{"id":"methylergonovine-maleate","_fda":{"id":"24b0446f-9cfa-4544-b677-8ff15e98ebcd","set_id":"0a318b77-d280-4571-992f-82e2e0a57c9b","openfda":{"upc":["0383400100120"],"unii":["IR84JPZ1RK"],"route":["ORAL"],"rxcui":["996824"],"spl_id":["24b0446f-9cfa-4544-b677-8ff15e98ebcd"],"brand_name":["Methylergonovine Maleate"],"spl_set_id":["0a318b77-d280-4571-992f-82e2e0a57c9b"],"package_ndc":["83400-100-12","83400-100-28"],"product_ndc":["83400-100"],"generic_name":["METHYLERGONOVINE MALEATE"],"product_type":["HUMAN PRESCRIPTION DRUG"],"substance_name":["METHYLERGONOVINE MALEATE"],"manufacturer_name":["Volley Pharmaceuticals, LLC"],"application_number":["ANDA212233"],"is_original_packager":[true]},"version":"1","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 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. However, in severe cases, respiratory and cardiovascular support is required. Methylergonovine maleate tablets, USP have 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 should be stored separately from medications intended for neonatal administration."],"pregnancy":["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":["OVERDOSAGE 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. 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 anticonvulsant agents. control of peripheral vasospasm with warmth to the extremities if needed."],"description":["DESCRIPTION Methylergonovine maleate is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine maleate tablets, USP are available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate. Tablets Active ingredient: Methylergonovine maleate, USP, 0.2 mg. Inactive ingredients: acacia, gelatin, lactose monohydrate, methylparaben, microcrystalline cellulose, povidone, propylparaben, sodium starch glycolate, stearic acid, and tartaric acid. 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: C 20 H 25 N 3 O 2 ∙C 4 H 4 O 4 Mol Wt: 455.51 Chemical Structure"],"precautions":["PRECAUTIONS General Caution should be exercised in the presence of sepsis, obliterative vascular disease. Also use with caution during the second stage of labor. The necessity for manual removal of a retained placenta should occur only rarely with proper technique and adequate allowance of time for its spontaneous separation. 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 coadministration 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, potent CYP 3A4 inhibitors should not be coadministered with methylergonovine. Examples of some of the more potent CYP 3A4 inhibitors include macrolide antibiotics (e.g., erythromycin, troleandomycin, clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g., ritonavir, indinavir, nelfinavir, delavirdine) or azole antifungals (e.g., ketoconazole, itraconazole, voriconazole). Less potent CYP 3A4 inhibitors should be administered with caution. Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with methylergonovine. CYP3A4 inducers Drugs (e.g. nevirapine, rifampicin) that are strong inducers of CYP3A4 are likely to decrease the pharmacological action of methylergonovine maleate tablets, USP. Beta-blockers Caution should be exercised when methylergonovine maleate tablets, USP are used concurrently with beta-blockers. Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids. Anesthetics Anesthetics like halothan and methoxyfluran may reduce the oxytocic potency of methylergonovine maleate tablets, USP. Glyceryl trinitrate and other antianginal drugs Methylergonovine maleate produces vasoconstriction and can be expected to reduce the effect of glyceryl trinitrate and other antianginal drugs. No pharmacokinetic interactions involving other cytochrome P450 isoenzymes are known. Caution should be exercised when methylergonovine maleate is used concurrently with other vasoconstrictors, ergot alkaloids, or prostaglandins. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies have been performed in animals to evaluate carcinogenic potential. The effect of the drug on mutagenesis or fertility has not been determined. 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 ). Labor and Delivery The uterotonic effect of methylergonovine maleate is utilized after delivery to assist involution and decrease hemorrhage, shortening the third stage of labor. Nursing Mothers Mothers should not breast-feed during treatment with methylergonovine maleate tablets, USP and at least 12 hours after administration of the last dose. Milk secreted during this period should be discarded. