संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - fesoterodine fumarate (unii: eos72165s7) (fesoterodine - unii:621g617227) - fesoterodine fumarate 4 mg - fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (oab) in adults with symptoms of urge urinary incontinence, urgency, and frequency. pediatric use information is approved for pfizer inc.'s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.'s marketing exclusivity rights, this drug product is not labeled with that information. fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following: - known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see clinical pharmacology (12.1)]. reactions have included angioedema [see warnings and precautions (5.1)]. - urinary retention [see warnings and precautions (5.2)] - gastric retention [see warnings and precautions (5.3)] - uncontrolled narrow-angle glaucoma [see warnings and precautions (5.4)] risk summary there are no available data with the use of fesoterodine fumarate in pregnant women and adolescents to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times respectively the maximum recommended human dose (mrhd) of 8 mg/day, based on auc (see data) . the background risk of major birth defects and miscarriage for the indicated population are unknown. however, 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. data animal data no dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits. in mice at 6 to 27 times the expected exposure at the maximum recommended human dose (mrhd) of 8 mg based on auc (75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. one fetus with cleft palate was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range. in rabbits treated at 3 to 11 times the mrhd (27 mg/kg/day, oral), incompletely ossified sternebrae (retardation of bone development) and reduced survival were observed in fetuses. in rabbits at 9 to 11 times the mrhd (4.5 mg/kg/day, subcutaneous), maternal toxicity and incompletely ossified sternebrae were observed in fetuses (at an incidence within the background historical range). in rabbits at 3 times the mrhd (1.5 mg/kg/day, subcutaneous), decreased maternal food consumption in the absence of any fetal effects was observed. oral administration of 30 mg/kg/day fesoterodine to mice in a pre-and post-natal development study resulted in decreased body weight of the dams and delayed ear opening of the pups. no effects were noted on mating and reproduction of the f1 dams or on the f2 offspring. risk summary there is no information on the presence of fesoterodine in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for fesoterodine fumarate and any potential adverse effects on the breastfed child from fesoterodine fumarate or from the underlying maternal condition. the safety and effectiveness of fesoterodine fumarate have not been established in pediatric patients younger than 6 years of age or weighing 25 kg or less. pediatric use information is approved for pfizer inc.'s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.'s marketing exclusivity rights, this drug product is not labeled with that information. no dose adjustment is recommended for the elderly. the pharmacokinetics of fesoterodine are not significantly influenced by age. of the 1,567 patients who received fesoterodine fumarate 4 mg or 8 mg orally once daily in phase 2 and 3, placebo-controlled, efficacy and safety studies for oab, 515 (33%) were 65 years of age or older, and 140 (9%) were 75 years of age or older. no overall difference in effectiveness was observed between patients younger than 65 years of age and those 65 years of age or older in these studies. however, the incidence of antimuscarinic adverse reactions, including dry mouth, constipation, dyspepsia, increase in residual urine, dizziness (8 mg only) and urinary tract infection, was higher in patients 75 years of age and older as compared to younger patients [see clinical studies (14.1) and adverse reactions (6)] . in adult patients with severe renal impairment (clcr <30 ml/min), cmax and auc are increased 2.0- and 2.3-fold, respectively. doses of fesoterodine fumarate extended-release tablets greater than 4 mg are not recommended in adult patients with severe renal impairment. in patients with mild or moderate renal impairment (clcr ranging from 30 to 80 ml/min), cmax and auc of the active metabolite are increased up to 1.5- and  1.8-fold, respectively, as compared to healthy subjects. no dose adjustment is recommended in patients with mild or moderate renal impairment [see clinical pharmacology (12.3) and dosage and administration (2.3)] . pediatric use information is approved for pfizer inc.'s toviaz® (fesoterodine fumarate) extended release tablets. however, due to pfizer inc.'s marketing exclusivity rights, this drug product is not labeled with that information. patients with severe hepatic impairment (child-pugh c) have not been studied; therefore fesoterodine fumarate is not recommended for use in these patients. in patients with moderate (child-pugh b) hepatic impairment, cmax and auc of the active metabolite are increased 1.4- and 2.1-fold, respectively, as compared to healthy subjects. no dose adjustment is recommended in patients with mild or moderate hepatic impairment [see clinical pharmacology (12.3)] .

