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U.S. Department of Health and Human Services

Safety

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Misoprostol tablets

  • Arthrotec (diclofenac sodium/misoprostol) oral tablets
  • Cytotec (misoprostol) tablets

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

 

Summary View

 

CLINICAL PHARMACOLOGY

  • After a single oral dose of misoprostol to nursing mothers, misoprostol acid was excreted in breast milk. The maximum concentration of misoprostol acid in expressed breast milk was achieved within 1 hour after dosing and was 7.6 pg/ml (CV 37%) and 20.9 pg/ml (CV 62%) after single 200 mg and 600 mg misoprostol administration, respectively. The misoprostol acid concentrations in breast milk declined to 1 pg/ml at 5 hours post-dose.

PRECUATIONS

Nursing mothers

 Misoprostol is rapidly metabolized in the mother to misoprostol acid which is biologically active and is excreted in breast milk. There are no published reports of adverse effects of misoprostol in breast-feeding infants of mothers taking misoprostol. Caution should be exercised when misoprostol is administered to a nursing woman.

ADVERSE REACTIONS

  • Body as a whole: chills
  • Hypersensitivity: anaphylactic reaction