Oxiconazole topical Pregnancy and Breastfeeding Warnings
Oxiconazole topical is also known as: Oxistat
Medically reviewed by Drugs.com. Last updated on Feb 20, 2019.
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.
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.
References for pregnancy information
- "Product Information. Oxistat (oxiconazole)." Glaxo Wellcome, Research Triangle Park, NC.
References for breastfeeding information
- United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
- "Product Information. Oxistat (oxiconazole)." Glaxo Wellcome, Research Triangle Park, NC.
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Further information
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