Torpezil 5/Torpezil 10 Use In Pregnancy & Lactation

Pregnancy: Pregnancy Category C. There are no adequate or well-controlled studies in pregnant women. Donepezil hydrochloride tablets 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 16 times the maximum recommended human dose [MRHD] of 10 mg/day on a mg/m basis) and 10 mg/kg/day (approximately 20 times the MRHD on a mg/m 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 still births and reduced offspring survival through postpartum day 4 at the highest dose. The no-effect dose of 3 mg/kg/day is approximately 3 times the MRHD on a mg/m basis.
Nursing Mothers: It is not known whether donepezil is excreted in human milk. Caution should be exercised when donepezil hydrochloride tablets are administered to a nursing woman.