Ergotrate® Ergonovine Maleate 0.2 mg Tablets USP

ERGONOVINE MALEATE - ergonovine maleate tablet 
Pharmacist Pharmaceutical, LLC

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Ergotrate®
Ergonovine Maleate 0.2 mg Tablets USP

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 itself. The empirical formula of ergonovine maleate is: C19H23N3O2•C4H4O4.

Inactive Ingredients

Lactose, Povidone, Crospovidone and Glyceryl Behenate.

Clinical Pharmacology

Within six to 15 minutes, ergonovine maleate produces a firm tetanic contraction of the postpartum uterus which, in the course of about 90 minutes, gradually changes to a series of clonic contractions that persist for another 90 minutes or more.

Indications and Usage

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

Contraindications

Ergonovine maleate 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 and 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 Precautions

Because of the high uterine tone produced, ergonovine maleate is not recommended for routine use prior to the delivery of the placenta unless the operator is versed in the technique described by Davis and others and has adequate facilities and personnel at his disposal.

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

Ergonovine maleate 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, and the intravenous route of administration of the 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 ergonovine maleate than with other oxytocics. They usually subside promptly following intravenous administration of 15 mg of chlorpromazine.

Overdosage

Symptoms

The principal manifestations of serious overdosage are convulsions and gangrene. Symptoms of overdosage include the following: vomiting, diarrhea, dizziness, rise or fall in blood pressure, weak pulse, dyspnea, loss of consciousness, numbness and coldness of the extremities, tingling, pain in the chest, gangrene of the fingers and toes, and hypercoagulability.

Treatment

Treat convulsions. Control hypercoagulability by the administration of heparin, and maintain blood-clotting time at approximately three times the normal. Give a vasodilator such as tolazine as an antidote; the rate of administration may be controlled by monitoring pulse rate and blood pressure. For emergency measures, delay absorption of ingested ergonovine maleate by giving tap water, milk, or activated charcoal and then removing by gastric lavage or emesis followed by catharsis. Gangrene will require surgical amputation.

Dosage and Administration

The immediate postpartum dose of ergonovine maleate is usually 0.2 mg. It is ordinarily administered parenterally. To minimize late postpartum bleeding, 1 or 2 tablets may be given orally two to four times daily (every six to 12 hours) until the danger of uterine atony has passed – usually 48 hours. Severe cramping is evidence of effectiveness but may justify reduction in dosage. Tablets may also be administered sublingually.

How supplied

Ergonovine Maleate 0.2 mg Tablets USP are white, round tablets, imprinted with "E".

Bottles of 100:
NDC 63704-001-01
Bottles of 250:
NDC 63704-001-25

Store at controlled room temperature 15°-30°C (59°-86°F).

Dispense in a tight, light-resistant container as defined in USP/NF with a child-resistant closure.

WARNING: KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

Rx Only

Manufactured For:
ErgoTab, LLC
Salem, Virginia 24153

Distributed By:
Pharmacist Pharmaceutical, LLC
Salem, Virginia 24153

PIN032007

Rev. 03/07

PRINCIPAL DISPLAY PANEL - 0.2 mg Bottle Label

NDC 63704-001 -01

Ergotrate®
(ergonovine maleate)

Tablets, USP

0.2 mg

Rx Only

100 TABLETS

PHARMACIST
PHARMACEUTICAL

PRINCIPAL DISPLAY PANEL - 0.2 mg Bottle Label

ERGONOVINE MALEATE 
ergonovine maleate   tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)63704-001
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ergonovine Maleate (Ergonovine) Ergonovine Maleate0.2 mg
Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found
Product Characteristics
ColorWHITEScore no score
ShapeROUNDSize6mm
FlavorImprint Code E
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
163704-001-01100 TABLET In 1 BOTTLENone
263704-001-25250 TABLET In 1 BOTTLENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other01/01/200712/31/2009

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