Detrol LA 4 mg/1

tolterodine tartrate · CAPSULE, EXTENDED RELEASE · Viatris Specialty LLC

No Recall History

Plain English

Detrol LA is a capsule, extended release containing tolterodine tartrate at 4 mg/1, taken oral. Manufactured by Viatris Specialty LLC.

Key Facts

Brand Name: Detrol LA
Generic Name: tolterodine tartrate
NDC Code (Product): 58151-104
Manufacturer: Viatris Specialty LLC
Strength: 4 mg/1
Dosage Form: CAPSULE, EXTENDED RELEASE
Route: ORAL
Marketing Status
Application #: NDA021228
Marketing Start: 03/20/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective1,409 reports

dry mouth528 reports

fall527 reports

dizziness483 reports

fatigue476 reports

diarrhoea459 reports

nausea446 reports

headache443 reports

constipation410 reports

pain389 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 Clinical Studies (14) ] . DETROL LA is an antimuscarinic indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. ( 1 )

Dosage & Administration

2 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: o mild to moderate hepatic impairment (Child-Pugh class A or B) ( 2.2 ) o severe renal impairment [Creatinine Clearance (CCr) 10‑30 mL/min] ( 2.2 ) o 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 ) 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 lowered to 2 mg daily based on individual response and tolerability; however, limited efficacy data are available for DETROL LA 2 mg [see Clinical Studies (14) ] . 2.2 Dosage Adjustment in Specific Populations For patients with mild to moderate hepatic impairment (Child-Pugh Class A or B) or severe renal impairment (CCr 10-30 mL/min), the recommended dose of DETROL LA is 2 mg once daily. DETROL LA is not recommended for use in patients with severe hepatic impairment (Child…

Contraindications

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 drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like DETROL LA, are metabolized to 5-hydroxymethyl tolterodine [see Warnings and Precautions (5.2 , 5.3 , 5.4) ]. 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 )

Drug Interactions

7 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 ) 7.1 Potent CYP2D6 Inhibitors Fluoxetine, a potent inhibitor of CYP2D6 activity, significantly inhibited the metabolism of tolterodine immediate release in CYP2D6 extensive metabolizers, resulting in a 4.8-fold increase in tolterodine AUC. There was a 52% decrease in C max and a 20% decrease in AUC of 5-hydroxymethyl tolterodine (5-HMT), the pharmacologically active metabolite of tolterodine [see Clinical Pharmacology (12.1) ] . The sums of unbound serum concentrations of tolterodine and 5-HMT are only 25% higher during the interaction. No dose adjustment is required when tolterodine and fluoxetine are co-administered [see Clinical Pharmacology (12.3) ]. 7.2 Potent CYP3A4 Inhibitors Ketoconazole (200 mg daily), a potent CYP3A4 inhibitor, increased the mean C max and AUC of tolterodine by 2-…

Adverse Reactions

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 another drug and may not reflect the rates observed in practice. 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 Viatris at 1-877-446-3679 (1-877-4-INFO-RX) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience The efficacy and safety of DETROL LA Capsules was evaluated in 1073 patients (537 assigned to DETROL LA; 536 assigned to placebo) who were treated with 2, 4, 6, or 8 mg/day for up to 15 months. These included a total of 1012 patients (505 randomized to DETROL LA 4 mg once daily and 507 randomized to placebo) enrolled in a randomized, placebo-controlled, double-blind, 12-week clinical efficacy and safety study. Adverse events were reported in 52% (n=263) of patients receiving DETROL LA and in 49% (n=247) of patients receiving placebo. The most common adverse events reported by patients receiving DETROL LA w…

Frequently Asked Questions

What is Detrol LA used for?

Detrol LA contains tolterodine tartrate. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is Detrol LA a controlled substance?

Detrol LA is not classified as a controlled substance by the DEA.

What is the generic name for Detrol LA?

The generic name for Detrol LA is tolterodine tartrate. There are 12 other brand versions of tolterodine tartrate.

What is the NDC code for Detrol LA 4 mg/1?

The NDC (National Drug Code) for Detrol LA 4 mg/1 is 58151-104, listed by Viatris Specialty LLC.

Product NDC

58151-104

Package NDC

58151-104-77

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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