Category C—No reports describing the use of donepezil in human pregnancy have been located. Because of its indication, such reports should be rare. Moreover, the animal data suggest that the risk to the embryo and/ or fetus is low. Therefore, inadvertent exposure to donepezil during pregnancy should not be a reason for pregnancy termination.
No reports describing the use of donepezil during human lactation have been located. The molecular weight of the parent compound and its long t½ suggest that donepezil, and possible the active metabolites, will be excreted into breast milk. The extensive protein binding (about 96%), however, should limit this excretion. The effects of this exposure on a nursing infant are unknown.
No dosage adjustment necessary.
Only a minimal dose decrease required in hepatic impairment.