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U.S. Department of Health and Human Services

Safety

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Methergine (methylergonovine maleate) tablet and injection

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2012

 

Summary View

 

WARNINGS

  • Warning on not breast-feeding during Methergine treatment and for at least 12 hours after the last dose of Methergine
  • Warning on an increased risk of developing myocardial ischemia and infarction in patients with coronary artery disease or risk factors for coronary artery disease
  • Warning of the accidental administration of Methergine injection to newborn infants
 

PRECAUTIONS

Drug Interactions
  • Addition of drug interactions with CYP3A4 inducers, Beta-blockers, Anesthetics, and Glyceryl trinitrate and antianginal drugs
Nursing Mothers
  • Addition of a warning on not breast-feeding during Methergine treatment and for at least 12 hours after the last dose of Methergine.
 

ADVERSE REACTIONS

Postmarketing Experience
  • Containing reported adverse drug reactions related to nervous system and cardiac disorders.