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| Drug Name |
SANCTURA |
| Active Ingredient(s) |
TROSPIUM CHLORIDE |
Form(s) and
Strength(s) Available |
TABLET; ORAL:20MG |
Product Information / Press Release Sanctura, a quarternary ammonium compound, belongs to a class of anticholinergic compounds known as muscarinic receptor antagonists. These compounds relax smooth muscle tissue found in the bladder, thus decreasing bladder contractions. Overactive or unstable detrusor muscle function is believed to be the cause of overactive bladder.
The FDA approval of Sanctura was based on a review of data from clinical studies conducted in the U.S. and Europe involving approximately 3,000 subjects. Sanctura was well tolerated, and the most commonly reported side effects in Phase III U.S. clinical trials were dry mouth (20.1 percent for Sanctura vs. 5.8 percent for placebo) and constipation (9.6 percent for Sanctura vs. 4.6 percent for placebo). Patients who have urinary retention, gastric retention, uncontrolled narrow-angle glaucoma or hypersensitivity to Sanctura should not use Sanctura.
Sanctura has been extensively studied and is currently marketed as a prescription drug product in Europe, where it is one of the leading products for overactive bladder / urinary incontinence. Indevus licensed exclusive U.S. rights to Sanctura from Madaus AG, a German pharmaceutical company, in late 1999.
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