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U.S. Department of Health and Human Services


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Entocort EC (budesonide) Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009


Summary View



Nursing Mothers
  • The disposition of budesonide when delivered by inhalation from a dry powder inhaler at doses of 200 or 400 mcg twice daily for at least 3 months was studied in eight lactating women with asthma from 1 to 6 months postpartum... 
  • The recommended daily dose of Entocort EC capsules is higher (up to 9 mg daily) compared with inhaled budesonide (up to 800 g daily) given to mothers in the above study...
  • Since there are no data from controlled trials on the use of Entocort EC by nursing mothers or their infants, and because of the potential for serious adverse reactions in nursing infants from Entocort EC, a decision should be made whether to discontinue nursing or to discontinue Entocort EC, taking into account the clinical importance of Entocort EC to the mother. 
  • Budesonide, like other corticosteroids, is secreted in human milk. Data from budesonide delivered via dry powder inhaler indicates that the total daily oral dose of budesonide available in breast milk to the infant is approximately 0.3% to 1% of the dose inhaled by the mother...


Postmarketing Experience 
  • The following adverse reactions have been identified during postapproval use of Entocort EC. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 
  • Immune System Disorders: Anaphylactic reactions; 
  • Nervous System Disorders: Benign intracranial hypertension.