pharmacopeia
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/api/v1/drug/methylergonovine

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Dopamine Antagonists; HIV Protease Inhibitors.

DopamineHIV Protease

Indications

Sourced from openFDA
  • Following delivery of 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.

Contraindications

Sourced from openFDA
  • Hypertension; toxemia; pregnancy; and hypersensitivity.contraindicated

Dosage & administration

Sourced from openFDA

Orally One tablet, 0.2 mg, 3 or 4 times daily in the puerperium for a maximum of 1 week.

Warnings & precautions

Sourced from openFDA

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 presence of impaired hepatic or renal function. Breast-feeding Mothers should not breast-feed during treatment with methylergonovine maleate tablets, USP. Milk secreted during this period should be discarded. Methylergonovine maleate tablets, USP may produce adverse effects in the breast-feeding infant. Methylergonovine maleate tablets, USP may also reduce the yield of breast milk. Mothers should wait at least 12 hours after administration of the last dose of methylergonovine maleate tablets, USP before initiating or resuming breast feeding. 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. Medication errors Inadvertent administration of methylergonovine maleate tablets, USP 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.

Adverse reactions

Sourced from openFDA

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. 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

Use in specific populations

Sourced from openFDA

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

Overdosage

Sourced from openFDA

Symptoms of acute overdose may include: nausea, vomiting, oliguria, abdominal pain, numbness, tingling of the extremities, rise in blood pressure, in severe cases followed by hypotension, respiratory depression, hypothermia, convulsions, and coma. Because reports of overdosage with methylergonovine maleate are infrequent, the lethal dose in humans has not been established. The oral LD 50 (in mg/kg) for the mouse is 187, the rat 93, and the rabbit 4.5. Several cases of accidental methylergonovine maleate injection in newborn infants have been reported, and in such cases 0.2 mg represents an overdose of great magnitude. However, recovery occurred in all but one case following a period of respiratory depression, hypothermia, hypertonicity with jerking movements, and convulsions. Also, several children 1-3 years of age have accidentally ingested up to 10 tablets (2 mg) with no apparent ill effects. A postpartum patient took 4 tablets at one time in error and reported paresthesias and clamminess as her only symptoms.

Approval history

Sourced from openFDA
  • Nov 24, 2008ANDAANDA090193Am Regent
  • Sep 13, 2010ANDAANDA040889Breckenridge
  • May 2, 2011ANDAANDA091577Chartwell Rx
  • May 15, 2018ANDAANDA210424Granules
  • Sep 10, 2018ANDAANDA211483Amneal Pharms
  • Mar 20, 2019ANDAANDA211455Teva Pharms Usa
  • May 1, 2020ANDAANDA212233Tp Anda Holdings
  • Jan 15, 2021ANDAANDA211919Rising

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
663 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Wrong Drug Administered6910%
  2. 2Drug Exposure During Pregnancy517.7%
  3. 3Vomiting466.9%
  4. 4Drug Ineffective446.6%
  5. 5Dyspnoea395.9%
  6. 6Headache385.7%
  7. 7Abdominal Pain365.4%
  8. 8Nausea365.4%
  9. 9Haemorrhage304.5%
  10. 10Dizziness274.1%
  11. 11Cyanosis263.9%
  12. 12Maternal Exposure During Pregnancy263.9%
  13. 13Pain263.9%
  14. 14Hypertension243.6%
  15. 15Accidental Exposure223.3%

Literature

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Recent PubMed references pinned to Methylergonovine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 15 ClinicalTrials.gov registrations naming Methylergonovine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Methylergonovine work?
Mechanism-of-action classes: Dopamine Antagonists; HIV Protease Inhibitors.
What is Methylergonovine used for?
According to FDA labeling, Methylergonovine carries indications including: Following delivery of 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Methylergonovine?
Methylergonovine is classified as Ergot alkaloids, Ergot Derivative, Dopamine Antagonists, HIV Protease Inhibitors, Increased Uterine Smooth Muscle Contraction or Tone.
What are the brand names for Methylergonovine?
Methylergonovine is marketed under brand names including Methergine.
What are the contraindications for Methylergonovine?
Methylergonovine labeling lists contraindications including: Hypertension; toxemia; pregnancy; and hypersensitivity.. Always consult the full prescribing information and a clinician.
Note. Data for methylergonovine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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