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

hikma pharmaceuticals usa inc. - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg in 1 ml - galantamine is indicated for the treatment of mild to moderate dementia of the alzheimer’s type. galantamine is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. there are no adequate and well-controlled studies in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically. galantamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in rats, administration of galantamine (oral doses of 2 mg, 8 mg, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses. the no-effect dose for embryo-fetal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the maximum recommended human dose (mrhd of 24 mg/day) on a body surface area (mg/m2 ) basis. when galantamine (oral doses of 4 mg, 12 mg, 28 mg, or 48 mg/kg/day) was administered to pregnant rabbits throughout the period of organogenesis, small increases in fetal visceral malformations and skeletal variations were observed at the highest dose. the no-effect dose for embryo-fetal developmental toxicity in rabbits (28 mg/kg/day) is approximately 20 times the mrhd on a mg/m2 basis. in a study in which pregnant rats were orally dosed with galantamine (2 mg, 8 mg, or 16 mg/kg/day) from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at birth and during the lactation period at the two highest doses. the no-effect dose for pre- and postnatal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the mrhd on a mg/m2 basis. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when galantamine is administered to a nursing woman. the safety and effectiveness in pediatric patients have not been established. eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6519 patients have investigated galantamine in the treatment of mild to moderate dementia of the alzheimer’s type [see adverse reactions (6.1) and clinical studies (14)] . the mean age of patients enrolled in these clinical studies was 75 years; 78% of these patients were between 65 and 84 years of age, and 10% of patients were 85 years of age or older. in patients with moderate hepatic impairment, a dosage adjustment is recommended. the use of galantamine in patients with severe hepatic impairment is not recommended [see dosage and administration (2.3) and clinical pharmacology (12.3)] . in patients with a creatinine clearance of 9 ml to 59 ml/min, a dosage adjustment is recommended. the use of galantamine in patients with creatinine clearance less than 9 ml/min is not recommended [see dosage and administration (2.4) and clinical pharmacology (12.3)] .

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

apotex corp. - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - galantamine tablets are indicated for the treatment of mild to moderate dementia of the alzheimer’s type. galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine hydrobromide tablets in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (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 in rats, administration of galantamine (oral

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

zydus lifesciences limited - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - galantamine tablets, usp are indicated for the treatment of mild to moderate dementia of the alzheimer's type. galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. pregnancy category c there are no adequate and well-controlled studies in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically. galantamine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. in rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses. the

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

aurobindo pharma limited - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 8 mg - galantamine extended-release capsules are indicated for the treatment of mild to moderate dementia of the alzheimer’s type. galantamine extended-release capsules are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine extended-release capsules or galantamine tablets  in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (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   in rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses, which were associated with maternal toxicity. the no-effect dose for embryo-fetal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the maximum recommended human dose (mrhd) of 24 mg/day on a body surface area (mg/m2 ) basis. when galantamine (oral doses of 4, 12, 28, or 40 mg/kg/day) was administered to pregnant rabbits throughout the period of organogenesis, small increases in fetal visceral malformations and skeletal variations were observed at the highest dose which was associated with maternal toxicity.  the no‑effect dose for embryo-fetal developmental toxicity in rabbits (28 mg/kg/day) is approximately 20 times the mrhd on a mg/m2 basis. in a study in which pregnant rats were orally dosed with galantamine (2, 8, or 16 mg/kg/day) from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at birth and during the lactation period at the two highest doses. the no-effect dose for pre- and postnatal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the mrhd on a mg/m2 basis. risk summary there are no data on the presence of galantamine in human milk, the effects on the breastfed infant, or the effects of galantamine extended-release capsules on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for galantamine extended-release capsules and any potential adverse effects on the breastfed infant from galantamine extended-release capsules or from the underlying maternal condition. the safety and effectiveness in pediatric patients have not been established. eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6519 patients have investigated galantamine extended-release capsules  and galantamine tablets in the treatment of mild to moderate dementia of the alzheimer’s type [see adverse reactions (6.1) and clinical studies (14)] . the mean age of patients enrolled in these clinical studies was 75 years; 78% of these patients were between 65 and 84 years of age, and 10% of patients were 85 years of age or older. in patients with moderate hepatic impairment, a dosage adjustment is recommended. the use of galantamine extended-release capsules in patients with severe hepatic impairment is not recommended [see dosage and administration (2.2) and clinical pharmacology (12.3)] . in patients with a creatinine clearance of 9 to 59 ml/min, a dosage adjustment is recommended. the use of galantamine extended-release capsules in patients with creatinine clearance less than 9 ml/min is not recommended [see dosage and administration (2.3) and clinical pharmacology (12.3)] .

