Drugplain

Tolterodine Tartrate Extended Release 2 mg/1

tolterodine tartrate · CAPSULE, EXTENDED RELEASE · Mylan Pharmaceuticals Inc.

1 Recall on Record
Plain English

Tolterodine tartrate extended-release is a prescription medication taken by mouth that helps treat overactive bladder by reducing urinary urgency, frequency, and incontinence. It works by relaxing the bladder muscle to help improve bladder control.

Key Facts

Brand Name
Tolterodine Tartrate Extended Release
Generic Name
tolterodine tartrate
NDC Code (Product)
59762-0047
Manufacturer
Mylan Pharmaceuticals Inc.
Strength
2 mg/1
Dosage Form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
NDA021228
Marketing Start
01/22/2016

Recall History

1 Recall on Record
Class III03/04/2025

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective260 reports
fall151 reports
fatigue143 reports
nausea140 reports
headache129 reports
dizziness128 reports
diarrhoea125 reports
drug interaction108 reports
constipation98 reports
asthenia96 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Tolterodine tartrate extended-release capsules are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency [see Clinical Studies (14) ] . Tolterodine tartrate extended-release capsules are 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 ) • Tolterodine tartrate extended-release capsules are not recommended for use in patients with CCr <10 mL/min. ( 2.2 ) • Tolterodine tartrate extended-release capsules are not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). ( 2.2 ) 2.1 Dosing Information The recommended dose of tolterodine tartrate extended-release 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 tolterodine tartrate extended-release capsules 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),…

Contraindications

4 CONTRAINDICATIONS Tolterodine tartrate extended-release capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine tartrate extended-release capsules are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate extended-release capsules, are metabolized to 5-hydroxymethyl tolterodine [see Warnings and Precautions (5.2 , 5.3 , 5.4) ] . Tolterodine tartrate extended-release capsules are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Tolterodine tartrate extended-release capsules are also contraindicated in patients with known hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like tolterodine tartrate extended-release capsules, are metabolized to 5-hydroxymethyl tolterodine. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS • Potent CYP3A4 Inhibitors: Coadministration may increase systemic exposure to tolterodine tartrate extended-release capsules. Reduce tolterodine tartrate extended-release capsules 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 pot…

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 tolterodine tartrate extended-release capsules was evaluated in 1073 patients (537 assigned to tolterodine tartrate extended-release capsules; 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 tolterodine tartrate extended-release capsules 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 tolterodine tartrate extended-r…

Frequently Asked Questions

What is Tolterodine Tartrate Extended Release used for?

Tolterodine tartrate extended-release is a prescription medication taken by mouth that helps treat overactive bladder by reducing urinary urgency, frequency, and incontinence. It works by relaxing the bladder muscle to help improve bladder control.

Is Tolterodine Tartrate Extended Release a controlled substance?

Tolterodine Tartrate Extended Release is not classified as a controlled substance by the DEA.

What is the generic name for Tolterodine Tartrate Extended Release?

The generic name for Tolterodine Tartrate Extended Release is tolterodine tartrate. There are 11 other brand versions of tolterodine tartrate.

What is the NDC code for Tolterodine Tartrate Extended Release 2 mg/1?

The NDC (National Drug Code) for Tolterodine Tartrate Extended Release 2 mg/1 is 59762-0047, listed by Mylan Pharmaceuticals Inc..

Product NDC

59762-0047

Package NDC

59762-0047-1

Other Tolterodine Tartrate Extended Release Dosages

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

Data from openFDA · Public domain (CC0 1.0)