Solifenacin Succinate

Solifenacin succinate tablet 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 muscarinic antagonist indicated for the treatment of 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)] , 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)] . Urinary retention (4, 5.2). Gastric retention (4, 5.3). Uncontrolled narrow-angle glaucoma (4, 5.5).

In patients who have demonstrated hypersensitivity to the drug (4, 6.2).

Angioedema and anaphylactic reactions: Reports of angioedema of the face, lips and/or larynx, in some cases occurring after the first dose, have been described. Anaphylactic reactions have been reported rarely (5.1). Urinary Retention: Administer with caution to patients with clinically significant bladder outflow obstruction (5.2). Gastrointestinal Disorders: Use with caution 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 with caution in patients being treated for narrow-angle glaucoma (5.5). QT Prolongation: Use with caution in patients with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval (5.8).

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. Cases of angioedema have been reported to occur hours after the first dose or after multiple doses. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, solifenacin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.