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

zydus lifesciences limited - fesoterodine fumarate (unii: eos72165s7) (fesoterodine - unii:621g617227) - fesoterodine fumarate 4 mg - fesoterodine fumarate extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. fesoterodine fumarate extended-release tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. fesoterodine fumarate extended-release tablets are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see  clinical  pharmacology  (12.1) ]. risk summary there are no data with the use of fesoterodine fumarate in pregnant women to inform a drug associated risk for birth defects or miscarriage. in animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times, respectively, the maximum recommended human dose (mrhd) o

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

dr.reddy's laboratories inc., - fesoterodine fumarate (unii: eos72165s7) (fesoterodine - unii:621g617227) - fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (oab) in adults with symptoms of urge urinary incontinence, urgency, and frequency. pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following, - known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see clinical pharmacology (12.1) ]. - reactions have included angioedema [see warnings and precautions (5.1) ]. - urinary retention [see warnings and precautions (5.2) ] - gastric retention [see warnings and precautions (5.3) ]  - uncontrolled narrow-angle glaucoma [see warnings and precautions (5.4) ] risk summary   there are no available data with the use of fesoterodine fumarate extended-release tablets in pregnant women and adolescents to evaluate for a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times, respectively the maximum recommended human dose (mrhd) of 8 mg/day based on auc (see data) . the background risk of major birth defects and miscarriage for the indicated population are unknown. however, 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. data animal data no dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits. in mice at 6 to 27 times the expected exposure at the maximum recommended human dose (mrhd) of 8 mg based on auc (75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. one fetus with cleft palate was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range. in rabbits treated at 3 to 11 times the mrhd (27 mg/kg/day, oral), incompletely ossified sternebrae (retardation of bone development) and reduced survival were observed in fetuses. in rabbits at 9 to 11 times the mrhd (4.5 mg/kg/day, subcutaneous), maternal toxicity and incompletely ossified sternebrae were observed in fetuses (at an incidence within the background historical range). in rabbits at 3 times the mrhd (1.5 mg/kg/day, subcutaneous), decreased maternal food consumption in the absence of any fetal effects was observed. oral administration of 30 mg/kg/day fesoterodine to mice in a pre- and post-natal development study resulted in decreased body weight of the dams and delayed ear opening of the pups. no effects were noted on mating and reproduction of the f1 dams or on the f2 offspring. risk summary   there is no information on the presence of fesoterodine fumarate in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fesoterodine fumarate and any potential adverse effects on the breastfed child from fesoterodine fumarate or from the underlying maternal condition. the safety and effectiveness of fesoterodine fumarate have not been established in pediatric patients younger than 6 years of age or weighing 25 kg or less. pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. no dose adjustment is recommended for the elderly. the pharmacokinetics of fesoterodine are not significantly influenced by age. of the 1,567 patients who received fesoterodine fumarate 4 mg or 8 mg orally once daily in phase 2 and 3, placebo-controlled, efficacy and safety studies for oab, 515 (33%) were 65 years of age or older, and 140 (9%) were 75 years of age or older. no overall difference in effectiveness was observed between patients younger than 65 years of age and those 65 years of age or older in these studies; however, the incidence of antimuscarinic adverse reactions, including dry mouth, constipation, dyspepsia, increase in residual urine, dizziness ( 8 mg only) and urinary tract infection, was higher in patients 75 years of age and older as compared to younger patients [see clinical studies (14.1) and adverse reactions (6)]. in adult patients with severe renal impairment (clcr <30 ml/min), cmax and auc are increased 2- and 2.3-fold, respectively. doses of fesoterodine fumarate extended-release tablets greater than 4 mg are not recommended in adult patients with severe renal impairment. in patients with mild or moderate renal impairment (clcr ranging from 30 to 80 ml/min), cmax and auc of the active metabolite are increased up to 1.5- and 1.8-fold, respectively, as compared to healthy subjects. no dose adjustment is recommended in patients with mild or moderate renal impairment [see clinical pharmacology (12.3), and dosage and administration (2.3)]. pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. patients with severe hepatic impairment (child-pugh c) have not been studied; therefore fesoterodine fumarate is not recommended for use in these patients. in patients with moderate (child-pugh b) hepatic impairment, cmax and auc of the active metabolite are increased 1.4- and 2.1-fold, respectively, as compared to healthy subjects. no dose adjustment is recommended in patients with mild or moderate hepatic impairment [see clinical pharmacology (12.3)].

