Ergotamine Tartrate + Caffeine Suppositories

— THERAPEUTIC CATEGORIES —
  • Migraine and headache
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Ergotamine Tartrate + Caffeine Suppositories Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Ergotamine tartrate 2mg, caffeine 100mg; rectal supp.

    Pharmacological Class

    Ergot alkaloid.

    How Supplied

    Contact supplier.

    Storage

    Refrigerate at 2° to 8°C (36° to 46°F).

    Manufacturer

    Various generic manufacturers

    Ergotamine Tartrate + Caffeine Suppositories Indications

    Indications

    Migraine, migraine variants, cluster headaches.

    Ergotamine Tartrate + Caffeine Suppositories Dosage and Administration

    Adult

    1 supp rectally at onset of attack, then 1 supp after 1 hour if needed; max 2 supps/attack, 5 supps/week.

    Children

    Not recommended.

    Ergotamine Tartrate + Caffeine Suppositories Contraindications

    Contraindications

    Peripheral vascular disease. Coronary heart disease. Hypertension. Hepatic or renal dysfunction. Sepsis. Concomitant potent CYP3A4 inhibitors (eg, ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) or other vasoconstrictors. Pregnancy. Labor and delivery.

    Ergotamine Tartrate + Caffeine Suppositories Boxed Warnings

    Boxed Warning

    Peripheral ischemia following coadministration with strong CYP3A4 inhibitors.

    Ergotamine Tartrate + Caffeine Suppositories Warnings/Precautions

    Warnings/Precautions

    Monitor for ergotism; do not exceed recommended dose. Nursing mothers: not recommended.

    Warnings/Precautions

    Ergotism

    • Manifested by intense arterial vasoconstriction, producing signs and symptoms of peripheral vascular ischemia.
    • Most cases have been associated with overdosage, though some have involved hypersensitivity.
    • Headache intermittent claudication, muscle pain, numbness, coldness and pallor of the digits may develop with chronic intoxication of ergot derivatives.
    • Do not exceed recommended dosages with long-term use.

    Pregnancy Considerations

    Contraindicated in pregnancy due to oxytocic effects of ergotamine.

    Contraindicated during labor and delivery due to its oxytocic effect which is maximal in the third trimester.

    Nursing Mother Considerations

    Ergotamine is excreted in the breast milk and may cause vomiting, diarrhea, weak pulse, and unstable blood pressure in nursing infants. A decision should be made to either discontinue nursing or discontinue the drug.

    Pediatric Considerations

    Safety and effectiveness in pediatric patients have not been established.

    Other Considerations for Specific Populations

    There have been reports of drug abuse and psychological dependence in patients on ergotamine tartrate and caffeine therapy.

    Ergotamine Tartrate + Caffeine Suppositories Pharmacokinetics

    Metabolism

    Hepatic.

    Elimination

    Fecal (ergotamine), renal (caffeine). Half-life: 2 hours (ergotamine).

    Ergotamine Tartrate + Caffeine Suppositories Interactions

    Interactions

    See Contraindications. Potentiated by CYP3A4 inhibitors (eg, protease inhibitors, macrolides, azole antifungals, saquinavir, nefazodone, fluoxetine, fluvoxamine, grapefruit juice, zileuton), propranolol, nicotine. Severe hypertension with sympathomimetics.

    Ergotamine Tartrate + Caffeine Suppositories Adverse Reactions

    Adverse Reactions

    Vasoconstrictive complications or ergotism (eg, ischemia, cold extremities, vasospasm, ECG changes, hyper- or hypotension, numbness, gangrene, dizziness), precordial or muscle pain, tachycardia, bradycardia, nausea, vomiting, local edema, itching; rarely: retroperitoneal and pleuropulmonary fibrosis, cardiac valve fibrosis (chronic use).

    Ergotamine Tartrate + Caffeine Suppositories Clinical Trials

    See Literature

    Ergotamine Tartrate + Caffeine Suppositories Note

    Notes

    Formerly known under the brand names Cafergot, Migergot.

    Ergotamine Tartrate + Caffeine Suppositories Patient Counseling

    Patient Counseling

    Do not exceed the dosing guidelines.

    Use only to treat migraine headaches; ergotamine/caffeine is not effective for other types of headaches and the product lacks analgesic properties.

    Numbness or tingling in the fingers and toes, muscle pain in the arms and legs, weakness in the legs, pain in the chest or temporary speeding or slowing of the heart rate, swelling or itching: Report immediately.

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