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DETROL® LA Highlights (tolterodine tartrate)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Detrol® LA safely and effectively. See full prescribing information for Detrol LA.

Detrol® LA (tolterodine tartrate extended release capsules)
For oral administration
Initial U.S. Approval: December 2000

INDICATIONS AND USAGE

DETROL LA is an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. (1)

DOSAGE AND ADMINISTRATION

  • 4 mg capsules taken orally once daily with water and swallowed whole. (2.1)
  • 2 mg capsules taken orally once daily with water and swallowed whole in the presence of:
    • mild to moderate hepatic impairment (Child-Pugh class A or B) (2.2)
    • severe renal impairment [Creatinine Clearance (CCr) 10–30 mL/min] (2.2)
    • drugs that are potent CYP3A4 inhibitors. (2.2)
  • DETROL LA is not recommended for use in patients with CCr <10 mL/min. (2.2)
  • DETROL LA is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). (2.2)

DOSAGE FORMS AND STRENGTHS

Capsules: 2 mg and 4 mg (3)

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 drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like DETROL LA, are metabolized to 5-hydroxymethyl tolterodine. (4)

WARNINGS AND PRECAUTIONS

  • Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of DETROL LA. (5.1)
  • Urinary Retention: use caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention. (5.2)
  • Gastrointestinal Disorders: use caution in patients with gastrointestinal obstructive disorders or decreased gastrointestinal motility because of the risk of gastric retention. (5.3)
  • Controlled Narrow-Angle Glaucoma: use caution in patients being treated for narrow-angle glaucoma. (5.4)
  • Central Nervous System Effects: Somnolence has been reported with Detrol LA. Advise patients not to drive or operate heavy machinery until they know how Detrol LA affects them (5.5).
  • Myasthenia Gravis: use caution in patients with myasthenia gravis. (5.8)
  • QT Prolongation: consider observations from the thorough QT study in clinical decisions to prescribe DETROL LA to patients with a known history of QT prolongation or to patients who are taking Class IA (e.g., quinidine, procainamide) or Class III (e.g., amiodarone, sotalol) antiarrhythmic medications. (5.9)

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥4% and >placebo) were dry mouth, headache, constipation, and abdominal pain. (6.1)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Potent CYP3A4 Inhibitors: Coadministration may increase systemic exposure to DETROL LA. Reduce DETROL LA dose to 2 mg once daily. (7.2)
  • Other Anticholinergics (antimuscarinics): Concomitant use with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision, and other anticholinergic pharmacological effects. (7.6)

USE IN SPECIFIC POPULATIONS

  • Renal Impairment: DETROL LA is not recommended for use in patients with CCr <10 mL/min. Dose adjustment in severe renal impairment (CCr: 10–30 mL/min). (8.6)
  • Hepatic Impairment: Not recommended for use in severe hepatic impairment (Child Pugh Class C). Dose adjustment in mild to moderate hepatic impairment (Child Pugh Class A, B). (8.7)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 7/2018

 
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Report Adverse Event

Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch