Tacrolimus topical Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Apr 12, 2023.

Tacrolimus topical is also known as: Protopic

Tacrolimus topical Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.

US FDA pregnancy category: C

This drug undergoes minimal systemic absorption after topical administration, resulting in peak blood levels ranging from undetectable to 20 ng/mL. Systemic administration has been associated with neonatal hyperkalemia and renal dysfunction.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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Tacrolimus topical Breastfeeding Warnings

Some experts advise that topical administration of this drug presents a low risk to the nursing infant because it is poorly absorbed after topical application and peak blood concentrations are less than 2 mcg/L in most patients. This skin of the infant should not come into direct contact with the areas of skin that have been treated.

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Exclusively breastfed infants should be monitored if this drug is used during lactation, possibly including measurement of serum levels to rule out toxicity.
-If this drug is applied to the nipple, an alternate drug is preferred.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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