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Topic: Ergotamine Warning (Read 659 times) |
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Becca
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Ergotamine Warning
« on: Dec 2nd, 2002, 4:44am » |
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I think that ergotamines are more often prescribed for migraines than for CH, but just in case ayone here could use the info below, here's an FYI. I am passing on a warning from the pharmacy of a hospital where I work.
Novartis recently issued a statement regarding changes to the prescribing information for Cafergot (ergotamine tartrate and caffeine), a medication prescribed for migraine sufferers. The message includes a new boxed warning section related to interactions between Cafergot and potent CYP 3A4 inhibitors.
WARNING:
SERIOUS AND/OR LIFE-THREATENING PERIPHERAL ISCHEMIA HAS BEEN ASSOCIATED WITH THE COADMINISTRATION OF CAFERGOT WITH POTENT CYP 3A4 INHIBITORS INCLUDING PROTEASE INHIBITORS AND MACROLIDE ANTIBIOTICS. BECAUSE CYP 3A4 INHIBITION
ELEVATES THE SERUM LEVELS OF CAFERGOT, THE RISK FOR VASOSPASM LEADING TO CEREBRAL ISCHEMIA AND/OR ISCHEMIA OF THE EXTREMITIES IS INCREASED. HENCE, CONCOMITANT USE OF THESE MEDICATIONS IS CONTRAINDICATED.
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, WITH SOME CASES RESULTING IN AMPUTATION. THERE HAVE BEEN RARE REPORTS OF CEREBRAL ISCHEMIA IN PATIENTS ON PROTEASE INHIBITOR THERAPY WHEN CAFERGOT (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).
THE SECTIONS ADDRESSING CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, CLINICAL PHARMCOLOGY, AND INTERACTIONS OF THE PI HAVE BEEN UPDATED ACCORDINGLY.
AT THE SAME TIME OF THIS REVISION OF THE PI, NOVARTIS ALSO UPDATED THE ALREADY EXISTING INFORMATION ABOUT FIBROTIC COMPLICATIONS (SEE WARNINGS SECTION), AND HAVE REINFORCED THAT CAFERGOT (ERGOTAMINE TARTRATE AND CAFFEINE)
SHOULD NOT BE USED FOR CHRONIC DAILY ADMINISTRATION (SEE DOSAGE AND ADMINISTRATION SECTION).
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