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zentiva - memantine hydrochloride - oral solution - 10mg/1ml

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jubilant cadista pharmaceuticals inc. - 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. 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

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

lupin 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 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 extended release 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 [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 2 times the maximum recommended human daily dose (mrhd) of memantine hydrochloride extended release (28 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 20 times the mrhd of memantine hydrochloride extended release 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 2 times the mrhd of memantine hydrochloride extended release 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 2 times the mrhd of memantine hydrochloride extended release 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 extended release on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for memantine hydrochloride extended release and any potential adverse effects on the breastfed infant from memantine hydrochloride extended release 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 safety profile of memantine in pediatric patients was generally consistent with the known safety 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 twice that of the full-dose memantine treatment group (n=157) was irritability (5.0% vs 2.5%). juvenile animal study in a juvenile animal study, male and female juvenile rats were administered memantine (15, 30, and 45 mg/kg/day) starting on postnatal day (pnd) 14 through pnd 70. body weights were reduced at 45 mg/kg/day. delays in sexual maturation were noted in male and female rats at doses ≥ 30 mg/kg/day. memantine induced neuronal lesions in several areas of the brain on pnd 15 and 17 at doses ≥ 30 mg/kg/day. behavioral toxicity (decrease percent of auditory startle habituation) was noted for animals in the 45 mg/kg/day dose group. the 15 mg/kg/day dose was considered the no-observed-adverse-effect-level (noael) for this study. in a second juvenile rat toxicity study, male and female juvenile rats were administered memantine (1, 3, 8, 15, 30, and 45 mg/kg/day) starting on postnatal day (pnd) 7 through pnd 70. due to early memantine-related mortality, the 30 and 45 mg/kg/day dose groups were terminated without further evaluation. memantine induced apoptosis or neuronal degeneration in several areas of the brain on pnd 8, 10, and 17 at a dose of 15 mg/kg/day. the noael for apoptosis and neuronal degeneration was 8 mg/kg/day. behavioral toxicity (effects on motor activity, auditory startle habituation, and learning and memory) was noted at doses ≥ 3 mg/kg/day during treatment, but was not seen after drug discontinuation. therefore, the 1 mg/kg/day dose was considered the noael for the neurobehavioral effect in this study. the majority of people with alzheimer's disease are 65 years of age and older. in the clinical study of memantine hydrochloride extended-release, the mean age of patients was approximately 77 years; over 91% of patients were 65 years and older, 67% were 75 years and older, and 14% 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 reactions 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 (2.3) and clinical pharmacology (12.3)]. no dosage adjustment is needed in patients with mild or moderate hepatic impairment. memantine hydrochloride extended-release was not studied in patients with severe hepatic impairment [see clinical pharmacology (12.3)].

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

mylan institutional inc. - 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. there are no adequate and well-controlled studies of memantine in pregnant women. memantine 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 rats were given oral memantine beginning pre-mating and continui

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

mylan pharmaceuticals inc. - 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. there are no adequate and well-controlled studies of memantine in pregnant women. memantine 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 and continuin

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

american health packaging - 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 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/m 2 ) 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/m 2 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/m 2 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/m 2 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: table 2: study a commonly reported adverse reactions with a frequency ≥ 5% and twice that of placebo adverse reaction memantine n=56 placebo n=58 cough 8.9% 3.4% influenza 7.1% 3.4% rhinorrhea 5.4% 0% agitation 5.4% 1.7% discontinuations due to adverse reactions * aggression 3.6% 1.7% irritability 1.8% 3.4% 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: table 3: 12 to 48 week open label lead-in study to study b commonly reported adverse reactions with a frequency ≥ 5% adverse reaction memantine n=903 headache 8.0% nasopharyngitis 6.3% pyrexia 5.8% irritability 5.4% discontinuations due to adverse reactions * irritability 1.2% aggression 1.0% 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% 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)

amneal pharmaceuticals ny llc - memantine hydrochloride (unii: jy0wd0ua60) (memantine - unii:w8o17sjf3t), donepezil hydrochloride (unii: 3o2t2pj89d) (donepezil - unii:8ssc91326p) - memantine hydrochloride 14 mg - memantine and donepezil hydrochlorides extended-release capsules are indicated for the treatment of moderate to severe dementia of the alzheimer’s type in patients stabilized on 10 mg of donepezil hydrochloride once daily. memantine and donepezil hydrochlorides extended-release capsules are contraindicated in patients with known hypersensitivity to memantine hydrochloride, donepezil hydrochloride, piperidine derivatives, 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 and donepezil hydrochlorides extended-release capsules or its active ingredients (memantine hydrochloride and donepezil hydrochloride) in pregnant women. adverse developmental effects (mortality and decreased body weight and skeletal ossification) were observed in the offspring of rats administered memantine or donepezil during pregnancy at doses associated with minimal maternal toxicity. these doses are higher than those used in humans at the re

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

macleods pharmaceuticals limited - 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)

major pharmaceuticals - 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 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicat

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

cardinal health 107, llc - 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 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicat