Methylergonovine Maleate .2 mg/1
Methylergonovine maleate · TABLET · Volley Pharmaceuticals, LLC
Methylergonovine Maleate is a tablet containing methylergonovine maleate at .2 mg/1, taken oral. Manufactured by Volley Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Methylergonovine Maleate
- Generic Name
- Methylergonovine maleate
- NDC Code (Product)
83400-100- Manufacturer
- Volley Pharmaceuticals, LLC
- Strength
- .2 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA212233
- Marketing Start
- 03/15/2024
Recall History
Aidapak Services, LLC
Labeling: Label Mixup; METHYLERGONOVINE MALEATE Tablet, 0.2 mg may be potentially mislabeled as ISOSORBIDE MONONITRATE, Tablet, 20 mg, NDC 62175010701, Pedigree: AD52778_31, EXP: 5/20/2014; LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00378180701, Pedigree: W003476, EXP: 6/20/2014.
Amneal Pharmaceuticals, Inc.
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Amneal Pharmaceuticals of New York, LLC
Failed Dissolution Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Orally One tablet, 0.2 mg, 3 or 4 times daily in the puerperium for a maximum of 1 week.
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 deve…
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…
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, ventricu…
Frequently Asked Questions
What is Methylergonovine Maleate used for?
Methylergonovine Maleate contains Methylergonovine maleate. It is a tablet taken oral. Consult your doctor for specific uses.
Is Methylergonovine Maleate a controlled substance?
Methylergonovine Maleate is not classified as a controlled substance by the DEA.
What is the generic name for Methylergonovine Maleate?
The generic name for Methylergonovine Maleate is Methylergonovine maleate. There are 7 other brand versions of Methylergonovine maleate.
What is the NDC code for Methylergonovine Maleate .2 mg/1?
The NDC (National Drug Code) for Methylergonovine Maleate .2 mg/1 is 83400-100, listed by Volley Pharmaceuticals, LLC.