Ozenoxacin topical Pregnancy and Breastfeeding Warnings

Brand names: Xepi

Medically reviewed by Drugs.com. Last updated on Oct 12, 2023.

Ozenoxacin topical Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk Summary: No data available on use of this drug in pregnant women to inform a drug-related risk.

Comments: Systemic absorption is negligible following topical administration.

Animal reproduction studies have not been reported. However, toxicity studies conducted in pregnant rats and rabbits using the oral form of this drug showed no significant adverse developmental effects. Due to negligible systemic exposure, it is not expected that maternal use of this drug will result in fetal exposure. There are no controlled data 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.

See references

Ozenoxacin topical Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-Breastfeeding is not expected to result in exposure of the child to this drug due to negligible systemic absorption following topical administration.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-Potential side effects in the breastfed child due to the drug or the mother's underlying condition should be considered.

See references

Further information

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