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Ciprofloxacin otic Pregnancy and Breastfeeding Warnings

Ciprofloxacin otic is also known as: Cetraxal, Otiprio

Ciprofloxacin otic Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C

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 drug systemically at maternally toxic doses had an increased incidence of abortion, intra-uterine deaths, and fetal retardation; however, teratogenicity was not observed. 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.

See references

Ciprofloxacin otic Breastfeeding Warnings

Arthropathy and other serious adverse events have occurred in immature animals.

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.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Cetraxal (ciprofloxacin otic)." WraSer Pharmaceuticals, Madison, MS.
  3. "Product Information. Otiprio (ciprofloxacin otic)." Otonomy, Inc., San Diego, CA.

References for breastfeeding information

  1. "Product Information. Otiprio (ciprofloxacin otic)." Otonomy, Inc., San Diego, CA.
  2. 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 -]):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Cetraxal (ciprofloxacin otic)." WraSer Pharmaceuticals, Madison, MS.

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