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: 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

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)

avkare - solifenacin succinate (unii: kka5dld701) (solifenacin - unii:a8910sqj1u) - solifenacin succinate tablets is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. solifenacin 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-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 incidence of cleft palate. in utero and lactational exposures to maternal doses of solifenacin succinate of 3.6 times (100 mg/kg/day) the mrhd resulted in reduced peripartum and postnatal survival, reductions in body weight gain, and delayed physical development (eye opening and vaginal patency). an increase in the percentage of male offspring was also observed in litters from offspring exposed to maternal doses of 250 mg/kg/day. no embryotoxic effects were observed in rats at up to 50 mg/kg/day (<1 times the exposure at the mrhd) or in rabbits at up to 1.8 times (50 mg/kg/day) the exposure at the mrhd. because animal reproduction studies are not always predictive of human response, solifenacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. the effect of solifenacin on labor and delivery in humans has not been studied. there were no effects on natural delivery 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 at 3.6 times (100 mg/kg/day) the exposure at the mrhd or greater increased peripartum pup mortality. after oral administration of 14 c-solifenacin succinate to lactating mice, radioactivity was detected in maternal milk. there were no adverse observations in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [mrhd]. pups of female mice treated with 3.6 times (100 mg/kg/day) the exposure at the mrhd or greater revealed reduced body weights, postpartum pup mortality or delays in the onset of reflex and physical development during the lactation period. it is not known whether solifenacin is excreted in human milk. because many drugs are excreted in human milk, solifenacin should not be administered during nursing. a decision should be made whether to discontinue nursing or to discontinue solifenacin in nursing mothers. the safety and effectiveness of solifenacin in pediatric patients have not been established. in placebo-controlled clinical studies, similar safety and effectiveness were observed between older (623 patients ≥ 65 years and 189 patients ≥ 75 years) and younger patients (1188 patients < 65 years) treated with solifenacin. multiple dose studies of solifenacin in elderly volunteers (65 to 80 years) showed that c max , auc and t 1/2 values were 20-25% higher as compared to the younger volunteers (18 to 55 years). solifenacin should be used with caution in patients with renal impairment. there is a 2.1-fold increase in auc and 1.6-fold increase in t 1/2 of solifenacin in patients with severe renal impairment. doses of solifenacin greater than 5 mg are not recommended in patients with severe renal impairment (cl cr < 30 ml/min) [ see warnings and precautions ( 5.7); dosage and administration ( 2.2) ]. solifenacin should be used with caution in patients with reduced hepatic function. there is a 2-fold increase in the t 1/2 and 35% increase in auc of solifenacin in patients with moderate hepatic impairment. doses of solifenacin greater than 5 mg are not recommended in patients with moderate hepatic impairment (child-pugh b). solifenacin is not recommended for patients with severe hepatic impairment (child-pugh c) [ see warnings and precautions ( 5.6); dosage and administration ( 2.3) ]. the pharmacokinetics of solifenacin is not significantly influenced by gender.

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)

camber pharmaceuticals, 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, mis

Australia - English - Department of Health (Therapeutic Goods Administration)

accelagen pty ltd - solifenacin succinate, quantity: 10 mg (equivalent: solifenacin, qty 7.5 mg) - tablet, film coated - excipient ingredients: titanium dioxide; lactose monohydrate; triacetin; hypromellose; purified talc; magnesium stearate; iron oxide red - solifenacin dr.reddy's is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

Australia - English - Department of Health (Therapeutic Goods Administration)

accelagen pty ltd - solifenacin succinate, quantity: 5 mg (equivalent: solifenacin, qty 3.75 mg) - tablet, film coated - excipient ingredients: magnesium stearate; purified talc; iron oxide yellow; hypromellose; triacetin; titanium dioxide; lactose monohydrate - solifenacin dr.reddy's is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.

Malta - English - Medicines Authority

portfarma ehf. borgartúni 26, is – 105 reykjavík, iceland - solifenacin succinate - film-coated tablet - solifenacin succinate 5 mg - urologicals

Malta - English - Medicines Authority

portfarma ehf. borgartúni 26, is – 105 reykjavík, iceland - solifenacin succinate - film-coated tablet - solifenacin succinate 10 mg - urologicals

New Zealand - English - Medsafe (Medicines Safety Authority)

viatris limited - solifenacin succinate 10mg;   - film coated tablet - 10 mg - active: solifenacin succinate 10mg   excipient: hypromellose   iron oxide red iron oxide yellow lactose magnesium stearate maize starch propylene glycol purified talc titanium dioxide - solifenacin viatris is indicated for the treatment of unstable bladder with symptoms of increased urinary urgency, frequent microurination, and/or urge incontinence.