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Ergonovine (Systemic)



INN:

Ergometrine {02}

VA CLASSIFICATION
Primary: GU600
Secondary: GU900; DX900

Commonly used brand name(s): Ergotrate; Ergotrate Maleate.

Another commonly used name is
ergometrine . {26} {34}
Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Uterine stimulant—

diagnostic aid (coronary vasospasm)—

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Hemorrhage, postpartum and postabortal (prophylaxis and treatment){03}{05}{07}{13}{22}{25}{26}{29}{35}—Ergonovine is indicated in the prevention or treatment of postpartum or postabortal uterine bleeding due to uterine atony or subinvolution. {03} {05} {07} {22} {25} {34} {39} Its use is not recommended prior to delivery of the placenta since placental entrapment may occur {25} {26} {34} {35} {39}.

[Abortion, incomplete (treatment)]1—In cases of incomplete abortion, ergonovine may be used to hasten expulsion of uterine contents.

[Angina pectoris (diagnosis)]1{14}{15}{16}{17}{18}{19}{20}{25}{26}{30}{34}—Ergonovine is used as an aid in the diagnosis of variant angina pectoris {14} {15} {16} {17} {18} {19} {20} {25} {26} {30} {34}. Use of ergonovine for this indication should only be undertaken by cardiologists experienced in this use. Careful monitoring is required, as myocardial infarction and death have been reported with the use of ergonovine during this procedure. {28}

Unaccepted
Ergonovine is not as effective in treatment of migraine as other ergot alkaloids and, therefore, its use for this indication is not recommended. {26}

Ergonovine is not indicated for induction or augmentation of labor, to induce abortion, or in cases of threatened spontaneous abortion because of its propensity to produce nonphysiologic, tetanic contractions and its long duration of action {03} {07} {22} {25} {26} {29} {33} {34} {35}.

Ergonovine has been used in the diagnosis of esophageal spasm. {14} {15} {16} {26} {40} However, its use for this procedure is not generally recommended. {26} {40}

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:

Chemical group—
    Amine ergot alkaloid {03} {05} {25} {34}.
Molecular weight—
    441.48 {02}

Mechanism of action/Effect:


Uterine stimulant:

Ergonovine directly stimulates the uterine muscle to increase force and frequency of contractions. {22} {23} {25} {34} With usual doses, these contractions precede periods of relaxation; with larger doses, basal uterine tone is elevated and these relaxation periods will be decreased. {25} {34} {41} Contraction of the uterine wall around bleeding vessels at the placental site produces hemostasis {39}. Ergonovine also induces cervical contractions. {25} {43} The sensitivity of the uterus to the oxytocic effect is much greater toward the end of pregnancy. {07} {22} {26} {34} {35} The oxytocic actions of ergonovine are greater than its vascular effects. {28} {34} {35}



Vasoconstriction:

Ergonovine, like other ergot alkaloids, produces arterial vasoconstriction by stimulation of alpha-adrenergic and serotonin receptors and inhibition of endothelial-derived relaxation factor release. {16} {19} {23} {30} {34} {38} It is a less potent vasoconstrictor than ergotamine. {07} {35}



Diagnostic aid (coronary vasospasm):

Ergonovine causes vasoconstriction of coronary arteries. {16} {17} {18} {19} {20} {25} {34} {38}



Other actions/effects:

Ergonovine has minor actions on the central nervous system (CNS). {34} In the CNS, ergonovine is a partial agonist and partial antagonist at some serotonin and dopamine receptors. {34} Ergonovine also possesses weak dopaminergic antagonist actions in certain blood vessels {34} and partial agonist actions at serotonin receptors in umbilical and placental blood vessels {34}. It does not possess significant alpha-adrenergic blocking activity. {07} {34} {35}

Absorption:

Absorption is rapid and complete after oral or intramuscular administration. {25} {26} {34}

Biotransformation:

Hepatic {25} {34} {41}.

Onset of action:


Contraction of uterus, postpartum {03}:

Oral: 6 to 15 minutes. {03} {07} {25} {26} {34} {35}

Intramuscular: 2 to 3 minutes. {05} {07} {25} {35}

Intravenous: One minute or less. {07} {25} {26} {35}


Time to peak concentration:

60 to 90 minutes (plasma), after oral dosing. {34} {41}

Duration of action:


Contraction of uterus, postpartum:

Oral: Approximately 3 hours. {03} {07} {25}

Intramuscular: Approximately 3 hours. {25}

Intravenous: 45 minutes {25} (although rhythmic contractions may persist for up to 3 hours).


