Solifenacin Succinate

Clinical summary

Indications and usage 1 INDICATIONS AND USAGE 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 Succinate Tablets is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency (1) Dosage and administration 2 DOSAGE AND ADMINISTRATION 5 mg tablet taken once daily, and if well tolerated may be increased to 10 mg once daily ( 2.1 ) Do not exceed 5 mg tablet once daily in patients with: o severe renal impairment [Creatinine Clearance] (CLcr <30 ml/min) ( 2.2 ) o moderate hepatic impairment (Child-Pugh B) ( 2.3 ) o concomitant use of potent CYP3A4 inhibitors ( 2.4 ) Use of Solifenacin Succinate Tablets is not recommended in patients with severe hepatic impairment (Child-Pugh C) ( 2.3 ) 2.1 Dosing Information The recommended dose of Solifenacin Succinate Tablets is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily. Solifenacin Succinate Tablets should be taken with water and swallowed whole. Solifenacin Succinate Tablets can be administered with or without food. 2.2 Dose Adjustment in Patients with Renal Impairment For patients with severe renal impairment (CL cr <30 mL/min), a daily dose of Solifenacin Succinate Tablets greater than 5 mg is not recommended [ see Warnings and Precautions ( 5.7 ); Use in Specific Populations ( 8.6 ) ]. 2.3 Dose Adjustment in Patients with Hepatic Impairment For patients with moderate hepatic impairment (Child-Pugh B), a daily dose of Solifenacin Succinate Tablets greater than 5 mg is not recommended. Use of Solifenacin Succinate Tablets in patients with severe hepatic impairment (Child-Pugh C) is not recommended [ see Warnings and Precautions ( 5.6 ); Use in Specific Populations ( 8.7 ) ]. 2.4 Dose Adjustment in Patients Taking CYP3A4 Inhibitors When administered with potent CYP3A4 inhibitors such as ketoconazole, a daily dose of Solifenacin Succinate Tablets greater than 5 mg is not recommended [ see Drug Interactions ( 7.1 ) ]. Warnings and cautions 5 WARNINGS AND PRECAUTIONS 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. Advise patients not to drive or operate heavy machinery until they know how Solifenacin 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. Anaphylactic reactions have been reported rarely in patients treated with solifenacin succinate. Solifenacin succinate should not be used in patients with a known or suspected hypersensitivity to solifenacin succinate. In patients who develop anaphylactic reactions, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken. 5.2 Urinary Retention Solifenacin, like other anticholinergic drugs, should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [ see Contraindications ( 4 ) ]. 5.3 Gastrointestinal Disorders Solifenacin, like other anticholinergics, should be used with caution in patients with decreased gastrointestinal motility [ see Contraindications ( 4 ) ]. 5.4 Central Nervous System Effects Solifenacin is associated with anticholinergic central nervous system (CNS) effects [ see Adverse Reactions ( 6.2 ) ]. A variety of CNS anticholinergic effects have been reported, including headache, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how Solifen