Topic: Rocephin Plus Calcium Linked to Fatal Reactions in Neonates
Melanie Reber
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Rocephin Plus Calcium Linked to Fatal Reactions in Neonates
Yael Waknine
Medscape Medical News 2007. � 2007 Medscape
July 6, 2007 -- The safety labeling for ceftriaxone sodium injection (Rocephin; Roche Pharmaceuticals, Inc) has been updated to describe the potential risks associated with concomitant use of calcium or calcium-containing solutions and products, the US Food and Drug Administration (FDA) advised healthcare professionals yesterday.
Cases of fatal reactions with calcium-ceftriaxone precipitates in the lungs and kidneys of both term and premature neonates have been reported, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program. Some of these cases occurred when ceftriaxone and the calcium-containing products were administered by different routes at different times.
In vitro studies have shown that ceftriaxone can displace bilirubin from binding to serum albumin, potentially leading to bilirubin encephalopathy, the FDA said. Use of ceftriaxone is therefore contraindicated in hyperbilirubinemic neonates, especially those who are premature.
Because of the risk for particulate precipitation, ceftriaxone should not be mixed with calcium-containing solutions/products or reconstituted with calcium-containing diluents such as Ringer's or Hartmann's solution.
Concomitant administration of ceftriaxone with calcium-containing solutions or products is likewise contraindicated, even via different infusion lines; 48 hours should elapse between the last dose of ceftriaxone and their use.
Ceftriaxone injection is indicated for the treatment of lower respiratory tract infections, urinary tract infections, bacterial septicemia, skin and skin structure infections, bone and joint infections, pelvic inflammatory disease, uncomplicated gonorrhea, intraabdominal infections, acute bacterial otitis media, and meningitis caused by susceptible microorganisms. It also is approved for surgical prophylaxis in patients undergoing certain procedures classified as contaminated or potentially contaminated.
Healthcare professionals are encouraged to report ceftriaxone-related adverse events to the FDA's MedWatch reporting program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to 5600 Fishers Lane, Rockville, MD 20852-9787.
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