Benzoyl peroxide / erythromycin topical Pregnancy and Breastfeeding Warnings
Brand names: Aktipak, Benzamycin, Benzamycin Pak
Medically reviewed by Drugs.com. Last updated on Jul 12, 2023.
Benzoyl peroxide / erythromycin topical Pregnancy Warnings
Animal studies have not been reported. There was no evidence of teratogenicity when erythromycin was administered orally to rats. There are no controlled data in human pregnancy.
US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
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.
This drug should be used during pregnancy only if clearly needed.
US FDA pregnancy category:
-Aktipak: C
-Benzamycin: Not assigned.
Risk summary: No data available on use of this drug in pregnant women to inform a drug-related risk.
Benzoyl peroxide / erythromycin topical Breastfeeding Warnings
Caution is recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The infant's skin should not come into direct contact with areas of skin that have been treated.
-Benzoyl peroxide topical: This drug has not been studied during breastfeeding; it is considered low risk to nursing infants as only about 5% is absorbed after topical application.
-Erythromycin topical: This drug undergoes minimal systemic absorption; infant side effects are unlikely with topical application for acne but topical application to the nipple may increase the risk of diarrhea in the infant.
-Low levels of erythromycin are excreted in breast milk after systemic administration; it is considered compatible with breastfeeding by the American Academy of Pediatrics and other experts.
See also
References for pregnancy information
- Product Information. Benzamycin (benzoyl peroxide-erythromycin topical). Apothecon Inc. 2022.
- Product Information. Aktipak (benzoyl peroxide-erythromycin topical). Cutanea Life Sciences, Inc. 2019.
References for breastfeeding information
- Product Information. Benzamycin (benzoyl peroxide-erythromycin topical). Apothecon Inc. 2022.
- American Academy of Pediatrics Committee on Drugs. The transfer of drugs and other chemicals into human milk Pediatrics. 2001;108:776-789.
- United States National Library of Medicine. Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT 2013.
- Product Information. Aktipak (benzoyl peroxide-erythromycin topical). Cutanea Life Sciences, Inc. 2019.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
