Ceftriaxone Pregnancy and Breastfeeding Warnings
Brand names: Rocephin
Medically reviewed by Drugs.com. Last updated on Aug 8, 2023.
Ceftriaxone Pregnancy Warnings
This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk.
AU TGA pregnancy category: B1
US FDA pregnancy category: B
Animal studies have failed to reveal evidence of embryotoxicity, fetotoxicity, or teratogenicity. This drug crosses the placenta. There are no controlled data in human pregnancy.
AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Ceftriaxone Breastfeeding Warnings
Use is considered acceptable; caution is recommended.
-UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the child.
Excreted into human milk: Yes (small amounts)
Comments:
-The effects in the nursing infant are unknown; low levels in milk not expected to cause harmful effects in the nursing infant.
-This drug is considered compatible with breastfeeding by the American Academy of Pediatrics.
After 1 g IM or IV on day 3 postpartum to 20 women, peak milk levels averaged about 0.7 and 0.5 mg/L, respectively, at about 4 hours after the dose. Levels decreased very slowly over 24 hours with half-lives of 13 to 17 hours. Amounts in milk correspond to infant dose of about 0.5% of the maternal weight-adjusted dose. With usual doses, only a few mg of this drug expected to be ingested per day by the infant.
Disruption of infant's gastrointestinal flora (resulting in diarrhea or thrush) reported occasionally with cephalosporins; such effects have not been adequately evaluated. Risk of diarrhea and mucous membrane fungal infections cannot be excluded; possible sensitization should be considered.
See also
References for pregnancy information
- Product Information. Rocephin (ceftriaxone). Roche Laboratories. 2002;PROD.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. http://www.tga.gov.au/docs/pdf/medpreg.pdf 2007.
- Cerner Multum, Inc. Australian Product Information.
- Christiansen K, et al. Therapeutic Guidelines: Antibiotic. Melbourne, Australia , AK: Therapeutic Guidelines Ltd. 2006.
References for breastfeeding information
- Product Information. Rocephin (ceftriaxone). Roche Laboratories. 2002;PROD.
- Committee on Drugs, 1992 to 1993. The transfer of drugs and other chemicals into human milk. Pediatrics. 1994;93:137-50.
- Cerner Multum, Inc. UK Summary of Product Characteristics.
- Cerner Multum, Inc. Australian Product Information.
- Christiansen K, et al. Therapeutic Guidelines: Antibiotic. Melbourne, Australia , AK: Therapeutic Guidelines Ltd. 2006.
- United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
