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In an opennon-randomizedcross-over study6 healthy subjects were given budesonide 10 mg as a single doseeither alone or concomitantly with the last ketoconazole dose of 3 days treatment with ketoconazole 100 mg twice dailyCo-administration of ketoconazole resulted in an eight-fold increase in AUC of budesonidecompared to budesonide alonesee DRUG INTERACTIONS

Advise Patients to read the FDA-Approved patient labelingPATIENT INFORMATION

Budesonide is a substrate for CYP3A4Avoid use with CYP3A4 inhibitorsConcomitant oral administration of a strong CYP3A4 inhibitorketoconazolecaused an eight-fold increase of the systemic exposure to oral budesonideInhibitors of CYP3A4e.gketoconazoleitraconazoleritonavirindinavirsaquinavirerythromycinand cyclosporinecan increase systemic budesonide concentrationssee CLINICAL PHARMACOLOGY

Take ENTOCORT EC exactly as your healthcare provider tells youYour healthcare provider will tell you how many ENTOCORT EC capsules to takeYour healthcare provider may change your dose if neededTake ENTOCORT EC 1 time each day in the morningTake ENTOCORT EC capsules wholeDo not chew or crush ENTOCORT EC capsules before swallowingIf you take too much ENTOCORT EC call your healthcare provider right away or go to the nearest hospital emergency room.

Monitor patients who are transferred from corticosteroid treatment with high systemic effects to corticosteroids with lower systemic availabilitysuch as ENTOCORT ECsince symptoms attributed to withdrawal of steroid therapyincluding those of acute adrenal axis suppression or benign intracranial hypertensionmay developAdrenocortical function monitoring may be required in these patients and the dose of corticosteroid treatment with high systemic effects should be reduced cautiously.

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Orphan designationbudesonideUcerisfor treatment ulcerative colitis in pediatric patients aged 0 through 16 years.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effectsMany people using this medication do not have serious side effects.

Pediatric patients 8 to 17 years who weigh more than 25 kg9 mg orally once daily for up to 8 weeksfollowed by 6 mg once daily for 2 weeks.

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