The FDA ( Food and Drug Administration ) has approved a new drug to help patients suffering from overactive bladder. Toviaz ( Fesoterodine ) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence, that are characteristic symptoms of overactive bladder.
Toviaz is available by prescription only, as an extended release tablet in either 4 mg or 8 mg dosage strengths. It is to be administered once daily. The recommended starting dose is 4 mg, which can be increased to 8 mg if needed, based upon individual response and tolerability. Toviaz is only approved for adults.
The safety and effectiveness of Toviaz were studied in two, 12-week, randomized controlled studies of the 4 mg and 8 mg doses. For the combined studies, a total of 554 patients received placebo, 554 patients received Toviaz 4 mg daily, and 566 patients received the drug 8 mg daily. The majority of patients were female with a mean age of 58 years. Toviaz is not approved for pediatric use.
In each of those two studies, the product showed a statistically significant and clinically meaningful improvement in decreasing the number of times patients needed to urinate per day, as well as the number of urine leaking episodes they experienced per day, as compared to placebo.
Common side effects associated with Toviaz included dry mouth and constipation. Less frequently reported side effects included dry eyes and trouble emptying the bladder.
Toviaz is not recommended in doses above 4 mg in those patients with severe reduction in kidney function or in those patients taking medications, such as Ketoconazole, that block the metabolism of the drug. It should not be used in patients who suffer from urinary or gastric retention or in patients with uncontrolled, narrow-angle glaucoma. It should also not be used in patients with severe liver impairment. The product should be used with caution in patients who suffer from decreased gastrointestinal motility, such as those with severe constipation.
Source: FDA, 2008
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