Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

remedyrepack inc. - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2), drug interactions ( 7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405- 6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ risk summary published prospective cohort studies, case series, and case reports over several decades with trazodone use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 to 11 times the maximum recommended human dose (mrhd) of 400 mg/day in adults on a mg/m 2  basis. there was also an increase in congenital anomalies in the rabbit at approximately 7.3 to 22 times the mrhd on a mg/m 2  basis (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. clinical considerations disease-associated maternal and/or embryofetal risk a prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. the women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression that women who continued antidepressants. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. data human data while available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with trazodone use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. all available studies have methodological limitations, including small sample size and inconsistent comparator groups. animal data no teratogenic effects were observed when trazodone was given to pregnant rats and rabbits during the period of organogenesis at oral doses up to 450 mg/kg/day. this dose is 11 and 22 times, in rats and rabbits, respectively, the maximum recommended human dose (mrhd) of 400 mg/day in adults on a mg/m 2 basis. increased fetal resorption and other adverse effects on the fetus in rats at 7.3 to 11 times the mrhd and increase in congenital anomalies in rabbits at 7.3 to 22 times the mrhd on a mg/m 2 basis were observed. no further details on these studies are available. risk summary data from published literature report the transfer of trazodone into human milk. there are no data on the effect of trazodone on milk production. limited data from postmarketing reports have not identified and association of adverse effects on the breastfed child. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for trazodone and any potential adverse effects on the breastfed child from trazodone or from the underlying maternal condition. safety and effectiveness in the pediatric population have not been established. antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see boxed warning, warnings and precautions ( 5.1)]. reported clinical literature and experience with trazodone has not identified differences in responses between elderly and younger patients. however, as experience in the elderly with trazodone hydrochloride is limited, it should be used with caution in geriatric patients. serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see warnings and precautions ( 5.11)]. trazodone has not been studied in patients with renal impairment. trazodone should be used with caution in this population. trazodone has not been studied in patients with hepatic impairment. trazodone should be used with caution in this population. trazodone hydrochloride tablets are not a controlled substance. although trazodone hydrochloride has not been systematically studied in preclinical or clinical studies for its potential for abuse, no indication of drug-seeking behavior was seen in the clinical studies with trazodone hydrochloride.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

remedyrepack inc. - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride tablets, usp are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2), drug interactions ( 7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ risk summary published prospective cohort studies, case series, and case reports over several decades with trazodone use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 to 11 times the maximum recommended human dose (mrhd) of 400 mg/day in adults on a mg/m 2 basis. there was also an increase in congenital anomalies in the rabbit at approximately 7.3 to 22 times the mrhd on a mg/m 2 basis (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. clinical considerations disease-associated maternal and/or embryofetal risk a prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. the women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression that women who continued antidepressants. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. data human data while available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with trazodone use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. all available studies have methodological limitations, including small sample size and inconsistent comparator groups. animal data no teratogenic effects were observed when trazodone was given to pregnant rats and rabbits during the period of organogenesis at oral doses up to 450 mg/kg/day. this dose is 11 and 22 times, in rats and rabbits, respectively, the maximum recommended human dose (mrhd) of 400 mg/day in adults on a mg/m 2 basis. increased fetal resorption and other adverse effects on the fetus in rats at 7.3 to 11 times the mrhd and increase in congenital anomalies in rabbits at 7.3 to 22 times the mrhd on a mg/m 2 basis were observed. no further details on these studies are available. risk summary data from published literature report the transfer of trazodone into human milk. there are no data on the effect of trazodone on milk production. limited data from postmarketing reports have not identified and association of adverse effects on the breastfed child. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for trazodone and any potential adverse effects on the breastfed child from trazodone or from the underlying maternal condition. safety and effectiveness in the pediatric population have not been established. antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see boxed warning, warnings and precautions ( 5.1)]. reported clinical literature and experience with trazodone has not identified differences in responses between elderly and younger patients. however, as experience in the elderly withtrazodone hydrochloride is limited, it should be used with caution in geriatric patients. serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see warnings and precautions ( 5.11)] . trazodone has not been studied in patients with renal impairment. trazodone should be used with caution in this population. trazodone has not been studied in patients with hepatic impairment. trazodone should be used with caution in this population. trazodone hydrochloride tablets are not a controlled substance. although trazodone hydrochloride has not been systematically studied in preclinical or clinical studies for its potential for abuse, no indication of drug-seeking behavior was seen in the clinical studies with trazodone hydrochloride.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

apotex corp - vilazodone hydrochloride (unii: u8htx2gk8j) (vilazodone - unii:s239o2oov3) - vilazodone is indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies ( 14 )]. vilazodone is contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2 ) , drug interactions ( 7 ) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy.  healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. risk summary there are no adequate and well-controlled studies of vilazodone in pregnant women. the background risk of major birth defects and miscarriage for the indicated population is

