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

major pharmaceuticals - trospium chloride (unii: 1e6682427e) (trospium - unii:t4y8ork057) - trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. trospium chloride tablets are contraindicated in patients with: teratogenic effects pregnancy category c: there are no adequate and well-controlled studies of trospium chloride in pregnant women. trospium chloride should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during trospium chloride treatment are encouraged to contact their physician. risk summary based on animal data, trospium chloride is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. adverse developmental findings were not observed to correlate with dose in rats or in rabbits. no increased risk above background was observed in rats and rabbits treated at an exposure approximately equivalent to the maximal rec

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

biomes pharmaceuticals llc - trospium chloride (unii: 1e6682427e) (trospium - unii:t4y8ork057) - trospium chloride tablets usp are a muscarinic antagonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. trospium chlorideis contraindicated in patients with: - urinary retention - gastric retention - uncontrolled narrow-angle  glaucoma. - known hypersensitivity to the drug or its ingredients. angioedema, rash and anaphylactic reaction have been reported. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies of trospium chloride in pregnant women. trospium chlorideshould be used during pregnancy only if the potential benefit to the patient outweighs the risk to  the patient and fetus. women who become pregnant during trospium chloride treatment are encouraged to contact their physician. risk summary based on animal data, trospium chloride is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. adverse developmental findings were

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

glenmark pharmaceuticals inc., usa - trospium chloride (unii: 1e6682427e) (trospium - unii:t4y8ork057) - trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. trospium chloride is contraindicated in patients with: there are no adequate and well-controlled studies of trospium chloride in pregnant women. trospium chloride should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during trospium chloride treatment are encouraged to contact their physician. based on animal data, trospium chloride is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. adverse developmental findings were not observed to correlate with dose in rats or in rabbits. no increased risk above background was observed in rats and rabbits treated at an exposure approximately equivalent to the maximal recommended human dose (mrhd) of 40 mg. in a rat embryo/fetal development study, pregnant rats received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate, with maternal systemic exposures corresponding to approximately nine times the exposure of women treated at the mrhd of 40 mg, based on auc. no malformations or fetal toxicity were observed. the offspring of female rats exposed orally, pre- and post-natally, to trospium chloride up to 200 mg/kg/day showed no increased developmental toxicity over background in surviving pups. however, maternal toxicity (death, irregular breathing, increased excitability) was observed at 200 mg/kg/day. a no-effect level for maternal and pup toxicity (survival to day 4) was 20 mg/kg/day, an exposure approximately equivalent to the maximal recommended human dose (mrhd) of 40 mg. in a rabbit embryo/fetal development study, pregnant rabbits received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate. at 200 mg/kg/day, maternal systemic exposures corresponded to approximately 16 times the exposure of women treated at the mrhd of 40 mg, based on auc. however, one fetus in each of the three treated dose groups (0.3 to 16 times exposures at the mrhd) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. a maternal no-effect level was set at 20 mg/kg/day, at an exposure approximately equivalent to the maximal recommended human dose (mrhd) of 40 mg, due to clinical signs (reduced feces, hunched posture, diarrhea) observed in a pharmacokinetic study at 200 mg/kg/day. the effect of trospium chloride tablets on labor and delivery is unknown. trospium chloride (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (less than 1%), into the milk of lactating rats (primarily as parent compound). it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, trospium chloride should be used during lactation only if the potential benefit justifies the potential risk to the newborn. the safety and effectiveness of trospium chloride in pediatric patients have not been established. of the 591 patients with overactive bladder who received treatment with trospium chloride in the two u.s., placebo-controlled, efficacy and safety studies, 249 patients (42%) were 65 years of age and older. eighty-eight trospium chloride treated patients (15%) were greater than or equal to 75 years of age. in these 2 studies, the incidence of commonly reported anticholinergic adverse reactions in patients treated with trospium chloride (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) was higher in patients 75 years of age and older as compared to younger patients. this effect may be related to an enhanced sensitivity to anticholinergic agents in this patient population [see clinical pharmacology (12.3) ]. therefore, based upon tolerability, the dose frequency of trospium chloride may be reduced to 20 mg once daily in patients 75 years of age and older. severe renal impairment (creatinine clearance less than 30 ml/minute) significantly altered the disposition of trospium chloride. a 4.2-fold and 1.8-fold increase in mean auc(0 to ∞) and cmax , respectively, and the appearance of an additional elimination phase with a long half-life (~33 hr) were detected in patients with severe renal impairment compared with nearly age-matched subjects with creatinine clearance equal to or higher than 80 ml/min. the different pharmacokinetic behavior of trospium chloride in patients with severe renal impairment necessitates adjustment of dosage frequency [see dosage and administration (2) ]. the pharmacokinetics of trospium have not been studied in patients with creatinine clearance ranging from 30 to 80 ml/min. trospium is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. there is no information regarding the effect of severe hepatic impairment on exposure to trospium chloride. in a study of patients with mild and with moderate hepatic impairment, given 40 mg of immediate-release trospium chloride, mean cmax increased 12% and 63%, respectively, and mean auc(0 to ∞) decreased 5% and 15%, respectively, compared to healthy subjects. the clinical significance of these findings is unknown. caution should be used when administering trospium chloride to patients with moderate and severe hepatic impairment.

