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Angioedema: Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of DETRUSITOL SR. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, DETRUSITOL SR should be discontinued and appropriate therapy promptly provided.
Urinary Retention: Administer DETRUSITOL SR Capsules with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see CONTRAINDICATIONS].
Gastrointestinal Disorders: Administer DETRUSITOL SR with caution in patients with gastrointestinal obstructive disorders because of the risk of gastric retention.
DETRUSITOL SR, like other antimuscarinic drugs, may decrease gastrointestinal motility and should be used with caution in patients with conditions associated with decreased gastrointestinal motility (e.g. intestinal atony) [see CONTRAINDICATIONS].
Controlled Narrow-Angle Glaucoma: Administer DETRUSITOL SR with caution in patients being treated for narrow-angle glaucoma [see CONTRAINDICATIONS].
Central Nervous System Effects: DETRUSITOL SR is associated with anticholinergic central nervous system (CNS) effects [see Post-marketing Experience under Adverse Reactions] including dizziness and somnolence [see Clinical Trials Experience under Adverse Reactions]. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until the drug's effects have been determined. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.
Hepatic Impairment: The clearance of orally administered tolterodine immediate release was substantially lower in cirrhotic patients than in the healthy volunteers. For patients with mild to moderate hepatic impairment (Child-Pugh Class A or B), the recommended dose for DETRUSITOL SR is 2 mg once daily. DETRUSITOL SR is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C) [see DOSAGE & ADMINISTRATION and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions].
Renal Impairment: Renal impairment can significantly alter the disposition of tolterodine and its metabolites. The dose of DETRUSITOL SR should be reduced to 2 mg once daily in patients with severe renal impairment (CCr: 10-30 mL/min). Patients with CCr<10 mL/min have not been studied and use of DETRUSITOL SR in this population is not recommended [see DOSAGE & ADMINISTRATION and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions].
Myasthenia Gravis: Administer DETRUSITOL SR with caution in patients with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction.
Use in Patients with Congenital or Acquired QT Prolongation: In a study of the effect of tolterodine immediate release tablets on the QT interval [see PHARMACOLOGY under Actions] 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). 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. However, the confidence intervals overlapped.
These observations should be considered in clinical decisions to prescribe DETRUSITOL SR 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. There has been no association of Torsade de Pointes in the international post-marketing experience with DETRUSITOL or DETRUSITOL SR.