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies of methylergonovine maleate did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."],"how_supplied":["HOW SUPPLIED White, round, biconvex compressed tablets debossed with \"T\" on one side and \"01\" on the other side. Available in bottles of 12 and 28 tablets. Bottles of 12 NDC 83400-100-12 Bottles of 28 NDC 83400-100-28 STORE AND DISPENSE Tablets: Store below 25°C (77°F); in a tight, light-resistant container."],"geriatric_use":["Geriatric Use Clinical studies of methylergonovine maleate did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy."],"pediatric_use":["Pediatric Use Safety and effectiveness in pediatric patients have not been established."],"effective_time":"20240321","nursing_mothers":["Nursing Mothers Mothers should not breast-feed during treatment with methylergonovine maleate tablets, USP and at least 12 hours after administration of the last dose. Milk secreted during this period should be discarded."],"adverse_reactions":["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. 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"],"contraindications":["CONTRAINDICATIONS Hypertension; toxemia; pregnancy; and hypersensitivity."],"drug_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 coadministration 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, potent CYP 3A4 inhibitors should not be coadministered with methylergonovine. Examples of some of the more potent CYP 3A4 inhibitors include macrolide antibiotics (e.g., erythromycin, troleandomycin, clarithromycin), HIV protease or reverse transcriptase inhibitors (e.g., ritonavir, indinavir, nelfinavir, delavirdine) or azole antifungals (e.g., ketoconazole, itraconazole, voriconazole). Less potent CYP 3A4 inhibitors should be administered with caution. Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with methylergonovine. CYP3A4 inducers Drugs (e.g. nevirapine, rifampicin) that are strong inducers of CYP3A4 are likely to decrease the pharmacological action of methylergonovine maleate tablets, USP. Beta-blockers Caution should be exercised when methylergonovine maleate tablets, USP are used concurrently with beta-blockers. Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids. Anesthetics Anesthetics like halothan and methoxyfluran may reduce the oxytocic potency of methylergonovine maleate tablets, USP. Glyceryl trinitrate and other antianginal drugs Methylergonovine maleate produces vasoconstriction and can be expected to reduce the effect of glyceryl trinitrate and other antianginal drugs. No pharmacokinetic interactions involving other cytochrome P450 isoenzymes are known. Caution should be exercised when methylergonovine maleate is used concurrently with other vasoconstrictors, ergot alkaloids, or prostaglandins."],"how_supplied_table":["<table width=\"40%\" styleCode=\"Noautorules\"><col width=\"50%\" align=\"left\" valign=\"top\"/><col width=\"50%\" align=\"right\" valign=\"top\"/><tbody><tr><td>Bottles of 12</td><td>NDC 83400-100-12</td></tr><tr><td>Bottles of 28</td><td>NDC 83400-100-28</td></tr></tbody></table>"],"labor_and_delivery":["Labor and Delivery The uterotonic effect of methylergonovine maleate is utilized after delivery to assist involution and decrease hemorrhage, shortening the third stage of labor."],"general_precautions":["General Caution should be exercised in the presence of sepsis, obliterative vascular disease. Also use with caution during the second stage of labor. The necessity for manual removal of a retained placenta should occur only rarely with proper technique and adequate allowance of time for its spontaneous separation."],"storage_and_handling":["STORE AND DISPENSE Tablets: Store below 25°C (77°F); in a tight, light-resistant container."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Methylergonovine maleate acts directly on the smooth muscle of the uterus and increases the tone, rate, and amplitude of rhythmic contractions. Thus, it induces a rapid and sustained tetanic uterotonic effect which shortens the third stage of labor and reduces blood loss. The onset of action after I.V. administration is immediate; after I.M. administration, 2-5 minutes, and after oral administration, 5-10 minutes. Pharmacokinetic studies following an I.V. injection have shown that methylergonovine is rapidly distributed from plasma to peripheral tissues within 2-3 minutes or less. The bioavailability after oral administration was reported to be about 60% with no accumulation after repeated doses. During delivery, with intramuscular injection, bioavailability increased to 78%. Ergot alkaloids are mostly eliminated by hepatic metabolism and excretion, and the decrease in bioavailability following oral administration is probably a result of first-pass metabolism in the liver. Bioavailability studies conducted in fasting healthy female volunteers have shown that oral absorption of a 0.2 mg methylergonovine tablet was fairly rapid with a mean peak plasma concentration of 3243 ± 1308 pg/mL observed at 1.12 ± 0.82 hours. For a 0.2 mg intramuscular injection, a mean peak plasma concentration of 5918 ± 1952 pg/mL was observed at 0.41 ± 0.21 hours. The extent of absorption of the tablet, based upon methylergonovine plasma concentrations, was found to be equivalent to that of the I.M. solution given orally, and the extent of oral absorption of the I.M. solution was proportional to the dose