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

bluepoint laboratories - trospium chloride (unii: 1e6682427e) (trospium - unii:t4y8ork057) - trospium chloride extended-release capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. trospium chloride extended-release capsules are contraindicated in patients with: • urinary retention • gastric retention • uncontrolled narrow-angle glaucoma • known hypersensitivity to the drug or its ingredients. angioedema, rash and anaphylactic reaction have been reported. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies of trospium chloride extended-release capsules in pregnant women. trospium chloride extended-release capsules should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during trospium chloride extended-release capsules treatment are encouraged to contact their physician.

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

slate run pharmaceuticals, llc - trospium chloride (unii: 1e6682427e) (trospium - unii:t4y8ork057) - trospium chloride extended-release capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. trospium chloride extended-release capsules are contraindicated in patients with: • urinary retention • gastric retention • uncontrolled narrow-angle glaucoma • known hypersensitivity to the drug or its ingredients. angioedema, rash and anaphylactic reaction have been reported. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies of trospium chloride extended-release capsules in pregnant women. trospium chloride extended-release capsules should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during trospium chloride extended-release capsules treatment are encouraged to contact their physician. trospium chloride was not teratogenic at statistically significant levels in rats or rabbits administered doses up to 200 mg/kg/day. this corresponds to systemic exposures up to approximately 16 and 32 times, respectively (based on auc), the clinical exposure at the maximum recommended human dose (mrhd) of 60 mg. however, in rabbits, one fetus in each of the three treated dose groups (1, 1, and 32 times the mrhd) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. a no effect level for maternal and fetal toxicity was observed at levels approximately equivalent to the clinical exposure at the mrhd (20 mg/kg/day in rats and rabbits). no developmental toxicity was observed in the offspring of female rats exposed pre- and post-natally to up to 200 mg/kg/day. the effect of trospium chloride extended-release capsules on labor and delivery is unknown. trospium chloride (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (less than 1%), into the milk of lactating rats (primarily as parent compound). it is not known whether this drug is excreted into human milk. because many drugs are excreted into human milk, trospium chloride extended-release capsules should be used during lactation only if the potential benefit justifies the potential risk. the safety and effectiveness of trospium chloride extended-release capsules in pediatric patients have not been established. of 1,165 patients in phase 3 clinical studies of trospium chloride extended-release capsules, 37% (n=428) were ages 65 and over, while 12% (n=143) were ages 75 and over. no overall differences in effectiveness were observed between those subjects aged 65 and over and younger subjects. in trospium chloride extended-release capsules subjects ages 65 and over compared to younger subjects, the following adverse reactions were reported at a higher incidence: dry mouth, constipation, abdominal pain, dyspepsia, urinary tract infection and urinary retention. in subjects ages 75 and over, three reported a fall and in one of them a relationship to the event could not be excluded. severe renal impairment (creatinine clearance less than 30 ml/minute) may significantly alter the disposition of trospium chloride extended-release capsules. in a study of immediate-release trospium chloride, 4.2-fold and 1.8-fold increases in mean auc (0-∞) and c max , respectively, were detected in patients with severe renal impairment. use of trospium chloride extended-release capsules is not recommended in patients with severe renal impairment [see warnings and precautions ( 5.4) and clinical pharmacology ( 12.3)] . the pharmacokinetics of trospium chloride have not been studied in patients with creatinine clearance ranging from 30 to 80 ml/min. trospium is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. there is no information regarding the effect of severe hepatic impairment on exposure to trospium chloride extended-release capsules. in a study of patients with mild and with moderate hepatic impairment, given 40 mg of immediate-release trospium chloride, mean c max increased 12% and 63%, respectively, and mean auc (0-∞) decreased 5% and 15%, respectively, compared to healthy subjects. the clinical significance of these findings is unknown. caution is advised, however, when administering trospium chloride extended-release capsules to patients with moderate to severe hepatic impairment.

