Ciprofloxacin / hydrocortisone otic Pregnancy and Breastfeeding Warnings

Brand names: Cipro HC

Medically reviewed by Drugs.com. Last updated on Mar 18, 2024.

Ciprofloxacin / hydrocortisone otic Pregnancy Warnings

Caution is recommended.

AU TGA pregnancy category: B3
US FDA pregnancy category: Not assigned.

Risk summary: No data are available on use of this drug combination (as an otic formulation) in pregnant women to inform a drug-related risk.

Animal reproduction studies have not been conducted with this formulation of this drug. There are no controlled data from human pregnancy studies. Some animal models given this ciprofloxacin systemically at maternally toxic doses had an increased incidence of abortion, intra-uterine deaths, and fetal retardation; however, teratogenicity was not observed. Hydrocortisone is teratogenic and can cause reproductive toxicity when given systemically, and has increased risk of teratogenicity as seen with more potent corticosteroids when administered dermally.

AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans.

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

Ciprofloxacin / hydrocortisone otic Breastfeeding Warnings

Use is not recommended and 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 (ciprofloxacin)
Excreted into animal milk: Data not available (hydrocortisone)

Comments:
-The effects in the nursing infant are unknown.
-Ciprofloxacin is excreted into human milk when given systemically.
-The American Academy of Pediatrics classifies ciprofloxacin as compatible with breastfeeding.

Safety has not been established in female patients during lactation.

See references

Further information

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