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

golden state medical supply, inc. - fesoterodine fumarate (unii: eos72165s7) (fesoterodine - unii:621g617227) - fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (oab) in adults with symptoms of urge urinary incontinence, urgency, and frequency. pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following, - known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [s ee clinical pharmacology ( 12.1) ]. - reactions have included angioedema [ see warnings and precautions ( 5.1) ]. - urinary retention [ see warnings and precautions ( 5

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

ani pharmaceuticals, inc. - fesoterodine fumarate (unii: eos72165s7) (fesoterodine - unii:621g617227) - fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (oab) in adults with symptoms of urge urinary incontinence, urgency, and frequency. pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following: risk summary there are no available data with the use of fesoterodine in pregnant women and adolescents to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times respectively the maximum recommended human dose (mrhd) of 8 mg/day, based on auc (see data) . the background risk of major birth defects and miscarriage for the indicated population are unknown. however, 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. data animal data no dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits. in mice at 6 to 27 times the expected exposure at the maximum recommended human dose (mrhd) of 8 mg based on auc (75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. one fetus with cleft palate was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range. in rabbits treated at 3 to 11 times the mrhd (27 mg/kg/day, oral), incompletely ossified sternebrae (retardation of bone development) and reduced survival were observed in fetuses. in rabbits at 9 to 11 times the mrhd (4.5 mg/kg/day, subcutaneous), maternal toxicity and incompletely ossified sternebrae were observed in fetuses (at an incidence within the background historical range). in rabbits at 3 times the mrhd (1.5 mg/kg/day, subcutaneous), decreased maternal food consumption in the absence of any fetal effects was observed. oral administration of 30 mg/kg/day fesoterodine to mice in a pre- and post-natal development study resulted in decreased body weight of the dams and delayed ear opening of the pups. no effects were noted on mating and reproduction of the f1 dams or on the f2 offspring. risk summary there is no information on the presence of fesoterodine in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fesoterodine and any potential adverse effects on the breastfed child from fesoterodine or from the underlying maternal condition. the safety and effectiveness of fesoterodine fumarate extended-release tablets have not been established in pediatric patients younger than 6 years of age or weighing 25 kg or less. pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. no dose adjustment is recommended for the elderly. the pharmacokinetics of fesoterodine are not significantly influenced by age. of the 1,567 patients who received fesoterodine fumarate extended-release tablets 4 mg or 8 mg orally once daily in phase 2 and 3, placebo-controlled, efficacy and safety studies for oab, 515 (33%) were 65 years of age or older, and 140 (9%) were 75 years of age or older. no overall difference in effectiveness was observed between patients younger than 65 years of age and those 65 years of age or older in these studies. however, the incidence of antimuscarinic adverse reactions, including dry mouth, constipation, dyspepsia, increase in residual urine, dizziness (8 mg only) and urinary tract infection, was higher in patients 75 years of age and older as compared to younger patients [see clinical studies (14.1) and adverse reactions (6)] . in adult patients with severe renal impairment (clcr <30 ml/min), cmax and auc are increased 2.0- and 2.3-fold, respectively. doses of fesoterodine fumarate extended-release tablets greater than 4 mg are not recommended in adult patients with severe renal impairment. in patients with mild or moderate renal impairment (clcr ranging from 30-80 ml/min), cmax and auc of the active metabolite are increased up to 1.5- and 1.8-fold, respectively, as compared to healthy subjects. no dose adjustment is recommended in patients with mild or moderate renal impairment [see clinical pharmacology (12.3) and dosage and administration (2.3)] . pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. patients with severe hepatic impairment (child-pugh c) have not been studied; therefore, fesoterodine fumarate extended-release tablets are not recommended for use in these patients. in patients with moderate (child-pugh b) hepatic impairment, cmax and auc of the active metabolite are increased 1.4- and 2.1-fold, respectively, as compared to healthy subjects. no dose adjustment is recommended in patients with mild or moderate hepatic impairment [see clinical pharmacology (12.3)] .

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

amneal pharmaceuticals llc - fesoterodine fumarate (unii: eos72165s7) (fesoterodine - unii:621g617227) - fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (oab) in adults with symptoms of urge urinary incontinence, urgency, and frequency. pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following: - known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see clinical pharmacology (12.1)] . reactions have included angioedema [see warnings and precautions (5.1)] . - urinary retention [see warnings and precautions (5.2)] - gastric retention [see warnings and precautions (5.3)] - uncontrolled narrow-angle glaucoma [see warnings and precautions (5.4)] ris

