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Consider reducing the dosage of ENTOCORT EC to 3 mg once daily for adult patients with moderate hepatic impairmentChild-Pugh Class BAvoid use in patients with severe hepatic impairmentChild-Pugh Class Csee WARNINGS AND PRECAUTIONSUse In Specific Populations

General disorders and administration site conditionsastheniachest paindependent edemaface edemaflu-like disordermalaisefever.

The efficacy of ENTOCORT EC for maintenance of clinical remission were evaluated in four double-blindplacebo-controlled12-month trials in which 380 patients were randomized and treated once daily with 3 mg or 6 mg ENTOCORT EC or placeboPatients ranged in age from 18 to 73mean 37yearsSixty percent of the patients were female and 99were CaucasianThe mean CDAI at entry was 96Among the four clinical trialsapproximately 75of the patients enrolled had exclusively ileal diseaseColonoscopy was not performed following treatmentENTOCORT EC 6 mg per day prolonged the time to relapsedefined as an increase in CDAI of at least 60 units to a total score greater than 150 or withdrawal due to disease deteriorationThe median time to relapse in the pooled population of the 4 studies was 154 days for patients taking placeboand 268 days for patients taking ENTOCORT EC 6 mg per dayENTOCORT EC 6 mg per day reduced the proportion of patients with loss of symptom control relative to placebo in the pooled population for the 4 studies at 3 months28versus 45for placebo

The dosage and length of treatment are based on your medical conditionresponse to treatmentand age.

Do not drink grapefruit juice during your treatment with ENTOCORT ECDrinking grapefruit juice can increase the level of ENTOCORT EC in your blood.

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reducing the dose of entocort ec capsules should be considered in these patients see warnings and precautions 5.

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