Luliconazole topical Pregnancy and Breastfeeding Warnings

Brand names: Luzu

Medically reviewed by Drugs.com. Last updated on Mar 13, 2024.

Luliconazole topical Pregnancy Warnings

Animal studies have failed to reveal evidence of adverse developmental effects with subcutaneous doses up to 3 (rats) and 24 (rabbits) times the maximum recommended human dose (MRHD). In rats, no therapy-related effects on maternal toxicity or malformations were observed at 25 mg/kg/day (3 times the MRHD based on body surface area [BSA] comparisons); while increased incidences of skeletal variation (14th rib) were seen at 25 mg/kg/day, no therapy-related effects on skeletal variation were seen at 5 mg/kg/day (0.6 times the MRHD based on BSA comparisons); with maternal toxicity present, embryofetal toxicity (increased prenatal and postnatal pup mortality, reduced live litter sizes) was seen at 25 mg/kg/day. In rabbits, no therapy-related effects on maternal toxicity, embryofetal toxicity, or malformations were observed at 100 mg/kg/day (24 times the MRHD based on BSA comparisons). 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.

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.

See references

Luliconazole topical Breastfeeding Warnings

Benefit should outweigh risk.

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

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered.
-This drug has not been studied during breastfeeding; low risk to the nursing infant expected as this drug is poorly absorbed after topical use and is highly plasma protein bound.
-Application to the nipple area should be avoided.

See references

Further information

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