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

zameer pharmaceuticals llc - trospium chloride (unii: 1e6682427e) (trospium - unii:t4y8ork057) - trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. trospium chloride tablets are contraindicated in patients with: - urinary retention - gastric retention - uncontrolled narrow-angle glaucoma. - known hypersensitivity to the drug or its ingredients.  angioedema, rash and anaphylactic reaction have been reported. teratogenic effects pregnancy category c : there are no adequate and well-controlled studies of trospium chloride tablets in pregnant women. trospium chloride tablets should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during trospium chloride tablets treatment are encouraged to contact their physician. risk summary based on animal data, trospium chloride is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. adverse developmental findings were not observed to correlate with dose in rats or in rabbits. no increased risk above background was observed in rats and rabbits treated at an exposure approximately equivalent to the maximal recommended human dose (mrhd) of 40 mg. animal data in a rat embryo/fetal development study, pregnant rats received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate, with maternal systemic exposures corresponding to approximately nine times the exposure of women treated at the mrhd of 40 mg, based on auc. no malformations or fetal toxicity were observed. the offspring of female rats exposed orally, pre- and post-natally, to trospium chloride up to 200 mg/kg/day showed no increased developmental toxicity over background in surviving pups. however, maternal toxicity (death, irregular breathing, increased excitability) was observed at 200 mg/kg/day. a no-effect level for maternal and pup toxicity (survival to day 4) was 20 mg/kg/day, an exposure approximately equivalent to the maximal recommended human dose (mrhd) of 40 mg. in a rabbit embryo/fetal development study, pregnant rabbits received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate. at 200 mg/kg/day, maternal systemic exposures corresponded to approximately 16 times the exposure of women treated at the mrhd of 40 mg, based on auc. however, one fetus in each of the three treated dose groups (0.3 to 16 times exposures at the mrhd) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. a maternal no-effect level was set at 20 mg/kg/day, at an exposure approximately equivalent to the maximal recommended human dose (mrhd) of 40 mg, due to clinical signs (reduced feces, hunched posture, diarrhea) observed in a pharmacokinetic study at 200 mg/kg/day. the effect of trospium chloride tablets on labor and delivery is unknown. trospium chloride (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (less than 1%), into the milk of lactating rats (primarily as parent compound). it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, trospium chloride tablets should be used during lactation only if the potential benefit justifies the potential risk to the newborn. the safety and effectiveness of trospium chloride tablets in pediatric patients have not been established. of the 591 patients with overactive bladder who received treatment with trospium chloride tablets in the two u.s., placebo-controlled, efficacy and safety studies, 249 patients (42%) were 65 years of age and older. eighty-eight trospium chloride tablets treated patients (15%) were greater than or equal to 75 years of age. in these 2 studies, the incidence of commonly reported anticholinergic adverse reactions in patients treated with trospium chloride tablets (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) was higher in patients 75 years of age and older as compared to younger patients. this effect may be related to an enhanced sensitivity to anticholinergic agents in this patient population [see clinical pharmacology (12.3) ]. therefore, based upon tolerability, the dose frequency of trospium chloride tablets may be reduced to 20 mg once daily in patients 75 years of age and older. severe renal impairment (creatinine clearance less than 30 ml/minute) significantly altered the disposition of trospium chloride tablets. a 4.2-fold and 1.8-fold increase in mean auc(0-∞) and cmax , respectively, and the appearance of an additional elimination phase with a long half-life (~33 hr) were detected in patients with severe renal impairment compared with nearly age-matched subjects with creatinine clearance equal to or higher than 80 ml/min. the different pharmacokinetic behavior of trospium chloride tablets in patients with severe renal impairment necessitates adjustment of dosage frequency [see dosage and administration (2) ]. the pharmacokinetics of trospium have not been studied in patients with creatinine clearance ranging from 30-80 ml/min. trospium is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. there is no information regarding the effect of severe hepatic impairment on exposure to trospium chloride tablets. in a study of patients with mild and with moderate hepatic impairment, given 40 mg of immediate-release trospium chloride, mean cmax increased 12% and 63%, respectively, and mean auc(0-∞) decreased 5% and 15%, respectively, compared to healthy subjects. the clinical significance of these findings is unknown. caution should be used when administering trospium chloride tablets to patients with moderate and severe hepatic impairment.

