Ciprofloxacin / fluocinolone otic Pregnancy and Breastfeeding Warnings
Brand names: Otovel
Medically reviewed by Drugs.com. Last updated on Aug 13, 2024.
Ciprofloxacin / fluocinolone 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: 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.
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.
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 also
References for pregnancy information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- (2016) "Product Information. Otovel (ciprofloxacin-fluocinolone otic)." Arbor Pharmaceuticals
References for breastfeeding information
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- (2016) "Product Information. Otovel (ciprofloxacin-fluocinolone otic)." Arbor Pharmaceuticals
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.