Detrol (Tolterodine Tartrate) - Indications and Dosage

INDICATIONS AND USAGE

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

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 and PRECAUTIONS, Drug Interactions).

HOW SUPPLIED

DETROL Tablets 1 mg (white, round, biconvex, film-coated tablets engraved with arcs above and below the letters "TO") and DETROL Tablets 2 mg (white, round, biconvex, film-coated tablets engraved with arcs above and below the letters "DT") are supplied as follows:

Bottles of 60
1 mg                                                                NDC 0009-4541-02
2 mg                                                                NDC 0009-4544-02

Bottles of 500
1 mg                                                                NDC 0009-4541-03
2 mg                                                                NDC 0009-4544-03

Unit Dose Pack of 140
1 mg                                                                NDC 0009-4541-01
2 mg                                                                NDC 0009-4544-01

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

Rx only

LAB-0257-8.0

March 2008