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Use in Pregnancy: Teratology studies conducted in pregnant rats at doses up to approximately 80 times the human dose and in pregnant rabbits at doses up to approximately 50 times the human dose did not dis-close any evidence for a teratogenic potential. However, in a study in which pregnant rats were given approximately 50 times the human dose from day 17 of gestation through day 20 postpartum, there was a slight increase in stillbirths and a slight decrease in pup survival through day 4 postpartum. No effect was observed at the next lower dose tested, approximately 15 times the human dose. ARICEPT should not be used during pregnancy. For donepezil no clinical data on exposed pregnancies are available.
Use in Lactation: It is not known whether donepezil hydrochloride is excreted in human breast milk and there are no studies in lactating women. Therefore, women on donepezil should not breast feed.
