986°F) [See USP Controlled Room Temperature].

Keep container tightly closed.

Manufactured by: AstraZeneca AB, S-151 85 Södertälje, Sweden. Distributed by: Prometheus Laboratories Inc. San Diego, CA 92121. Revised: 12/2011

Last reviewed on RxList: 1/10/2012
This monograph has been modified to include the generic and brand name in many instances.

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