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Ofloxacin otic Pregnancy and Breastfeeding Warnings

Ofloxacin otic is also known as: Floxin Otic

Medically reviewed on June 6, 2017.

Ofloxacin otic Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk Summary: Use has not been associated with adverse events at doses used in this formulation.

Animal models have revealed evidence of decreased fetal weight, increased fetal mortality, and an increased frequency of fetal skeletal variations at high doses. There are no controlled data in human pregnancy.

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

Ofloxacin otic Breastfeeding Warnings

This drug is expressed into breastmilk when given orally.

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.

See references

References for pregnancy information

  1. "Product Information. Floxin otic (ofloxacin otic)." Daiichi Pharmaceuticals, Fort Lee, NJ.

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. "Product Information. Floxin otic (ofloxacin otic)." Daiichi Pharmaceuticals, Fort Lee, NJ.

Further information

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

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