Skip to Content

Ciprofloxacin / fluocinolone otic Pregnancy and Breastfeeding Warnings

Ciprofloxacin / fluocinolone otic is also known as: Otovel

Medically reviewed by Drugs.com. Last updated on Aug 13, 2020.

Ciprofloxacin / fluocinolone otic Pregnancy Warnings

Animal studies using dermal and parenteral corticosteroids have revealed evidence of teratogenicity. There are no controlled data using any of the drugs, alone or in combination, 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.

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: This drug has negligible absorption after otic administration; use is not expected to result in fetal exposure of either active component. Animal studies using ciprofloxacin have failed to reveal evidence of fetotoxicity or neonatal toxicity.

See references

Ciprofloxacin / fluocinolone otic Breastfeeding Warnings

Caution is recommended.

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

Comment: 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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "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.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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