Darifenacin

Darifenacin is muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

The recommended starting dose of darifenacin extended-release tablets is 7.5 mg orally 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 extended-release tablets should be taken orally once daily with water. Darifenacin extended-release tablets 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 extended-release tablets should not exceed 7.5 mg. Darifenacin is not recommended for use in patients with severe hepatic impairment (Child-Pugh C)

Darifenacin Extended-Release Tablets 7.5 mg are white colored, round, biconvex film-coated tablets debossed with L408 on one side and plain on other side.

Darifenacin Extended-Release Tablets 15 mg are light peach colored, round, biconvex film-coated tablets debossed with L409 on one side and plain on other side.

• Pregnancy: Darifenacin should be used during pregnancy only if the benefit to the mother outweighs the potential risk to the fetus (8.1)
• Nursing Mothers: It is not known whether darifenacin is excreted into human milk and therefore caution should be exercised before darifenacin are administered to a nursing woman (8.3)
• Pediatric Use: The safety and effectiveness of darifenacin in pediatric patients have not been established (8.4)

• Darifenacin should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention  (5.1)
• Darifenacin should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention (5.2)
• Darifenacin should be used with caution in patients being treated for narrow-angle glaucoma and only where the potential benefits outweigh the risks (5.3)
• Central Nervous System Effects: Somnolence has been reported with darifenacin . Advise patients not to drive or operate heavy machinery until they know how darifenacin affect them (5.5)