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Oxiconazole topical Pregnancy and Breastfeeding Warnings

Brand names: Oxistat

Medically reviewed by Drugs.com. Last updated on Aug 22, 2022.

Oxiconazole topical Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed.

US FDA pregnancy category: B

Animal studies have failed to reveal evidence of fetal harm; rabbits, rats, and mice were administered oral doses up to 100, 150, and 200 mg/kg/day (57, 40, and 27 times the human dose based on mg/m2), respectively. There are no controlled data in human pregnancy.

US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

See references

Oxiconazole topical Breastfeeding Warnings

Caution is recommended.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown; low risk is expected (less than 1% absorbed after topical use).
-Application to the nipple area should be avoided; the infant's skin should not come into direct contact with skin that has been treated.

See references

References for pregnancy information

  1. "Product Information. Oxistat (oxiconazole topical)." Glaxo Wellcome

References for breastfeeding information

  1. "Product Information. Oxistat (oxiconazole topical)." Glaxo Wellcome
  2. United States National Library of Medicine (2013) Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT

Further information

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