methylergonovine maleate
Methylergonovine Maleate is an ergot derivative used to treat Postpartum Hemorrhage.
Ergot Derivative · by Am Regent
Generic of Methergine
Key facts
- Active ingredient
- Methylergonovine Maleate
- Drug class
- Ergot Derivative
- Form
- Injectable, Tablet
- Strength
- Methylergonovine Maleate 0.2MG/ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- postpartum hemorrhage
- Manufacturer
- Am Regent
- Half-life
- a mean of about 3.4 hours (range 1.5 to 12.7 hours) (how long it stays in your system)
- What the pharmacy pays
- ~$158.98 for 30 — not your price
- FDA application
- ANDA090193
What is Methylergonovine Maleate?
From the FDA label: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. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9,10-didehydro-N-[1-(hydroxymethyl)propyl]-6-methyl-,[8β(S)]-, (Z)-2-butenedioate (1:1) (salt). Its structural formula is: structure
How to use
Methylergonovine Maleate is sold in more than one form (Injectable and Tablet), and each is dosed differently. The instructions below come from the FDA label for application ANDA090193 — follow the label that came with the product you were actually prescribed.
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 (SeeWARNINGS.) 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
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. Post marketing 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 American Regent at 1-800-734-9236 or…
Warnings
Important safety information
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 CONTRAINDICATION and DRUG INTERACTION). 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.
Who should not take Methylergonovine Maleate
Hypertension; toxemia; pregnancy; and hypersensitivity.
Overdose — what happens if you take too much
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 LD50 (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 to 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. Treatment of acute overdosage is symptomatic and includes the usual procedures of: removal of offending drug by inducing emesis, gastric lavage, catharsis, and supportive diuresis. maintenance of adequate pulmonary ventilation, especially if convulsions or coma develop. correction of hypotension with pressor drugs as needed. control of convulsions with standard…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
How long does Methylergonovine Maleate stay in your body?
The elimination half-life of methylergonovine maleate is a mean of about 3.4 hours (range 1.5 to 12.7 hours) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the terminal (elimination) half-life: the label states the plasma decline is biphasic and reports a mean elimination half-life of 3.39 hours (range 1.5 to 12.7 hours), so the value given is the beta/terminal phase, not the rapid distribution phase (distribution from plasma to tissues occurs within about 2-3 minutes after IV). Methylergonovine is not a prodrug and the label names no active metabolite that outlasts the parent. It is cleared mainly by hepatic metabolism and excretion, so liver impairment would be expected to prolong the half-life, but the label does not quantify this and gives no separate half-life figures for older adults or kidney or liver impairment. The wide upper end of the range (up to 12.7 hours) reflects inter-individual variability rather than a named population.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Methylergonovine Maleate label — DailyMed (Clinical Pharmacology).
Drug class
May treat (source: NIH RxClass)
Dosage forms
Injectable and Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Methylergonovine Maleate treat?
- Methylergonovine Maleate (Methylergonovine Maleate) may be used to treat postpartum hemorrhage, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Methylergonovine Maleate cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $158.98 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Bromocriptine Mesylate — about $52.02 on the same basis.
- Is there a coupon or discount for Methylergonovine Maleate?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Methylergonovine Maleate. To pay less, Methylergonovine Maleate is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Methylergonovine Maleate?
- Methylergonovine Maleate is marketed by Am Regent. You can see Am Regent's full profile, rating, and other products on pharmaranks.
- Is Methylergonovine Maleate a brand-name or generic drug?
- Methylergonovine Maleate is a generic medication; its active ingredient is Methylergonovine Maleate. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Methylergonovine Maleate available over the counter?
- No. Methylergonovine Maleate is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Methylergonovine Maleate come in?
- Methylergonovine Maleate is currently marketed as injectable and tablet, per the FDA's National Drug Code Directory.
- What class of drug is Methylergonovine Maleate?
- Methylergonovine Maleate is classified as ergot derivative, per the FDA's Established Pharmacologic Class.
- Is Methylergonovine Maleate FDA-registered?
- Methylergonovine Maleate is on record with the U.S. FDA under application number ANDA090193. You can verify this on its official FDA label.
- Is Methylergonovine Maleate safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Methylergonovine Maleate. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Methylergonovine Maleate?
- Methylergonovine Maleate's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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