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Enablex (Darifenacin) - Indications and Dosage

 
 



INDICATIONS AND USAGE

ENABLEX®  (darifenacin) extended-release tablets are indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

DOSAGE AND ADMINISTRATION

The recommended starting dose of ENABLEX®  (darifenacin) extended-release tablets is 7.5 mg once daily. Based upon individual response, the dose may be increased to 15 mg once daily, as early as two weeks after starting therapy.

ENABLEX extended-release tablets should be taken once daily with liquid. They may be taken with or without food, and should be swallowed whole and not chewed, divided or crushed.

For patients with moderate hepatic impairment or when coadministered with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), the daily dose of ENABLEX should not exceed 7.5 mg. ENABLEX is not recommended for use in patients with severe hepatic impairment (see CLINICAL PHARMACOLOGY and PRECAUTIONS).

HOW SUPPLIED

ENABLEX® 7.5 mg extended-release tablets are round, shallow, convex, white-colored tablets, and are identified with “DF” on one side and “7.5” on the reverse.

Bottle of 30       NDC 0078-0419-15

Bottle of 90       NDC 0078-0419-34

ENABLEX® 15 mg extended-release tablets are round, shallow, convex, light peach-colored tablets, and are identified with “DF” on one side and “15” on the reverse.

Bottle of 30       NDC 0078-0420-15

Bottle of 90       NDC 0078-0420-34

Storage

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

Keep this and all drugs out of the reach of children.

REV: OCTOBER 2010                                                                   T2010-99

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