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Warnings & Precautions
PRECAUTIONS
General Risk of Urinary Retention and Gastric Retention: Text Continues Below
DETROL LA Capsules should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention and to patients with gastroin-testinal obstructive disorders, such as pyloric stenosis, because of the risk of gastric retention (see CONTRAINDICATIONS). Controlled Narrow-Angle Glaucoma: DETROL LA should be used with caution in patients being treated for narrow-angle glaucoma. Reduced Hepatic and Renal Function: For patients with significantly reduced hepatic function or renal function, the recommended dose for DETROL LA is 2 mg daily (see CLINICAL PHARMACOLOGY, Pharmacokinetics in Special Populations). Information for Patients Patients should be informed that antimuscarinic agents such as DETROL LA may produce the following effects: blurred vision, dizziness, or drowsiness. Drug Interactions CYP3A4 Inhibitors: Ketoconazole, an inhibitor of the drug metabolizing enzyme CYP3A4, significantly increased plasma concentrations of tolterodine when coadministered to subjects who were poor metabolizers (see CLINICAL PHAR-MACOLOGY, Variability in Metabolism and Drug-Drug Interactions). For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as other azole antifungals (eg, itraconazole, miconazole) or macrolide antibiotics (eg, erythro-mycin, clarithromycin) or cyclosporine or vinblastine, the recommended dose of DETROL LA is 2 mg daily. Drug-Laboratory-Test Interactions. Interactions between tolterodine and laboratory tests have not been studied. Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies with tolterodine immediate release were conducted in mice and rats. At the maximum tolerated dose in mice (30 mg/ kg/ day), female rats (20 mg/ kg/ day), and male rats (30 mg/ kg/ day), AUC values obtained for toltero-dine were 355, 291, and 462 µg° h/ L, respectively. In comparison, the human AUC value for a 2-mg dose administered twice daily is estimated at 34 µg° h/ L. Thus, tolterodine exposure in the carcinogenicity studies was 9-to 14-fold higher than expected in humans. No increase in tumors was found in either mice or rats. Page: 1 | 2 | Next >>
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