Methylergonovine Maleate

Generic Name: methylergonovine maleate

Over-the-Counter (OTC)

Brand Names:

DESCRIPTION Methylergonovine maleate is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine maleate injection is a clear, colorless, sterile solution available in 1 mL single dose vials, containing methylergonovine maleate 0.2 mg for intramuscular or intravenous injection. Active Ingredient : methylergonovine maleate, USP 0.2 mg. Inactive Ingredients: maleic acid 0.10 mg; sodium chloride 7.0 mg; water for injection qs to 1 mL.

Overview

Uses

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.

Dosage

DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Intramuscularly 1 mL, 0.2 mg, after delivery of the anterior shoulder, after delivery of the placenta, or during the puerperium. May be repeated as required, at intervals of 2 to 4 hours. Intravenously 1 mL, 0.2 mg, administered slowly over a period of no less than 60 seconds (See WARNINGS .) Orally The recommended dosage of methylergonovine maleate is One tablet, 0.2 mg, orally 3 or 4 times daily in the puerperium for a maximum of 1 week.

Side Effects

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.

Interactions

Drug Interactions CYP3A4 Inhibitors (e.g., Macrolide Antibiotics and Protease Inhibitors) There have been rare reports of serious adverse events in connection with the coadministration of certain ergot alkaloid drugs (e.g., dihydroergotamine and ergotamine) and potent CYP3A4 inhibitors, resulting in vasospasm leading to cerebral ischemia and/or ischemia of the extremities. Although there have been no reports of such interactions with methylergonovine alone, strong and moderate CYP3A4 inhibitors should not be coadministered with methylergonovine.

Warnings

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. CONTRAINDICATIONS Hypertension; toxemia; pregnancy; and hypersensitivity.

Pregnancy

Pregnancy Use of methylergonovine maleate is contraindicated during pregnancy because of its uterotonic effects. (See INDICATIONS AND USAGE ) Animal reproductive studies have not been conducted with methylergonovine maleate. It is not known whether methylergonovine maleate can cause fetal harm or can affect reproductive capacity.

Storage

HOW SUPPLIED NDC 0517-0740-20 0.2 mg/mL 1 mL Single Dose Vials Packages of 20 Store and Dispense Store in refrigerator, 2º to 8ºC (36º to 46ºF). Protect from light. Use carton to protect contents until used. Administer only if solution is clear and colorless. Revised August 2025 Distributed by: AMERICAN REGENT, INC. SHIRLEY, NY 11967

Frequently Asked Questions

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.