1/14/2024 0 Comments Er caps![]() Dry mouth was the most frequently reported adverse event for patients treated with tolterodine tartrate extended-release capsules, occurring in 23.4% of patients treated with tolterodine tartrate extended-release capsules and 7.7% of placebo-treated patients. The most common adverse events reported by patients receiving tolterodine tartrate extended-release capsules were dry mouth, headache, constipation, and abdominal pain. These included a total of 1,012 patients (505 randomized to tolterodine tartrate extended-release capsules 4 mg once daily and 507 randomized to placebo) enrolled in a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study.Īdverse events were reported in 52% (n=263) of patients receiving tolterodine tartrate extended-release capsules and in 49% (n=247) of patients receiving placebo. The efficacy and safety of tolterodine tartrate extended-release capsules was evaluated in 1,073 patients (537 assigned to tolterodine tartrate extended-release capsules 536 assigned to placebo) who were treated with 2, 4, 6, or 8 mg/day for up to 15 months. There has been no association of Torsade de Pointes in the international post-marketing experience with tolterodine tartrate tablets or tolterodine tartrate extended-release capsules. These observations should be considered in clinical decisions to prescribe tolterodine tartrate extended-release capsules to patients with a known history of QT prolongation or to patients who are taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications. ![]() However, the confidence intervals overlapped. The effect of tolterodine 8 mg/day was not as large as that observed after four days of therapeutic dosing with the active control moxifloxacin. , the effect on the QT interval appeared greater for 8 mg/day (two times the therapeutic dose) compared to 4 mg/day and was more pronounced in CYP2D6 poor metabolizers (PM) than extensive metabolizers (EMs). In a study of the effect of tolterodine immediate release tablets on the QT interval (ĥ.9 Use in Patients with Congenital or Acquired QT Prolongation :consider observations from the thorough QT study in clinical decisions to prescribe tolterodine tartrate extended-release capsules to patients with a known history of QT prolongation or to patients who are taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications. Myasthenia Gravis: use caution in patients with myasthenia gravis.Advise patients not to drive or operate heavy machinery until they know how tolterodine tartrate extended-release capsules affect them ( Central Nervous System Effects: Somnolence has been reported with tolterodine tartrate extended-release capsules. ![]()
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