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

alembic pharmaceuticals inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 5 mg - memantine hydrochloride is indiacted 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 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data

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

upsher-smith laboratories, llc - 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 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% to 4% and 15% to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal d

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

strides pharma science limited - 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.  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)

unichem pharmaceuticals (usa), 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 hydrochloride 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 po

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - memantine hydrochloride - tablet - 10mg

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

teva uk ltd - memantine hydrochloride - tablet - 20mg

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

amneal pharmaceuticals llc - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 7 mg - memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hydrochloride extended-release capsules 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 extended-release capsules 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 extended-release capsules [see data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively

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

zydus lifesciences limited - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 7 mg - memantine hydrochloride extended-release capsules are 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 6 and 21 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 memant

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

zydus pharmaceuticals usa inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 7 mg - memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the alzheimer's type. memantine hydrochloride extended-release capsules 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 extended-release capsules 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 extended-release capsules [see data]. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively

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

mylan pharmaceuticals inc. - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t) - memantine hydrochloride 7 mg - memantine hydrochloride extended-release capsules are indicated for the treatment of moderate to severe dementia of the alzheimer’s type. memantine hydrochloride extended-release capsules are contraindicated in patients with known hypersensitivity to memantine hydrochloride or to any excipients used in the formulation. there are no adequate data on the developmental risk associated with the use of memantine hydrochloride extended-release capsules 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 extended-release capsules [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