SANCTURA XR® (trospium chloride extended release capsules)
SANCTURA XR® (trospium chloride extended release capsules), approved by the U.S. Food and Drug Administration in August 2007, is a once daily medication for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency.
OAB is the most common cause of urinary incontinence or loss of bladder control in adults and affects approximately 33 million Americans.1 SANCTURA XR® belongs to a drug class of anticholinergic agents known as muscarinic receptor antagonists, which work by relaxing smooth muscle tissue found in the bladder, thus decreasing bladder contractions that are thought to be a cause of OAB.2 In clinical studies, SANCTURA XR® was shown to be effective and well tolerated by patients, demonstrating significant improvements in OAB symptoms. Dry mouth is a common side effect in this drug class, and SANCTURA XR® has a low incidence of dry mouth – just 10.7 percent. This is significant because as many as 70 percent of idiopathic OAB patients, the most common form of OAB, discontinue medication due to insufficient relief of symptoms or intolerable side effects (e.g., dry mouth, dry eyes, constipation, headache).3 Talk with your urologist about whether SANCTURA XR® is right for you.
Important Safety Information
SANCTURA XR® is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions. It is also contraindicated in patients who have demonstrated hypersensitivity to the drug or any of its ingredients.
SANCTURA XR® should be administered with caution to patients with clinically significant bladder outflow obstruction or gastrointestinal obstructive disorders due to risk of urinary or gastric retention. SANCTURA XR®, like other antimuscarinic agents, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony and myasthenia gravis. In patients being treated for narrow-angle glaucoma, SANCTURA XR® should be used only if the potential benefits outweigh the risks, and in that circumstance only with careful monitoring. SANCTURA XR® is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute). Alcohol should not be consumed within two hours of SANCTURA XR® administration. In addition, patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents. The most common adverse reactions with SANCTURA XR® were dry mouth (10.7 percent) and constipation (8.5 percent).