Ergotamine Tartrate And Caffeine

Prescription

Brand names: MIGERGOT

Dosage Form

Suppository

Route

RECTAL

Manufacturer

Cosette Pharmaceuticals, Inc.

About This Medication

DESCRIPTION: Ergotamine Tartrate and Caffeine Suppository ergotamine tartrate USP 2 mg caffeine USP 100 mg Inactive Ingredients: tartaric acid NF, and hard fat NF Ergotamine Tartrate and Caffeine Suppositories are for rectal administration only. Ergotamine Tartrate and Caffeine Suppositories are sealed in foil to afford protection from leakage. If an unavoidable period of exposure to heat softens the suppository, it should be chilled in ice-cold water to solidify it before removing the foil.

Active Ingredients

Ingredient	Strength
Caffeine	-
Ergotamine Tartrate	-

Indications & Usage

INDICATIONS AND USAGE Ergotamine Tartrate and Caffeine Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called “histaminic cephalalgia”.

Dosage & Administration

DOSAGE AND ADMINISTRATION Procedure For best results, dosage should start at the first sign of an attack. Rectally Two suppositories is the maximum dose for an individual attack. Total weekly dosage should not exceed 5 suppositories. Ergotamine Tartrate and Caffeine Suppositories should not be used for chronic daily administration. In carefully selected patients, with due consideration of maximum dosage recommendations, administration of the drug at bedtime may be an appropriate short-term preventive measure. Maximum Adult Dosage: One suppository at start of attack; second suppository after 1 hour, if needed for full relief. Early administration gives maximum effectiveness.

Side Effects Overview

ADVERSE REACTIONS 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; rectal or anal ulcer (from overuse of suppositories). Neurological: Paresthesias, numbness, weakness, and vertigo. Allergic: Localized edema and itching. Fibrotic Complications: (See WARNINGS ). To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Warnings & Precautions

WARNINGS 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. Ergotamine tartrate suppositories should not be used for chronic daily administration (see DOSAGE AND ADMINISTRATION ).

Contraindications

CONTRAINDICATIONS 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 tartrate and caffeine was coadministered, at least one resulting in death. Because of the increased risk for ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drugs and other potent inhibitors of CYP 3A4 (e.g., ketoconazole, itraconazole) (see WARNINGS : CYP 3A4 Inhibitors). Ergotamine tartrate and caffeine may cause fetal harm when administered to pregnant women. Ergotamine tartrate and caffeine is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this product, the patient should be apprised of the potential hazard to the fetus. Peripheral vascular disease, coronary heart disease, hypertension, impaired hepatic or renal function and sepsis. Hypersensitivity to any of the components.

Frequently Asked Questions

INDICATIONS AND USAGE Ergotamine Tartrate and Caffeine Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called “histaminic cephalalgia”.

DOSAGE AND ADMINISTRATION Procedure For best results, dosage should start at the first sign of an attack. Rectally Two suppositories is the maximum dose for an individual attack. Total weekly dosage should not exceed 5 suppositories. Ergotamine Tartrate and Caffeine Suppositories should not be used for chronic daily administration. In carefully selected patients, with due consideration of maximum dosage recommendations, administration of the drug at bedtime may be an appropriate short-term preventive measure. Maximum Adult Dosage: One suppository at start …

WARNINGS 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 …

CONTRAINDICATIONS 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 tartrate and caffeine was coadministered, at least one resulting in death. Because of the increased risk for ergotism and other serious …

Ergotamine Tartrate And Caffeine is a prescription medication. You will need a valid prescription from a licensed healthcare provider.

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References & Data Sources

• DailyMed — Ergotamine Tartrate And Caffeine drug label (National Library of Medicine)
• openFDA — Ergotamine Tartrate And Caffeine label data (U.S. Food & Drug Administration)
• RxNorm — RXCUI 1293508 (NLM Normalized Drug Names)
• NDC Directory — Ergotamine Tartrate And Caffeine (FDA National Drug Code)

Medical Disclaimer

The information on this page is intended for educational purposes only and should not be used as a substitute for professional medical advice, diagnosis, or treatment.

Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication.

Data sources: DailyMed (NLM), openFDA, MFDS