Tadalafil and/ or its metabolites cross the placenta, resulting in fetal exposure
in rats. Tadalafil and/ or its metabolites were secreted into the milk in lactating
rats at concentrations approximately 2.4-fold greater than found in the plasma.
Following a single-oral dose of 10 mg/ kg, approximately 0.1% of the total radioactive
dose was excreted into the milk within 3 hours. It is not known if tadalafil
and/ or its metabolites is excreted in human breast milk. Use of tadalafil in
nursing mothers is not recommended.
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