pharmacopeia
GET
/api/v1/drug/ergotamine

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. (See also CONTRAINDICATIONS and WARNINGS section)

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Adrenergic alpha-Agonists; Cytochrome P450 3A Inhibitors; Cytochrome P450 3A4 Inhibitors; Dopamine Receptor Interactions; Serotonin Antagonists.

Cytochrome P450 3ACytochrome P450 3A4Serotonin

Indications

Sourced from openFDA
  • Ergomar ® is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called "histaminic cephalalgia".ICD-10: G43.909, R51.9

Contraindications

Sourced from openFDA
  • Coadministration of ergotamine with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities ( See PRECAUTIONS: Drug Interactions ), with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when ergotamine was coadministered, at least one resulting in death.contraindicated

Dosage & administration

Sourced from openFDA

Procedure 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 24 hour period. Total weekly dosage should not exceed five tablets (10 mg) in any one week. Ergomar ® Sublingual Tablets should not be used for chronic daily administration.

Warnings & precautions

Sourced from openFDA

CYP 3A4 Inhibitors (e.g., Macrolide Antibiotics and Protease Inhibitors) Coadministration of ergotamine with potent CYP 3A4 inhibitors such as protease inhibitors or macrolide antibiotics has been associated with serious adverse events; for this reason, these drugs should not be given concomitantly with ergotamine ( See CONTRAINDICATIONS ). While these reactions have not been reported with less potent CYP 3A4 inhibitors, there is a potential risk for serious toxicity including vasospasm when these drugs are used with ergotamine. Examples of less potent CYP 3A4 inhibitors include: saquinavir, nefazodone, fluconazole, fluoxetine, grapefruit juice, fluvoxamine, zileuton, metronidazole, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP 3A4 of other agents being considered for concomitant use with ergotamine. Fibrotic Complications There have been a few reports of patients on ergotamine tartrate and caffeine therapy developing retroperitoneal and/or pleuropulmonary fibrosis. There have also been rare reports of fibrotic thickening of the aortic, mitral, tricuspid, and/or pulmonary valves with long-term continuous use of ergotamine tartrate and caffeine. Ergomar ® Sublingual Tablets should not be used for chronic daily administration (See DOSAGE AND ADMINISTRATION ).

Adverse reactions

Sourced from openFDA

Cardiovascular: Vasoconstrictive complications of a serious nature may occur at times. These include ischemia, cyanosis, absence of pulse, cold extremities, gangrene, precordial distress and pain, EKG changes and muscle pains. Although these effects occur most commonly with long-term therapy at relatively high doses, they have also been reported with short-term or normal doses. Other cardiovascular adverse effects include transient tachycardia or bradycardia and hypertension. Gastrointestinal: Nausea and vomiting. Neurological: paresthesias, numbness, weakness, and vertigo. Allergic: Localized edema and itching. Fibrotic Complications: ( See WARNINGS ).

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects Pregnancy Category X: There are no studies on the placental transfer or teratogenicity of Ergomar ® . Ergotamine crosses the placenta in small amounts, although it does not appear to be embryotoxic in this quantity. However, prolonged vasoconstriction of the uterine vessels and/or increased myometrial tone leading to reduced myometrial and placental blood flow may have contributed to fetal growth retardation observed in animals. (See CONTRAINDICATIONS ) Nonteratogenic Effects Ergomar ® is contraindicated in pregnancy due to its oxytocic effects of ergotamine (See CONTRAINDICATIONS )

Pharmacokinetics

Sourced from openFDA
Metabolism
Interactions Pharmacokinetic interactions (increased blood levels of ergotamine) have been reported in patients treated orally with ergotamine and macrolide antibiotics (e.g., troleandomycin, clarithromycin, erythromycin), and in patients treated orally with ergotamine and protease inhibitors (e.g., ritonavir) presumably due to inhibition of cytochrome P450 3A metabolism of ergotamine ( See CONTRAINDICATIONS ). Ergotamine has also been shown to be an inhibitor of cytochrome P450 3A catalyzed reactions.

Overdosage

Sourced from openFDA

Symptoms include vomiting, numbness, tingling, pain and cyanosis of the extremities associated with diminished or absent peripheral pulses; hypertension or hypotension; drowsiness, stupor, coma, convulsions and shock. A case has been reported of reversible bilateral papillitis with ring scotomata in a patient who received five times the recommended daily adult dose over a period of 14 days. Treatment consists of removal of the offending drug. Maintenance of adequate pulmonary ventilation, correction of hypotension, and control of convulsions and blood pressure are important considerations. Treatment of peripheral vasospasm should consist of warmth, but not heat, and protection of the ischemic limbs. Vasodilators may be beneficial but caution must be exercised to avoid aggravating an already existent hypotension.

Approval history

Sourced from openFDA
  • Oct 4, 1983ANDAANDA086557Cosette
  • Sep 25, 1992ANDAANDA087693Pangea
  • Sep 16, 2005ANDAANDA040590Mikart

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
349 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective349.7%
  2. 2Headache318.9%
  3. 3Nausea267.4%
  4. 4Migraine257.2%
  5. 5Drug Interaction216.0%
  6. 6Ergot Poisoning205.7%
  7. 7Drug Hypersensitivity185.2%
  8. 8Dyspnoea174.9%
  9. 9Fatigue154.3%
  10. 10Pain133.7%
  11. 11Pain In Extremity123.4%
  12. 12Vomiting123.4%
  13. 13Malaise113.2%
  14. 14Pyrexia113.2%
  15. 15Chest Pain102.9%

Literature

View JSON

Recent PubMed references pinned to Ergotamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 62 ClinicalTrials.gov registrations naming Ergotamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ergotamine work?
Mechanism-of-action classes: Adrenergic alpha-Agonists; Cytochrome P450 3A Inhibitors; Cytochrome P450 3A4 Inhibitors; Dopamine Receptor Interactions; Serotonin Antagonists.
What is Ergotamine used for?
According to FDA labeling, Ergotamine carries indications including: Ergomar ® is indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called "histaminic cephalalgia".. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ergotamine?
Ergotamine is classified as Ergot alkaloids, Ergotamine Derivative, Adrenergic alpha-Agonists, Cytochrome P450 3A Inhibitors, Cytochrome P450 3A4 Inhibitors, Dopamine Receptor Interactions, Serotonin Antagonists, Cerebral Arterial Vasoconstriction, Increased Uterine Smooth Muscle Contraction or Tone.
What are the brand names for Ergotamine?
Ergotamine is marketed under brand names including Cafergot, Ergomar, Migergot.
What are the contraindications for Ergotamine?
Ergotamine labeling lists contraindications including: Coadministration of ergotamine with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities ( See PRECAUTIONS: Drug Interactions ), with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when ergotamine was coadministered, at least one resulting in death.. Always consult the full prescribing information and a clinician.
Note. Data for ergotamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients