August 24, 2016
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Entocort

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Entocort EC




Indications
Dosage
How Supplied

INDICATIONS

Treatment Of 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 in patients 8 years of age and older .

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 in adults.

DOSAGE AND ADMINISTRATION

Administration Instructions

  • Take ENTOCORT EC capsules once daily in the morning.
  • Swallow ENTOCORT EC capsules whole. Do not chew or crush.
  • Avoid consumption of grapefruit juice for the duration of ENTOCORT EC therapy [see DRUG INTERACTIONS].

Treatment Of Mild To Moderate Active Crohn’s Disease

The recommended dosage of ENTOCORT EC is:

Adults

9 mg orally once daily for up to 8 weeks. Repeated 8 week courses of ENTOCORT EC can be given for recurring episodes of active disease.

Pediatric Patients 8 To 17 Years Who Weigh More Than 25 kg

9 mg orally once daily for up to 8 weeks, followed by 6 mg once daily for 2 weeks.

Maintenance Of Clinical Remission Of Mild To Moderate Crohn’s Disease

The recommended dosage in adults, following an 8 week course(s) of treatment for active disease and once the patient’s symptoms are controlled (CDAI less than 150), is ENTOCORT EC 6 mg orally 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.

Dosage Adjustment In Adult Patients With Hepatic Impairment

Consider reducing the dosage of ENTOCORT EC to 3 mg once daily for adult patients with moderate hepatic impairment (Child-Pugh Class B). Avoid use in patients with severe hepatic impairment (Child-Pugh Class C) [see WARNINGS AND PRECAUTIONS, Use In Specific Populations].

HOW SUPPLIED

Dosage Forms And Strengths

Capsules: 3 mg hard gelatin capsules with an opaque light grey body and an opaque pink cap, coded with ENTOCORT EC 3 mg.

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 0186–0702–10     Bottles of 100

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

REFERENCES

  1. Best WR, Becktel JM, Singleton JW, Kern F: Development of a Crohn’s Disease Activity Index, National Cooperative Crohn’s Disease Study. Gastroenterology 1976; 70(3): 439-444.

Manufactured and Distributed by: Perrigo, Allegan, MI 49010. Revised: Apr 2014

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 8/1/2016

Indications
Dosage
How Supplied

Entocort EC - User Reviews

Entocort EC User Reviews

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