Methergine .2 mg/1

Methylergonovine maleate · TABLET · Lupin Pharmaceuticals,Inc.

No Recall History

Plain English

Methergine is a tablet containing methylergonovine maleate at .2 mg/1, taken oral. Manufactured by Lupin Pharmaceuticals,Inc..

Key Facts

Brand Name: Methergine
Generic Name: Methylergonovine maleate
NDC Code (Product): 27437-050
Manufacturer: Lupin Pharmaceuticals,Inc.
Strength: .2 mg/1
Dosage Form: TABLET
Route: ORAL
Marketing Status
Application #: ANDA091577
Marketing Start: 04/04/2016

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

wrong drug administered68 reports

drug exposure during pregnancy51 reports

vomiting45 reports

dyspnoea38 reports

abdominal pain36 reports

headache36 reports

nausea35 reports

drug ineffective31 reports

haemorrhage28 reports

dizziness25 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

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 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 2-4 hours. Intravenously 1 mL, 0.2 mg, administered slowly over a period of no less than 60 seconds (See WARNINGS .) 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, Methergine (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 Methergine. Milk secreted during this period should be discarded. Methergine may produce adverse effects in the breast-feeding infant. Methergine may also reduce the yield of breast milk. Mothers should wait at least 12 hours after administration of the last dose of Methergine 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. M…

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. 1 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 Methergine 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 tachycar…

Frequently Asked Questions

What is Methergine used for?

Methergine contains Methylergonovine maleate. It is a tablet taken oral. Consult your doctor for specific uses.

Is Methergine a controlled substance?

Methergine is not classified as a controlled substance by the DEA.

What is the generic name for Methergine?

The generic name for Methergine is Methylergonovine maleate. There are 11 other brand versions of Methylergonovine maleate.

What is the NDC code for Methergine .2 mg/1?

The NDC (National Drug Code) for Methergine .2 mg/1 is 27437-050, listed by Lupin Pharmaceuticals,Inc..

Product NDC

27437-050

Package NDC

27437-050-56

Other Methylergonovine Brands

See all →

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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