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Before you take entocort.
Information about Entocort.
Do not stop taking this medication without consulting your doctorSome conditions may become worse when this drug is suddenly stoppedYour dose may need to be gradually decreased.
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
This is not a complete list of possible side effectsIf you notice other effects not listed abovecontact your doctor or pharmacist.
Read this Patient Information before you start taking ENTOCORT EC and each time you get a refillThere may be new informationThis information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
In an openrandomizedcross-over study8 healthy subjects were given ENTOCORT EC capsules 3 mgeither aloneor concomitantly with 600 mL concentrated grapefruit juicewhich inhibits CYP3A4 activity predominantly in the intestinal mucosaon the last of 4 daily administrationsConcomitant administration of grapefruit juice resulted in a 2-fold increase of the bioavailability of budesonide compared to budesonide alonesee DRUG INTERACTIONS
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