DARIFENACIN HYDROBROMIDE

AbsorptionAfter oral administration of darifenacin to healthy volunteers, peak plasma concentrations of darifenacin are reached approximately seven hours after multiple dosing and steady-state plasma concentrations are achieved by the sixth day of dosing. The mean (SD) steady-state time course of darifenacin 7.5 mg and 15 mg extended-release tablets is depicted in Figure 1. Figure 1: Mean (SD) Steady-State Darifenacin Plasma Concentration-Time Profiles for Darifenacin 7.5 mg and 15 mg in Health...

Darifenacin extended-release tablets were evaluated for the treatment of patients with overactive bladder with symptoms of urgency, urge urinary incontinence, and increased urinary frequency in three randomized, fixed-dose, placebo-controlled, multicenter, double-blind, 12-week studies (Studies 1, 2 and 3) and one randomized, double-blind, placebo-controlled, multicenter, dose-titration study (Study 4). For study eligibility in all four studies, patients with symptoms of overactive bladder for at least six months were required to demonstrate at least eight micturitions and at least one episode...

The most frequently reported adverse reactions (>3 percent) for darifenacin are: constipation, dry mouth, headache, dyspepsia, nausea, urinary tract infection, accidental injury, and flu symptoms. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Polygen Pharmaceuticals Inc. at 1-888-291-7337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical tri...

Darifenacin is contraindicated in patients with, or at risk for, the following conditions: urinary retention gastric retention, or uncontrolled narrow-angle glaucoma. Darifenacin is contraindicated in patients with, or at risk for, the following conditions ( 4 ): urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma.

Darifenacin should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. ( 5.1 ) Darifenacin should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention. ( 5.2 ) Darifenacin should be used with caution in patients being treated for narrow- angle glaucoma and only where the potential benefits outweigh the risks. ( 5.3 ) Central Nervous Syste...

7 DRUG INTERACTIONS Caution should be taken when darifenacin is used concomitantly with medications that are predominantly metabolized by CYP2D6 and which have a narrow therapeutic window, such as flecainide, thioridazine and tricyclic antidepressants. ( 7.2 ) The concomitant use of darifenacin with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation,...