Rocephin use in the NICU

Ceftriaxone (Rocephin) has many attractive features as an antibiotic: it provides broad-spectrum coverage, it only requires once-a–day dosing due to its long half-life, and it can achieve nearly equal serum concentrations when administered either IV or IM.   However, Rocephin has two potentially serious side effects  in neonates that mandates thought and caution when prescribing it:

  1. Ceftriaxone potently competes with bilirubin for albumin binding sites.  By displacing bilirubin from albumin, ceftriaxone increases serum free bilirubin which is lipid-soluble and readily crosses the blood brain barrier, thereby increasing the risk of kernicterus at lower bilirubin levels than would otherwise be considered dangerous.

  2. Cases of fatal reactions with calcium-ceftriaxone precipitates in the lungs and kidneys in both term and premature neonates have been reported.  The drug must not be mixed or administered simultaneously with calcium-containing solutions 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. 

Circumstances in which one may consider Rocephin in the NICU

1)      A single 50 mg/kg dose of Rocephin is the drug of choice to treat gonococcal ophthalmia neonatorum.

2)      IM Rocephin may be given to complete a day or two of an antibiotic course in an infant who has lost IV access.

HOWEVER, neonates may only receive Rocephin IF:

  1. The baby is > 2 weeks of age AND anicteric OR, if the baby is < 2 weeks old

  2. The baby is of term gestation AND the indirect bilirubin is < 8 AND the baby is Coombs – with no signs of hemolysis

  3. The baby is not receiving calcium-containing products currently and will not receive them for 48 hours after the dose of ceftriaxone.

If neither of these conditions are met, then substitute cefotaxime (Claforan) or another appropriate antibiotic or combination of antibiotics.

Dosing information:

Cefotaxime (Claforan)  if < 1.2 kg OR  < 7 days old:  50 mg/kg/dose IV q 12h

                                              if > 1.2 kg AND >7 days old: 50 mg/kg/dose IV q 8h

 

Ceftriaxone (Rocephin) 50 mg/kg/dose IV/IM q 24h

 

To ensure that a neonate does not receive an inappropriate dose of Rocephin, the pharmacy will call to confirm with the NICU physician when Rocephin is ordered on a NICU patient.

 Approved by the pharmacy 8/23/02.

References:

AAP. Red Book, 25th ed. Report of the Committee on Infectious Diseases. pgs. 260; 651t

Martin E, et al. Ceftriaxone-bilirubin-albumin interactions in the neonate: an in vivo study. Eur J Pediatr 1993; 152: 530-4.

Wagner CL, et al. Early discharge with home antibiotic therapy in the treatment of neonatal infection. J Perinatol 2000; 20: 346-50

www.fda.gov/medwatch/safety/2007/rocephin_DHCP_june2007.pdf

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