Ergotamine tartrate (sublingual tablet)

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Ergotamine tartrate (sublingual tablet)
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

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Black Box Warning

WARNING
See full prescribing information for complete Boxed Warning.
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated.

Overview

Ergotamine tartrate (sublingual tablet) is an alpha adrenergic blocking agent that is FDA approved for the prophylaxis of vascular migraine. There is a Black Box Warning for this drug as shown here. Common adverse reactions include pruritus, nausea and vomiting, muscle weakness, paresthesia and visual disturbance.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Abortion or prevention of vascular headache, e.g., migraine, migraine variants or a so-called "histaminic cephalalgia"
  • For best results, dosage should start at the first sign of an attack. Early administration gives maximum effectiveness. At the first sign of an attack or to relieve symptoms after onset of an attack, one 2 mg tablet is placed under the tongue. Another tablet should be taken at half-hour intervals thereafter, if necessary, but dosage must not exceed three tablets in any 24hour period. Total weekly dosage should not exceed five tablets (10 mg) in any one week. Sublingual Tablets should not be used for chronic daily administration.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ergotamine in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ergotamine in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Ergotamine tartrate (sublingual tablet) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ergotamine in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ergotamine in pediatric patients.

Contraindications

Warnings

WARNING
See full prescribing information for complete Boxed Warning.
Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of ergotamine tartrate with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of ergotamine tartrate, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated.
CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors)
Fibrotic Complications

Adverse Reactions

Clinical Trials Experience

Cardiovascular Effects=

Gastrointestinal Effects
Neurological Effects
Allergic Effects
Fibrotic Complications

Postmarketing Experience

There is limited information regarding Ergotamine tartrate (sublingual tablet) Postmarketing Experience in the drug label.

Drug Interactions

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): X


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ergotamine tartrate (sublingual tablet) in women who are pregnant.

Labor and Delivery

  • Ergomar is contraindicated in pregnancy due to its oxytocic effect which is maximal in the third trimester.

Nursing Mothers

  • Ergot drugs are known to inhibit prolactin but there are no reports of decreased lactation with Ergomar. Ergotamine is excreted in breast milk and may cause symptoms of vomiting, diarrhea, weak pulse and unstable blood pressure in nursing infants. Because of the potential for serious adverse reactions in nursing infants from Ergomar, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

  • Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

There is no FDA guidance on the use of Ergotamine tartrate (sublingual tablet) in geriatric settings.

Gender

There is no FDA guidance on the use of Ergotamine tartrate (sublingual tablet) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ergotamine tartrate (sublingual tablet) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ergotamine tartrate (sublingual tablet) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ergotamine tartrate (sublingual tablet) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ergotamine tartrate (sublingual tablet) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ergotamine tartrate (sublingual tablet) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Sublingual tablets

Monitoring

There is limited information regarding Ergotamine tartrate (sublingual tablet) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Ergotamine tartrate (sublingual tablet) and IV administrations.

Overdosage

Pharmacology

Mechanism of Action

  • Ergotamine is a alpha adrenergic blocking agent with a direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels and produces depression of central vasomotor centers. The compound also has the properties of serotonin antagonism. In comparison to hydrogenated ergotamine, the adrenergic blocking actions are less pronounced and vasoconstrictive actions are greater.

Structure

  • D.H.E. 45® is ergotamine hydrogenated in the 9, 10 position as the mesylate salt. D.H.E. 45® is known chemically as ergotaman-3´,6´,18-trione,9,10-dihydro-12´-hydroxy-2´-methyl-5´-(phenylmethyl)-,(5´α)-, monomethanesulfonate. Its molecular weight is 679.80 and its empirical formula is C33H37N5O5•CH4O3S.
  • The chemical structure is:

Pharmacodynamics

There is limited information regarding Ergotamine tartrate (sublingual tablet) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Ergotamine tartrate (sublingual tablet) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Ergotamine tartrate (sublingual tablet) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Ergotamine tartrate (sublingual tablet) Clinical Studies in the drug label.

How Supplied

Ergotamine Tartrate Sublingual Tablets
  • Ergomar® Sublingual Tablets are round, green tablets each containing 2 mg of ergotamine tartrate. They are debossed with the product identification code "LB2" on one side, and are supplied in individual foil strips packaged in a plastic child resistant canister containing 20 tablets (5 – 2 × 2 foil strips) NDC 10802-12020

Storage

  • Store at 20°- 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F). Protect from light and heat. Keep out of reach of children.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Ergotamine tartrate (sublingual tablet) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Ergotamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

There is limited information regarding Ergotamine tartrate (sublingual tablet) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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