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DETROL® LA (tolterodine tartrate)

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DETROL® LA Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

DETROL LA Capsules is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see...

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2 DOSAGE AND ADMINISTRATION

2.1 Dosing Information

The recommended dose of DETROL LA Capsules is 4 mg once daily with water and swallowed whole. The dose may be...

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3 DOSAGE FORMS AND STRENGTHS

The 2 mg capsules are blue-green with symbol and 2 printed in white ink.

The 4 mg capsules are blue with symbol and 4 printed in white ink.

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4 CONTRAINDICATIONS

DETROL LA is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. DETROL LA is also contraindicated in patients with known hypersensitivity to the...

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5 WARNINGS AND PRECAUTIONS

5.1 Angioedema

Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or...

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6 ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of...

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7 DRUG INTERACTIONS

7.1 Potent CYP2D6 Inhibitors

Fluoxetine, a potent inhibitor of CYP2D6 activity, significantly inhibited the metabolism of tolterodine immediate...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no available...

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10 OVERDOSAGE

Overdosage with DETROL LA Capsules can potentially result in severe central anticholinergic effects and should be treated accordingly.

ECG monitoring is recommended in the event of overdosage. In dogs,...

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11 DESCRIPTION

DETROL LA Capsules contain tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-N,N-diisopropyl-3-(2-hydroxy-5-...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Tolterodine acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors. Both urinary...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies with tolterodine were conducted in mice and rats. At the...

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14 CLINICAL STUDIES

DETROL LA Capsules 2 mg were evaluated in 29 patients in a Phase 2 dose-effect study. DETROL LA 4 mg was evaluated for the treatment of overactive bladder with symptoms of urge urinary incontinence and...

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16 HOW SUPPLIED/STORAGE AND HANDLING

DETROL LA Capsules are supplied as follows:

...
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17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

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This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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