Is Rocephin (Ceftriaxone) safe to use during the third trimester of pregnancy?

From the Guidelines

Rocephin (ceftriaxone) is generally considered safe to use during the third trimester of pregnancy when medically necessary. This third-generation cephalosporin antibiotic has been widely used in pregnant women with no consistent evidence of harm to the developing fetus 1. The standard adult dosing of ceftriaxone is typically 1-2 grams given once or twice daily, depending on the type and severity of infection being treated. When prescribed during pregnancy, healthcare providers carefully weigh the benefits of treating maternal infection against any potential risks. Ceftriaxone works by inhibiting bacterial cell wall synthesis and has minimal placental transfer. Unlike some antibiotics that are contraindicated in pregnancy (such as tetracyclines or fluoroquinolones), ceftriaxone has not been associated with specific fetal abnormalities or pregnancy complications.

Some key points to consider when using ceftriaxone during pregnancy include:

• Ceftriaxone is a preferred parenteral regimen for treating certain infections, such as Lyme disease, in pregnant women 1
• The dosage for adults is typically 2 grams intravenously once per day, while for children it is 50–75 mg/kg intravenously per day in a single dose (maximum, 2 g) 1
• Ceftriaxone has been shown to be effective against a range of bacterial infections, including those caused by Streptococcus and Staphylococcus species 1
• As with any medication during pregnancy, ceftriaxone should only be used when clearly indicated for treating bacterial infections that are susceptible to this antibiotic.

It's also important to note that while ceftriaxone is considered safe for use during pregnancy, other antibiotics, such as tetracyclines and fluoroquinolones, are contraindicated due to the risk of harm to the developing fetus 1. Any woman receiving ceftriaxone during pregnancy should inform all healthcare providers about her pregnancy status and medication use.

From the FDA Drug Label

Pregnancy Teratogenic Effects Pregnancy Category B: 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. In primates, no embryotoxicity or teratogenicity was demonstrated at a dose approximately 3 times the human dose There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed

Rocephin (Ceftriaxone) is classified as Pregnancy Category B, which means that reproductive studies in animals have shown no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women.

• Key points:
  • No evidence of embryotoxicity, fetotoxicity, or teratogenicity in animal studies
  • No adequate and well-controlled studies in pregnant women
  • Should be used during pregnancy only if clearly needed 2
  • The same information is also present in the IV formulation of the drug 3

From the Research

Safety of Rocephin in the Third Trimester of Pregnancy

• The safety of Rocephin (Ceftriaxone) in the third trimester of pregnancy can be evaluated based on its pharmacokinetics and protein binding during pregnancy 4.
• A study on the pharmacokinetics and protein binding of ceftriaxone during pregnancy found that the pharmacokinetic parameters measured in pregnant patients during the third trimester of pregnancy were similar to those measured in healthy subjects 4.
• The study also found that there was no accumulation of ceftriaxone during treatment, and the profiles of the drug determined at days 1 and 7 were not significantly different 4.
• Another study evaluated the efficacy of ceftriaxone in pregnant women diagnosed with early syphilis and found that ceftriaxone may be considered as an alternative for treatment of early syphilis in pregnancy 5.
• However, it is essential to note that the use of any medication during pregnancy should be based on a risk-benefit assessment, and the decision to use ceftriaxone should be made on a case-by-case basis 6.
• The risk of birth defects associated with ceftriaxone is not well established, but it is known that only a few drugs are known to cause birth defects in humans, and the risk should not be exaggerated 7.
• In general, ceftriaxone has been found to be effective and safe for the treatment of various infections, including those caused by multidrug-resistant Gram-negative bacteria 8.

Key Findings

• Ceftriaxone pharmacokinetics during pregnancy are similar to those in healthy subjects 4.
• No accumulation of ceftriaxone was noted during treatment 4.
• Ceftriaxone may be considered as an alternative for treatment of early syphilis in pregnancy 5.
• The use of ceftriaxone during pregnancy should be based on a risk-benefit assessment 6.
• The risk of birth defects associated with ceftriaxone is not well established 7.