Following delivery of the 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.
Hypertension; toxemia; pregnancy; and hypersensitivity.
Hypertension; toxemia; pregnancy; and hypersensitivity.
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: 1. removal of offending drug by inducing emesis, gastric lavage, catharsis, and supportive diuresis. 2. maintenance of adequate pulmonary ventilation, especially if convulsions or coma develop. 3. correction of hypotension with pressor drugs as needed. 4. control of convulsions with standard anticonvulsant agents. 5. control of peripheral vasospasm with warmth to the extremities if needed.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
NDC 51991-144-17 Methylergonovine Maleate Injection, USP 0.2 mg/mL Rx Only 10 x 1 mL ampules single dose breckenridge A Towa Company
| Class | Version | Type | Effective |
|---|---|---|---|
| METHYLERGONOVINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| f8d59645-13e1-4381-94b1-6ca9c8d64fc8 | Product name | 5 | 20210615 |
| 12fc2a28-7c95-8272-24e2-ad0f6361d10b | Product name | 2 | 20180723 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51991-144-17 | METHYLERGONOVINE MALEATE | 1 mL in 1 AMPULE | INJECTION | 1 | 8 | |
| 51991-144-17 | METHYLERGONOVINE MALEATE | 10 in 1 BOX | INJECTION | 10 | 8 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 51991-144-17 | ML - Milliliter | 51991-144 | 08f511eb-6c16-46a0-b813-7dc4ad768f8d | 1 | 2016-12-07 |
| Product NDC | Package NDC |
|---|---|
| 51991-144 | 51991-144-17 |
| Name | UNII | Kind |
|---|---|---|
| Methylergonovine Maleate | IR84JPZ1RK | ACTIB |
| Maleic Acid | 91XW058U2C | IACT |
| Sodium Chloride | 451W47IQ8X | IACT |
| Water | 059QF0KO0R | IACT |
Rx only
Methylergonovine Maleate Injection, USP is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum hemorrhage. Methylergonovine Maleate Injection, USP is available in sterile ampules of 1 mL, containing 0.2 mg methylergonovine maleate for intramuscular or intravenous injection. Ampules: 1 mL, clear, colorless solution. Active Ingredient: methylergonovine maleate, USP, 0.2 mg. Inactive Ingredients: maleic acid, 0.10 mg; sodium chloride, 7.0 mg; water for injection, qs to 1 mL. Chemically, methylergonovine maleate is designated as ergoline-8-carboxamide, 9,10-didehydro- N -[l-(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
Following delivery of the 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.
Hypertension; toxemia; pregnancy; and hypersensitivity.
Methylergonovine maleate has not been associated with drug abuse or dependence of either a physical or psychological nature.
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: 1. removal of offending drug by inducing emesis, gastric lavage, catharsis, and supportive diuresis. 2. maintenance of adequate pulmonary ventilation, especially if convulsions or coma develop. 3. correction of hypotension with pressor drugs as needed. 4. control of convulsions with standard anticonvulsant agents. 5. control of peripheral vasospasm with warmth to the extremities if needed.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.
REV: June 2025 Manufactured by: Pharmaceutical Works Jelfa S.A. 58-500 Jelenia Góra, Poland Distributed by: Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922 210114
NDC 51991-144-17 Methylergonovine Maleate Injection, USP 0.2 mg/mL Rx Only 10 x 1 mL ampules single dose breckenridge A Towa Company