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

nucare pharmaceuticals, inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 5 mg - donepezil hydrochloride tablet, usp 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 tablet 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 10 mg/kg/day (approximately 7 times the mrhd on a mg/m 2 basis). 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

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

nucarepharmaceuticals, inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 5 mg - donepezil hydrochloride tablet, usp 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 tablet 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 10 mg/kg/day (approximately 7 times the mrhd on a mg/m 2 basis). 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

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

nucare pharmaceuticals, inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - donepezil hydrochloride 10 mg - donepezil hydrochloride tablet, usp 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 tablet 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 10 mg/kg/day (approximately 7 times the mrhd on a mg/m 2 basis). 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

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

preferred pharmaceuticals inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - 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 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

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - donepezil hydrochloride monohydrate, quantity: 5.22 mg (equivalent: donepezil hydrochloride, qty 5 mg) - tablet, film coated - excipient ingredients: lactose monohydrate; microcrystalline cellulose; magnesium stearate; maize starch; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; lecithin - treatment of mild, moderate and severe alzheimer's disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - donepezil hydrochloride monohydrate, quantity: 10.43 mg (equivalent: donepezil hydrochloride, qty 10 ) - tablet, film coated - excipient ingredients: lactose monohydrate; magnesium stearate; maize starch; microcrystalline cellulose; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350; lecithin - treatment of mild, moderate and severe alzheimer's disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - donepezil hydrochloride monohydrate, quantity: 10.43 mg (equivalent: donepezil hydrochloride, qty 10 mg) - tablet, film coated - excipient ingredients: pregelatinised maize starch; hyprolose; lactose monohydrate; microcrystalline cellulose; magnesium stearate; titanium dioxide; hypromellose; iron oxide yellow; macrogol 400 - treatment of mild, moderate and severe alzheimer's disease.

Australia - English - Department of Health (Therapeutic Goods Administration)

dr reddys laboratories australia pty ltd - donepezil hydrochloride monohydrate -

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

rising pharma holdings, inc. - donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - 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 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 birth defects and miscarriage for the indicated population are unknown. data animal data 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 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. risk summary there are no data on the presence of donepezil or its metabolites in human milk, the effects on the breastfed infant, or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for donepezil hydrochloride and any potential adverse effects on the breastfed infant from donepezil hydrochloride or from the underlying maternal condition. the safety and effectiveness in pediatric patients have not been established. alzheimer’s disease is a disorder occurring primarily in individuals over 55 years of age. the mean age of patients enrolled in the clinical studies with donepezil hydrochloride was 73 years; 80% of these patients were between 65 and 84 years old, and 49% of patients were at or above the age of 75. the efficacy and safety data presented in the clinical trials section were obtained from these patients. there were no clinically significant differences in most adverse reactions reported by patient groups ≥ 65 years old and < 65 years old. in the controlled clinical trial, among patients in the donepezil hydrochloride 23 mg treatment group, those patients weighing < 55 kg reported more nausea, vomiting, and decreased weight than patients weighing 55 kg or more. there were more withdrawals due to adverse reactions as well. this finding may be related to higher plasma exposure associated with lower weight.

Canada - English - Health Canada

dr reddy's laboratories ltd - donepezil hydrochloride (donepezil hydrochloride monohydrate) - tablet - 5mg - donepezil hydrochloride (donepezil hydrochloride monohydrate) 5mg - parasympathomemetic (cholinergic) agents