Detrol LA - Indications & Dosage

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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