INDICATIONS AND USAGE Following delivery of the placenta, for routine management of uterine atony, hemorrhage and subinvolution of the uterus.

For control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.

WARNINGS General This drug should not be administered I.V.

routinely because of the possibility of inducing sudden hypertensive and cerebrovascular accidents.

If I.V.

administration is considered essential as a lifesaving measure, methylergonovine maleate should be given slowly over a period of no less than 60 seconds with careful monitoring of blood pressure.

Intra-arterial or periarterial injection should be strictly avoided.

Caution should be exercised in the presence of impaired hepatic or renal function.

Coronary artery disease Patients with coronary artery disease or risk factors for coronary artery disease (e.g., smoking, obesity, diabetes, high cholesterol) may be more susceptible to developing myocardial ischemia and infarction associated with methylergonovine-induced vasospasm.

Risk of Adverse Reactions or Reduced Therapeutic Effect Due to Drug Interactions The concomitant use of methylergonovine maleate and certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions or reduced therapeutic effect of methylergonovine maleate or the concomitant drug (see CONTRAINDICATIONS and DRUG INTERACTIONS ).

Medication errors Inadvertent administration of methylergonovine maleate to newborn infants has been reported.

In these cases of inadvertent neonatal exposure, symptoms such as respiratory depression, convulsions, cyanosis and oliguria have been reported.

Usual treatment is symptomatic.

However, in severe cases, respiratory and cardiovascular support is required.

Methylergonovine maleate has been administered instead of vitamin K and Hepatitis B vaccine, medications which are routinely administered to the newborn.

Due to the potential for accidental neonatal exposure, methylergonovine maleate injection should be stored separately from medications intended for neonatal administration.

ADVERSE REACTIONS Clinical trials experience Common Adverse Reactions The most common adverse reaction is hypertension associated in several cases with seizure and/or headache.

Hypotension has also been reported.

Abdominal pain (caused by uterine contractions), nausea and vomiting have occurred occasionally.

Rare Adverse Reactions Rarely observed reactions have included: acute myocardial infarction, transient chest pains, vasoconstriction, vasospasm, coronary arterial spasm, bradycardia, tachycardia, dyspnea, hematuria, thrombophlebitis, water intoxication, hallucinations, leg cramps, dizziness, tinnitus, nasal congestion, diarrhea, diaphoresis, palpitation, rash, and foul taste.

There have been rare isolated reports of anaphylaxis, without a proven causal relationship to the drug product.

Postmarketing Experience The following adverse drug reactions have been derived from post-marketing experience with methylergonovine maleate via spontaneous case reports.

Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known.

Nervous system disorders Cerebrovascular accident, paraesthesia Cardiac disorders Ventricular fibrillation, ventricular tachycardia, angina pectoris, atrioventricular block To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.