United States - English - NLM (National Library of Medicine)

actavis pharma, inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 23 mg - donepezil hydrochloride tablets are indicated for the treatment of dementia of the alzheimer’s type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer’s disease. donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. risk summary there are no adequate data on the developmental risks associated with the use of donepezil hydrochloride in pregnant women. in animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [see data ]. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. the background risks of major

United States - English - NLM (National Library of Medicine)

dr. reddys laboratories limited - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 23 mg - donepezil hydrochloride tablets are indicated for the treatment of dementia of the alzheimer’s type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer’s disease. donepezil hydrochloride tablets are contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. risk summary there are no adequate data on the developmental risks associated with the use of donepezil in pregnant women. in animal studies, developmental toxicity was not observed when donepezil was administered to pregnant rats and rabbits during organogenesis, but administration to rats during the latter part of pregnancy and throughout lactation resulted in increased stillbirths and decreased offspring survival at clinically relevant doses [see data]. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. the background risks of major birth

United States - English - NLM (National Library of Medicine)

solco healthcare us, llc - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 23 mg - donepezil hydrochloride tablets are indicated for the treatment of dementia of the alzheimer's type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer's disease. donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. pregnancy category c there are no adequate or well-controlled studies in pregnant women. donepezil hydrochloride 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 6 times the maximum recommended human dose [mrhd] of 23 mg/day on a mg/m2 basis) and 10 mg/kg/day (approximately 7 times the mrhd 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 prod

United States - English - NLM (National Library of Medicine)

par pharmaceutical, inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 23 mg - donepezil hydrochloride is indicated for the treatment of dementia of the alzheimer’s type. efficacy has been demonstrated in patients with mild, moderate and severe alzheimer’s disease. donepezil is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. pregnancy category c there are no adequate or well-controlled studies in pregnant women. donepezil hydrochloride 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 6 times the maximum recommended human dose [mrhd] of 23 mg/day on a mg/m 2 basis) and 10 mg/kg/day (approximately 7 times the mrhd 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 sti

United States - English - NLM (National Library of Medicine)

dexcel pharma technologies ltd. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 23 mg - donepezil hydrochloride tablets are indicated for the treatment of dementia of the alzheimer's type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer's disease. donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. pregnancy category c there are no adequate or well-controlled studies in pregnant women. donepezil hydrochloride 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 6 times the maximum recommended human dose [mrhd] of 23 mg/day on a mg/m 2 basis) and 10 mg/kg/day (approximately 7 times the mrhd on a mg/m 2 basis), respectively. oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation and th

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals, inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 5 mg - donepezil hydrochloride is indicated for the treatment of dementia of the alzheimer's type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer's disease. donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. pregnancy category c: there are no adequate or well-controlled studies in pregnant women. donepezil hydrochloride 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 2 basis)  and 10 mg/kg/day (approximately 20 times the mrhd 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

United States - English - NLM (National Library of Medicine)

nucare pharmaceuticals,inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 10 mg - donepezil hydrochloride is indicated for the treatment of dementia of the alzheimer's type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer's disease. donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. pregnancy category c: there are no adequate or well-controlled studies in pregnant women. donepezil hydrochloride 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 2 basis)  and 10 mg/kg/day (approximately 20 times the mrhd 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

United States - English - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 5 mg - donepezil hydrochloride tablets are an acetylcholinase inhibitor indicated for the treatment of dementia of the alzheimer’s type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer’s disease (1.0). donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. pregnancy category c : there are no adequate or well-controlled studies in pregnant women. donepezil hydrochloride 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 2 basis) and 10 mg/kg/day (approximately 20 times the mrhd on a mg/m2 basis), respectively. oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late gestation

United States - English - NLM (National Library of Medicine)

proficient rx lp - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 10 mg - donepezil hydrochloride tablets, usp are indicated for the treatment of dementia of the alzheimer's type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer's disease. donepezil hydrochloride is contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. pregnancy category c:   there are no adequate or well-controlled studies in pregnant women. donepezil hydrochloride 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 6 times the maximum recommended human dose [mrhd] of 23 mg/day on a mg/m2 basis) and 10 mg/kg/day (approximately 7 times the mrhd 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 wean

United States - English - NLM (National Library of Medicine)

avkare - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 23 mg - donepezil hydrochloride tablets are indicated for the treatment of dementia of the alzheimer’s type. efficacy has been demonstrated in patients with mild, moderate, and severe alzheimer’s disease. donepezil hydrochloride tablets are contraindicated in patients with known hypersensitivity to donepezil hydrochloride or to piperidine derivatives. 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 6 times the maximum recommended human dose [mrhd] of 23 mg/day on a mg/m 2 basis) and 10 mg/kg/day (approximately 7 times the mrhd on a mg/m 2 basis), respectively. oral administration of donepezil (1, 3, 10 mg/kg/day) to rats during late g