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)

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 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

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

teva pharma belgium sa-nv - memantine hydrochloride 5 mg - eq. memantine 4,15 mg (white tablet "5"); memantine hydrochloride 10 mg - eq. memantine 8,31 mg (white tablet "10"); memantine hydrochloride 15 mg - eq. memantine 12,46 mg ((light) orange tablet); memantine hydrochloride 20 mg - eq. memantine 16,62 mg ((light) pink tablet) - film-coated tablet - 5 mg + 10 mg + 15 mg + 20 mg - memantine hydrochloride 5 mg; memantine hydrochloride 10 mg; memantine hydrochloride 15 mg; memantine hydrochloride 20 mg - memantine

Singapore - English - HSA (Health Sciences Authority)

lundbeck singapore pte. ltd. - memantine hcl - tablet, film coated - 10 mg - memantine hcl 10 mg

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

lupin pharmaceuticals, inc. - 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 tablet 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 animal data: oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats during the period of organogenesis resulted in decreased skeletal ossification in fetuses at the highest dose tested. the higher no-effect dose for adverse developmental effects (6 mg/kg) is 3 times the maximum recommended human daily dose (mrhd) of memantine hydrochloride (20 mg) on a body surface area (mg/m2 ) basis. oral administration of memantine to rabbits (0, 3, 10, or 30 mg/kg/day) during the period of organogenesis resulted in no adverse developmental effects. the highest dose tested is approximately 30 times the mrhd of memantine hydrochloride on a mg/m2 basis. in rats, memantine (0, 2, 6, or 18 mg/kg/day) was administered orally prior to and throughout mating and, in females, through the period of organogenesis or continuing throughout lactation to weaning. decreased skeletal ossification in fetuses and decreased body weight in pups were observed at the highest dose tested. the higher no-effect dose for adverse developmental effects (6 mg/kg/day) is 3 times the mrhd of memantine hydrochloride on a mg/m2 basis. oral administration of memantine (0, 2, 6, or 18 mg/kg/day) to rats from late gestation throughout lactation to weaning, resulted in decreased pup weights at the highest dose tested. the higher no-effect dose (6 mg/kg/day) is approximately 3 times the mrhd of memantine hydrochloride on a mg/m2 basis. risk summary there are no data on the presence of memantine in human milk, the effects on the breastfed infant, or the effects of memantine hydrochloride on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for memantine hydrochloride and any potential adverse effects on the breastfed infant from memantine hydrochloride or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. memantine failed to demonstrate efficacy in two 12-week controlled clinical studies of 578 pediatric patients aged 6 to 12 years with autism spectrum disorders (asd), including autism, asperger's disorder and pervasive development disorder - not otherwise specified (pdd-nos). memantine has not been studied in pediatric patients under 6 years of age or over 12 years of age. memantine treatment was initiated at 3 mg/day and the dose was escalated to the target dose (weight-based) by week 6. oral doses of memantine 3, 6, 9, or 15 mg extended-release capsules were administered once daily to patients with weights < 20 kg, 20 to 39 kg, 40 to 59 kg and ≥ 60 kg, respectively. in a randomized, 12-week double-blind, placebo-controlled parallel study (study a) in patients with autism, there was no statistically significant difference in the social responsiveness scale (srs) total raw score between patients randomized to memantine (n=54) and those randomized to placebo (n=53). in a 12-week responder-enriched randomized withdrawal study (study b) in 471 patients with asd, there was no statistically significant difference in the loss of therapeutic response rates between patients randomized to remain on full-dose memantine (n=153) and those randomized to switch to placebo (n=158). the overall risk profile of memantine in pediatric patients was generally consistent with the known risk profile in adults [see adverse reactions (6.1)]. in study a, the adverse reactions in the memantine group (n=56) that were reported in at least 5% of patients and at least twice the frequency of the placebo group (n=58) are listed in table 2: the adverse reactions that were reported in at least 5% of patients in the 12 to 48 week open-label study to identify responders to enroll in study b are listed in table 3: in the randomized withdrawal study (study b), the adverse reaction in patients randomized to placebo (n=160) and reported in at least 5% of patients and at twice the frequency of the full-dose memantine treatment group (n=157) was irritability (5.0% vs 2.5%). juvenile animal study in a study in which memantine (0, 15, 30 or 45 mg/kg/day) was orally administered to rats during the juvenile period of development (postnatal days [pnd] 14 through 70), delays in sexual maturation were noted in males and females at all but the lowest dose tested, and body weight was reduced at the high dose. in rats orally administered memantine as a single dose (pnd 14) or three daily doses (pnd 14 to 16), neuronal lesions were observed in several areas of the brain at all but the lowest dose tested. adverse neurobehavioral effects (decreased auditory startle habituation) were observed at the high dose. the no-effect dose for developmental toxicity was the lowest dose tested (15 mg/kg/day). in a second juvenile animal study, memantine (0, 1, 3, 8, 15, 30, and 45 mg/kg/day) was orally administered to male and female rats beginning on pnd 7 and continuing for various periods during postnatal development. because of early memantine-related mortality, the 30 and 45 mg/kg/day groups were terminated without further evaluation. apoptosis or neuronal degeneration in the brain was observed on pnds 8 to 17 at a dose of 15 mg/kg/day. the no-effect dose for apoptosis and neuronal degeneration was 8 mg/kg/day. in animals in which memantine (0, 1, 3, 8, or 15 mg/kg/day) was orally administered on pnds 7 to 70, adverse neurobehavioral effects (increased locomotor motor activity, increased auditory startle response and decreased habituation, and deficit in learning and memory) were observed at all but the lowest dose tested. effects on auditory startle persisted after drug discontinuation. the no-effect dose for developmental toxicity was the lowest dose tested (1 mg/kg/day). the majority of people with alzheimer's disease are 65 years and older. in the clinical studies of memantine hydrochloride the mean age of patients was approximately 76; over 90% of patients were 65 years and older, 60% were 75 years and older, and 12% were at or above 85 years of age. the efficacy and safety data presented in the clinical trial sections were obtained from these patients. there were no clinically meaningful differences in most adverse events reported by patient groups ≥65 years old and <65 years old. no dosage adjustment is needed in patients with mild or moderate renal impairment. a dosage reduction is recommended in patients with severe renal impairment [see dosage and administration (2) and clinical pharmacology (12.3)] . no dosage adjustment is needed in patients with mild or moderate hepatic impairment. memantine hydrochloride should be administered with caution to patients with severe hepatic impairment [see dosage and administration (2) and clinical pharmacology (12.3)] .

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)

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

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

pahang pharmacy sdn. bhd. - memantine hydrochloride -