Acyclovir topical Pregnancy and Breastfeeding Warnings

Acyclovir topical is also known as: Sitavig, Zovirax Cream, Zovirax Ointment

Acyclovir topical Pregnancy Warnings

In a review of 229,101 deliveries to Michigan Medicaid patients, 391 first trimester exposures to acyclovir and 1081 exposures any time during pregnancy were recorded. These exposures include systemic and nonsystemic exposures. A total of 18 birth defects were reported with first trimester exposure (17 expected) and included (observed/expected) 5/4 cardiovascular defects, 1 polydactyly, and limb reductions. (Written communication, Franz Rosa, MD, Food and Drug Administration, 1994.)

Acyclovir topical has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetotoxicity. There are no controlled data in human pregnancy. Acyclovir topical should only be used during pregnancy when the potential benefits outweigh the potential risks.

Acyclovir topical Breastfeeding Warnings

There are no data on the excretion of topically applied acyclovir into breast milk. Systemically administered acyclovir is excreted into and concentrated in human milk. However, the agent is used to treat viral infections in the neonate and adverse effects in nursing infants exposed via breast milk have not been reported in the literature. In one woman, measurement of breast milk levels revealed an infant would be exposed to 1% of the maternal dosage or 0.73 mg/kg/day. No adverse effects were noted in this nursing infant. Acyclovir is considered compatible with breast-feeding by the American Academy of Pediatrics. Breast-feeding should be avoided if herpetic lesions are on or near the breast.

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