Solifenacin Succinate

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 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 ) ].
• 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 and provide appropriate therapy. ( 5.1 ) ● Urinary Retention : Solifenacin succinate is not recommended for use in patients with clinically significant bladder outlet obstruction. ( 5.2 ) ● Gastrointestinal Disorders : Solifenacin succinate is not recommended for use in patients with decreased gastrointestinal motility. ( 5.3 ) ● Central Nervous System Effects : Somnolence has been reported with solifenacin succinate.

Advise patients not to drive or operate heavy machinery until they know how solifenacin succinate affects them. ( 5.4 ) ● Controlled Narrow-Angle Glaucoma : Use solifenacin succinate with caution in patients being treated for narrow-angle glaucoma. ( 5.5 ) ● QT Prolongation in Patients at High Risk of QT Prolongation : Solifenacin succinate is 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. 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 been reported rarely in patients treated with solifenacin succinate. Angioedema associated with upper airway swelling and anaphylactic reactions may be life-threatening.