following administration of 0.1, 0.2, and 0.4 mg. When given intramuscularly, the extent of absorption of methylergonovine maleate solution was about 25% greater than the tablet. The volume of distribution (Vd ss /F) of methylergonovine was calculated to be 56.1 ± 17.0 liters, and the plasma clearance (CLp/F) was calculated to be 14.4 ± 4.5 liters per hour. The plasma level decline was biphasic with a mean elimination half-life of 3.39 hours (range 1.5 to 12.7 hours). A delayed gastrointestinal absorption (T max about 3 hours) of methylergonovine maleate tablets might be observed in postpartum women during continuous treatment with this oxytocic agent."],"indications_and_usage":["INDICATIONS AND USAGE 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."],"spl_unclassified_section":["Rx Only","Manufactured by: Tulex Pharmaceuticals, Inc. Cranbury, NJ 08512 Manufactured for: Volley Pharmaceuticals, LLC Chester, NJ 07930 PI10001 Rev. 03/2024"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Orally One tablet, 0.2 mg, 3 or 4 times daily in the puerperium for a maximum of 1 week."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Methylergonovine maleate has not been associated with drug abuse or dependence of either a physical or psychological nature."],"spl_product_data_elements":["Methylergonovine Maleate Methylergonovine maleate Methylergonovine maleate Methylergonovine Acacia GELATIN, UNSPECIFIED Lactose monohydrate Methylparaben Microcrystalline cellulose POVIDONE, UNSPECIFIED Propylparaben SODIUM STARCH GLYCOLATE TYPE A Stearic acid Tartaric acid T;01"],"package_label_principal_display_panel":["PRINCIPAL DISPLAY PANEL - 0.2 mg Tablet Bottle Label NDC 83400-100-12 Methylergonovine Maleate Tablets, USP 0.2mg Volley Pharmaceuticals Rx Only 12 Tablets PRINCIPAL DISPLAY PANEL - 0.2 mg Tablet Bottle Label"],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term studies have been performed in animals to evaluate carcinogenic potential. The effect of the drug on mutagenesis or fertility has not been determined."]},"safety":{"boxedWarnings":[],"drugInteractions":[{"drug":"CYP 3A4 inhibitors (e.g., Macrolide Antibiotics and Protease Inhibitors)","severity":"major","mechanism":"Inhibition of CYP 3A4 metabolism","management":"Potent CYP 3A4 inhibitors should not be coadministered with methylergonovine. Less potent CYP 3A4 inhibitors should be administered with caution.","clinicalEffect":"Serious adverse events including vasospasm leading to cerebral ischemia and/or ischemia of the extremities"},{"drug":"CYP3A4 inducers (e.g., nevirapine, rifampicin)","severity":"moderate","mechanism":"Induction of CYP 3A4 metabolism","management":"Monitor for reduced efficacy of methylergonovine maleate.","clinicalEffect":"Decreased pharmacological action of methylergonovine maleate"},{"drug":"Beta-blockers","severity":"moderate","mechanism":"Enhanced vasoconstrictive action","management":"Exercise caution when using methylergonovine maleate with beta-blockers.","clinicalEffect":"Increased risk of vasoconstriction"},{"drug":"Anesthetics (e.g., halothan, methoxyfluran)","severity":"moderate","mechanism":"Reduction in oxytocic potency","management":"Monitor for reduced efficacy of methylergonovine maleate.","clinicalEffect":"Reduced effectiveness of methylergonovine maleate"},{"drug":"Glyceryl trinitrate and other antianginal drugs","severity":"moderate","mechanism":"Vasoconstriction","management":"Monitor for reduced efficacy of antianginal drugs.","clinicalEffect":"Reduced effect of glyceryl trinitrate and other antianginal drugs"}],"commonSideEffects":[{"effect":"Hypertension","drugRate":"","severity":"common","organSystem":""},{"effect":"Headache","drugRate":"","severity":"common","organSystem":""},{"effect":"Seizure","drugRate":"","severity":"common","organSystem":""},{"effect":"Hypotension","drugRate":"","severity":"common","organSystem":""},{"effect":"Abdominal pain","drugRate":"","severity":"common","organSystem":""},{"effect":"Nausea","drugRate":"","severity":"common","organSystem":""},{"effect":"Vomiting","drugRate":"","severity":"common","organSystem":""}],"contraindications":["Hypertension","Toxemia","Pregnancy","Hypersensitivity"],"seriousAdverseEvents":[{"effect":"Acute myocardial infarction","drugRate":"","severity":"serious"},{"effect":"Coronary arterial spasm","drugRate":"","severity":"serious"},{"effect":"Vasospasm","drugRate":"","severity":"serious"},{"effect":"Vasoconstriction","drugRate":"","severity":"serious"},{"effect":"Cerebrovascular accident","drugRate":"","severity":"serious"},{"effect":"Ventricular fibrillation","drugRate":"","severity":"serious"},{"effect":"Ventricular tachycardia","drugRate":"","severity":"serious"},{"effect":"Atrioventricular block","drugRate":"","severity":"serious"},{"effect":"Anaphylaxis","drugRate":"","severity":"serious"},{"effect":"Water intoxication","drugRate":"","severity":"serious"}]},"_chembl":null,"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=METHYLERGONOVINE