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In September 2007, the FDA notified healthcare professionals that the labeling for ceftriaxone had been revised to indicate that it should not be mixed with (or administered within 48 hours of) calcium-containing products for any patient. This warning was based on postmarketing reports of neonatal deaths resulting from crystalline deposits in the lungs and kidneys.
The FDA updated its recommendations in April 2009, based on the manufacturer’s in vitro tests with ceftriaxone and calcium at various concentrations. The new recommendations: Ceftriaxone should still not be reconstituted or mixed with a calcium-containing product (e.g., Ringer’s or Hartmann’s solution or parenteral nutrition). The drug should also still be avoided in infants aged ≤28 days if they are receiving or expected to receive intravenous calcium-containing products. However, ceftriaxone and calcium-containing products may now be used concomitantly in patients aged >28 days, provided that the infusion lines are thoroughly flushed between infusions and the preparations are not coadministered via a Y-site.
Food and Drug Administration. Information for healthcare professionals: Ceftriaxone (marketed as Rocephin and generics). Apr 21, 2009. (http://www.fda.gov/cder/drug/InfoSheets/HCP/ceftriaxone042009HCP.htm)
Comment
This update is most welcome. Clearly, reports of deaths among neonates who received both ceftriaxone and intravenous calcium-containing products indicate that the combination must be avoided in this age group. However, ceftriaxone has been used for many years without reports of similar incidents in patients other than neonates. Unfortunately, because of the 2007 FDA alert and the impossibility of predicting need for a calcium-containing product within 48 hours, some institutions abandoned this useful antibiotic altogether. Others prohibited use of ceftriaxone only in neonates. This FDA update should once again put healthcare professionals at ease regarding use of ceftriaxone in patients aged >28 days.