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

pd-rx pharmaceuticals, inc. - trospium chloride (unii: 1e6682427e) (trospium - unii:t4y8ork057) - trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. trospium chloride tablets are contraindicated in patients with: - urinary retention - gastric retention - uncontrolled narrow-angle glaucoma. - known hypersensitivity to the drug or its ingredients. angioedema, rash and anaphylactic reaction have been reported. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies of trospium chloride tablets in pregnant women. trospium chloride tablets should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during trospium chloride tablets treatment are encouraged to contact their physician. risk summary based on animal data, trospium chloride is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. adverse developmental findings were not observed to correlate with dose in rats or in rabbits. no increased risk above background was observed in rats and rabbits treated at an exposure approximately equivalent to the maximal recommended human dose (mrhd) of 40 mg. animal data in a rat embryo/fetal development study, pregnant rats received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate, with maternal systemic exposures corresponding to approximately nine times the exposure of women treated at the mrhd of 40 mg, based on auc. no malformations or fetal toxicity were observed. the offspring of female rats exposed orally, pre- and post-natally, to trospium chloride up to 200 mg/kg/day showed no increased developmental toxicity over background in surviving pups. however, maternal toxicity (death, irregular breathing, increased excitability) was observed at 200 mg/kg/day. a no-effect level for maternal and pup toxicity (survival to day 4) was 20 mg/kg/day, an exposure approximately equivalent to the maximal recommended human dose (mrhd) of 40 mg. in a rabbit embryo/fetal development study, pregnant rabbits received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate. at 200 mg/kg/day, maternal systemic exposures corresponded to approximately 16 times the exposure of women treated at the mrhd of 40 mg, based on auc. however, one fetus in each of the three treated dose groups (0.3 to 16 times exposures at the mrhd) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. a maternal no-effect level was set at 20 mg/kg/day, at an exposure approximately equivalent to the maximal recommended human dose (mrhd) of 40 mg, due to clinical signs (reduced feces, hunched posture, diarrhea) observed in a pharmacokinetic study at 200 mg/kg/day. the effect of trospium chloride tablets on labor and delivery is unknown. trospium chloride (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (< 1%), into the milk of lactating rats (primarily as parent compound). it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, trospium chloride tablets should be used during lactation only if the potential benefit justifies the potential risk to the newborn. the safety and effectiveness of trospium chloride tablets in pediatric patients have not been established. of the 591 patients with overactive bladder who received treatment with trospium chloride tablets in the two u.s., placebo-controlled, efficacy and safety studies, 249 patients (42%) were 65 years of age and older. eighty-eight trospium chloride tablet treated patients (15%) were ≥ 75 years of age. in these 2 studies, the incidence of commonly reported anticholinergic adverse reactions in patients treated with trospium chloride tablets (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) was higher in patients 75 years of age and older as compared to younger patients. this effect may be related to an enhanced sensitivity to anticholinergic agents in this patient population [ see clinical pharmacology (12.3) ]. therefore, based upon tolerability, the dose frequency of trospium chloride tablets may be reduced to 20 mg once daily in patients 75 years of age and older. severe renal impairment (creatinine clearance < 30 ml/minute) significantly altered the disposition of trospium chloride tablets. a 4.2-fold and 1.8-fold increase in mean auc (0-∞) and c max , respectively, and the appearance of an additional elimination phase with a long half-life (~33 hr) were detected in patients with severe renal impairment compared with nearly age-matched subjects with creatinine clearance ≥ 80 ml/min. the different pharmacokinetic behavior of trospium chloride tablets in patients with severe renal impairment necessitates adjustment of dosage frequency [ see dosage and administration (2) ]. the pharmacokinetics of trospium have not been studied in patients with creatinine clearance ranging from 30 to 80 ml/min. trospium is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. there is no information regarding the effect of severe hepatic impairment on exposure to trospium chloride tablets. in a study of patients with mild and with moderate hepatic impairment, given 40 mg of immediate-release trospium chloride, mean c max increased 12% and 63%, respectively, and mean auc (0-∞) decreased 5% and 15%, respectively, compared to healthy subjects. the clinical significance of these findings is unknown. caution should be used when administering trospium chloride tablets to patients with moderate and severe hepatic impairment.

