Warnings for Rocephin

Posted on April 29, 2008

Roche Laboratories is warning about the danger of administering the antibiotic Rocephin (ceftriaxone sodium) along with IV products that contain calcium, such as parenteral nutrition, because harmful precipitates can occur.

The labeling describes cases of fatal reactions in neonates where precipitates were found in the infants' lungs or kidneys. In some of these cases, the Rocephin and the calcium-containing solutions were administered through different infusion lines or at different times. Even though there are no reported cases of these precipitates in patients other than neonates, there's a potential for this type of interaction in patients of any age.

Because particulates could form, the labeling now says:

-- Don't reconstitute or mix Rocephin with products that contain calcium. These include Ringer's solution, Hartmann's solution and parenteral nutrition formulations with calcium.

-- Don't administer Rocephin at the same time as calcium-containing solutions, even if they're delivered through different infusion lines.

-- Don't administer Rocephin and solutions that contain calcium with within 48 hours of each other.

There are no data on whether Rocephin might interact with calcium-containing products that are given orally. It is also not clear whether intramuscular Rocephin might interact with calcium-containing products, either IV or oral.

The labeling also reemphasizes that neonates with hyperbilirubinemia should not be treated with Rocephin, especially premature neonates. That's because in vitro studies have shown that Rocephin, like some other cephalosporins, can displace bilirubin from its binding to serum albumin, and that could result in bilirubin encephalopathy.

Additional Information:

FDA MedWatch Safety Alert. Rocephin (ceftriaxone sodium). September 11, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Rocephin