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

ajanta pharma usa inc. - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see clinical studies (14)]. tolterodine tartrate extended-release capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. tolterodine tartrate extended-release capsules are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate extended-release capsules, are metabolized to 5-hydroxymethyl tolterodine [see warnings and precautions (5.2)(5.3), (5.4)]. risk summary there are no available data with tolterodine tartrate extended-release capsules use in pregnant women to inform drug-associated risks. in animal reproduction studies, oral administration of tolterodine and its 5-hmt metabolite to pregnant mice during organogenesis did not produce adverse developmen

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

athem llc - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. tolterodine tartrate tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. tolterodine tartrate is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate, are metabolized to 5-hydroxymethyl tolterodine.

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

marlex pharmaceuticals inc - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. tolterodine tartrate tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. tolterodine tartrate is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate, are metabolized to 5-hydroxymethyl tolterodine.

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

unichem pharmaceuticals (usa), inc. - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. tolterodine tartrate tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. tolterodine tartrate is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate, are metabolized to 5-hydroxymethyl tolterodine.

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

remedyrepack inc. - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. tolterodine tartrate tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. tolterodine tartrate is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate, are metabolized to 5-hydroxymethyl tolterodine.

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

rising pharma holdings, inc. - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. tolterodine tartrate tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. tolterodine tartrate tablets are also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate tablets, are metabolized to 5-hydroxymethyl tolterodine.

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

slate run pharmaceuticals, llc - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see clinical studies (14) ] . tolterodine tartrate extended-release capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. tolterodine tartrate extended-release capsules are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate extended-release capsules, are metabolized to 5-hydroxymethyl tolterodine [see warnings and precautions (5.2),  (5.3),  (5.4) ]. risk summary there are no available data with tolterodine tartrate extended-release capsules use in pregnant women to inform drug-associated risks. in animal reproduction studies, oral administration of tolterodine and its 5-hmt metabolite to pregnant mice during organogenesis did not produce adverse developmental outcomes at doses approximately 9 to 12 times the clinical exposure at a dose of 20 mg/kg/day; however, higher doses produced adverse developmental outcomes (see data) . in the u.s. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data no anomalies or malformations were observed after oral administration of tolterodine to pregnant mice during organogenesis at approximately 9 to 12 times the clinical exposure to the pharmacologically active components of tolterodine tartrate extended-release capsules (based on the auc of tolterodine and its 5-hmt metabolite at a dose of 20 mg/kg/day). at 14 to 18 times the clinical exposure (doses of 30 to 40 mg/kg/day) in mice, tolterodine was embryo-lethal, caused reduced fetal weight, and increased the incidence of fetal abnormalities (cleft palate, digital abnormalities, intra-abdominal hemorrhage, and various skeletal abnormalities, primarily reduced ossification). pregnant rabbits administered tolterodine subcutaneously at about 0.3 to 2.5 times the clinical exposure (dose of 0.8 mg/kg/day) did not show any embryotoxicity or teratogenicity. risk summary there is