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Ciprofloxacin / hydrocortisone otic Pregnancy and Breastfeeding Warnings

Ciprofloxacin / hydrocortisone otic is also known as: Cipro HC

Ciprofloxacin / hydrocortisone otic Pregnancy Warnings

Animal reproduction studies have not been conducted with this formulation of this drug. There are no controlled data from human pregnancy studies. Some animal models given this ciprofloxacin systemically at maternally toxic doses had an increased incidence of abortion, intra-uterine deaths, and fetal retardation; however, teratogenicity was not observed. Hydrocortisone is teratogenic when given systemically, with an increased risk of teratogenicity with more potent corticosteroids. AU TGA pregnancy category B3: 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 shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Caution is recommended. AU TGA pregnancy category: B3 US FDA pregnancy category: C

See references

Ciprofloxacin / hydrocortisone otic Breastfeeding Warnings

Use is not recommended and 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: Unknown Excreted into animal milk: Data not available Comments: -The effects in the nursing infant are unknown. -This drug is excreted into human milk when given systemically.

Safety has not been established in female patients during lactation.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Cipro HC Otic (ciprofloxacin-hydrocortisone otic)." Bayer, West Haven, CT.

References for breastfeeding information

  1. "Product Information. Cipro HC Otic (ciprofloxacin-hydrocortisone otic)." Bayer, West Haven, CT.
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. 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 -]):

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