Tolterodine Tartrate label

Tolterodine Tartrate

Tolterodine Tartrate Recall

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Side Effects & Adverse Reactions

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

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

Tolterodine tartrate tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

History

There is currently no drug history available for this drug.

Other Information

This product contains tolterodine tartrate. The active moiety, tolterodine, is a muscarinic receptor antagonist. The chemical name of tolterodine tartrate is (R)-2-[3-[bis(1-methylethyl)-amino]1-phenylpropyl]-4-methylphenol [R-(R*,R*)]-2,3-dihydroxybutanedioate (1:1) (salt). The empirical formula of tolterodine tartrate is C26H37NO7, and its molecular weight is 475.6. The structural formula of tolterodine tartrate is represented below:

Tolterodine tartrate is a white, crystalline powder. The pKa value is 9.87 and the solubility in water is 12 mg/mL. It is soluble in methanol, slightly soluble in ethanol, and practically insoluble in toluene. The partition coefficient (Log D) between n-octanol and water is 1.83 at pH 7.3.

Tolterodine tartrate tablets for oral administration contain 1 or 2 mg of tolterodine tartrate. The inactive ingredients are colloidal silicon dioxide, dibasic calcium phosphate dihydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate and titanium dioxide.

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Tolterodine Tartrate Recall

Side Effects & Adverse Reactions

FDA Safety Alerts

Manufacturer Warnings

FDA Labeling Changes

Other Information

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Tolterodine Tartrate Manufacturers

Apotex Corp.
No Recall
Tolterodine Tartrate | Apotex Corp.
The initial recommended dose of tolterodine tartrate 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 tolterodine tartrate is 1 mg twice daily (see PRECAUTIONS, General, PRECAUTIONS, Reduced Hepatic and Renal Function, and PRECAUTIONS, Drug Interactions).
Mylan Pharmaceuticals Inc.
No Recall
Tolterodine Tartrate | Mylan Pharmaceuticals Inc.
The initial recommended dose of tolterodine tartrate 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 tolterodine tartrate tablets is 1 mg twice daily (see PRECAUTIONS: General, PRECAUTIONS: Reduced Hepatic and Renal Function, and PRECAUTIONS: Drug Interactions).
Mylan Institutional Inc.
No Recall
Tolterodine Tartrate | Apotheca Company
DIRECTIONS: 10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.
Teva Pharmaceuticals Usa Inc
No Recall
Tolterodine Tartrate | Teva Pharmaceuticals Usa Inc
The initial recommended dose of tolterodine tartrate 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 tolterodine tartrate is 1 mg twice daily (see PRECAUTIONS, General, PRECAUTIONS, Reduced Hepatic and Renal Function and PRECAUTIONS, Drug Interactions).
Mylan Pharmaceuticals Inc.
No Recall
Tolterodine Tartrate | Mylan Pharmaceuticals Inc.
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 to 30 mL/min), the recommended dose of tolterodine tartrate extended-release capsules is 2 mg once daily. Tolterodine tartrate extended-release capsules are not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Patients with CCr < 10 mL/min have not been studied and use of tolterodine tartrate extended-release capsules in this population is not recommended [see Warnings and Precautions (5.6), Use in Specific Populations (8.6, 8.7)].
2.3 Dosage Adjustment in Presence of Concomitant Drugs
For patients who are taking drugs that are potent inhibitors of CYP3A4 [e.g., ketoconazole, clarithromycin, ritonavir], the recommended dose of tolterodine tartrate extended-release capsules is 2 mg once daily [see Drug Interactions (7.2)].
Teva Pharmaceuticals Usa Inc
No Recall
Tolterodine Tartrate | Teva Pharmaceuticals Usa Inc
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), the recommended dose of tolterodine tartrate extended-release capsules is 2 mg once daily. Tolterodine tartrate extended-release capsules are not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Patients with CCr<10 mL/min have not been studied and use of tolterodine tartrate extended-release capsules in this population is not recommended [see WARNINGS AND PRECAUTIONS (5.6) and USE IN SPECIFIC POPULATIONS (8.6, 8.7)].
2.3 Dosage Adjustment in Presence of Concomitant Drugs
For patients who are taking drugs that are potent inhibitors of CYP3A4 [e.g., ketoconazole, clarithromycin, ritonavir], the recommended dose of tolterodine tartrate extended-release capsules is 2 mg once daily [see DRUG INTERACTIONS (7.2)].
Mylan Institutional Inc.
No Recall
Tolterodine Tartrate | Mylan Institutional Inc.
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 to 30 mL/min), the recommended dose of tolterodine tartrate extended-release capsules is 2 mg once daily. Tolterodine tartrate extended-release capsules are not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C). Patients with CCr < 10 mL/min have not been studied and use of tolterodine tartrate extended-release capsules in this population is not recommended [see Warnings and Precautions (5.6), Use in Specific Populations (8.6, 8.7)].
2.3 Dosage Adjustment in Presence of Concomitant Drugs
For patients who are taking drugs that are potent inhibitors of CYP3A4 [e.g., ketoconazole, clarithromycin, ritonavir], the recommended dose of tolterodine tartrate extended-release capsules is 2 mg once daily [see Drug Interactions (7.2)].
Greenstone Llc
No Recall
Tolterodine Tartrate | Greenstone Llc
The initial recommended dose of tolterodine tartrate 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 tolterodine tartrate is 1 mg twice daily (see PRECAUTIONS, General, PRECAUTIONS, Reduced Hepatic and Renal Function, and PRECAUTIONS, Drug Interactions).
Macleods Pharmaceuticals Limited
No Recall
Tolterodine Tartrate | Macleods Pharmaceuticals Limited
The initial recommended dose of tolterodine tartrate 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 tolterodine tartrate is 1 mg twice daily (see PRECAUTIONS, General, PRECAUTIONS, Reduced Hepatic and Renal Function, and PRECAUTIONS, Drug Interactions).
Teva Pharmaceuticals Usa Inc
No Recall
Tolterodine Tartrate | Teva Pharmaceuticals Usa Inc
The initial recommended dose of tolterodine tartrate 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 tolterodine tartrate is 1 mg twice daily (see PRECAUTIONS, General; PRECAUTIONS, Reduced Hepatic and Renal Function, and PRECAUTIONS, Drug Interactions).