Acyclovir / hydrocortisone topical Pregnancy and Breastfeeding Warnings

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

Acyclovir / hydrocortisone topical Pregnancy Warnings

Acyclovir-hydrocortisone topical has been assigned to pregnancy category B by the FDA. 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 following dermal administration. There are no controlled data in human pregnancy; however, systemic exposure of acyclovir and hydrocortisone following topical administration of acyclovir-hydrocortisone topical is minimal. Acyclovir-hydrocortisone topical is only recommended for use during pregnancy when benefit outweighs risk.

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.

Acyclovir / hydrocortisone topical Breastfeeding Warnings

There are no data on the excretion of topically applied acyclovir or hydrocortisone into human milk. Systemic exposure is expected to be undetectable following topical administration of either drug. The manufacturer recommends that caution be used when administering acyclovir-hydrocortisone topical to nursing women.

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