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Gender The pharmacokinetics of tolterodine immediate release and the 5-hydroxymethyl metabolite are not influenced by gender. Mean Cmax of tolterodine immediate release (1.6 µg/ L in males versus 2.2 µg/ L in females) and the active 5-hydroxymethyl metabolite (2.2 µg/ L in males versus 2.5 µg/ L in females) are similar in males and females who were administered tolterodine immediate release 2 mg. Mean AUC values of tolterodine (6.7 µg° h/ L in males versus 7.8 µg° h/ L in females) and the 5-hydroxymethyl metabolite (10 µg° h/ L in males versus 11 µg° h/ L in females) are also similar. The elimination half-life of tolterodine immediate release for both males and females is 2.4 hours, and the half-life of the 5-hydroxymethyl metabolite is 3.0 hours in females and 3.3 hours in males. Text Continues Below
Race: Pharmacokinetic differences due to race have not been established. Renal Insufficiency: 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 imme-diate release and the 5-hydroxymethyl metabolite levels were approximately 2-3 fold higher in patients with renal impairment than in healthy volunteers. Exposure levels of other metabolites of tolterodine (eg, tolterodine acid, N-dealkylated tolterodine acid, N-dealkylated tolterodine and N-dealkylated hydroxy tolterodine) were significantly higher (10-30 fold) in renally impaired patients as compared to the healthy volunteers. The recommended dose for patients with significantly reduced renal function is tolterodine 2 mg daily (see PRECAUTIONS, General). Hepatic Insufficiency: Liver impairment can significantly alter the disposition of tolterodine immediate release. In a study of tolterodine immediate release conducted in cirrhotic patients, the elimination half-life of tolterodine immediate release was longer in cirrhotic patients (mean, 7.8 hours) than in healthy, young, and elderly volunteers (mean, 2 to 4 hours). The clearance of orally administered tolterodine immediate release was substantially lower in cirrhotic patients (1.0 ± 1.7 L/ h/ kg) than in the healthy volunteers (5.7 ± 3.8 L/ h/ kg). The recommended dose for patients with significantly reduced hepatic function is tolterodine 2 mg daily (see PRECAUTIONS, General). Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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