Ceftriaxone Use During Pregnancy
Ceftriaxone is considered safe for use during pregnancy and is classified as FDA Pregnancy Category B, indicating no evidence of risk to the fetus based on animal studies and limited human data. 1
Safety Profile
- Ceftriaxone has been used in pregnant women without evidence of increased risk of birth defects or adverse fetal outcomes 1, 2
- The FDA drug label states: "Reproductive studies have been performed in mice and rats at doses up to 20 times the usual human dose and have 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
- Pharmacokinetic studies in pregnant women during the third trimester show that no dosage adjustments are needed compared to non-pregnant adults 2, 3
Clinical Evidence
- A study evaluating ceftriaxone in pregnant women with early syphilis found it to be effective without adverse effects on mothers or neonates 4
- Another study examining ceftriaxone for perinatal infections reported a 75% efficacy rate with no adverse reactions observed in mothers or neonates 5
- Ceftriaxone has been specifically recommended for use in pregnant women with various infections, including:
Specific Recommendations
- Ceftriaxone is specifically mentioned in guidelines as an appropriate antibiotic choice during pregnancy for:
Dosing Considerations
- Standard adult dosing can be used during pregnancy 2, 3
- For most infections, the typical dose is 1-2g daily 2
- No accumulation of the drug occurs during pregnancy, and pharmacokinetic profiles are similar to non-pregnant adults 2, 3
Precautions
- While generally safe, ceftriaxone should only be used during pregnancy when clearly needed 1
- As with all medications during pregnancy, the benefits of treatment should be weighed against potential risks 6
- Ceftriaxone should not be used in hyperbilirubinemic neonates, especially prematures, but this is a consideration for neonatal use, not maternal use during pregnancy 1
Breastfeeding Considerations
- Low concentrations of ceftriaxone are excreted in human milk 1
- Caution should be exercised when administering ceftriaxone to nursing women, though it is generally considered compatible with breastfeeding 1
In summary, ceftriaxone is considered a safe and effective antibiotic option during pregnancy when indicated for bacterial infections. Its FDA Pregnancy Category B status and extensive clinical experience support its use when appropriate antimicrobial therapy is needed during pregnancy.