Ergotamine Tartrate And Caffeine
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Questions & Answers
Side Effects & Adverse Reactions
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.
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.
Uses
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.
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 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.
Sources
Ergotamine Tartrate And Caffeine Manufacturers
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Mikart, Inc
![Ergotamine Tartrate And Caffeine (Ergotamine Tartrate And Caffeine) Tablet [Mikart, Inc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Ergotamine Tartrate And Caffeine | Cintas First Aid & Safety
adults and children 2 years of age and older: to affected area not more than 3-4 times daily children under 2 years: consult a doctor -
Kaiser Foundation Hospitals
Ergotamine Tartrate And Caffeine | Kaiser Foundation Hospitals
Procedure:
For the best results, dosage should start at the first sign of an attack.
Adults: Take 2 tablets at the start of attack; 1 additional tablet every ½ hour, if needed for full relief (maximum 6 tablets per attack, 10 per week).
Early Administration Gives Maximum Effectiveness.
Maximum Adult Dosage:
Six tablets is the maximum dose for an individual attack.
Total weekly dosage should not exceed 10 tablets. Ergotamine tartrate and caffeine tablets 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.
![Ergotamine Tartrate And Caffeine Tablet [Kaiser Foundation Hospitals]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ed1ede57-1317-491a-9ebb-edee9aef5b3b&name=ergotamine-tartra-03.jpg)
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