Elimination:
    Renal excretion of metabolites. {25} {34} {41}

Note: It is not known if use of forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion will hasten the elimination of ergonovine, especially in overdose. {03}



Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to other ergot derivatives may be sensitive to this medication also, although there is some degree of variation among ergot alkaloids in their ability to elicit oxytocic, CNS, or vasoconstrictive effects. {03} {34}

Pregnancy/Reproduction
Fertility—
Ergonovine has been shown to increase fallopian tube motility. {26}

Pregnancy—
Use of ergonovine is contraindicated during pregnancy. {23} {27} Tetanic contractions may result in decreased uterine blood flow and fetal distress. {27}


Labor and delivery—

High doses of ergonovine administered prior to delivery may cause uterine tetany and problems in the infant (hypoxia, intracranial hemorrhage) {03}. Ergonovine should not be administered prior to delivery of the placenta. {07} {22} {24} {25} {26} {34} {35} {39} Administration prior to delivery of the placenta may cause captivation of the placenta {07} {22} {24} {25} {26} {34} {35} {39} or missed diagnosis of a second infant, due to excessive uterine contraction. {39}

Breast-feeding

Problems in humans have not been documented. However, ergot alkaloids are excreted in breast milk. {07} {35} Although inhibition of lactation has not been reported for ergonovine, other ergot alkaloids inhibit lactation. Also, studies have shown that ergonovine interferes with the secretion of prolactin (to a lesser degree than bromocriptine) in the immediate postpartum period. {22} {27} {34} This could result in delayed or diminished lactation with prolonged use. {22} {27} {34} {39}

Ergot alkaloids have the potential to cause chronic ergot poisoning in the infant if used in higher-than-recommended doses or if used for a longer period of time than is generally recommended. {07} {27} {34}

Pediatrics

Elimination of ergonovine may be prolonged in newborns {25}. Neonates inadvertently administered ergonovine in overdose amounts have developed respiratory depression, cyanosis, seizures, decreased urine output, and severe peripheral vasoconstriction. {26} {28} {32}


Geriatrics


No information is available on the effects of ergonovine in geriatric patients.

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

Anesthetics, general, especially halothane{26}{28}{29}{35}    (peripheral vasoconstriction may be potentiated by the concurrent use of general anesthetics {28})

    (concurrent use of halothane in concentrations greater than 1% may interfere with the oxytocic actions of ergonovine, resulting in severe uterine hemorrhage {26} {29})


Bromocriptine{10}{38} or
Ergot alkaloids, other{38}{46}    (the incidence of rare cases of hypertension, strokes, seizures, and myocardial infarction associated with the postpartum use of bromocriptine may be increased with the use of ergot alkaloids {10} {38} {41} {46})


Nicotine or
Smoking, tobacco    (nicotine absorption from heavy smoking may result in enhanced vasoconstriction)


Nitroglycerin{21}{40} or
Antianginal agents, other{40}    (ergot alkaloids may induce coronary vasospasm, lowering the efficacy of nitroglycerin or other antianginal agents {21} {40}; increased doses of nitroglycerin or antianginal agents and/or use of intracoronary nitroglycerin may be necessary {42})


Vasoconstrictors, other, including those present in some local anesthetics or{07}{25}{26}{35}{39}
Vasopressors{07}{21}{26}    (concurrent use may result in enhanced vasoconstriction; dosage adjustments may be necessary {07} {26} {35})

    (the pressor effect of sympathomimetic pressor amines may be potentiated, resulting in potentially severe hypertension, headache, and rupture of cerebral blood vessels {25} {26}; gangrene developed in a patient receiving both dopamine and ergonovine infusions {21} {26})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With physiology/laboratory test values
Blood pressure{25}{29}{34}{38}{39}{46} or
Central venous pressure{25}    (may be elevated due to peripheral vasoconstriction, primarily of postcapillary vessels {25} {34} {38} {46}; has sometimes been associated with preeclampsia, history of hypertension, intravenous administration of ergonovine, or concurrent use of local anesthetics containing vasoconstrictors {03} {38} {46}; hypotension has also been reported {25} {34} {38})


Heart rate{28}{34}{38}    (may be decreased due primarily to an increase in vagal tone, and possibly to decreased central sympathetic activity and direct depression of the myocardium {28} {34} {38})


Prolactin{22}    (serum concentrations may be decreased during the postpartum period {22} {41})


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Except under special circumstances, this medication should not be used when the following medical problems exist:

For all indications:
» Angina pectoris, unstable or{19}{25}{26}{40}
» Myocardial infarction, recent{19}{25}{26}{40}    (vasospasm caused by ergonovine may precipitate angina or myocardial infarction {03} {07} {16} {40})


