Tolterodine

Renal Impairment Renal impairment can significantly alter the disposition of tolterodine immediate release and its metabolites. In a study conducted in patients with creatinine clearance between 10 and 30 mL/min, tolterodine and 5-HMT levels were approximately 2 to 3 fold higher in patients with renal impairment than in healthy volunteers.

Exposure levels of other metabolites of tolterodine (e.g., tolterodine acid, N -dealkylated tolterodine acid, N -dealkylated tolterodine, and N -dealkylated hydroxy tolterodine) were significantly higher (10 to 30 fold) in renally impaired patients as compared to the healthy volunteers. The recommended dose for patients with severe renal impairment (CCr: 10 to 30 mL/min) is tolterodine tartrate extended-release capsules 2 mg daily.

Patients with CCr<10 mL/min have not been studied and use of tolterodine tartrate extended-release capsules in this population is not recommended [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS ]. Tolterodine tartrate extended-release capsules have not been studied in patients with mild to moderate renal impairment [CCr 30 to 80 mL/min].

Dosage Adjustment in Specific Populations For patients with mild to moderate hepatic impairment (Child-Pugh Class A or B) or severe renal impairment (CCr 10 to 30 mL/min), the recommended dose of tolterodine tartrate extended-release capsules is 2 mg once daily. Tolterodine tartrate extended-release capsules are not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C).

Patients with CCr<10 mL/min have not been studied and use of tolterodine tartrate extended-release capsules are in this population is not recommended [see WARNINGS AND PRECAUTIONS and USE IN SPECIFIC POPULATIONS (8.6 , 8.7) ].