Detrol LA

[Tolterodine]

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).

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For patients with significantly reduced hepatic or renal function or who are currently taking drugs that are potent inhibitors of CYP3A4, the recommended dose of DETROL LA is 2 mg daily (see CLINICAL PHARMACOLOGY and PRECAUTIONS, Drug Interactions).

HOW SUPPLIED

DETROL LA Capsules 2 mg are blue-green with symbol and 2 printed in white ink. DETROL LA Capsules 4 mg are blue with symbol and 4 printed in white ink. DETROL LA Capsules are supplied as follows:
Bottles of 30 Bottles of 500 2 mg Capsules NDC 0009-5190-01 2 mg Capsules NDC 0009-5190-03
4 mg Capsules NDC 0009-5191-01 4 mg Capsules NDC 0009-5191-03
Bottles of 90 Unit Dose Blisters 2 mg Capsules NDC 0009-5190-02 2 mg Capsules NDC 0009-5190-04

4 mg Capsules NDC 0009-5191-02 4 mg Capsules NDC 0009-5191-04
Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature].

Protect from light.
%only
U. S. Patent No. 5,382,600 Manufactured for

Pharmacia & Upjohn Company A subsidiary of Pharmacia Corporation
Kalamazoo, MI 49001, USA By
International Processing Corporation Winchester, Kentucky 40391, USA
Revised July 2003 818 229 006 692167
4688-76

DETROL LA tolterodine tartrate extended release capsules

Table 3. Incidence* (%) of Adverse Events Exceeding Placebo Rate and Reported in 1% of Patients Treated with DETROL LA (4 mg daily) in a 12-week, Phase 3 Clinical Trial
% DETROL LA % Placebo Body System Adverse Event n= 505 n= 507
Autonomic Nervous dry mouth 23 8
General headache 6 4
fatigue 2 1
Central/ Peripheral Nervous dizziness 2 1
Gastrointestinal constipation 6 4
abdominal pain 4 2
dyspepsia 3 1
Vision xerophthalmia 3 2
vision abnormal 1 0
Psychiatric somnolence 3 2
anxiety 1 0
Respiratory sinusitis 2 1
Urinary dysuria 1 0
* in nearest integer.

DETROL LA tolterodine tartrate extended release capsules DETROL LA tolterodine tartrate extended release capsules

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