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Ofloxacin otic Pregnancy and Breastfeeding Warnings

Ofloxacin otic is also known as: Floxin Otic

Ofloxacin otic Pregnancy Warnings

Ofloxacin otic has been assigned to pregnancy category C by the FDA. Animal studies using high systemic doses have revealed evidence of fetotoxicity and teratogenicity. There are no controlled data in human pregnancies. Cartilage damage and arthropathy are reported in immature animals giving rise to concern over effects on bone formation in the developing fetus. Ofloxacin otic is only recommended for use during pregnancy when benefit outweighs risk.

See references

Ofloxacin otic Breastfeeding Warnings

There are no data on the excretion of ofloxacin otic into human milk. Ofloxacin achieves low plasma levels after otic administration. Oral ofloxacin is excreted into milk at concentrations similar to plasma. Quinolone-induced cartilage erosion and arthropathies that have been observed in juvenile animals render some concern over its possible toxic effects on the developing joints of nursing infants. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue the drug or to discontinue nursing, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

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

References for breastfeeding information

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

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