New Warnings Added To Antibiotic’s Prescribing Information

July 17, 2007

Revisions have been made to the Contraindications, Warnings, Precautions, Adverse Reactions, and Dosage and Administration sections of the prescribing information for Roche’s ceftriaxone (Rocephin) for injection [more].

Revisions have been made to the Contraindications, Warnings, Precautions, Adverse Reactions, and Dosage and Administration sections of the prescribing information for Roche’s ceftriaxone (Rocephin) for injection. The revisions are based on new information that describes the potential risk associated with the concomitant use of ceftriaxone with calcium or calcium–containing solutions or products. Cases of fatal reactions with calcium–ceftriaxone precipitates in the lungs and kidneys in both term and premature infants have been reported.

According to the “Dear Healthcare Professional” letter from Roche; hyperbilirubinemic neonates, especially premature infants, should not be treated with ceftriaxone. The antibiotic must not be mixed or administered simultaneously with calcium-containing solutions (such as Ringer’s solution or Hartmann’s solution) or products, even via different infusion lines. Additionally, calcium–containing solutions or products must not be administered within 48 hours of the last administration of ceftriaxone. Health care providers may access the revised prescribing information at

www.rocheusa.com/products/rocephin

.