Cafergot 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.
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
CAFERGOT®(ergotamine tartrate and caffeine tablets, USP) are 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
Each tablet for oral administration contains 1 mg ergotamine tartrate, USP, and 100 mg caffeine, USP.
ERGOTAMINE TARTRATE:
(C33H35N5O5)2• C4H6O6 M.W. 1313.41
Ergotaman-3’, 6’, 18-trione, 12’-hydroxy-2’-methyl-5’-(phenyl-methyl)-, (5’α), [R-(R*, R*)]-2,3-dihydroxy-butanedioate (2:1) (salt)
CAFFEINE:
C8H10N4O2 (anhydrous) M.W. 194.19
1H-Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethyl-
Inactive ingredients include black iron oxide, compressible sugar, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide and yellow iron oxide.
Sources