» Cerebrovascular accident, history of or{19}{40}
» Transient ischemic attack, history of{19}{40}    (patients may be susceptible to recurrence due to increases in blood pressure)


» Hypertension, severe, or history of{03}{19}{23}{25}{26}{29}{35}{38}{39}{40}{46}    (may be exacerbated {03} {07} {16} {19} {25} {26} {46})


For obstetric uses only:
» Coronary artery disease{03}{07}{16}{19}{23}{25}{26}{34}{40}    (patients may be more susceptible to angina or myocardial infarction caused by ergonovine-induced vasospasm)


» Eclampsia or{40}{46}
» Preeclampsia{07}{25}{26}{35}{38}{39}{40}{46}    (may be exacerbated {03} {07} {16} {19} {25} {26} {46}; patients may be more likely to develop ergonovine-induced hypertension {25} {39} {46}; headaches, severe cardiac arrhythmias, seizures, and cerebrovascular accidents have occurred {25} {29} {40} {46})


» Occlusive peripheral vascular disease{07}{23}{25}{26}{29}{34}{40} or
» Raynaud's phenomenon, severe{19}{34}{35}{40}    (may be exacerbated {07} {19} {34}; a patient with Raynaud's phenomenon developed impalpable arterial pulses {28})


Risk-benefit should be considered when the following medical problems exist
Allergy, hypersensitivity, or intolerance to ergonovine or other ergot alkaloids{03}{25}{29}{35}
» Cardiovascular disease or{03}{25}{26}{29}{35}{38}{39}{40}
» Coronary artery disease (in diagnosis of angina){03}{07}{16}{19}{23}{25}{26}{34}{40} or
» Mitral valve stenosis or{03}{25}{40}
» Venoatrial shunts{03}{25}{40}    (vasospasm caused by ergonovine may precipitate angina or myocardial infarction {03} {07} {16} {40})

    (in patients with pre-existing coronary artery disease, careful monitoring is critical during the diagnosis of angina because severe chest pain, myocardial ischemia, myocardial infarction, and death may occur more frequently and/or as a result of overdose {03} {07} {16})


» Hepatic function impairment{03}{23}{25}{26}{29}{34}    (impaired metabolism of ergonovine may result in ergot overdose)


Hypocalcemia{03}{07}    (oxytocic response to ergonovine may be reduced; cautious use of intravenous calcium gluconate may restore oxytocic response to ergonovine {03})


» Positive response to ergonovine testing, history of or{17}
» Electrocardiograph abnormalities such as ST changes during exercise or episodes of chest pain or prolonged QT interval (atrioventricular block) during chest pain, rest, or activity{17}{40}    (ergonovine should not be used routinely in the diagnosis of variant angina in these patients because prolonged coronary vasoconstriction may precipitate angina, acute myocardial infarction, or heart failure {21})


» Renal function impairment{03}{19}{23}{25}{26}{29}
» Sepsis{03}{23}{25}{26}{34}    (possible increased sensitivity to the effects of ergonovine {34})



Patient monitoring
The following may be especially important in patient monitoring (other tests may be warranted in some patients, depending on condition; » = major clinical significance):


For obstetric uses
Blood pressure determinations and{03}
Pulse rate determinations and{03}
Uterine response{03}    (recommended at frequent intervals after parenteral therapy to monitor for adverse reactions; especially important with intravenous administration {03})


For diagnosis of variant angina pectoris
Blood pressure and{19}{20}
Electrocardiogram (ECG){17}{18}{20}{28}{34}    (recommended throughout procedure)




Side/Adverse Effects

Note: Because the duration of therapy with ergonovine is generally short, many of the side effects seen with other ergot alkaloids do not occur.

The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence less frequent
    
Bradycardia {26}{28}{34}{39}(slow heartbeat)
    
coronary vasospasm {07}{13}{14}{16}{18}{19}{20}{21}{23}{25}{26}{34}{35}{38}{39}(chest pain)

Incidence rare
    
Allergic reaction{03}{25} , including shock
    
cardiac arrest{26}{28}{30}{38}{39} or ventricular arrhythmias, including fibrillation and tachycardia {19}{20}{25}{26}{30}{35}{39}(irregular heartbeat)
    
dyspnea {25}{26}{35}(unexplained shortness of breath)
    
hypertension, sudden and severe {03}{07}{16}{19}{25}{26}{28}{28}{29}{31}{34}{35}{38}{39}(sudden, severe headache; blurred vision; seizures)
    
myocardial infarction {03}{13}{20}{26}{30}{38}{39}(crushing chest pain; unexplained shortness of breath)—has occurred with the use of ergot preparations in the postpartum period{03}{38}{39} and with the use of ergonovine for the diagnosis of variant angina{28}
    
peripheral vasospasm (itching of skin; pain in arms, legs, or lower back; pale or cold hands or feet; weakness in legs)—dose-related{25}{31}{34}



