"Jan. 25, 2013 -- The FDA has approved Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women 18 and older.
The condition affects more than 20 million American women, according to Merck, the drug's manu"...
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
VESIcare has been evaluated for safety in 1811 patients in randomized, placebo-controlled trials. Expected adverse reactions of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes. The incidence of dry mouth and constipation in patients treated with VESIcare was higher in the 10 mg compared to the 5 mg dose group.
In the four 12-week double-blind clinical trials, severe fecal impaction, colonic obstruction, and intestinal obstruction were reported in one patient each, all in the VESIcare 10 mg group. Angioneurotic edema has been reported in one patient taking VESIcare 5 mg. Compared to 12 weeks of treatment with VESIcare, the incidence and severity of adverse reactions were similar in patients who remained on drug for up to 12 months.
The most frequent adverse reaction leading to study discontinuation was dry mouth (1.5%). Table 1 lists the rates of identified adverse reactions, derived from all reported adverse events, in randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with VESIcare 5 or 10 mg once daily for up to 12 weeks.
Table 1: Percentages of Patients with Identified
Adverse Reactions, Derived from All Adverse Events Exceeding Placebo Rate and
Reported by 1% or More Patients for Combined Pivotal Studies
|Placebo (%)||VESIcare 5 mg (%)||VESIcare 10 mg (%)|
|Number of Patients||1216||578||1233|
|Abdominal Pain Upper||1||1.9||1.2|
|INFECTIONS AND INFESTATIONS|
|Urinary Tract Infection NOS||2.8||2.8||4.8|
|NERVOUS SYSTEM DISORDERS|
|Dry Eyes NOS||0.6||0.3||1.6|
|RENAL AND URINARY DISORDERS|
|GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS|
|Edema Lower Limb||0.7||0.3||1.1|
|RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS|
Because these spontaneously reported events are from the worldwide postmarketing experience, the frequency of events and the role of solifenacin in their causation cannot be reliably determined.
The following events have been reported in association with solifenacin use in worldwide postmarketing experience:
Metabolism and nutrition disorders: decreased appetite, hyperkalemia;
Respiratory, thoracic and mediastinal disorders: dysphonia;
Musculoskeletal and connective tissue disorders: muscular weakness;
Read the VESIcare (solifenacin succinate) Side Effects Center for a complete guide to possible side effects
Potent CYP3A4 Inhibitors
Following the administration of 10 mg of VESIcare in the presence of 400 mg of ketoconazole, a potent inhibitor of CYP3A4, the mean Cmax and AUC of solifenacin increased by 1.5 and 2.7-fold, respectively. Therefore, it is recommended not to exceed a 5 mg daily dose of VESIcare when administered with therapeutic doses of ketoconazole or other potent CYP3A4 inhibitors [see DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY]. The effects of weak or moderate CYP3A4 inhibitors were not examined.
There were no in vivo studies conducted to evaluate the effect of CYP3A4 inducers on VESIcare. In vitro drug metabolism studies have shown that solifenacin is a substrate of CYP3A4. Therefore, inducers of CYP3A4 may decrease the concentration of solifenacin.
Drugs Metabolized by Cytochrome P450
At therapeutic concentrations, solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 derived from human liver microsomes.
Solifenacin has no significant effect on the pharmacokinetics of R-warfarin or S-warfarin [see CLINICAL PHARMACOLOGY].
Solifenacin had no significant effect on the pharmacokinetics of digoxin (0.125 mg/day) in healthy subjects [see CLINICAL PHARMACOLOGY].
Read the VESIcare Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 11/5/2013
Additional VESIcare Information
VESIcare - User Reviews
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Report Problems to the Food and Drug Administration
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