ERGOTRATE® ERGONOVINE MALEATE INJECTION, USP

ERGOTRATE MALEATE - ergonovine maleate injection, solution 
Pharmacist Pharmaceutical, LLC

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ERGOTRATE®
ERGONOVINE MALEATE INJECTION, USP

This product is to be used by or under the direction of a physician.

Rx ONLY.

DESCRIPTION

Ergonovine is the hydroxyisopropylamide of lysergic acid. It is somewhat soluble in water, and its salts are readily soluble. It is obtained from ergot and has been shown to possess all of the desirable oxytocic activity of ergot.

Each ampul contains 0.2 mg (0.45 µmol) of ergonovine maleate and water for injection USP.

The molecular formula of ergonovine maleate is C19H23N3O2 • C4H4O4. Chemically, it is 9, 10-didehydro-N-[(S)-2-hydroxy-1-methylethyl]-6-methylergoline-8β-carboxamide maleate (1:1)(salt), which can be represented by the following formula:

Chemical Structure

Molecular Weight: 441.48

CLINICAL PHARMACOLOGY

Ergotrate® (Ergonovine Maleate Injection, USP) produces a firm contraction of the uterus. Superimposed upon the initial tetanic contraction is a succession of minor relaxations and contractions. The extent of relaxation gradually increases over a period of about 1 1/2 hours, but vigorous rhythmic contractions continue for a period of 3 or more hours after injection. The prolonged initial contraction is the type necessary to control uterine hemorrhage.

INDICATIONS AND USAGE

Ergotrate® is indicated for the prevention and treatment of postpartum and postabortal hemorrhage due to uterine atony.

CONTRAINDICATIONS

Ergotrate® is contraindicated for the induction of labor and in cases of threatened spontaneous abortion. It should not be administered to those patients who have shown allergic or idiosyncratic reactions to it.

WARNINGS

All oxytocic agents are potentially dangerous. Mothers and infants have been injured, and some have died because of their injudicious use. Hyperstimulation of the uterus during labor may lead to uterine tetany with marked impairment of the uteroplacental blood flow, uterine rupture, cervical and perineal lacerations, amniotic fluid embolism, and trauma to the infant (e.g., hypoxia, intracranial hemorrhage). Because of these hazards, which result from overdosage, oxytocic agents must be administered under conditions of meticulous observation.

PRECAUTIONS

General

Because of the high uterine tone produced, Ergotrate® is not recommended for routine use prior to the delivery of the placenta unless the operator is versed in the technique described by Davis12and others and unless adequate facilities and personnel are available.

As is the case with all ergot preparations, prolonged use of Ergotrate® is to be avoided. Discontinue Ergotrate® if symptoms of ergotism appear.

Ergotrate® should be used cautiously in patients with hypertension, heart disease, venoatrial shunts, mitral-valve stenosis, obliterative vascular disease, sepsis, or hepatic or renal impairment.

The character and amount of vaginal bleeding should be observed. Hypocalcemia may affect patient response to the drug. If the patient is not also taking digitalis, cautious administration of calcium gluconate IV may produce the desired oxytocic action.

Laboratory Tests

Blood pressure, pulse, and uterine response should be monitored. Sudden changes in vital signs or frequent periods of uterine relaxation should be noted.

ADVERSE REACTIONS

Nausea and vomiting may occur, but they are uncommon. Allergic phenomena, including shock, have been reported. Ergotism has also been reported. Elevation of blood pressure (sometimes extreme) may appear in a small percentage of patients, most frequently in association with regional anesthesia (caudal or spinal), previous administration of a vasoconstrictor, or the intravenous route of administration of an oxytocic. The mechanism of such hypertension is obscure, since it may occur in the absence of anesthesia, vasoconstrictors, and oxytocics. These elevations are no more frequent with Ergotrate® than with other oxytocics. They usually subside promptly following intravenous administration of 15 mg of chlorpromazine.

Postpartum use of ergotrates has been associated with rare cases of myocardial infarction.

OVERDOSAGE

Signs and Symptoms

Symptoms may begin within minutes of overdosage of ergot compounds and may include nausea, vomiting, headache, diarrhea, and, in women, uterine cramping. A neonate was reported to have respiratory depression, cyanosis, and convulsions. The vasoconstriction prominent with ergotamine, other ergots, and "Saint Anthony's Fire" is much less common with ergonovine. Severe chest pain, cardiac ischemia, myocardial infarction, and death may occur in patients with coronary artery disease.

