1. Aschenbrenner, Diane S. MS, APRN-BC


* The FDA has revised the warning label of the antibiotic ceftriaxone to indicate that the drug shouldn't be used intravenously in neonates if they are receiving or are expected to receive IV solutions containing calcium.


* Infants older than 28 days may receive ceftriaxone and a calcium-containing solution in sequence, but not together, and nurses must flush IV lines thoroughly between the infusions.



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The Food and Drug Administration (FDA) is alerting health care professionals to revised label warnings for ceftriaxone (Rocephin and generics), a cephalosporin used to treat lower respiratory infections, skin infections, otitis media, and many other infections. (See for more information.) The agency last revised the warnings section of the drug's labeling in September 2007, after it received case reports of neonatal deaths attributable to a drug interaction with calcium-containing infusion products (such as Ringer's solution, lactated Ringer's solution, and parenteral nutrition containing calcium). The current revision is based on the results of two in vitro studies conducted by the manufacturer, in which adult and neonatal plasma were used to determine the potential for ceftriaxone and calcium to precipitate when mixed in vials and IV tubing in varying concentrations. According to the results, it appears that neonates (infants 28 days old or younger) are at greater risk when the two IV products are used either concurrently or sequentially.


Neonates shouldn't be given ceftriaxone if they're receiving any IV product containing calcium.


The new warnings and information on drug administration are as follows:


* Ceftriaxone shouldn't be given to neonates (infants 28 days old or younger) if they are receiving or are expected to receive IV products containing calcium.


* Infants older than 28 days may receive ceftriaxone and a calcium-containing IV solution in sequence if the IV line is flushed thoroughly between the two infusions with a fluid compatible with both (formerly, in 2007, the FDA cautioned against sequential use in patients of all ages [that is, the use of one product within 48 hours of the other]).


* No patient of any age should receive simultaneous administration of ceftriaxone and any IV solution containing calcium via an IV tubing Y site.



Previous FDA recommendations and considerations still in effect are:


* Ceftriaxone shouldn't be reconstituted or mixed with any calcium-containing product.


* The interaction occurs only when both products are administered intravenously-no drug interactions have been noted between IV ceftriaxone and oral calcium-containing products, or between intramuscular ceftriaxone and either IV or oral calcium-containing products. Any adverse effects of ceftriaxone should be reported to the FDA MedWatch program at



Nurses should be aware of the new warnings. Those who administer the two products to infants older than 28 days may wish to exercise special caution by using separate IV tubing instead of trying to determine whether the IV line has been "flushed thoroughly." In any event, it's important to remember to flush any reused length of tubing and the IV access device.