솔리페나신타르타르산염

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 a muscarinic antagonist indicated for the treatment of adults with overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1 )

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 )]. • Urinary retention. ( 4 , 5.2 ) • Gastric retention. (4, 5.3 ) • Uncontrolled narrow-angle glaucoma. ( 4, 5.5 ) • Hypersensitivity to this product or any of its components. ( 4 , 5.1 , 6.2 )

• Angioedema and Anaphylactic Reactions: Promptly discontinue Solifenacin succinate and provide appropriate therapy. (5.1) • Urinary Retention: Solifenacin succinate tablets are not recommended for use in patients with clinically significant bladder outlet obstruction. (5.2) • Gastrointestinal Disorders: Solifenacin succinate tablets are not recommended for use in patients with decreased gastrointestinal motility. (5.3) • Central Nervous System Effects: Somnolence has been reported with solifenacin succinate tablets. Advise patients not to drive or operate heavy machinery until they know how solifenacin succinate tablets affects them. (5.4) • Controlled Narrow-Angle Glaucoma: Use solifenacin succinate tablets with caution in patients being treated for narrow-angle glaucoma. (5.5) • QT Prolongation in Patients at High Risk of QT Prolongation : Solifenacin succinate tablets are not recommended for use in patients at high risk of QT prolongation, including patients with a known history of QT prolongation and patients taking medications known to prolong the QT interval. (5.6) 5.1 Angioedema and Anaphylactic Reactions Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin succinate. In some cases, angioedema occurred after the first dose, however, cases have been reported to occur hours after the first dose or after multiple doses. Anaphylactic reactions have also been reported in patients treated with solifenacin succinate. Angioedema associated …

8.1 Pregnancy 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 …