Methylergonovine
Generic Name: methylergonovine
Brand Names:
Methylergonovine Maleate
DESCRIPTION Methylergonovine maleate, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine maleate, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate, USP. Tablets Active Ingredient: methylergonovine maleate, USP, 0.2 mg. Inactive Ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, povidone, stearic acid, and tartaric acid.
Overview
DESCRIPTION Methylergonovine maleate, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine maleate, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate, USP. Tablets Active Ingredient: methylergonovine maleate, USP, 0.2 mg. Inactive Ingredients: corn starch, lactose monohydrate, microcrystalline cellulose, povidone, stearic acid, and tartaric acid.
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 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 CYP 3A4 Inhibitors (e.g., Macrolide Antibiotics and Protease Inhibitors) There have been rare reports of serious adverse events in connection with the co-administration of certain ergot alkaloid drugs (e.g., dihydroergotamine and ergotamine) and potent CYP 3A4 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 CYP 3A4 inhibitors should not be co-administered 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 Tablets Methylergonovine Maleate Tablets USP, 0.2 mg are available as white round, biconvex tablets, debossed “ 60 ” on one side and “A” on the other side.
Frequently Asked Questions
What is Methylergonovine used for?▼
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.
What are the side effects of Methylergonovine?▼
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.
Can I take Methylergonovine during 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.
What are the important warnings for Methylergonovine?▼
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.
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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.