Is Rocephin (Ceftriaxone) safe to use during pregnancy?

Rocephin (Ceftriaxone) Safety During Pregnancy

Rocephin (ceftriaxone) is safe to use during pregnancy as it is classified as FDA Pregnancy Category B, indicating animal studies have shown no evidence of embryotoxicity, fetotoxicity, or teratogenicity, though adequate controlled studies in pregnant women are limited. 1

Safety Profile

• Reproductive studies in mice and rats at doses up to 20 times the usual human dose have shown no evidence of embryotoxicity, fetotoxicity, or teratogenicity 1
• In primates, no embryotoxicity or teratogenicity was demonstrated at doses approximately 3 times the human dose 1
• Ceftriaxone belongs to the cephalosporin class of antibiotics, which is considered one of the safest antibiotic classes during pregnancy 2
• Pharmacokinetic studies show that ceftriaxone dosing during the third trimester of pregnancy requires no particular adjustment from standard dosing regimens 3

Clinical Evidence

• A study evaluating ceftriaxone in pregnant women found excellent tolerance with complete remission of infections without premature delivery 3
• Ceftriaxone has been successfully used to treat various infections during pregnancy including:
  • Gonococcal infections (at 125 mg intramuscular dose) with 95% efficacy 4
  • Syphilis in penicillin-allergic pregnant women (250 mg intramuscular daily for 7-10 days) 5
  • Various perinatal infections including amniotic fluid infection, intrauterine infection, and pyelonephritis 6

Important Considerations

• Low concentrations of ceftriaxone are excreted in human milk, so caution should be exercised when administering to nursing women 1
• Ceftriaxone should NOT be administered to hyperbilirubinemic neonates, especially prematures (contraindicated) 1
• In Segment I (fertility and general reproduction) and Segment III (perinatal and postnatal) studies with intravenously administered ceftriaxone in rats, no adverse effects were noted on reproductive parameters during gestation and lactation 1

Monitoring Recommendations

• No specific fetal monitoring is required beyond standard prenatal care 1
• Monitor for maternal side effects as with non-pregnant patients 1
• For women with cholestatic liver diseases who are pregnant, laboratory values should be monitored at least once per trimester 2

Conclusion

Ceftriaxone is considered a safe antibiotic option during pregnancy when clinically indicated. The benefits of treating maternal infection generally outweigh the theoretical risks to the fetus, as untreated infections may pose greater risks to both mother and baby.