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

zydus lifesciences limited - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 5 mg - memantine hydrochloride tablets, usp are indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of memantine in pregnant women. adverse developmental effects (decreased body weight, and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the maximum recommended daily dose of memantine [see data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data

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

actavis pharma, inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 5 mg - memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of memantine hydrochloride in pregnant women. adverse developmental effects (decreased body weight, and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride [see data].    in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is

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

sun pharmaceutical industries, inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 5 mg - memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of memantine hydrochloride in pregnant women. adverse developmental effects (decreased body weight, and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride [see data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is u

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

contract pharmacy services-pa - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 10 mg - memantine hydrochloride tablets are indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride tablets are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [mrhd] on a mg/m 2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day

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

vivimed labs limited - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 5 mg - memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [mrhd] on a mg/m2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral memantine beginning pre-mating a

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

macleods pharmaceuticals limited - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 2 mg in 1 ml - memantine hydrochloride solution is indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride solution is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. teratogenic effects pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [mrhd] on a mg/m 2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical verte

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

wockhardt usa llc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 5 mg - memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [mrhd] on a mg/m2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral memantine beginning pre-mating a

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

lannett company, inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 2 mg in 1 ml - memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [mrhd] on a mg/m2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which rats were given oral memantine beginning pre-mating a

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

ajanta pharma usa inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 5 mg - memantine hydrochloride usp is indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of memantine hydrochloride in pregnant women. adverse developmental effects (decreased body weight, and skeletal ossification) were observed in the offspring of rats administered memantine during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the maximum recommended daily dose of memantine hydrochloride [see data] . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data a

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

patrin pharma - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 2 mg in 1 ml - memantine hydrochloride is indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride is contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. pregnancy category b there are no adequate and well-controlled studies of memantine in pregnant women. memantine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. memantine given orally to pregnant rats and pregnant rabbits during the period of organogenesis was not teratogenic up to the highest doses tested (18 mg/kg/day in rats and 30 mg/kg/day in rabbits, which are 9 and 30 times, respectively, the maximum recommended human dose [mrhd] on a mg/m 2 basis). slight maternal toxicity, decreased pup weights and an increased incidence of non-ossified cervical vertebrae were seen at an oral dose of 18 mg/kg/day in a study in which ra