Zypezil 5/Zypezil 10/Zypezil ODT 10 Use In Pregnancy & Lactation

Zypezil 5/Zypezil 10: Pregnancy: There are no adequate data from the use of donepezil in pregnant women. Studies in animals have not shown teratogenic effect but have shown peri and post natal toxicity. The potential risk for humans is unknown.
Donepezil should not be used during pregnancy unless clearly necessary.
Lactation: Donepezil is excreted in the milk of rats. 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.
Zypezil ODT 10: Pregnancy: Pregnancy Category C: There are no adequate or well-controlled studies in pregnant women. Donepezil HCl should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Oral administration of donepezil to pregnant rats and rabbits during the period of organogenesis did not produce any teratogenic effects at doses up to 16 mg/kg/day (approximately 13 times the human dose of 10 mg/day on a mg/m2 basis) and 10 mg/kg/day (approximately 16 times the human dose of 10 mg/day on a mg/m2 basis), respectively. Oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and throughout lactation to weaning produced an increase in stillbirths and reduced offspring survival through postpartum day 4 at the highest dose. The no-effect dose of 3 mg/kg/day is approximately equal to the MRHD on a mg/m2 basis.
Nursing Mothers: It is not known whether donepezil is excreted in human milk. Caution should be exercised when donepezil HCl is administered to a nursing woman.