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INDICATION

ENABLEX® (darifenacin) is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency in adults.

IMPORTANT SAFETY INFORMATION

ENABLEX® is contraindicated in patients with, or at risk for urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma. Daily dose should not exceed 7.5 mg when used with potent CYP3A4 inhibitors or in patients with moderate hepatic impairment. ENABLEX® is not recommended for patients with severe hepatic impairment.

ENABLEX® should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention, gastrointestinal obstructive disorders because of the risk of gastric retention, severe constipation, ulcerative colitis, or myasthenia gravis. In patients being treated for narrow-angle glaucoma, ENABLEX® should be used with caution and only where the potential benefits outweigh the risks.

Angioedema of the face, lips, tongue, and/or larynx have been reported with darifenacin, in some cases, after the first dose. Angioedema associated with upper airway swelling may be life threatening. Patients should be advised to promptly discontinue darifenacin therapy and seek immediate medical attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing.

Anticholinergic CNS effects have been reported with ENABLEX®, including headache, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose, and dose reduction or drug discontinuation should be considered if necessary. Advise patients not to drive or operate heavy machinery until they know how ENABLEX® affects them.

In controlled clinical studies the incidence of the most frequently reported adverse events for ENABLEX® 7.5 mg or 15 mg and greater than placebo in studies 1, 2, and 3 was: dry mouth (20.2%, 35.3%, 8.2%); constipation (14.8%, 21.3%, 6.2%); dyspepsia (2.7%, 8.4%, 2.6%); abdominal pain (2.4%, 3.9%, 0.5%); nausea (2.7%, 1.5%, 1.5%); diarrhea (2.1%, 0.9%, 1.8%); urinary tract infection (4.7%, 4.5%, 2.6%); dizziness (0.9%, 2.1%, 1.3%); asthenia (1.5%, 2.7%, 1.3%); and dry eyes (1.5%, 2.1%, 0.5%).

Please see full Prescribing Information.

OAB = overactive bladder.

References:
  1. Data on file, Warner Chilcott (US), LLC, Rockaway, NJ.
  2. ENABLEX® [prescribing information], Rockaway, NJ: Warner Chilcott (US), LLC; 2013.
  3. Yoshimura N, Chancellor MB. Physiology and pharmacology of the bladder and urethra. In: Wein AJ, ed. Campbell-Walsh Urology. 10th ed. Philadelphia, PA: Saunders Elsevier; 2012:1786-1833.
  4. Giebisch G, Windhager E. Organization of the urinary system. In: Boron WF, Boulpaep EL, eds. Medical Physiology: A Cellular and Molecular Approach. 2nd ed. Philadelphia, PA: Saunders Elsevier; 2012:749-766.
  5. Chapple CR. Muscarinic receptor antagonists in the treatment of overactive bladder. Urology. 2000;55(suppl 5A):33-46.
  6. Abrams P, Andersson KE, Buccafusco JJ, et al. Muscarinic receptors: their distribution and function in body systems, and the implications for treating overactive bladder. Br J Pharmacol. 2006;148(5):565-578.
  7. IMS Health, Inc. Formulary Impact Analyzer Data: July 2013-December 2013 (estimate derived from the use of information under license from IMS Health, Inc., which expressly reserves all rights, including rights of copying, distribution, and republication).
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