Bactopic Use In Pregnancy & Lactation

Pregnancy: Risk Summary: There are insufficient human data to establish whether there is a drug-associated risk with Mupirocin ointment in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of mupirocin ointment. No developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area).
The estimated background risk of major birth defects and miscarriages for the indicated population is unknown.
Data: Animal Data: Developmental toxicity studies have been performed with Mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day during organogenesis. This dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg Mupirocin per day) based on calculations of dose divided by the entire body surface area.
Maternal toxicity was observed (body weight loss/decreased body weight gain and reduced feeding) in both species with no evidence of developmental toxicity in rats. In rabbits, excessive maternal toxicity at the high dose precluded the evaluation of fetal outcomes. There was no developmental toxicity in rabbits at 40 mg per kg per day, 11 times the human topical dose based on calculations of dose divided by the entire body surface area.
Mupirocin administered subcutaneously to rats in a pre- and postnatal development study (dosed during late gestation through lactation) was associated with reduced offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in the presence of injection site irritation and/or subcutaneous hemorrhaging. This dose is 14 times the human topical dose based on calculations of dose divided by the entire body surface area. The no-observed adverse effect level in this study was 44.2 mg per kg per day, which is 6 times the human topical dose.
Lactation: Risk Summary: It is not known whether mupirocin is present in human milk, has effects on the breastfed child, or has effects on milk production. However, breastfeeding is not expected to result in exposure of the child to the drug due to the minimal systemic absorption of mupirocin in humans following topical administration of Mupirocin ointment. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for Mupirocin ointment and any potential adverse effects on the breastfed child from Mupirocin ointment or from the underlying maternal condition.
Clinical Considerations: To minimize oral exposure of the drug to children, a breast and/or nipple being treated with Mupirocin ointment should be thoroughly washed prior to breastfeeding.
Fertility: There are no data on the effects of mupirocin on human fertility. Studies in rats showed no effects on fertility.