Those indicating need for medical attention only if they continue or are bothersome
Incidence more frequent
    
Nausea —especially after intravenous use{03}{07}{25}{26}{28}{29}{34}{35}{44}{45}
    
uterine cramping{03}
    
vomiting —especially after intravenous use{03}{25}{26}{28}{29}{34}{35}{43}{44}{45}

Note: Uterine cramping will occur to some degree in all patients and is indicative of efficacy. However, dosage reduction may be required in occasional patients with severe or intolerable uterine cramps.


Incidence less frequent
    
Abdominal or stomach pain{26}{44}
    
diarrhea{07}{25}{34}{35}
    
dizziness{07}{25}{26}{34}{35}
    
headache, mild and transient{25}{26}
    
nasal congestion{25}
    
sweating{25}
    
tinnitus {25}{26}(ringing in the ears)
    
unpleasant taste{25}





Overdose
For specific information on the agents used in the management of ergonovine overdose, see:
   • Charcoal, Activated (Oral-Local) monograph;
   • Chlorpromazine in Phenothiazines (Systemic) monograph;
   • Diazepam in Benzodiazepines (Systemic) monograph;
   • Hydralazine (Systemic) monograph;
   • Laxatives (Local) monograph;
   • Nitroglycerin in Nitrates (Systemic) monograph;
   • Nitroprusside (Systemic) monograph;
   • Phentolamine (Systemic) monograph;
   • Phenytoin in Anticonvulsants, Hydantoin (Systemic) monograph; and/or
   • Tolazoline (Parenteral-Systemic) monograph.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing).

Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
Acute
    
Angina (chest pain){34}
    
bradycardia (slow heartbeat){34}
    
confusion {34}
    
drowsiness {34}
    
fast, weak pulse {34}
    
miosis (small pupils){34}
    
peripheral vasoconstriction, severe ( cool, pale, or numb arms or legs; muscle pain; weak or absent arterial pulse in arms or legs; tingling, itching, and cool skin {34})
    
respiratory depression ( decreased breathing rate or trouble in breathing; bluish color of skin or inside of nose or mouth){03}{26}
    
seizures {03} {26} {34}
    
tachycardia (fast heartbeat){34}
    
unconsciousness {25} {34}
    
unusual thirst {34}
    
uterine tetany (severe cramping of the uterus ){03}{34}

Chronic
    
Formication (false feeling of insects crawling on the skin){25}{34}
    
gangrene (dry, shriveled appearance of skin on hands, lower legs, or feet){11}{12}{26}{31}{34}{35}
    
hemiplegia (paralysis of one side of the body){34}
    
thrombophlebitis {25} {34} (pain and redness in an arm or leg)

Note: Chronic overdose symptoms are unlikely with proper use since treatment is of short duration. {11} {12} {25} {26} {34} {39}



Treatment of overdose
Immediate discontinuation of ergonovine. {03} {11} {12} {26} {34} Since there is no specific antidote for the management of ergonovine overdose, treatment is primarily supportive and symptomatic and may include the following: {26} {34}

To decrease absorption—Gastrointestinal decontamination for oral overdose, preferably with multiple doses of activated charcoal and an appropriate cathartic. {03} {23} Gastric lavage may also be considered. {03} {23} It is not known if use of forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion will hasten the elimination of ergonovine, especially in overdose. {03}

Specific treatment—

Use of nitroglycerin for treatment of myocardial ischemia {03} {16} {20} {26} {30} {34}. Intracoronary nitroglycerin may be necessary. {16} {17} {26} {30}

Use of diazepam or phenytoin for treatment of seizures. {03} {23} {26}

Use of sodium nitroprusside, tolazoline, or phentolamine for treatment of peripheral ischemia. {03} {23} {26}

Use of sodium nitroprusside, chlorpromazine 15 mg, or hydralazine for treatment of severe hypertension. {03} {07} {25} {26} {34} {35}

Monitoring—Frequent monitoring of vital signs, arterial blood gases, and electrolytes. {03} {23} Monitoring of serum ergonovine levels is not predictive of the outcome of overdose. {03} Electrocardiogram monitoring to assess cardiac function and perfusion. {03}

