The warning informed doctors that cases of fatal reactions in the lungs and kidneys in both term and premature babies had been found when the drug was administered simultaneously with calcium. The revisions are based on new information on the potential risks from postmarketing clinical use, the agency said.
The FDA added that calcium-containing solutions or products must not be administered within 48-hours of the last administration of the drug, generically known as ceftriaxone. In addition, Rocephin should not be given to babies with hyperbilirubinemia, also called neonatal jaundice.
Rocephin is approved to treat lower respiratory infections, urinary tract infections, gonorrhea and other infections.