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Cefepime Pregnancy and Breastfeeding Warnings

Brand names: Maxipime

Medically reviewed by Drugs.com. Last updated on Aug 14, 2023.

Cefepime Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: B

Comment: Use during labor and delivery has not been evaluated.

Animal studies have failed to reveal evidence of fertility impairments, teratogenicity, embryolethality, fetal harm, and direct/indirect post-natal development. 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.

See references

Cefepime Breastfeeding Warnings

This drug is excreted in a concentration of approximately 0.5 mcg/mL; nursing infants who consume 1000 mL of human milk/day would receive a dose of approximately 0.5 mg/day.

Caution is recommended.

Excreted into human milk: Yes

Comments:
-The American Academy of Pediatrics considered other cephalosporins (e.g., cefadroxil, cefazolin) compatible with breastfeeding.
-Maternal doses of cephalosporins have resulted in reports of neonatal diarrhea and thrush.
-The effects in the nursing infant are unknown.

See references

See also

References for pregnancy information

  1. Product Information. Maxipime (cefepime). Bristol-Myers Squibb. 2001;PROD.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.
  4. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm 2010.

References for breastfeeding information

  1. Product Information. Maxipime (cefepime). Bristol-Myers Squibb. 2001;PROD.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.
  4. United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
  5. Briggs GG, Freeman RK. Drugs in Pregnancy and Lactation. Philadelphia, PA: Wolters Kluwer Health. 2015.

Further information

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

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