Supportive care—May include maintaining an open airway and breathing, maintaining proper fluid and electrolyte balance, correcting hypertension, and controlling seizures. Patients in whom intentional overdose is known or suspected should be referred for psychiatric consultation.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Ergonovine/Methylergonovine (Systemic).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Allergies, hypersensitivity, or intolerance to ergonovine or other ergot alkaloids

Pregnancy—Should not be administered prior to delivery or delivery of the placenta





Breast-feeding—Ergot alkaloids are excreted in breast milk
Other medical problems, especially cardiac or vascular disease, hepatic function impairment, severe hypertension or history of hypertension, renal function impairment, and sepsis

Proper use of this medication
» Importance of not using more medication or for longer than prescribed; risk of ergotism and gangrene with prolonged use

» Proper dosing
Missed dose: Not taking at all; not doubling doses

» Proper storage

Precautions while using this medication
Notifying physician if infection develops, since infection may cause increased sensitivity to medication


Side/adverse effects
Signs of potential side effects, especially allergic reaction, coronary vasospasm or other cardiovascular complications, dyspnea, severe hypertension, or peripheral vasospasm


General Dosing Information
Antiemetic medications such as prochlorperazine may be administered prior to use of ergonovine. {25} {26} {34}

For parenteral dosage forms only
Because the risk of severe adverse effects is increased with intravenous use of ergonovine, its use is recommended only for emergencies such as excessive uterine bleeding. {05} {24} {25} {29} {35} {39} {46}

If intravenous use is warranted, administration must be done slowly, over a period of at least 1 minute {24}. Some clinicians recommend dilution of the solution before administration. {39}

In some patients who do not respond to ergonovine because of hypocalcemia, cautious intravenous administration of calcium gluconate (provided the patient is not receiving digitalis) may restore the oxytocic action. {25} {35}


Oral Dosage Forms

ERGONOVINE MALEATE TABLETS USP

Usual adult and adolescent dose
Uterine stimulant
Oral or sublingual, 200 to 400 mcg (0.2 to 0.4 mg) two to four times a day (every six to twelve hours) until the danger of uterine atony and hemorrhage has passed. {03} {07} {26} {35}


Note: Generally, a treatment course of 48 hours is sufficient. {03} Oral or sublingual administration usually follows an initial parenteral dose.


Strength(s) usually available
U.S.—


200 mcg (0.2 mg) (Rx) [Ergotrate{03}]

Canada—


200 mcg (0.2 mg) (Rx) [Ergotrate Maleate{07}{37}]

Packaging and storage:
Store below 40 °C (104 °F), preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Store in a well-closed container.



Parenteral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

ERGONOVINE MALEATE INJECTION USP

Usual adult and adolescent dose
Uterine stimulant
Intravenous, administered over at least one minute, or intramuscular, 200 mcg (0.2 mg), repeated in two to four hours if necessary {05} {07} {24} {26}, up to five doses. {24} {26} {29} {35} {41}

[Angina pectoris (diagnosis)]1
Intravenous, 50 mcg (0.05 mg), repeated every five minutes until chest pain occurs or a total dose of 400 mcg (0.4 mg) has been given. {19} {30}


Strength(s) usually available
U.S.—


200 mcg (0.2 mg) per mL (Rx) [Ergotrate{05}]

Canada—


250 mcg (0.25 mg) per mL (Rx)[Generic]{06}{36}

Packaging and storage:
Store below 8 °C (46 °F), preferably between 2 and 8 °C (36 and 46 °F), unless otherwise specified by manufacturer. Protect from light. Protect from freezing.

Stability:
Ergonovine maleate ampules may be stored at room temperature for up to 60 days. {05} {24} At any time, discolored solutions or solutions containing visible particles should not be used. {24} {25}



Revised: 06/07/1993



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  1. Panel comment. Panel survey date 3/8/90.
  1. Lauritz JB, Paull JD, McInnes M. Oxytocin: oxytocic of choice in first trimester. Med J Austr 1980; 2(6): 319-20.
  1. Cochrane GW, et al. Blood loss and side effects in day case abortion. Br J Obstet Gynaecol 1981; 88(11): 1120-3.
  1. Garrioch DB, Gilbert JR, Plantevin OM. Choice of ecbolic and the morbidity of day-case terminations of pregnancy. Br J Obstet Gynaecol 1981; 88(10): 1029-32.
  1. Watson DL, et al. Bromocriptine mesylate for lactation suppression: a risk factor for postpartum hypertension? Obstet Gynecol 1989; 74(4): 573-6.
  1. Panel question. Survey date 3/8/90.
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