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

ascend laboratories, llc - fesoterodine fumarate (unii: eos72165s7) (fesoterodine - unii:621g617227) - fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (oab) in adults with symptoms of urge urinary incontinence, urgency, and frequency. pediatric use information is approved for pfizer inc.'s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.'s marketing exclusivity rights, this drug product is not labeled with that pediatric information. fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following: - known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see clinical pharmacology (12.1)] . reactions have included angioedema [see warnings and precautions (5.1)]. - urinary retention [see warnings and precautions (5.2)] - gastric retention [see warnings and precautions (5.3)] - uncontrolled narrow-angle glaucoma [see warnings and precautions (

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

aurobindo pharma limited - fesoterodine fumarate (unii: eos72165s7) (fesoterodine - unii:621g617227) - fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (oab) in adults with symptoms of urge urinary incontinence, urgency, and frequency. pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following: - known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see clinical pharmacology (12.1)] . reactions have included angioedema [see warnings and precautions (5.1)] - urinary retention [see warnings and precautions (5.2)] - gastric retention [see warnings and precautions (5.3)] - uncontrolled narrow-angle glaucoma [see warnings and precautions (5.4)] risk summary there are no available data with the use of fesoterodine fumarate extended-release tablets in pregnant women and adolescents to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times respectively the maximum recommended human dose (mrhd) of 8 mg/day, based on auc (see data) . the background risk of major birth defects and miscarriage for the indicated population are unknown. however, 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. data animal data no dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits. in mice at 6 to 27 times the expected exposure at the maximum recommended human dose (mrhd) of 8 mg based on auc (75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. one fetus with cleft palate was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range. in rabbits treated at 3 to 11 times the mrhd (27 mg/kg/day, oral), incompletely ossified sternebrae (retardation of bone development) and reduced survival were observed in fetuses. in rabbits at 9 to 11 times the mrhd (4.5 mg/kg/day, subcutaneous), maternal toxicity and incompletely ossified sternebrae were observed in fetuses (at an incidence within the background historical range). in rabbits at 3 times the mrhd (1.5 mg/kg/day, subcutaneous), decreased maternal food consumption in the absence of any fetal effects was observed. oral administration of 30 mg/kg/day fesoterodine to mice in a pre- and post-natal development study resulted in decreased body weight of the dams and delayed ear opening of the pups. no effects were noted on mating and reproduction of the f1 dams or on the f2 offspring. risk summary there is no information on the presence of fesoterodine in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fesoterodine fumarate extended-release tablets and any potential adverse effects on the breastfed child from fesoterodine fumarate extended-release tablets or from the underlying maternal condition. the safety and effectiveness of fesoterodine fumarate extended-release tablets have not been established in pediatric patients younger than 6 years of age or weighing 25 kg or less. pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. no dose adjustment is recommended for the elderly. the pharmacokinetics of fesoterodine are not significantly influenced by age. of the 1,567 patients who received fesoterodine fumarate extended-release tablets 4 mg or 8 mg orally once daily in phase 2 and 3, placebo-controlled, efficacy and safety studies for oab, 515 (33%) were 65 years of age or older, and 140 (9%) were 75 years of age or older. no overall difference in effectiveness was observed between patients younger than 65 years of age and those 65 years of age or older in these studies. however, the incidence of antimuscarinic adverse reactions, including dry mouth, constipation, dyspepsia, increase in residual urine, dizziness (8 mg only) and urinary tract infection, was higher in patients 75 years of age and older as compared to younger patients [see clinical studies (14.1) and adverse reactions (6)] . in adult patients with severe renal impairment (clcr <30 ml/min), cmax and auc are increased 2- and 2.3-fold, respectively. doses of fesoterodine fumarate extended-release tablets greater than 4 mg are not recommended in adult patients with severe renal impairment. in patients with mild or moderate renal impairment (clcr ranging from 30 to 80 ml/min), cmax and auc of the active metabolite are increased up to 1.5- and 1.8-fold, respectively, as compared to healthy subjects. no dose adjustment is recommended in patients with mild or moderate renal impairment [see clinical pharmacology (12.3) and dosage and administration (2.3)]. pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. patients with severe hepatic impairment (child-pugh c) have not been studied; therefore, fesoterodine fumarate extended-release tablets are not recommended for use in these patients. in patients with moderate (child-pugh b) hepatic impairment, cmax and auc of the active metabolite are increased 1.4- and 2.1-fold, respectively, as compared to healthy subjects. no dose adjustment is recommended in patients with mild or moderate hepatic impairment [see clinical pharmacology (12.3)].

