SOLIFENACIN SUCCINATE

AbsorptionAfter oral administration of solifenacin succinate in healthy volunteers, peak plasma concentrations (C max ) of solifenacin were reached within 3 to 8 hours after administration and, at steady-state, ranged from 32.3 to 62.9 ng/mL for the 5 and 10 mg solifenacin succinate tablets, respectively. The absolute bioavailability of solifenacin is approximately 90%, with plasma concentrations of solifenacin proportional to the dose administered. Effect of Food Solifenacin succinate may be a...

Solifenacin succinate was evaluated in four twelve-week, double-blind, randomized, placebo-controlled, parallel group, multicenter clinical trials for the treatment of overactive bladder in adult patients having symptoms of urinary frequency, urgency, and/or urge or mixed incontinence (with a predominance of urge). Entry criteria required that patients have symptoms of overactive bladder for ≥3 months duration. These studies involved 3027 patients (1811 on solifenacin succinate and 1216 on placebo), and approximately 90% of these patients completed the 12-week studies. Two of the four studies ...

The most common adverse reactions (> 4% in solifenacin succinate-treated patients and > placebo-treated patients) were dry mouth and constipation at both 5 mg and 10 mg doses; and urinary tract infection and blurred vision at the 10 mg dose ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying ...

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 succin...

• Angioedema and Anaphylactic Reactions : Promptly discontinue solifenacin succinate 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 succi...

7 DRUG INTERACTIONS CYP3A4 Inhibitors : Do not exceed the 5 mg dose of solifenacin succinate with concomitant use of strong CYP3A4 inhibitors ( 7.1 ). 7.1 Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4. Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [see Clinical Pharmacology ( 12.3 ) ]. The dosage of solifenacin succ...