United States - English - 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

United States - English - 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

United States - English - 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)

United States - English - 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

United States - English - 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) .

United States - English - 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

United States - English - 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 (

United States - English - 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)] ris

United States - English - 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 p

United States - English - 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