The full prescribing information for Ceftriaxone ( Rocephin and its generics ) has been changed. This information updates a previous Alert and addresses the interaction of Ceftriaxone with calcium-containing products, based on previously reported fatal cases in neonates.

The manufacturer of Ceftriaxone ( Roche ) conducted two in vitro studies to assess the potential for precipitation of Ceftriaxone-Calcium when Ceftriaxone and Calcium-containing products are mixed in vials and in infusion lines. These two in vitro studies were conducted in neonatal and adult plasma to assess the potential for precipitation of Ceftriaxone-Calcium using varying Ceftriaxone and Calcium concentrations, including concentrations in excess of those achieved in vivo.

Based on the results from these studies, FDA has the following updated recommendations:

a) Concomitant use of Ceftriaxone and intravenous Calcium-containing products is contraindicated in neonates ( <28 days of age ). Ceftriaxone should not be used in neonates ( <28 days of age ) if they are receiving ( or are expected to receive ) Calcium-containing intravenous products.

b) In patients >28 days of age, Ceftriaxone and Calcium-containing products may be administered sequentially, provided the infusion lines are thoroughly flushed between infusions with a compatible fluid.

c) Ceftriaxone must not be administered simultaneously with intravenous Calcium-containing solutions via a Y-site in any age group.

FDA now recommends that Ceftriaxone and Calcium-containing products may be used concomitantly in patients >28 days of age, using the precautionary steps above because the risk of precipitation is low in this population. FDA had previously recommended, but no longer recommends, that in all age groups Ceftriaxone and Calcium-containing products should not be administered within 48 hours of one another.

Source: FDA, 2009

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