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Acyclovir / hydrocortisone topical Pregnancy and Breastfeeding Warnings

Acyclovir / hydrocortisone topical is also known as: Lipsovir, Xerese

Acyclovir / hydrocortisone topical Pregnancy Warnings

FDA pregnancy category: B The manufacturer makes no recommendation regarding use during pregnancy.

Animal studies have not been reported with acyclovir-hydrocortisone topical. Animal studies have failed to reveal evidence of teratogenicity with acyclovir. Animal studies have revealed evidence of teratogenicity with corticosteroids administered systemically at relatively low dosages and with more potent corticosteroids after dermal administration. There are no controlled data in human pregnancy; however, systemic exposure of acyclovir and hydrocortisone after topical administration of acyclovir-hydrocortisone topical is minimal. Between 1984 and 1999, 749 pregnancies in women exposed to systemic acyclovir during the first trimester of pregnancy (resulting in 756 outcomes) were followed through a prospective epidemiologic registry. The occurrence rate of birth defects approximated that found in the general population. However, the size of the registry was insufficient to evaluate the risk for less common defects or to permit reliable or definitive conclusions regarding the safety of acyclovir in pregnant women and their developing fetuses. 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.

Acyclovir / hydrocortisone topical Breastfeeding Warnings

Caution is recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: Systemic exposure is expected to be undetectable after topical administration of acyclovir or hydrocortisone.

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