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Detrol LA - Warnings & Precautions

[Tolterodine]




PRECAUTIONS

General

Risk of Urinary Retention and Gastric Retention:

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.
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