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Ceftriaxone (marketed as Rocephin) Information
FDA ALERT [9/2007] - This Alert highlights important revisions to the CONTRAINDICATIONS, WARNINGS, and DOSAGE and ADMINISTRATION sections of the full prescribing information for Rocephin. This new information addresses the interaction of ceftriaxone with calcium-containing products based on reports of fatal cases in neonates. Although there are no reported cases of ceftriaxone-calcium precipitates in patients other than neonates, the potential for this interaction exists in patients of any age. Generally, fatalities have been associated with simultaneous administration of ceftriaxone and calcium-containing products. However, administration of the two products at different times and via different infusion lines has also been fatal. Therefore, ceftriaxone should not be mixed with calcium-containing products and not administered in the same or different infusion lines or sites in any patient within 48 hours of each other. The information in the August 2007 ceftriaxone label clarifies the ceftriaxone labeling revision in May 2007 that first included information on this interaction.
This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this when additional information or analyses become available.
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Date created: September 11, 2007 |
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