Ergotamine

Ergotamine is a prescription medicine used to treat migraine and menopausal hot flashes.

• Ergotamine is available under the following different brand names: Ergomar

Adult and pediatric dosage

Tablet, SL

• 2 mg

Migraine

Adult dosage

• 2 mg SL followed by 1-2 mg every 30minutes until attack abated; not to exceed 6 mg/day and no more than 10 mg/week

Menopausal Hot Flashes

Adult dosage

• 0.6 mg orally every 12hours (as a fixed combo with belladonna and phenobarbital)
• Not to exceed 10 mg/week

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Ergotamine include:

• nausea,
• vomiting,
• dizziness,
• spinning sensation,
• weakness, and
• itching.

Serious side effects of Ergotamine include:

• angina,
• arrhythmia,
• vascular spasm,
• vasoconstriction,
• tachycardia,
• numbness of extremities,
• paraesthesia, and
• vertigo.

Rare side effects of Ergotamine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ergotamine has severe interactions with the following drugs:
  • almotriptan
  • clarithromycin
  • cobicistat
  • eletriptan
  • elvitegravir/cobicistat/emtricitabine/tenofovir DF
  • frovatriptan
  • glyceryl trinitrate pr
  • itraconazole
  • ketoconazole
  • letermovir
  • levoketoconazole
  • mifepristone
  • naratriptan
  • nirmatrelvir
  • nirmatrelvir/ritonavir
  • nitroglycerin IV
  • nitroglycerin sublingual
  • nitroglycerin topical
  • nitroglycerin transdermal
  • nitroglycerin translingual
  • ombitasvir/paritaprevir/ritonavir & dasabuvir (DSC)
  • pseudoephedrine
  • rizatriptan
  • sumatriptan
  • sumatriptan intranasal
  • voriconazole
  • zolmitriptan
• Ergotamine has serious interactions with at least 130 other drugs.
• Ergotamine has moderate interactions with at least 115 other drugs.
• Ergotamine has minor interactions with the following drugs:
  • azithromycin
  • green tea
  • ruxolitinib
  • ruxolitinib topical

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• Hypersensitivity to drug or excipients
• Concomitant strong CYP3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, and troleandomycin)

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ergotamine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ergotamine?”

Cautions

• Should be initiated at the first sign of a vascular headache
• Ineffective for muscle contraction headache
• Safety/efficacy not established for peds
• Although signs and symptoms of ergotism rarely develop even after long term intermittent use of the drug, care should be exercised to remain within the limits of the recommended dosage
• Ergotism is manifested by intense arterial vasoconstriction, producing signs and symptoms of peripheral vascular ischemia; therapy induces vasoconstriction by a direct action on the vascular smooth muscle; in chronic intoxication with ergot derivatives, headache, intermittent claudication, muscle pains, numbness, coldness, and pallor of the digits may occur
• If the condition is allowed to progress untreated, gangrene can result; while most cases of ergotism associated with ergotamine treatment result from frank overdosage, some cases have involved apparent hypersensitivity
• There are few reports of ergotism among patients taking doses within the recommended limits or for brief periods; in rare instances, patients, particularly those who have used the medication indiscriminately over long periods, may display withdrawal symptoms consisting of rebound headache upon discontinuation of the drug
• 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
  • The drug should not be used for the chronic daily administration
• Drug interaction overview
  • Sublingual tablets, USP) should not be administered with other vasoconstrictors; use with sympathomimetics (pressor agents) may cause extreme elevation of blood pressure
  • The beta-blocker Inderal (propranolol) has been reported to potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine
  • Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy; the blood levels of ergotamine-containing drugs are reported to be elevated by the concomitant administration of macrolide antibiotics and vasospastic reactions have been reported with therapeutic doses of the ergotamine-containing drugs when coadministered with these antibiotics
  • Coadministration with potent CYP3A4 inhibitors such as protease inhibitors or macrolide antibiotics associated with serious adverse events; for this reason, these drugs should not be given concomitantly with ergotamine
  • 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 CYP3A4 of other agents being considered for concomitant use with ergotamine

Pregnancy and Lactation

• Contraindicated in pregnancy due to oxytocic effects of ergotamine, which is maximal in the third trimester
• There are no studies on placental transfer or teratogenicity; 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 leads to reduced myometrial and placental blood flow may have contributed to fetal growth retardation observed in animals
• Lactation
  • Ergot drugs are known to inhibit prolactin but there are no reports of decreased lactation with therapy; the drug 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 the drug, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of therapy to the mother