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Ciprofloxacin / fluocinolone otic Pregnancy and Breastfeeding Warnings

Ciprofloxacin / fluocinolone otic is also known as: Otovel

Medically reviewed on Aug 23, 2018

Ciprofloxacin / fluocinolone otic Pregnancy Warnings

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.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: This drug has negligible absorption after otic administration; use is not expected to result in fetal exposure of either active component.

See references

Ciprofloxacin / fluocinolone otic Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
Excreted into animal milk: Unknown

Comments: The effects in the nursing infant are unknown.

This drug is negligibly absorbed after otic administration; breastfeeding is not expected to result in exposure of this drug to the infant.

See references

References for pregnancy information

  1. "Product Information. Otovel (ciprofloxacin-fluocinolone otic)." Arbor Pharmaceuticals, Atlanta, GA.

References for breastfeeding information

  1. "Product Information. Otovel (ciprofloxacin-fluocinolone otic)." Arbor Pharmaceuticals, Atlanta, GA.

Further information

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

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