DARIFENACIN- darifenacin hydrobromide tablet, extended release
Actavis Pharma, Inc.
1 INDICATIONS AND USAGE
Darifenacin is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
2 DOSAGE AND ADMINISTRATION
The recommended starting dose of Darifenacin 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.
Darifenacin should be taken once daily with water. Darifenacin may be taken with or without food, and should be swallowed whole and not chewed, divided or crushed.
For patients with moderate hepatic impairment (Child-Pugh B) or when co-administered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone), the daily dose of Darifenacin should not exceed 7.5 mg. Darifenacin is not recommended for use in patients with severe hepatic impairment (Child-Pugh C) [see Warnings & Precautions (5.6), Drug Interactions (7.1), Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].
3 DOSAGE FORMS AND STRENGTHS
Darifenacin extended-release tablets 7.5 mg are round, shallow, bi-convex, white-colored tablets, and are identified with "DF" on one side and "7.5" on the reverse.
Darifenacin extended-release tablets 15 mg are round, shallow, bi-convex, light peach-colored tablets, and are identified with "DF" on one side and "15" on the reverse.
4 CONTRAINDICATIONS
Darifenacin is contraindicated in patients with, or at risk for, the following conditions:
urinary retention
gastric retention, or
uncontrolled narrow-angle glaucoma.