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Tacrolimus topical Pregnancy and Breastfeeding Warnings

Tacrolimus topical is also known as: Protopic

Tacrolimus topical Pregnancy Warnings

Tacrolimus topical has been assigned to pregnancy category C by the FDA. Tacrolimus undergoes minimal systemic absorption after topical administration, resulting in peak blood levels ranging from undetectable to 20 ng/mL (45 of 49 patients had peak concentrations < 5 ng/mL). Animal studies with systemic tacrolimus have revealed evidence of decreased numbers of live births, fetolethality, malformations, late resorptions, increased abortions, and decreased birth weights. There are no controlled data in human pregnancy. Systemic tacrolimus has been associated with neonatal hyperkalemia and renal dysfunction. Tacrolimus topical is only recommended for use during pregnancy when benefit outweighs risk.

Tacrolimus topical Breastfeeding Warnings

Tacrolimus topical is excreted into human milk. Tacrolimus undergoes minimal systemic absorption after topical administration, resulting in peak blood levels ranging from undetectable to 20 ng/mL (45 of 49 patients had peak concentrations < 5 ng/mL). The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

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