no information on the presence of tolterodine or its 5-hmt metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. based on limited data, tolterodine is excreted into the milk in mice in low amounts (see data) . the development and health benefits of breastfeeding should be considered along with the mother's clinical need for tolterodine tartrate extended-release capsules and any potential adverse effects on the breastfed infant from tolterodine tartrate extended-release capsules or from the underlying maternal condition. animal data the use of radiolabeled tolterodine in pregnant mice produced milk: plasma ratios that ranged between 0.0 and 0.7. the effectiveness of tolterodine tartrate extended-release capsules has not been established in pediatric patients. efficacy was not established in two randomized, placebo-controlled, double-blind, 12-week studies that enrolled 710 pediatric patients (486 on tolterodine tartrate extended-release capsules, 224 on placebo) aged 5 to 10 years with urinary frequency and urge incontinence. the percentage of patients with urinary tract infections was higher in patients treated with tolterodine tartrate extended-release capsules (6.6%) compared to patients who received placebo (4.5%). aggressive, abnormal, and hyperactive behavior and attention disorders occurred in 2.9% of children treated with tolterodine tartrate extended-release capsules compared to 0.9% of children treated with placebo. no overall differences in safety were observed between the older and younger patients treated with tolterodine. in multiple-dose studies in which tolterodine immediate release 4 mg (2 mg bid) was administered, serum concentrations of tolterodine and of 5-hmt were similar in healthy elderly volunteers (aged 64 through 80 years) and healthy young volunteers (aged less than 40 years). in another clinical study, elderly volunteers (aged 71 through 81 years) were given tolterodine immediate release 2 or 4 mg (1 or 2 mg bid). mean serum concentrations of tolterodine and 5-hmt in these elderly volunteers were approximately 20% and 50% higher, respectively, than concentrations reported in young healthy volunteers. however, no overall differences were observed in safety between older and younger patients on tolterodine in the phase 3, 12-week, controlled clinical studies; therefore, no tolterodine dosage adjustment for elderly patients is recommended. renal impairment can significantly alter the disposition of tolterodine immediate release and its metabolites. in a study conducted in patients with creatinine clearance between 10 and 30 ml/min, tolterodine and 5-hmt levels were approximately 2 to 3 fold higher in patients with renal impairment than in healthy volunteers. exposure levels of other metabolites of tolterodine (e.g., tolterodine acid, n -dealkylated tolterodine acid, n -dealkylated tolterodine, and n -dealkylated hydroxy tolterodine) were significantly higher (10 to 30 fold) in renally impaired patients as compared to the healthy volunteers. the recommended dose for patients with severe renal impairment (ccr: 10 to 30 ml/min) is tolterodine tartrate extended-release capsules 2 mg daily. patients with ccr<10 ml/min have not been studied and use of tolterodine tartrate extended-release capsules in this population is not recommended [see dosage and administration (2.2) and warnings and precautions (5.6) ]. tolterodine tartrate extended-release capsules have not been studied in patients with mild to moderate renal impairment [ccr 30 to 80 ml/min]. liver impairment can significantly alter the disposition of tolterodine immediate release. in a study of tolterodine immediate release conducted in cirrhotic patients (child-pugh class a and b), the elimination half-life of tolterodine immediate release was longer in cirrhotic patients (mean, 7.8 hours) than in healthy, young, and elderly volunteers (mean, 2 to 4 hours). the clearance of orally administered tolterodine immediate release was substantially lower in cirrhotic patients (1.0±1.7 l/h/kg) than in the healthy volunteers (5.7±3.8 l/h/kg). the recommended dose for patients with mild to moderate hepatic impairment (child-pugh class a or b) is tolterodine tartrate extended-release capsules 2 mg once daily. tolterodine tartrate extended-release capsules are not recommended for use in patients with severe hepatic impairment (child-pugh class c) [see dosage and administration (2.2) and warnings and precautions (5.4) ].

