Detrol 1 mg/1

tolterodine tartrate · TABLET, FILM COATED · Viatris Specialty LLC

No Recall History

Plain English

Detrol is a tablet, film coated containing tolterodine tartrate at 1 mg/1, taken oral. Manufactured by Viatris Specialty LLC.

Key Facts

Brand Name: Detrol
Generic Name: tolterodine tartrate
NDC Code (Product): 58151-098
Manufacturer: Viatris Specialty LLC
Strength: 1 mg/1
Dosage Form: TABLET, FILM COATED
Route: ORAL
Marketing Status
Application #: NDA020771
Marketing Start: 05/21/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective1,964 reports

fall943 reports

fatigue898 reports

nausea826 reports

dizziness808 reports

headache751 reports

diarrhoea735 reports

pain692 reports

dry mouth684 reports

asthenia620 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE DETROL Tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Dosage & Administration

DOSAGE AND ADMINISTRATION The initial recommended dose of DETROL Tablets is 2 mg twice daily. The dose may be lowered to 1 mg twice daily based on individual response and tolerability. 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 is 1 mg twice daily (see PRECAUTIONS, General , PRECAUTIONS, Reduced Hepatic and Renal Function , and PRECAUTIONS, Drug Interactions ).

Warnings

WARNINGS Anaphylaxis and angioedema requiring hospitalization and emergency medical treatment have occurred with the first or subsequent doses of DETROL. In the event of difficulty in breathing, upper airway obstruction, or fall in blood pressure, DETROL should be discontinued and appropriate therapy promptly provided.

Contraindications

CONTRAINDICATIONS DETROL Tablets are contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. DETROL is also contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients, or to fesoterodine fumarate extended-release tablets which, like DETROL, are metabolized to 5-hydroxymethyl tolterodine.

Drug Interactions

Drug Interactions CYP3A4 Inhibitors Ketoconazole, an inhibitor of the drug metabolizing enzyme CYP3A4, significantly increased plasma concentrations of tolterodine when coadministered to subjects who were poor metabolizers (see CLINICAL PHARMACOLOGY, Variability in Metabolism and Drug-Drug Interactions ). For patients receiving ketoconazole or other potent CYP3A4 inhibitors such as other azole antifungals (e.g., itraconazole, miconazole) or macrolide antibiotics (e.g., erythromycin, clarithromycin) or cyclosporine or vinblastine, the recommended dose of DETROL is 1 mg twice daily (see DOSAGE AND ADMINISTRATION ).

Adverse Reactions

ADVERSE REACTIONS The Phase 2 and 3 clinical trial program for DETROL Tablets included 3071 patients who were treated with DETROL (N=2133) or placebo (N=938). The patients were treated with 1, 2, 4, or 8 mg/day for up to 12 months. No differences in the safety profile of tolterodine were identified based on age, gender, race, or metabolism. The data described below reflect exposure to DETROL 2 mg bid in 986 patients and to placebo in 683 patients exposed for 12 weeks in five Phase 3, controlled clinical studies. 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 adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and approximating rates. Sixty-six percent of patients receiving DETROL 2 mg bid reported adverse events versus 56% of placebo patients. The most common adverse events reported by patients receiving DETROL were dry mouth, headache, constipation, vertigo/dizzin…

Frequently Asked Questions

What is Detrol used for?

Detrol contains tolterodine tartrate. It is a tablet, film coated taken oral. Consult your doctor for specific uses.

Is Detrol a controlled substance?

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

What is the generic name for Detrol?

The generic name for Detrol is tolterodine tartrate. There are 11 other brand versions of tolterodine tartrate.

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

The NDC (National Drug Code) for Detrol 1 mg/1 is 58151-098, listed by Viatris Specialty LLC.

Product NDC

58151-098

Package NDC

58151-098-91

Other Tolterodine Brands

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

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