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

jubilant cadista pharmaceuticals inc. - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - darifenacin extended-release tablets are muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin is contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. pregnancy category c there are no studies of darifenacin in pregnant women. darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [mrhd] of 15 mg. at approximately 59 times the mrhd in rats, there was a delay in the ossification of the sacral and caudal vertebrae which was not observed at approximately 13 times the auc. dystocia was observed in dams at approximately 17 times the auc (10 mg/kg/day). slight developmental delays were observed in pups at this dose. at five times the auc (3 mg/kg/day), th

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

cipla usa inc. - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. risk summary there are no available data on darifenacin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in animal studies, darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 and 28 times the maximum recommended human dose (mrhd) of 15 mg, respectively. effects on embryofetal development were observed following administration of darifenacin during pregnancy (dilated ureter and/or kidney pelvis in rabbits at about 9 times the mrhd, post-implantation loss in rabbits at about 28 times, and delayed os

Canada - English - Health Canada

apotex inc - darifenacin (darifenacin hydrobromide) - tablet (extended-release) - 15mg - darifenacin (darifenacin hydrobromide) 15mg - antimuscarinics

Canada - English - Health Canada

apotex inc - darifenacin (darifenacin hydrobromide) - tablet (extended-release) - 7.5mg - darifenacin (darifenacin hydrobromide) 7.5mg - antimuscarinics

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

actavis pharma, inc. - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - darifenacin is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin is contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. pregnancy category c there are no studies of darifenacin in pregnant women. darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [mrhd] of 15 mg. at approximately 59 times the mrhd in rats, there was a delay in the ossification of the sacral and caudal vertebrae which was not observed at approximately 13 times the auc. dystocia was observed in dams at approximately 17 times the auc (10 mg/kg/day). slight developmental delays were observed in pups at this dose. at five times the auc (3 mg/kg/day), there were no effects on d

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

torrent pharmaceuticals limited - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - darifenacin extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: -   urinary retention -   gastric retention, or -   uncontrolled narrow-angle glaucoma. risk summary there are no available data on darifenacin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage,  or other adverse maternal or fetal outcomes. in animal studies, darifenacin was not teratogenic in rats and rabbits at plasma exposure of free drug (via auc) up to 59 and 28 times the maximum recommended human dose (mrhd) of 15 mg, respectively. effect on embryofetal development were observed following administration of darifenacn during pregnancy (dilated ureter and/or kidney pelvis in rabbits at asbout 9 times the mrhd, post-implantation loss in rabbits at about 28 times, and delays in rats at about

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

alembic pharmaceuticals limited - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - darifenacin is muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. pregnancy category c there are no studies of darifenacin in pregnant women. darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [mrhd] of 15 mg. at approximately 59 times the mrhd in rats, there was a delay in the ossification of the sacral and caudal vertebrae which was not observed at approximately 13 times the auc. dystocia was observed in dams at approximately 17 times the auc (10 mg/kg/day). slight developmental delays were observed in pups at this dose. at five times the auc (3 mg/kg/day), th

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

alembic pharmaceuticals inc. - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - darifenacin is muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. risk summary there are no available data on darifenacin use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in animal studies, darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 and 28 times the maximum recommended human dose (mrhd) of 15 mg, respectively. effects on embryofetal development were observed following administration of darifenacin during pregnancy (dilated ureter and/or kidney pelvis in rabbits at about 9 times the mrhd, post-implantation loss in rabbits at about 28 times, and delayed ossification in rats at

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

golden state medical supply, inc. - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - darifenacin hydrobromide extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin hydrobromide extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. pregnancy category c there are no studies of darifenacin in pregnant women. darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [mrhd] of 15 mg. at approximately 59 times the mrhd in rats, there was a delay in the ossification of the sacral and caudal vertebrae which was not observed at approximately 13 times the auc. dystocia was observed in dams at approximately 17 times the auc (10 mg/kg/day). slight developmental delays were observed in pups

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

par pharmaceutical, inc. - darifenacin hydrobromide (unii: cr02eyq8gv) (darifenacin - unii:apg9819vlm) - darifenacin 7.5 mg - darifenacin hydrobromide extended-release tablets are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. darifenacin hydrobromide extended-release tablets are contraindicated in patients with, or at risk for, the following conditions: - urinary retention - gastric retention, or - uncontrolled narrow-angle glaucoma. pregnancy category c there are no studies of darifenacin in pregnant women. darifenacin was not teratogenic in rats and rabbits at plasma exposures of free drug (via auc) up to 59 times and 28 times, respectively (doses up to 50 and 30 mg/kg/day, respectively) the maximum recommended human dose [mrhd] of 15 mg. at approximately 59 times the mrhd in rats, there was a delay in the ossification of the sacral and caudal vertebrae which was not observed at approximately 13 times the auc. dystocia was observed in dams at approximately 17 times the auc (10 mg/kg/day). slight developmental delays were observed in pups