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

bryant ranch prepack - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride tablets, usp are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [ see warnings and precautions ( 5.2), drug interactions ( 7.1) ]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ risk summary published prospective cohort studies, case series, and case reports over several decades with trazodone use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 to 11 times the maximum recommended human dose (mrhd) of 400 mg/day in adults on a mg/m 2 basis. there was also an increase in congenital anomalies in the rabbit at approximately 7.3 to 22 times the mrhd on a mg/m 2 basis (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. clinical considerations disease-associated maternal and/or embryofetal risk a prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. the women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression that women who continued antidepressants. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. data human data while available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with trazodone use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. all available studies have methodological limitations, including small sample size and inconsistent comparator groups. animal data no teratogenic effects were observed when trazodone was given to pregnant rats and rabbits during the period of organogenesis at oral doses up to 450 mg/kg/day. this dose is 11 and 22 times, in rats and rabbits, respectively, the maximum recommended human dose (mrhd) of 400 mg/day in adults on a mg/m 2 basis. increased fetal resorption and other adverse effects on the fetus in rats at 7.3 to 11 times the mrhd and increase in congenital anomalies in rabbits at 7.3 to 22 times the mrhd on a mg/m 2 basis were observed. no further details on these studies are available. risk summary data from published literature report the transfer of trazodone into human milk. there are no data on the effect of trazodone on milk production. limited data from postmarketing reports have not identified and association of adverse effects on the breastfed child. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for trazodone and any potential adverse effects on the breastfed child from trazodone or from the underlying maternal condition. safety and effectiveness in the pediatric population have not been established. antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see boxed warning, warnings and precautions ( 5.1)]. reported clinical literature and experience with trazodone has not identified differences in responses between elderly and younger patients. however, as experience in the elderly with trazodone hydrochloride is limited, it should be used with caution in geriatric patients. serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [ see warnings and precautions ( 5.11) ]. trazodone has not been studied in patients with renal impairment. trazodone should be used with caution in this population. trazodone has not been studied in patients with hepatic impairment. trazodone should be used with caution in this population. trazodone hydrochloride tablets are not a controlled substance. although trazodone hydrochloride has not been systematically studied in preclinical or clinical studies for its potential for abuse, no indication of drug-seeking behavior was seen in the clinical studies with trazodone hydrochloride.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

remedyrepack inc. - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride tablets, usp are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2), drug interactions ( 7.1)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/ risk summary published prospective cohort studies, case series, and case reports over several decades with trazodone use in pregnant women have not identified any drug-associated risks of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). trazodone hydrochloride has been shown to cause increased fetal resorption and other adverse effects on the fetus in the rat when given at dose levels approximately 7.3 to 11 times the maximum recommended human dose (mrhd) of 400 mg/day in adults on a mg/m 2 basis. there was also an increase in congenital anomalies in the rabbit at approximately 7.3 to 22 times the mrhd on a mg/m 2 basis (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. clinical considerations disease-associated maternal and/or embryofetal risk a prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants at the beginning of pregnancy. the women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression that women who continued antidepressants. consider the risk of untreated depression when discontinuing or changing treatment with antidepressant medication during pregnancy and postpartum. data human data while available studies cannot definitively establish the absence of risk, published data from prospective cohort studies, case series, and case reports over several decades have not identified an association with trazodone use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. all available studies have methodological limitations, including small sample size and inconsistent comparator groups. animal data no teratogenic effects were observed when trazodone was given to pregnant rats and rabbits during the period of organogenesis at oral doses up to 450 mg/kg/day. this dose is 11 and 22 times, in rats and rabbits, respectively, the maximum recommended human dose (mrhd) of 400 mg/day in adults on a mg/m 2 basis. increased fetal resorption and other adverse effects on the fetus in rats at 7.3 to 11 times the mrhd and increase in congenital anomalies in rabbits at 7.3 to 22 times the mrhd on a mg/m 2 basis were observed. no further details on these studies are available. risk summary data from published literature report the transfer of trazodone into human milk. there are no data on the effect of trazodone on milk production. limited data from postmarketing reports have not identified and association of adverse effects on the breastfed child. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for trazodone and any potential adverse effects on the breastfed child from trazodone or from the underlying maternal condition. safety and effectiveness in the pediatric population have not been established. antidepressants increased the risk of suicidal thoughts and behaviors in pediatric patients [see boxed warning, warnings and precautions ( 5.1)]. reported clinical literature and experience with trazodone has not identified differences in responses between elderly and younger patients. however, as experience in the elderly withtrazodone hydrochloride is limited, it should be used with caution in geriatric patients. serotonergic antidepressants have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see warnings and precautions ( 5.11)] . trazodone has not been studied in patients with renal impairment. trazodone should be used with caution in this population. trazodone has not been studied in patients with hepatic impairment. trazodone should be used with caution in this population. trazodone hydrochloride tablets are not a controlled substance. although trazodone hydrochloride has not been systematically studied in preclinical or clinical studies for its potential for abuse, no indication of drug-seeking behavior was seen in the clinical studies with trazodone hydrochloride.

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

golden state medical supply, inc. - vilazodone hydrochloride (unii: u8htx2gk8j) (vilazodone - unii:s239o2oov3) - vilazodone is indicated for the treatment of major depressive disorder (mdd) in adults  [see clinical studies ( 14 )]. vilazodone is contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2 ) , drug interactions ( 7 ) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy.  healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/. risk summary there are no adequate and well-controlled studies of vilazodone in pregnant women. the background risk of major birth defects and miscarriage for

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

exelan pharmaceuticals inc. - vilazodone hydrochloride (unii: u8htx2gk8j) (vilazodone - unii:s239o2oov3) - vilazodone hydrochloride is indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies (14)] . vilazodone hydrochloride is contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7)]. patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online a

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

sun pharmaceutical industries, inc. - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-researchprograms/ pregnancyregistry/antidepressants/ risk summary published prospective cohort studies, case series, and case reports over several decades with desyrel use in preg

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

cipla usa inc. - vilazodone hydrochloride (unii: u8htx2gk8j) (vilazodone - unii:s239o2oov3) - vilazodone hydrochloride is indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies (14)] . vilazodone hydrochloride is contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7)]. patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online a

Hoa Kỳ - Tiếng Anh - NLM (National Library of Medicine)

northstar rxllc - vilazodone hydrochloride (unii: u8htx2gk8j) (vilazodone - unii:s239o2oov3) - vilazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies ( 14)] . vilazodone hydrochloride tablets are contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2), drug interactions ( 7)]. patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions (