Migergot Recall
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Questions & Answers
Side Effects & Adverse Reactions
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)
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Ergotamine Tartrate and Caffeine
Indicated as therapy to abort or prevent vascular headache, e.g., migraine, migraine variants or so-called “histaminic cephalalgia”.
History
There is currently no drug history available for this drug.
Other Information
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.
Sources