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Pregnancy: There are no adequate data from the use of tacrolimus ointment in pregnant women. Animal studies have shown reproductive toxicity following systemic administration. The potential risk for humans is unknown.
Tacrolimus Ointment 0.03% w/w / Tacrolimus Ointment 0.1% w/w should not be used during pregnancy unless clearly necessary.
Breastfeeding: Human data demonstrate that, after systemic administration, tacrolimus is excreted into breast milk. Although clinical data have shown that systemic exposure from application of tacrolimus ointment is low, breastfeeding during treatment with Tacrolimus Ointment 0.03% w/w / Tacrolimus Ointment 0.1% w/w is not recommended.
