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)

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)

alphapharm pty ltd - solifenacin succinate, quantity: 10 mg - tablet - excipient ingredients: maize starch; hypromellose; purified talc; magnesium stearate; lactose monohydrate; titanium dioxide; propylene glycol; iron oxide yellow; iron oxide red - solifenacin succinate 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)

alphapharm pty ltd - solifenacin succinate, quantity: 5 mg - tablet - excipient ingredients: lactose monohydrate; maize starch; purified talc; hypromellose; magnesium stearate; titanium dioxide; propylene glycol; iron oxide yellow - solifenacin succinate 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)

sandoz pty ltd - solifenacin succinate, quantity: 5 mg (equivalent: solifenacin, qty 3.8 mg) - tablet, film coated - excipient ingredients: hypromellose; magnesium stearate; titanium dioxide; iron oxide yellow; pregelatinised maize starch; lactose monohydrate; purified talc; macrogol 6000 - solifenacin sandoz 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)

sandoz pty ltd - solifenacin succinate, quantity: 10 mg (equivalent: solifenacin, qty 7.5 mg) - tablet, film coated - excipient ingredients: iron oxide red; purified talc; pregelatinised maize starch; lactose monohydrate; titanium dioxide; hypromellose; magnesium stearate; macrogol 6000 - solifenacin sandoz 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)

sandoz pty ltd - solifenacin succinate, quantity: 5 mg (equivalent: solifenacin, qty 3.8 mg) - tablet, film coated - excipient ingredients: iron oxide yellow; macrogol 6000; magnesium stearate; lactose monohydrate; titanium dioxide; hypromellose; pregelatinised maize starch; purified talc - solifenacin sandoz 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)

sandoz pty ltd - solifenacin succinate, quantity: 10 mg (equivalent: solifenacin, qty 7.5 mg) - tablet, film coated - excipient ingredients: purified talc; macrogol 6000; lactose monohydrate; hypromellose; magnesium stearate; pregelatinised maize starch; iron oxide red; titanium dioxide - solifenacin sandoz 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)

generic health pty ltd - solifenacin succinate, quantity: 10 mg - tablet, film coated - excipient ingredients: magnesium stearate; maize starch; lactose monohydrate; hypromellose; titanium dioxide; purified talc; macrogol 6000; iron oxide red - solifenacin lupin is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency or increased urinary frequency.