Methylergonovine Maleate

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Methylergonovine Maleate Recall

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Side Effects & Adverse Reactions

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.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

For routine management after delivery of the placenta; postpartum atony and hemorrhage; subinvolution. Under full obstetric supervision, it may be given in the second stage of labor following delivery of the anterior shoulder.

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History

There is currently no drug history available for this drug.

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Other Information

Methylergonovine Maleate Tablets, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage.

Methylergonovine Maleate Tablets, USP is available in tablets for oral ingestion containing 0.2 mg methylergonovine maleate.

Tablets

Active ingredient: Methylergonovine maleate, USP 0.2 mg

Inactive ingredients: acacia, corn starch, gelatin, lactose anhydrous, methylparaben, microcrystalline cellulose, povidone, propylparaben, stearic acid, 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:

C20H25N3O2•C4H4O4 Mol Wt: 455.51

Sources

Methylergonovine Maleate Manufacturers

Novel Laboratories, Inc.

Methylergonovine Maleate | Novel Laboratories, Inc.

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

Dosage same as intramuscular. (See WARNINGS.)

Orally

One tablet, 0.2 mg, 3 to 4 times daily in the puerperium for a maximum of 1 week.

No Recall
Akorn, Inc.

Methylergonovine Maleate | Pernix Therapeutics, Llc

The recommended doses of CEDAX Oral Suspension are presented in the table below. CEDAX Oral Suspension must be administered at least 2 hours before or 1 hour after a meal.

No Recall
Pharmacist Pharmaceutical, Llc

Methylergonovine Maleate | Pharmacist Pharmaceutical, Llc

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
Dosage same as intramuscular. (See WARNINGS.)
Orally
One tablet, 0.2 mg, 3 to 4 times daily in the puerperium for a maximum of 1 week.

No Recall
Pd-rx Pharmaceuticals, Inc.

Methylergonovine Maleate | Pd-rx Pharmaceuticals, Inc.

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
Dosage same as intramuscular. (See WARNINGS.)
Orally
One tablet, 0.2 mg, 3 to 4 times daily in the puerperium for a maximum of 1 week.

No Recall
Kaiser Foundation Hospitals

Methylergonovine Maleate | Kaiser Foundation Hospitals

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

Dosage same as intramuscular. (See WARNINGS.)

Orally

One tablet, 0.2 mg, 3 to 4 times daily in the puerperium for a maximum of 1 week.

No Recall
American Health Packaging

Methylergonovine Maleate | American Health Packaging

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

Dosage same as intramuscular. (See WARNINGS )

Orally

One tablet, 0.2 mg, 3 to 4 times daily in the puerperium for a maximum of 1 week.

No Recall
American Regent, Inc.

Methylergonovine Maleate | American Regent, Inc.

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
One tablet, 0.2 mg, 3 or 4 times daily in the puerperium for a maximum of 1 week.

No Recall
Remedyrepack Inc.

Methylergonovine Maleate | Remedyrepack Inc.

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

Dosage same as intramuscular. (See WARNINGS.)

Orally

One tablet, 0.2 mg, 3 to 4 times daily in the puerperium for a maximum of 1 week.

No Recall
Pharmacist Pharmaceutical, Llc

Methylergonovine Maleate | Pharmacist Pharmaceutical, Llc

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.)

No Recall
Gavis Pharmaceuticals, Llc

Methylergonovine Maleate | Gavis Pharmaceuticals, Llc

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.

No Recall