Methergine (methylergonovine maleate) tablet and injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2012
- 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
- Addition of drug interactions with CYP3A4 inducers, Beta-blockers, Anesthetics, and Glyceryl trinitrate and antianginal drugs
- Addition of a warning on not breast-feeding during Methergine treatment and for at least 12 hours after the last dose of Methergine.
- Containing reported adverse drug reactions related to nervous system and cardiac disorders.