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Detrol LA - Indications & Dosage

[Tolterodine]

INDICATIONS AND USAGE

DETROL LA Capsules are once daily extended release capsules indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

tolterodine tartrate

extended release capsules

Table 1. Summary of Mean (± SD) Pharmacokinetic Parameters of Tolterodine Extended Release and its Active Metabolite (5-hydroxymethyl metabolite) in Healthy Volunteers

Tolterodine 5-hydroxymethyl metabolite

tmax * Cmax Cavg t1/ 2 tmax * Cmax Cavg t1/ 2

(h) (µg/ L) (µg/ L) (h) (h) (µg/ L) (µg/ L) (h)

Single dose 4 mg*

EM 4 (2 -6) 1.3 (0.8) 0.8 (0.57) 8.4 (3.2) 4 (3 -6) 1.6 (0.5) 1.0 (0.32) 8.8 (5.9)

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Multiple dose 4 mg

EM 4 (2 -6) 3.4 (4.9) 1.7 (2.8) 6.9 (3.5) 4 (2 -6) 2.7 (0.90) 1.4 (0.6) 9.9 (4.0) PM 4 (3 -6) 19 (16) 13 (11) 18 (16) Ñ * ÑÑÑ

*Parameter dose-normalized from 8 to 4 mg for the single-dose data. Cmax = Maximum serum concentration; tmax = Time of occurrence of Cmax;

Cavg = Average serum concentration; t1/ 2 = Terminal elimination half-life. * Data presented as median (range).

* = not applicable.

Table 2. 95% Confidence Intervals (CI) for the Difference between DETROL LA (4 mg daily) and Placebo for Mean Change at Week 12 from Baseline*

Treatment DETROL LA Placebo Difference, vs

(n= 507) (n= 508) * Placebo (95% CI)

Number of incontinence episodes/ week Mean Baseline 22.1 23.3 -4.8 *

Mean Change from Baseline -11.8 (SD 17.8) -6.9 (SD 15.4) (-6.9, -2.8)

Number of micturitions/ day Mean Baseline 10.9 11.3

Mean Change from Baseline -1.8 (SD 3.4) -1.2 (SD 2.9) -0.6 * (-1.0, -0.2)

Volume Voided per micturition (mL) Mean Baseline 141 136

Mean Change from Baseline 34 (SD 51) 14 (SD 41) 20 * (14, 26)

SD = Standard Deviation. * Intent-to-treat analysis.

* 1 to 2 patients missing in placebo group for each efficacy parameter.

* The difference between DETROL LA and placebo was statistically significant.

DETROL LA tolterodine tartrate extended release capsules

DOSAGE AND ADMINISTRATION

The recommended dose of DETROL LA Capsules are 4 mg daily. DETROL LA should be taken once daily with liquids and swallowed whole. The dose may be lowered to 2 mg daily based on individual response and tolerability, however, limited efficacy data is available for DETROL LA 2 mg (see CLINICAL STUDIES).