The FDA updated the full prescribing information of ceftriaxone (Rocephin and generics). This is an update to a previous ( september 2007) alert on the risk of interaction between ceftriaxone and calcium-containing IV products, the 2007 alert was based on reported fatal cases in neonates.
In addition to the alert, the FDA requested the manufacturer (Roche) to conduct in vitro studies to assess the potential of precipitation of ceftriaxone and calcium when ceftriaxone and calcium-containing products are mixed in vials and infusion lines.
The updated recommendations include the following:
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.
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.
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.
In addition, the agency repeats three of the 2007 recommendations:
Do not reconstitute or mix ceftriaxone with a calcium-containing product, such as Ringer’s or Hartmann’s solution or parenteral nutrition containing calcium, because particulate formation can result.
There are no data on interactions between intravenous ceftriaxone and oral calcium-containing products or between intramuscular ceftriaxone and intravenous or oral calcium-containing products.
Report patients who have adverse events following ceftriaxone administration to the FDA’s MedWatch program.