Methylergonovine Maleate

Name: Methylergonovine Maleate

Warnings

General

This drug should not be administered I.V. routinely because of the possibility of inducing sudden hypertensive and cerebrovascular accidents. If I.V administration is considered essential as a lifesaving measure, Methergine (methylergonovine maleate) should be given slowly over a period of no less than 60 seconds with careful monitoring of blood pressure. Intra-arterial or periarterial injection should be strictly avoided.

Caution should be exercised in presence of impaired hepatic or renal function.

Breast-feeding

Mothers should not breast-feed during treatment with Methergine. Milk secreted during this period should be discarded. Methergine may produce adverse effects in the breast-feeding infant. Methergine may also reduce the yield of breast milk. Mothers should wait at least 12 hours after administration of the last dose of Methergine before initiating or resuming breast feeding.

Coronary Artery Disease

Patients with coronary artery disease or risk factors for coronary artery disease (e.g., smoking, obesity, diabetes, high cholesterol) may be more susceptible to developing myocardial ischemia and infarction associated with methylergonovine-induced vasospasm.

Medication Errors

Inadvertent administration of Methergine to newborn infants has been reported. In these cases of inadvertent neonatal exposure, symptoms such as respiratory depression, convulsions, cyanosis and oliguria have been reported. Usual treatment is symptomatic. However, in severe cases, respiratory and cardiovascular support is required.

Methergine has been administered instead of vitamin K and Hepatitis B vaccine, medications which are routinely administered to the newborn. Due to the potential for accidental neonatal exposure, Methergine injection should be stored separately from medications intended for neonatal administration.

What is methylergonovine (methergine)?

Methylergonovine is in a group of drugs called ergot alkaloids. It affects the smooth muscle of a woman's uterus, improving the muscle tone as well as the strength and timing of uterine contractions.

Methylergonovine is used just after a baby is born, to help deliver the placenta (also called the "afterbirth"). It is also used to help control bleeding and to improve muscle tone in the uterus after childbirth.

Methylergonovine may also be used for purposes than those listed in this medication guide.

What is the most important information i should know about methylergonovine (methergine)?

You should not use methylergonovine during your pregnancy. This medication is to be used only after delivery of your baby.

Do not breast-feed within 12 hours after taking methylergonovine. Methylergonovine may pass into breast milk in small amounts and could affect a nursing baby. In some cases, you will need to use this medication for up to 1 week after your baby is born. You may need to use a breast pump to establish and maintain your milk flow until your methylergonovine treatment is finished. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Seek emergency medical attention if you think you have symptoms of possible methylergonovine overdose, such as nausea, vomiting, stomach pain, numbness or tingling, muscle twitching, feeling light-headed, fainting, shallow breathing, coldness, or seizure (convulsions).

There may be other drugs that can interact with methylergonovine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Grapefruit and grapefruit juice may interact with methylergonovine and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.

What should i discuss with my health care provider before using methylergonovine (methergine)?

You should not use this medication if you have:

  • high blood pressure;
  • toxemia of pregnancy; or
  • if your baby has not yet been born.

If possible before you receive methylergonovine, tell your doctor if you have:

  • liver or kidney disease; or
  • risk factors for coronary artery disease (such as diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease).

You should not use methylergonovine during your pregnancy. This medication is to be used only after delivery of your baby.

Do not breast-feed within 12 hours after taking methylergonovine. Methylergonovine may pass into breast milk in small amounts and could affect a nursing baby. In some cases, you will need to use this medication for up to 1 week after your baby is born. You may need to use a breast pump to establish and maintain your milk flow until your methylergonovine treatment is finished. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Cautions for Methylergonovine Maleate

Contraindications

  • Hypersensitivity to ergonovine, methylergonovine, or any ingredient in the formulation.b i j

  • Hypertension.b

  • Toxemia.b

  • Pregnancy.b

Warnings/Precautions

Warnings

IV Administration

Methylergonovine maleate: Do not routinely administer IV.b Possibility of sudden hypertension and cerebrovascular accident when administered IV.b

Methylergonovine maleate: If IV administration is considered lifesaving, administer slowly; monitor BP.b (See IV Administration under Dosage and Administration.)

General Precautions

Avoid prolonged use; discontinue if ergotism develops.i j

Concomitant Diseases

Caution in patients with sepsis, heart disease, venoatrial shunts, mitral valve stenosis, or obliterative vascular disease.a b i j

Specific Populations

Pregnancy

Methylergonovine maleate: Category C.b

Methylergonovine and Ergonovine: contraindicated during pregnancy because of the drugs’ uterotonic effects.b (See Contraindications.)

Lactation

Methylergonovine maleate: Distributed into human milk.b h Use with caution in nursing women.b

Methylergonovine maleate: May be administered orally for a maximum of 1 week postpartum to control uterine bleeding.b (See Postpartum Hemorrhage under Dosage and Administration.)

Pediatric Use

Safety and efficacy not established in children.b

Geriatric Use

Methylergonovine maleate: Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.b

Hepatic Impairment

Use with caution.a b i j

Renal Impairment

Use with caution.a b i j

Common Adverse Effects

Hypertension, seizures, headache, hypotension, nausea, vomiting.a b i j

Stability

Storage

Oral

Tablets

Ergonovine maleate: Tight, light-resistant container at 15–30°C.i

Methylergonovine maleate: Tight, light-resistant container at <25°C.b

Parenteral

Injection

Ergonovine maleate: <8°C.j May be stored at room temperature for short periods of time (i.e., <60 days).j Protect from light.a

Methylergonovine maleate: 2–8°C.b Protect from light. a b

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Drug Compatibility

Y-Site Compatibility for Methylergonovine MaleateHID

Compatible

Heparin sodium

Hydrocortisone sodium succinate

Potassium chloride

Vitamin B complex with C

Advice to Patients

  • Importance of women informing clinicians if they plan to breast-feed.b

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.b

  • Importance of informing patients of other important precautionary information.b (See Cautions.)

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