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About VESIcare
Adverse reactions
| The most common adverse events occurring in randomized, placebo-controlled clinical trials of VESIcare were those associated with antimuscarinic activity: dry mouth, constipation, and blurred vision. Dry mouth was the most frequent adverse event causing treatment discontinuation (1.5%). As indicated in the chart below, the incidence rates of side effects were dose related. Rates were higher in patients treated with VESIcare 10 mg than in those treated with VESIcare 5 mg.15
The overall rate of serious adverse events was 2% and included three intestinal obstructive disorders and one angioneurotic edema. Compared to twelve weeks of treatment with VESIcare, the incidence and severity of adverse events were similar in patients who remained on the drug for up to 12 months.15 Angioneurotic edema has been reported in one patient treated with VESIcare 5 mg.15 Percentages of patients with Treatment-emergent AE exceeding placebo rate and reported by 1% or more patients for combined Pivotal Studies
91% of OAB patients who completed two 12-week randomized trials chose to participate in a long-term (40-week, open-label) safety study. 81% of those patients completed the 40-week extension trial. Only 4.7% of the 1637 patients in the extension study discontinued their participation due to adverse events, and only 0.4% discontinued due to dry mouth.17 Learn more about the tolerability profile for VESIcare. |
| vesicarerx.com |
| Learn more about VESIcare with an interactive online experience. Click here. |
| Patient Resources |
| VESIcare can help you and your patients address overactive bladder together. The Fresh Approach Kit includes a bladder checklist, a bladder diary, and a list of questions for patients to ask physicians. Download Fresh Approach Kit. The Vantage ProgramSM provides valuable information and exclusive savings for your patients. Click here to learn more. |
| Important Safety Information VESIcare tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. The recommended dose of VESIcare is 5 mg once daily. If the 5-mg dose is well tolerated, the dose may be increased to 10 mg once daily. As with other anticholinergic agents, VESIcare is contraindicated in patients with urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in patients with hypersensitivity to the product. As with other anticholinergic agents, VESIcare should be administered with caution to patients with bladder outflow obstruction, decreased gastrointestinal motility, controlled narrow-angle glaucoma, or reduced renal or hepatic function. Doses of VESIcare higher than 5 mg are not recommended in patients with severe renal impairment, moderate hepatic impairment, or when administered with ketoconazole or other potent CYP3A4 inhibitors. Use of VESIcare in patients with severe hepatic impairment is not recommended. In placebo-controlled studies, the most common adverse events reported by patients were dry mouth (10.9%, 27.6%, 4.2%), constipation (5.4%, 13.4%, 2.9%), blurred vision (3.8%, 4.8%, 1.8%), and dyspepsia (1.4%, 3.9%, 1.0%) with VESIcare 5 mg, 10 mg, and placebo, respectively. The overall rate of serious adverse events was 2%. For the 10-mg dose, three intestinal serious adverse events were reported (one fecal impaction, one colonic obstruction, and one intestinal obstruction). For the 5-mg dose, one case of angioneurotic edema was reported. |
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Complete Prescribing Information for VESIcare |
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