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Vancomycin Pregnancy and Breastfeeding Warnings

Vancomycin is also known as: Firvanq, Lyphocin, Vancocin, Vancocin HCl, Vancocin HCl Pulvules

Medically reviewed on March 27, 2018

Vancomycin Pregnancy Warnings

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

AU TGA pregnancy category: B2
US FDA pregnancy categories:
-Oral capsules: B
-Oral solution: Not assigned.
-Parenteral formulations: Not assigned.

Risk summary: No data are available on use of this formulation in pregnant women to inform a drug-related risk.

Comments:
-If treatment is necessary, some experts recommend close monitoring of maternal blood to reduce the risk of ototoxicity and nephrotoxicity in the fetus.
-Pregnant patients may require higher doses to achieve therapeutic concentrations.

Animal models have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy.

AU TGA pregnancy category B2: 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 are inadequate or may be lacking, but available data show no 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.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Vancomycin Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-Some experts recommend using this drug with caution during breastfeeding.
-The effects in the nursing infant are unknown.
-The WHO considers this agent a restricted use drug, but does not have data to inform of a recommendation.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Vancocin (vancomycin)." Lilly, Eli and Company, Indianapolis, IN.

References for breastfeeding information

  1. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization "Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. Available from: URL: http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1" ([2003]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Vancocin (vancomycin)." Lilly, Eli and Company, Indianapolis, IN.
  5. 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 -]):

Further information

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

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