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

alembic pharmaceuticals inc. - fesoterodine fumarate (unii: eos72165s7) (fesoterodine - unii:621g617227) - fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (oab) in adults with symptoms of urge urinary incontinence, urgency, and frequency. pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. fesoterodine fumarate extended-release tablet is contraindicated in patients with any of the following: • known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see clinical pharmacology (12.1)] . reactions have included angioedema [see warnings and precautions (5.1)] • urinary retention [see warnings and precautions (5.2)] • gastric retention [see warnings and precautions (5.3)] • uncontrolled narrow-angle glaucoma [see warnings and precautions (5.4)] risk summary there are no available data with the use of fesoterodine in pregnant women and adolescents to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times respectively the maximum recommended human dose (mrhd) of 8 mg/day, based on auc (see data) . the background risk of major birth defects and miscarriage for the indicated population are unknown. however, 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. data animal data  no dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits. in mice at 6 to 27 times the expected exposure at the maximum recommended human dose (mrhd) of 8 mg based on auc (75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. one fetus with cleft palate was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range. in rabbits treated at 3 to 11 times the mrhd (27 mg/kg/day, oral), incompletely ossified sternebrae (retardation of bone development) and reduced survival were observed in fetuses. in rabbits at 9 to 11 times the mrhd (4.5 mg/kg/day, subcutaneous), maternal toxicity and incompletely ossified sternebrae were observed in fetuses (at an incidence within the background historical range). in rabbits at 3 times the mrhd (1.5 mg/kg/day, subcutaneous), decreased maternal food consumption in the absence of any fetal effects was observed. oral administration of 30 mg/kg/day fesoterodine to mice in a pre- and post-natal development study resulted in decreased body weight of the dams and delayed ear opening of the pups. no effects were noted on mating and reproduction of the f1 dams or on the f2 offspring. risk summary there is no information on the presence of fesoterodine in human milk, the effects on the breastfed child, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fesoterodine fumarate and any potential adverse effects on the breastfed child from fesoterodine fumarate or from the underlying maternal condition. the safety and effectiveness of fesoterodine fumarate have not been established in pediatric patients younger than 6 years of age or weighing 25 kg or less. pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. no dose adjustment is recommended for the elderly. the pharmacokinetics of fesoterodine are not significantly influenced by age.  of the 1,567 patients who received fesoterodine fumarate 4 mg or 8 mg orally once daily in phase 2 and 3, placebo-controlled, efficacy and safety studies for oab, 515 (33%) were 65 years of age or older, and 140 (9%) were 75 years of age or older. no overall differences in effectiveness was observed between patients younger than 65 years of age and those 65 years of age or older in these studies. however, the incidence of antimuscarinic adverse reactions, including dry mouth, constipation, dyspepsia, increase in residual urine, dizziness (8 mg only) and urinary tract infection, was higher in patients 75 years of age and older as compared to younger patients [see clinical studies (14.1) and adverse reactions (6)]. in adult patients with severe renal impairment (clcr <30 ml/min), cmax and auc are increased 2- and 2.3-fold, respectively. doses of fesoterodine fumarate greater than 4 mg are not recommended in adult patients with severe renal impairment. in patients with mild or moderate renal impairment (clcr ranging from 30 to 80 ml/min), cmax and auc of the active metabolite are increased up to 1.5- and 1.8-fold, respectively, as compared to healthy subjects. no dose adjustment is recommended in patients with mild or moderate renal impairment [see clinical pharmacology (12.3) and dosage and administration (2.3)] .    pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. patients with severe hepatic impairment (child-pugh c) have not been studied; therefore, fesoterodine fumarate is not recommended for use in these patients. in patients with moderate (child-pugh b) hepatic impairment, cmax and auc of the active metabolite are increased 1.4- and 2.1-fold, respectively, as compared to healthy subjects. no dose adjustment is recommended in patients with mild or moderate hepatic impairment [see clinical pharmacology (12.3)] .

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

alembic pharmaceuticals limited - fesoterodine fumarate (unii: eos72165s7) (fesoterodine - unii:621g617227) - fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (oab) in adults with symptoms of urge urinary incontinence, urgency, and frequency. pediatric use information is approved for pfizer inc.’s toviaz® (fesoterodine fumarate) extended-release tablets. however, due to pfizer inc.’s marketing exclusivity rights, this drug product is not labeled with that information. fesoterodine fumarate extended-release tablet is contraindicated in patients with any of the following: • known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [see clinical pharmacology (12.1)] . reactions have included angioedema [see warnings and precautions (5.1)] . • urinary retention [see warnings and precautions (5.2)] • gastric retention [see warnings and precautions (5.3)] • uncontrolled narrow-angle glaucoma [see warnings and p