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Desyrel (trazodone hydrochloride)

May 12, 2004

Audience: Neuropsychiatric healthcare professionals

FDA and Bristol-Myers Squibb notified healthcare professionals of revisions to the CLINICAL PHARMACOLOGY and PRECAUTIONS sections of the Desyrel labeling. Desyrel is indicated for the treatment of depression. In vitro drug metabolism studies suggest that there is a potential for drug interactions when trazodone is given with the CYP3A4 inhibitors ketoconazole, ritonavir, and indinavir. It is likely that CYP3A4 inhibitors may lead to substantial increases in trazodone plasma concentrations with the potential for adverse effects. If trazodone is used with a potent CYP3A4 inhibitor, a lower dose of trazodone should be considered. Conversely, carbamazepine reduced plasma concentrations of trazodone when coadministered. Patients should be closely monitored to see if there is a need for an increased dose of trazodone when taken with carbamazepine.

[May, 2004 Letter - Bristol-Myers Squibb]
[September, 2003 Label - Bristol-Myers Squibb]

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