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Ceftaroline Pregnancy and Breastfeeding Warnings

Ceftaroline is also known as: Teflaro

Ceftaroline Pregnancy Warnings

Animal studies have failed to reveal evidence of fetal harm. No malformations or other adverse developmental effects seen in offspring of rats exposed to this drug at up to 4 times the maximum recommended human dose (MRHD); despite maternal toxicity, no drug-induced fetal malformations seen in offspring of rabbits exposed to levels about equal to the MRHD. 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 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus; as a precaution, some experts prefer to avoid use during pregnancy unless clearly needed. AU TGA pregnancy category: B1 US FDA pregnancy category: Not assigned. Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

See references

Ceftaroline Breastfeeding Warnings

AU: This drug should be used only if clearly needed; breastfeeding should be interrupted. UK: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. US: Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -The effects in the nursing infant are unknown. -In general, side effects in nursing infants are not expected with cephalosporins; disruption of infant's gastrointestinal flora (resulting in diarrhea or thrush) reported occasionally with cephalosporins, but such effects have not been adequately evaluated. -Many beta-lactams are excreted into breast milk.

See references

References for pregnancy information

  1. "Product Information. Teflaro (ceftaroline)." Forest Pharmaceuticals, St. Louis, MO.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. 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 -]):
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Teflaro (ceftaroline)." Forest Pharmaceuticals, St. Louis, MO.

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