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Ceftriaxone Pregnancy and Breastfeeding Warnings

Ceftriaxone is also known as: Rocephin

Ceftriaxone Pregnancy Warnings

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.

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

See references

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 references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Heikkila A, Erkkola R "Review of beta-lactam antibiotics in pregnancy - the need for adjustment of dosage schedules." Clin Pharmacokinet 27 (1994): 49-62
  3. Christiansen K, et al. "Therapeutic Guidelines: Antibiotic. 13th ed." Melbourne, Australia , AK: Therapeutic Guidelines Ltd. (2006):
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL: http://www.tga.gov.au/docs/pdf/medpreg.pdf." ([1999]):
  6. "Product Information. Rocephin (ceftriaxone)." Roche Laboratories, Nutley, NJ.
  7. Donders GGG "Treatment of sexually transmitted bacterial diseases in pregnant women." Drugs 59 (2000): 477-85
  8. Ramus RM, Sheffield JS, Mayfield JA, Wendel GD Jr "A randomized trial that compared oral cefixime and intramuscular ceftriaxone for the treatment of gonorrhea in pregnancy." Am J Obstet Gynecol 185 (2001): 629-32
  9. Royal Australian College of General Practicioners (RACGP), the Pharmaceutical Society of Australia (PSA), the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT) "Australian Medicines Handbook. Available from: URL: https://www.amh.net.au/"

References for breastfeeding information

  1. Christiansen K, et al. "Therapeutic Guidelines: Antibiotic. 13th ed." Melbourne, Australia , AK: Therapeutic Guidelines Ltd. (2006):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  4. Cerner Multum, Inc. "Australian Product Information." O 0
  5. Royal Australian College of General Practicioners (RACGP), the Pharmaceutical Society of Australia (PSA), the Australasian Society of Clinical and Experimental Pharmacologists and Toxicologists (ASCEPT) "Australian Medicines Handbook. Available from: URL: https://www.amh.net.au/"
  6. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  7. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  8. "Product Information. Rocephin (ceftriaxone)." Roche Laboratories, Nutley, NJ.
  9. Kafetzis DA, Brater DC, Fanourgakis JE, et al "Ceftriaxone distribution between maternal blood and fetal blood and tissues at parturition and between blood and milk postpartum." Antimicrob Agents Chemother 23 (1983): 870-3

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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