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Tolterodine Extended Release (Tolterodine Tartrate) - Indications and Dosage

 
 



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 ].

DOSAGE AND ADMINISTRATION

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 ].

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 and USE IN SPECIFIC POPULATIONS (8.6, 8.7) ].

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 ].

DOSAGE FORMS AND STRENGTHS

The 2 mg capsules are blue-green with symbol and 2 printed in white ink.

The 4 mg capsules are blue with symbol and 4 printed in white ink.

HOW SUPPLIED/STORAGE AND HANDLING

Tolterodine tartrate extended-release capsules are supplied as follows:

Bottles of 30 Bottles of 500
2 mg Capsules NDC 59762-0047-1 2 mg Capsules NDC 59762-0047-3
4 mg Capsules NDC 59762-0048-1 4 mg Capsules NDC 59762-0048-3
Bottles of 90
2 mg Capsules NDC 59762-0047-2
4 mg Capsules NDC 59762-0048-2

Store at 20°–25°C (68°–77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from light.

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