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

golden state medical supply, inc. - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see clinical studies (14) ] . tolterodine tartrate extended-release capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. tolterodine tartrate extended-release capsules are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate extended-release capsules, are metabolized to 5-hydroxymethyl tolterodine [see warnings and precautions (5.2), (5.3), (5.4) ]. risk summary there are no available data with tolterodine tartrate extended-release capsules use in pregnant women to inform drug-associated risks. in animal reproduction studies, oral administration of tolterodine and its 5-hmt metabolite to pregnant mice during organogenesis did not produce adverse developmental outcomes at doses approximately 9 to 12 times the clinical exposure at a dose of 20 mg/kg/day; however, higher doses produced adverse developmental outcomes (see data) . in the u.s. general population, the estimated background rate of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data no anomalies or malformations were observed after oral administration of tolterodine to pregnant mice during organogenesis at approximately 9-12 times the clinical exposure to the pharmacologically active components of tolterodine tartrate extended-release capsules (based on the auc of tolterodine and its 5-hmt metabolite at a dose of 20 mg/kg/day). at 1418 times the clinical exposure (doses of 30 to 40 mg/kg/day) in mice, tolterodine was embryo-lethal, caused reduced fetal weight, and increased the incidence of fetal abnormalities (cleft palate, digital abnormalities, intra-abdominal hemorrhage, and various skeletal abnormalities, primarily reduced ossification). pregnant rabbits administered tolterodine subcutaneously at about 0.3-2.5 times the clinical exposure (dose of 0.8 mg/kg/day) did not show any embryotoxicity or teratogenicity. risk summary there is no information on the presence of tolterodine or its 5-hmt metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. based on limited data, tolterodine is excreted into the milk in mice in low amounts ( see data ). the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for tolterodine tartrate extended-release capsules and any potential adverse effects on the breastfed infant from tolterodine tartrate extended-release capsules or from the underlying maternal condition. animal data the use of radiolabeled tolterodine in pregnant mice produced milk: plasma ratios that ranged between 0.0 and 0.7. the effectiveness of tolterodine tartrate extended-release capsules has not been established in pediatric patients. efficacy was not established in two randomized, placebo-controlled, double-blind, 12-week studies that enrolled 710 pediatric patients (486 on tolterodine tartrate extended-release capsules, 224 on placebo) aged 5–10 years with urinary frequency and urge incontinence. the percentage of patients with urinary tract infections was higher in patients treated with tolterodine tartrate extended-release capsules (6.6%) compared to patients who received placebo (4.5%). aggressive, abnormal, and hyperactive behavior and attention disorders occurred in 2.9% of children treated with tolterodine tartrate extended-release capsules compared to 0.9% of children treated with placebo. no overall differences in safety were observed between the older and younger patients treated with tolterodine. in multiple-dose studies in which tolterodine immediate release 4 mg (2 mg bid) was administered, serum concentrations of tolterodine and of 5-hmt were similar in healthy elderly volunteers (aged 64 through 80 years) and healthy young volunteers (aged less than 40 years). in another clinical study, elderly volunteers (aged 71 through 81 years) were given tolterodine immediate release 2 or 4 mg (1 or 2 mg bid). mean serum concentrations of tolterodine and 5-hmt in these elderly volunteers were approximately 20% and 50% higher, respectively, than concentrations reported in young healthy volunteers. however, no overall differences were observed in safety between older and younger patients on tolterodine in the phase 3, 12-week, controlled clinical studies; therefore, no tolterodine dosage adjustment for elderly patients is recommended. renal impairment can significantly alter the disposition of tolterodine immediate release and its metabolites. in a study conducted in patients with creatinine clearance between 10 and 30 ml/min, tolterodine and 5-hmt levels were approximately 2–3 fold higher in patients with renal impairment than in healthy volunteers. exposure levels of other metabolites of tolterodine (e.g., tolterodine acid, n -dealkylated tolterodine acid, n- dealkylated tolterodine and n -dealkylated hydroxy tolterodine) were significantly higher (10–30 fold) in renally impaired patients as compared to the healthy volunteers. the recommended dose for patients with severe renal impairment (ccr: 10-30 ml/min) is tolterodine tartrate extended-release capsules 2 mg daily. patients with ccr<10 ml/min have not been studied and use of tolterodine tartrate extended-release capsules in this population is not recommended [see   dosage and administration (2.2) and warnings and precautions (5.6) ] .tolterodine tartrate extended-release capsules have not been studied in patients with mild to moderate renal impairment [ccr 30-80 ml/min]. liver impairment can significantly alter the disposition of tolterodine immediate release. in a study of tolterodine immediate release conducted in cirrhotic patients (child-pugh class a and b), the elimination half-life of tolterodine immediate release was longer in cirrhotic patients (mean, 7.8 hours) than in healthy, young, and elderly volunteers (mean, 2 to 4 hours). the clearance of orally administered tolterodine immediate release was substantially lower in cirrhotic patients (1.0 ± 1.7 l/h/kg) than in the healthy volunteers (5.7 ± 3.8 l/h/kg). the recommended dose for patients with mild to moderate hepatic impairment (child-pugh class a or b) is tolterodine tartrate extended-release capsules 2 mg once daily. tolterodine tartrate extended-release capsules are not recommended for use in patients with severe hepatic impairment (child-pugh class c) [see   dosage and administration (2.2) and warnings and precautions (5.6) ] .

Malta - English - Medicines Authority

1 a pharma gmbh keltenring 1+3, 82041 oberhaching, germany - tolterodine l, tartrate - modified-release capsule - tolterodine l-tartrate 4 mg - urologicals

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

pd-rx pharmaceuticals, inc. - tolterodine tartrate (unii: 5t619tqr3r) (tolterodine - unii:whe7a56u7k) - tolterodine tartrate 4 mg - detrol la capsules is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see clinical studies (14) ] . detrol la is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. detrol la is also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like detrol la, are metabolized to 5-hydroxymethyl tolterodine [see warnings and precautions (5.2) (5.3) , (5.4) ]. risk summary there are no available data with detrol la use in pregnant women to inform drug-associated risks. in animal reproduction studies, oral administration of tolterodine and its 5-hmt metabolite to pregnant mice during organogenesis did not produce adverse developmental outcomes at doses approximately 9 to 12 times the clinical exposure at a dose of 20