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

rising pharma holdings, inc. - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - galantamine tablets are indicated for the treatment of mild to moderate dementia of the alzheimer’s type. galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine hydrobromide in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (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 in rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses, which were associated with maternal toxicity. the no-effect dose for embryo-fetal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the maximum recommended human dose (mrhd) of 24 mg/day on a body surface area (mg/m2 ) basis. when galantamine (oral doses of 4, 12, 28, or 40 mg/kg/day) was administered to pregnant rabbits throughout the period of organogenesis, small increases in fetal visceral malformations and skeletal variations were observed at the highest dose which was associated with maternal toxicity. the no-effect dose for embryo-fetal developmental toxicity in rabbits (28 mg/kg/day) is approximately 20 times the mrhd on a mg/m2 basis. in a study in which pregnant rats were orally dosed with galantamine (2, 8, or 16 mg/kg/day) from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at birth and during the lactation period at the two highest doses. the no-effect dose for pre- and postnatal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the mrhd on a mg/m2 basis. risk summary there are no data on the presence of galantamine in human milk, the effects on the breastfed infant, or the effects of galantamine hydrobromide on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for galantamine hydrobromide and any potential adverse effects on the breastfed infant from galantamine hydrobromide or from the underlying maternal condition. the safety and effectiveness in pediatric patients have not been established. eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6519 patients have investigated galantamine hydrobromide in the treatment of mild to moderate dementia of the alzheimer’s type [see adverse reactions (6.1) and clinical studies (14)] . the mean age of patients enrolled in these clinical studies was 75 years; 78% of these patients were between 65 and 84 years of age, and 10% of patients were 85 years of age or older. in patients with moderate hepatic impairment, a dosage adjustment is recommended. the use of galantamine hydrobromide in patients with severe hepatic impairment is not recommended [see dosage and administration (2.3) and clinical pharmacology (12.3)] . in patients with a creatinine clearance of 9 to 59 ml/min, a dosage adjustment is recommended. the use of galantamine hydrobromide in patients with creatinine clearance less than 9 ml/min is not recommended [see dosage and administration (2.4) and clinical pharmacology (12.3)] .

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

sun pharmaceutical industries, inc. - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 8 mg - galantamine hydrobromide extended-release capsules are indicated for the treatment of mild to moderate dementia of the alzheimer's type. galantamine hydrobromide extended-release capsules are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine hydrobromide extended-release capsules in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (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 unkn

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

slate run pharmaceuticals, llc - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - galantamine tablets are indicated for the treatment of mild to moderate dementia of the alzheimer’s type. galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine tablets in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (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 in rats, administration of ga

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

patriot pharmaceuticals, llc - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - galantamine er is indicated for the treatment of mild to moderate dementia of the alzheimer's type. galantamine er is contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine er or galantamine tablets in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (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 in rats, administration of galantamine (oral doses of 2, 8, or 16

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

aurobindo pharma limited - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - galantamine tablets are indicated for the treatment of mild to moderate dementia of the alzheimer’s type. galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine hydrobromide in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (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 in rats, administration of galantamine (oral doses of 2, 8, or 16 mg/kg/day), from day 14 (females) or day 60 (males) prior to mating and continuing in females through the period of organogenesis, resulted in an increased incidence of fetal skeletal variations at the two highest doses, which were associated with maternal toxicity. the no-effect dose for embryo-fetal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the maximum recommended human dose (mrhd) of 24 mg/day on a body surface area (mg/m2 ) basis. when galantamine (oral doses of 4, 12, 28, or 40 mg/kg/day) was administered to pregnant rabbits throughout the period of organogenesis, small increases in fetal visceral malformations and skeletal variations were observed at the highest dose which was associated with maternal toxicity. the no-effect dose for embryo-fetal developmental toxicity in rabbits (28 mg/kg/day) is approximately 20 times the mrhd on a mg/m2 basis. in a study in which pregnant rats were orally dosed with galantamine (2, 8, or 16 mg/kg/day) from the beginning of organogenesis through day 21 post-partum, pup weights were decreased at birth and during the lactation period at the two highest doses. the no-effect dose for pre- and postnatal developmental toxicity in rats (2 mg/kg/day) is approximately equal to the mrhd on a mg/m2 basis. risk summary there are no data on the presence of galantamine in human milk, the effects on the breastfed infant, or the effects of galantamine hydrobromide on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for galantamine hydrobromide and any potential adverse effects on the breastfed infant from galantamine hydrobromide or from the underlying maternal condition. the safety and effectiveness in pediatric patients have not been established. eight double-blind, placebo-controlled clinical trials and 5 open-label trials in a total of 6519 patients have investigated galantamine hydrobromide in the treatment of mild to moderate dementia of the alzheimer’s type [see adverse reactions (6.1) and clinical studies (14)] . the mean age of patients enrolled in these clinical studies was 75 years; 78% of these patients were between 65 and 84 years of age, and 10% of patients were 85 years of age or older. in patients with moderate hepatic impairment, a dosage adjustment is recommended. the use of galantamine hydrobromide in patients with severe hepatic impairment is not recommended [see dosage and administration (2.3) and clinical pharmacology (12.3)] . in patients with a creatinine clearance of 9 to 59 ml/min, a dosage adjustment is recommended. the use of galantamine hydrobromide in patients with creatinine clearance less than 9 ml/min is not recommended [see dosage and administration (2.4) and clinical pharmacology (12.3)] .

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

american health packaging - galantamine hydrobromide (unii: mj4ptd2vvw) (galantamine - unii:0d3q044kca) - galantamine 4 mg - galantamine tablets are indicated for the treatment of mild to moderate dementia of the alzheimer’s type. galantamine tablets are contraindicated in patients with known hypersensitivity to galantamine hydrobromide or to any excipients used in the formulation. risk summary there are no adequate data on the developmental risk associated with the use of galantamine hydrobromide in pregnant women. in studies conducted in animals, administration of galantamine during pregnancy resulted in developmental toxicity (increased incidence of morphological abnormalities and decreased growth in offspring) at doses similar to or greater than those used clinically (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 in rats, administration of galantamine (