Toxicity may be seen with doses of 3 mg or more. Death was reported in a 14-month-old following a dose of 12 mg. Twenty-five mg given over several days proved fatal in 1 case. Toxicity and serum concentrations do not correlate well. No median lethal dose information is available.

Treatment

To obtain up-to-date information about the treatment of overdose, a good resource is your certified Regional Poison Control Center. Telephone numbers of certified poison control centers are listed in the Physicians' Desk Reference (PDR). In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in your patient.

Patients with ergot overdose should be monitored closely. A secure airway should be established and electrocardiograms monitored to assess cardiac ischemia and rhythm. Cardiac ischemia may be treated with nitoglycerin. Seizures may respond to diazepam or phenytoin. If peripheral vasoconstriction is a problem, sodium nitroprusside or phentolamine may be useful.

Protect the patient's airway and support ventilation and perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs, blood gases, serum electrolytes, etc. If ergonovine was recently ingested and vomiting has not occurred, absorption of drugs from the gastrointestinal tract may be decreased by giving activated charcoal, which, in many cases, is more effective than emesis or lavage; consider charcoal instead of or in addition to gastric emptying. Repeated doses of charcoal over time may hasten elimination of some drugs that have been absorbed. Safeguard the patient's airway when employing gastric emptying or charcoal.

Forced diuresis, peritoneal dialysis, hemodialysis, or charcoal hemoperfusion have not been established as beneficial for an overdose of ergonovine.

DOSAGE AND ADMINISTRATION

Ergotrate® is intended primarily for routine intramuscular injection in obstetric practice. By this route, it usually produces a firm contraction of the uterus within a few minutes.

Intravenous administration leads to a quicker response. However, because of the higher incidence of nausea and other side effects, it is recommended that the intravenous route be confined to emergencies such as excessive uterine bleeding.

The usual intramuscular (or emergency intravenous) dose of Ergotrate® is 0.2 mg per 1 mL. Severe uterine bleeding may call for repeated doses, but injection will rarely be required more often than once in 2 to 4 hours.

In some calcium-deficient patients, the uterus may fail to respond to Ergotrate®. In such instances, responsiveness can be immediately restored by the cautious intravenous injection of calcium salts. Calcium should not be given intravenously to patients under the influence of digitalis.

Storage

Ergotrate® should be stored in a cold place (below 46°F). However, delivery-room stock may be kept at room temperature (although periods of more than 60 days at room temperature prior to use are not recommended).

HOW SUPPLIED

Ergotrate® (Ergonovine Maleate Injection, USP) 0.2 mg per 1 mL is supplied in cartons of 10 × 1 mL ampuls NDC 63704-002-01. Protect from light.

REFERENCES

  1. Davis ME: Postpartum hemorrhage. AM J Surg 1940; 48:154.
  2. Davis ME, Boynton MW: The use of ergonovine in the placental stage of labor. AM J Obstet Gynecol 1942: 43: 775.

Manfactured by : STEROP, Brussels, Belgium

Manufactured for : ErgoJect LLC, Salem, Virginia 24153

Marketed by : Pharmacist Pharmaceutical LLC, Salem, Virginia 24153

PRINCIPAL DISPLAY PANEL - 0.2 mg Carton

PHARMACIST
PHARMACEUTICAL

NDC 63704-002-01

Ergotrate®
(ergonovine maleate)
Injection, USP

0.2 mg/mL

Rx ONLY

For IM or in emergency
IV Administration

10 × 1 mL ampuls

PRINCIPAL DISPLAY PANEL - 0.2 mg Carton

ERGOTRATE MALEATE 
ergonovine maleate   injection, solution
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63704-002
Route of AdministrationINTRAMUSCULARDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ergonovine Maleate (Ergonovine) Ergonovine Maleate0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
163704-002-0110 AMPULE In 1 CARTONcontains a AMPULE
11 mL In 1 AMPULEThis package is contained within the CARTON (63704-002-01)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/200612/31/2009

Labeler - Pharmacist Pharmaceutical, LLC (830838251)
Revised: 07/2010Pharmacist Pharmaceutical, LLC