SANCTURA XR®
This product information is intended for U.S. residents only.
SANCTURA XR® (trospium chloride extended release capsules), a once-daily formulation of SANCTURA® is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Endo currently co-promotes SANCTURA and SANCTURA XR in the U.S. with its marketing partner, Allergan, Inc.
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www.sancturaxr.com to learn more
- 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 < 30mL/minute). Alcohol should not be consumed within 2 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%) and constipation (8.5%).
- Administration of SANCTURA XR® immediately after a high fat-content meal reduced the oral
bioavailability of trospium chloride by 35% for AUC(0-Tlast) and by 60% for Cmax. It is therefore recommended that SANCTURA XR® be taken on an empty stomach at least one hour before a meal.
- Please see the Full Prescribing Information for SANCTURA XR.
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