MALEATE","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T07:04:29.961887+00:00"},"aiSummary":{"url":"","method":"ai_extraction","source":"AI Strategic Summary","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"ai_extraction","retrievedAt":"2026-04-20T07:05:39.838904+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T07:04:35.966664+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=METHYLERGONOVINE MALEATE","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T07:04:36.598768+00:00"},"administration.route":{"url":"","method":"deterministic","source":"FDA Label","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:04:27.886122+00:00"},"indications.approved":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:05:33.164286+00:00"},"safety.boxedWarnings":{"url":"","method":"deterministic","source":"FDA Label (no boxed warning)","rawText":"","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:04:27.886178+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Dopamine D1 receptor antagonist","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T07:04:37.345292+00:00"},"safety.drugInteractions":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.9,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:05:21.144701+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1200843/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T07:04:37.252241+00:00"},"safety.commonSideEffects":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"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. Rarely observed reactions have included: acute myocardial infarction, transient chest pains, vasoconstriction, vasospasm, coronary arterial spasm, bradycardia, tachycardia, dyspnea, hematuria, thrombophlebitis, water intoxication, hallucinati","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:04:41.966247+00:00"},"safety.contraindications":{"url":"","method":"ai_extraction","source":"FDA Label + AI","aiModel":"featherless","rawText":"","confidence":0.95,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:04:45.159957+00:00"},"regulatory.fda_application":{"url":"","method":"deterministic","source":"FDA Label","rawText":"ANDA212233","confidence":1,"sourceType":"fda_label","retrievedAt":"2026-04-20T07:04:27.886190+00:00"}},"_dailymed":{"setId":"4ddcdfff-1468-bff0-e063-6294a90a5480","title":"METHYLERGONOVINE MALEATE INJECTION, SOLUTION [HF ACQUISITION CO. LLC. DBA HEALTHFIRST]"},"aiSummary":"Methylergonovine Maleate is a marketed drug primarily indicated for the routine management of uterine atony. The key composition patent is set to expire in 2028, providing a clear period of exclusivity and potential revenue stability. The primary risk is the lack of significant trial results or revenue data, which may limit strategic planning and investor confidence.","_scrapedAt":"2026-03-28T00:33:53.973Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"_validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-20T07:05:39.839221+00:00","fieldsConflicting":0,"overallConfidence":0.95},"indications":{"approved":[{"id":"methylergonovine-maleate-routine-management-of-uterine-","name":"Routine management of uterine atony","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Postpartum patients","pivotalTrial":null,"restrictions":[],"patientPopulation":"Postpartum patients","diagnosticRequired":null,"brandNameForIndication":""},{"id":"methylergonovine-maleate-control-of-uterine-hemorrhage-","name":"Control of uterine hemorrhage in second stage of labor","dosing":null,"approvals":[],"diseaseId":"","eligibility":"Patients in the second stage of labor","pivotalTrial":null,"restrictions":[],"patientPopulation":"Patients in the second stage of labor","diagnosticRequired":null,"brandNameForIndication":""}]},"trialDetails":[{"nctId":"NCT07390864","phase":"NA","title":"Ergometrine Versus Carbetocin to Decrease Blood Loss in Myomectomy","status":"RECRUITING","sponsor":"Cairo University","startDate":"2026-01-18","conditions":"Myoma;Uterus","enrollment":40},{"nctId":"NCT07318467","phase":"NA","title":"Prophylactic Regimen of Intravenous Oxytocin, Intravenous Tranexamic Acid, and Intramuscular Ergot Derivative for Primary Prevention of Postpartum Hemorrhage in Intrapartum Cesarean Section Versus Intravenous Carbetocin Alone","status":"NOT_YET_RECRUITING","sponsor":"Cairo University","startDate":"2026-01-01","conditions":"Post Partum Hemorrhage","enrollment":80},{"nctId":"NCT03584854","phase":"PHASE4","title":"Second-Line Uterotonics in Postpartum Hemorrhage: A Randomized Clinical Trial","status":"COMPLETED","sponsor":"Brigham and Women's Hospital","startDate":"2019-03-01","conditions":"Postpartum Hemorrhage, Uterine Atony","enrollment":100},{"nctId":"NCT05772156","phase":"PHASE4","title":"Prophylactic Methylergonovine for Twin Cesarean","status":"COMPLETED","sponsor":"Columbia University","startDate":"2023-03-07","conditions":"Twin; 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