Methylergonovine Maleate (Page 2 of 2)

Pregnancy

Category C. Animal reproductive studies have not been conducted with methylergonovine maleate. It is also not known whether methylergonovine maleate can cause fetal harm or can affect reproductive capacity. Use of methylergonovine maleate is contraindicated during pregnancy because of its uterotonic effects (see INDICATIONS AND USAGE).

Labor and Delivery

The uterotonic effect of methylergonovine maleate is utilized after delivery to assist involution and decrease hemorrhage, shortening the third stage of labor.

Nursing Mothers

Mothers should not breast-feed during treatment with methylergonovine maleate and at least 12 hours after administration of the last dose. Milk secreted during this period should be discarded.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of methylergonovine maleate did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in response between the elderly and younger patients. In general dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

The most common adverse reaction is hypertension associated in several cases with seizure and/or headache. Hypotension has also been reported. Abdominal pain (caused by uterine contractions), nausea and vomiting have occurred occasionally. Rarely observed reactions have included: acute myocardial infarction, transient chest pains, vasoconstriction, vasospasm, coronary arterial spasm, bradycardia, tachycardia, dyspnea, hematuria, thrombophlebitis, water intoxication, hallucinations, leg cramps, dizziness, tinnitus, nasal congestion, diarrhea, diaphoresis, palpitation, rash, and foul taste.¹

There have been rare isolated reports of anaphylaxis, without a proven causal relationship to the drug product.

Postmarketing Experience

The following adverse drug reactions have been derived from post-marketing experience with methylergonovine maleate via spontaneous case reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency which is therefore categorized as not known.

Nervous system disorders

Cerebrovascular accident, paraesthesia

Cardiac disorders

Ventricular fibrillation, ventricular tachycardia, angina pectoris, atrioventricular block

To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG ABUSE AND DEPENDENCE

Methylergonovine maleate has not been associated with drug abuse or dependence of either a physical or psychological nature.

OVERDOSAGE

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 LD₅₀ (in mg/kg) for the mouse is 187, the rat 93, and the rabbit 4.5.² 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 to 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.³

DOSAGE AND ADMINISTRATION

Orally

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

HOW SUPPLIED

Tablets

Methylergonovine Maleate Tablets USP, 0.2 mg are available as white round, biconvex tablets, debossed “60” on one side and “A” on the other side.

They are supplied as follows:

Bottles of 12 with child-resistant closure NDC 69238-1605-2

Bottles of 28 with child-resistant closure NDC 69238-1605-8

Store and Dispense

Tablets: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; in tight, light-resistant container.

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 11-2017-00

PRINCIPAL DISPLAY PANEL

NDC 69238-1605-2

Methylergonovine Maleate Tablets USP, 0.2 mg

Rx Only

12 Tablets

Amneal Pharmaceuticals LLC

NDC 69238-1605-8

Methylergonovine Maleate Tablets USP, 0.2 mg

Rx Only

28 Tablets

Amneal Pharmaceuticals LLC

METHYLERGONOVINE MALEATE methylergonovine tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69238-1605 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLERGONOVINE MALEATE (METHYLERGONOVINE) METHYLERGONOVINE MALEATE 0.2 mg

Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE MICROCRYSTALLINE CELLULOSE POVIDONE STARCH, CORN STEARIC ACID TARTARIC ACID

Product Characteristics Color WHITE (White) Score no score Shape ROUND (Round, biconvex tablets) Size 6mm Flavor Imprint Code 60;A Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69238-1605-2 12 TABLET in 1 BOTTLE None 2 NDC:69238-1605-8 28 TABLET in 1 BOTTLE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA211483 09/12/2018

Labeler — Amneal Pharmaceuticals NY LLC (123797875)

Establishment
Name	Address	ID/FEI	Operations
Amneal Pharmaceuticals of New York, LLC		123797875	ANALYSIS (69238-1605), LABEL (69238-1605), MANUFACTURE (69238-1605), PACK (69238-1605)

Revised: 12/2020 Amneal Pharmaceuticals NY LLC