Tacrolimus topical Pregnancy and Breast Feeding Warnings
Tacrolimus topical is also known as: Protopic
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tacrolimus Ointment while you are pregnant. Tacrolimus Ointment is found in breast milk. Do not breast-feed while taking Tacrolimus Ointment.
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 Lactation 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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