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

granules pharmaceuticals inc. - trospium chloride (unii: 1e6682427e) (trospium - unii:t4y8ork057) - trospium chloride extended-release capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. trospium chloride extended-release capsules are contraindicated in patients with: • urinary retention • gastric retention • uncontrolled narrow-angle glaucoma • known hypersensitivity to the drug or its ingredients. angioedema, rash and anaphylactic reaction have been reported. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies of trospium chloride extended-release capsules in pregnant women. trospium chloride extended-release capsules should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during trospium chloride extended-release capsules treatment are encouraged to contact their physician. trospium chloride was not teratogenic at statistically significant levels in r

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

bryant ranch prepack - trospium chloride (unii: 1e6682427e) (trospium - unii:t4y8ork057) - trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. trospium chloride tablets are contraindicated in patients with: teratogenic effects pregnancy category c: there are no adequate and well-controlled studies of trospium chloride tablets in pregnant women. trospium chloride tablets should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during trospium chloride tablets treatment are encouraged to contact their physician. risk summary based on animal data, trospium chloride is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. adverse developmental findings were not observed to correlate with dose in rats or in rabbits. no increased risk above background was observed in rats and rabbits treated at an exposure approximately equiv

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

proficient rx lp - trospium chloride (unii: 1e6682427e) (trospium - unii:t4y8ork057) - trospium chloride extended-release capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (oab) with symptoms of urge urinary incontinence, urgency, and urinary frequency. trospium chloride extended-release capsules are contraindicated in patients with: • urinary retention • gastric retention • uncontrolled narrow-angle glaucoma • known hypersensitivity to the drug or its ingredients. angioedema, rash and anaphylactic reaction have been reported. teratogenic effects pregnancy category c: there are no adequate and well-controlled studies of trospium chloride extended-release capsules in pregnant women. trospium chloride extended-release capsules should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. women who become pregnant during trospium chloride extended-release capsules treatment are encouraged to contact their physician. trospium chloride was not teratogenic at s