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

unichem pharmaceuticals (usa), inc. - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate is contraindicated in patients: • with urinary retention [see warnings and precautions (5.2) ], • with gastric retention [see warnings and precautions (5.3) ], • with uncontrolled narrow-angle glaucoma [see warnings and precautions (5.5) ], and • who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingradients in solifenacin succinate. reported adverse reactions have included anaphylaxis and angioedema [see adverse reactions (6.2) ]. risk summary there are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. no adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period o

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

aurobindo pharma limited - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate tablets are contraindicated in patients: - with urinary retention [see warnings and precautions (5.2)] , - with gastric retention [see warnings and precautions (5.3)] , - with uncontrolled narrow-angle glaucoma [see warnings and precautions (5.5)] , and - who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. reported adverse reactions have included anaphylaxis and angioedema [see adverse reactions (6.2)] . risk summary there are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. no adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice du

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

american health packaging - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablet is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate tablets are contraindicated in patients with: - urinary retention [see warnings and precautions ( 5.2)], - gastric retention [see warnings and precautions ( 5.3)], - uncontrolled narrow-angle glaucoma [see warnings and precautions ( 5.5)], and - in patients who have demonstrated hypersensitivity to the drug [see adverse reactions ( 6.2)]. pregnancy category c there are no adequate and well-controlled studies in pregnant women. reproduction studies have been performed in mice, rats and rabbits. after oral administration of 14 c-solifenacin succinate to pregnant mice, drug-related material was shown to cross the placental barrier. no embryotoxicity or teratogenicity was observed in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recomme

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

apotex corp. - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate tablets are contraindicated in patients: •with urinary retention [see warnings and precautions ( 5.2)] , •with gastric retention [see warnings and precautions ( 5.3)] , •with uncontrolled narrow-angle glaucoma [see warnings and precautions ( 5.5)] , and •who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. reported adverse reactions have included anaphylaxis and angioedema [see adverse reactions ( 6.2)] . risk summary there are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated ri

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

proficient rx lp - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate is contraindicated in patients with: pregnancy category c there are no adequate and well-controlled studies in pregnant women. reproduction studies have been performed in mice, rats and rabbits. after oral administration of 14 c-solifenacin succinate to pregnant mice, drug-related material was shown to cross the placental barrier. no embryotoxicity or teratogenicity was observed in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [mrhd] of 10 mg. administration of solifenacin succinate to pregnant mice at 3.6 times and greater (100 mg/kg/day and greater) the exposure at the mrhd, during the major period of organ development resulted in reduced fetal body weights. administration of 7.9 times (250 mg/kg/day) the mrhd to pregnant mice resulted in an increased incide

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

proficient rx lp - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate tablets are contraindicated in patients: •with urinary retention [see warnings and precautions ( 5.2)] , •with gastric retention [see warnings and precautions ( 5.3)] , •with uncontrolled narrow-angle glaucoma [see warnings and precautions ( 5.5)] , and •who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. reported adverse reactions have included anaphylaxis and angioedema [see adverse reactions ( 6.2)] . risk summary there are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated ri

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

proficient rx lp - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate tablets are contraindicated in patients: •with urinary retention [see warnings and precautions ( 5.2)] , •with gastric retention [see warnings and precautions ( 5.3)] , •with uncontrolled narrow-angle glaucoma [see warnings and precautions ( 5.5)] , and •who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. reported adverse reactions have included anaphylaxis and angioedema [see adverse reactions ( 6.2)] . risk summary there are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated ri

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

lannett company, inc. - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablets are indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate tablets are contraindicated in patients: - with urinary retention [see warnings and precautions ( 5.2 ) ] , - with gastric retention [see warnings and precautions ( 5.3 )] , - with uncontrolled narrow-angle glaucoma [see warnings and precautions ( 5.5 )] , and - who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. reported adverse reactions have included anaphylaxis and angioedema [see adverse reactions  ( 6.2 )] . risk summary there are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. no adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregna

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

sunshine lake pharma co., ltd. - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate is contraindicated in patients with: - urinary retention [see warnings and precautions ( 5.2)] , - gastric retention [see warnings and precautions ( 5.3)] , - uncontrolled narrow-angle glaucoma [see warnings and precautions ( 5.5)] , and - in patients who have demonstrated hypersensitivity to the drug [see adverse reactions ( 6.2)] . pregnancy category c there are no adequate and well-controlled studies in pregnant women. reproduction studies have been performed in mice, rats and rabbits. after oral administration of 14 c-solifena

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

alembic pharmaceuticals inc. - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablet is indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin succinate tablets are contraindicated in patients: - with urinary retention [see warnings and precautions (5.2)], - with gastric retention [see warnings and precautions (5.3)], - with uncontrolled narrow-angle glaucoma [see warnings and precautions (5.5)], and - who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. reported adverse reactions have included anaphylaxis and angioedema [see adverse reactions (6.2)]. risk summary there are no studies with the use of solifenacin succinate in pregnant women to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. no adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during