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

glenmark pharmaceuticals inc., usa - 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: 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 of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (mrhd) of 10 mg/day. however, administration of doses 3.6 times and greater than the mrhd during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring [see data] . in the u.s. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data oral administration of 14 c-solifenacin succinate to pregnant mice resulted in the recovery of radiolabel in the fetus indicating that solifenacin-related product can cross the placental barrier. in pregnant mice, administration of solifenacin succinate at a dose of 250 mg/kg/day (7.9 times the systemic exposure at the mrhd of 10 mg), resulted in an increased incidence of cleft palate and increased maternal lethality. administration of solifenacin succinate to pregnant mice during organogenesis at greater than or equal to 3.6 times (100 mg/kg/day and greater) the systemic exposure at the mrhd, resulted in reduced fetal body weights and reduced maternal body weight gain. no embryo-fetal toxicity or teratogenicity was observed in fetuses from pregnant mice treated with solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the mrhd). administration of solifenacin succinate to pregnant rats and rabbits at a dose of 50 mg/kg/day (< 1 times and 1.8 times the systemic exposure at the mrhd, respectively), resulted in no findings of embryo-fetal toxicity. oral pre- and post-natal administration of solifenacin succinate at 100 mg/kg/day (3.6 times the systemic exposure at the mrhd) during the period of organogenesis through weaning, resulted in reduced peripartum and postnatal survival, reduced body weight gain by the pups, and delayed physical development (eye opening and vaginal patency). an increase in the percentage of male offspring was also observed in litters from offspring (f2 generation) exposed to maternal doses of 250 mg/kg/day. there were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected systemic exposure at the mrhd. risk summary there is no information on the presence of solifenacin in human milk, the effects on the breastfed child, or the effects on milk production. solifenacin is present in mouse milk [see data] . when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for solifenacin succinate and any potential adverse effects on the breastfed child from solifenacin succinate or from the underlying maternal condition. data animal data oral administration of 14 c-solifenacin succinate to lactating mice resulted in the recovery of radioactivity in maternal milk. lactating female mice orally administered solifenacin succinate at a maternally toxic dose of 100 mg/kg/day (3.6 times the systemic exposure at the mrhd) had increased postpartum pup mortality, pups with reduced body weights, or delays in the onset of reflex and physical development. pups from lactating dams orally administered solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the mrhd) had no discernible adverse findings. the concentrations of solifenacin in animal milk does not necessarily predict the concentration of drug in human milk. the safety and effectiveness of solifenacin succinate have not been established in pediatric patients. in placebo-controlled clinical studies, similar safety and effectiveness were observed between geriatric patients (623 patients ≥ 65 years and 189 patients ≥ 75 years) and younger adult patients (1188 patients < 65 years) treated with solifenacin succinate [see clinical pharmacology (12.3) ]. solifenacin plasma concentrations are greater in patients with severe renal impairment compared to subjects with normal renal function [see clinical pharmacology (12.3) ]. because increased solifenacin plasma concentrations increase the risk of antimuscarinic adverse reactions, the maximum recommended dose of solifenacin succinate in patients with severe renal impairment (clcr < 30 ml/min/1.73 m2 ) is 5 mg once daily [see dosage and administration (2.2) ]. the recommended dose in patients with mild or moderate renal impairment is the same as in patients with normal renal function. solifenacin plasma concentrations are greater in patients with moderate hepatic impairment compared to subjects with normal hepatic function [see clinical pharmacology (12.3) ]. because increased solifenacin plasma concentrations increase the risk of antimuscarinic adverse reactions, the maximum recommended dose of solifenacin succinate in patients with moderate hepatic impairment (child-pugh b) is 5 mg once daily [see dosage and administration (2.3) ] and solifenacin succinate is not recommended for use in patients with severe hepatic impairment (child-pugh c). the pharmacokinetics of solifenacin is not significantly influenced by gender.

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)

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

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

amneal pharmaceuticals ny llc - 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 d

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

cipla usa inc. - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate 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

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

ajanta pharma 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 tablets are contraindicated in patients: - with urinary retention [see warnings and precautions (5.2)] , with urinary retention [see warnings and precautions (5.2)] , - with gastric retention [see warnings and precautions (5.3)] , with gastric retention [see warnings and precautions (5.3)] , - with uncontrolled narrow-angle glaucoma [see warnings and precautions (5.5)] , and 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)] . who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in solifenacin succinate tablets. reported

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

prasco - 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 tablets are 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 increas

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

breckenridge pharmaceutical, inc. - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablets are 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 recommended human dose [mrhd] of 10 mg. administr

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

sciegen pharmaceuticals, inc. - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate is 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 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 solifen

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

ascend laboratories, llc - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablets is 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 ingredients in solifenacin 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 the per