Ergotamine Tartrate And Caffeine

Ergotamine Tartrate And Caffeine

Ergotamine Tartrate And Caffeine 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 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 and caffeine. Ergotamine tartrate 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.


Ergotamine tartrate and caffeine tablets are indicated as therapy to abort or prevent vascular headache; e.g., migraine, migraine variants or so-called histaminic cephalalgia.


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.


Image from Drug Label Content

(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)


Image from Drug Label Content

C8H10N4O2 (anhydrous)                                                                                 M.W. 194.19

1H-Purine-2,6-dione, 3,7-dihydro-1,3,7-trimethyl-

Inactive ingredients include colloidal silicon dioxide, crospovidone, magnesium stearate, and microcrystalline cellulose. Film coating includes the following ingredients: macrogol/PEG 3350, polyvinyl alcohol, purified water, talc, titanium dioxide, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake, and FD&C yellow #5 tartrazine aluminum lake.

Ergotamine Tartrate And Caffeine Manufacturers

  • Mikart, Inc
    Ergotamine Tartrate And Caffeine (Ergotamine Tartrate And Caffeine) Tablet [Mikart, Inc]
  • Kaiser Foundation Hospitals
    Ergotamine Tartrate And Caffeine Tablet [Kaiser Foundation Hospitals]

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