EXPAND
CLOSE

INDICATIONS

Methergine® (methylergonovine maleate) is indicated for routine management of uterine atony, hemorrhage and subinvolution of the uterus following delivery of placenta and for control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.

IMPORTANT SAFETY INFORMATION

Methergine Tablets are contraindicated for patients with the following conditions: hypertension, toxemia, pregnancy, and hypersensitivity.

 

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.

Medication errors: Inadvertent administration of Methergine 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. Methergine 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, Methergine injection should be stored separately from medications intended for neonatal administration.

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: 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.

Caution should be exercised when Methergine® Tablets are used concurrently with beta-blockers. Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids.

ADVERSE REACTIONS

The most common adverse reaction is hypertension associated in several cases with seizure and/or headache. Hypotension and anaphylaxis has also been reported. Cerebrovascular accident, paraesthesia, ventricular fibrillation, ventricular tachycardia, angina pectoris, atrioventricular block were also reported post-marketing.

Safety and effectiveness in pediatric patients have not been established.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or contact Lupin at 1-800-399-2561.


Please note that this information is not comprehensive. Please see full Prescribing Information.

EXPAND
CLOSE

INDICATIONS

Methergine® (methylergonovine maleate) is indicated for routine management of uterine atony, hemorrhage and subinvolution of the uterus following delivery of placenta and for control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder.

IMPORTANT SAFETY INFORMATION

Methergine Tablets are contraindicated for patients with the following conditions: hypertension, toxemia, pregnancy, and hypersensitivity.

 

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.

Medication errors: Inadvertent administration of Methergine 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. Methergine 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, Methergine injection should be stored separately from medications intended for neonatal administration.

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: 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.

Caution should be exercised when Methergine® Tablets are used concurrently with beta-blockers. Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids.

ADVERSE REACTIONS

The most common adverse reaction is hypertension associated in several cases with seizure and/or headache. Hypotension and anaphylaxis has also been reported. Cerebrovascular accident, paraesthesia, ventricular fibrillation, ventricular tachycardia, angina pectoris, atrioventricular block were also reported post-marketing.

Safety and effectiveness in pediatric patients have not been established.


You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088, or contact Lupin at 1-800-399-2561.


Please note that this information is not comprehensive. Please see full Prescribing Information.