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



ENABLEX® is contraindicated in patients with, or at risk for, the following conditions:

  • urinary retention
  • gastric retention, or
  • uncontrolled narrow-angle glaucoma

Warnings and Precautions

  • Risk of Urinary Retention: ENABLEX® should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
  • Decreased Gastrointestinal Motility: ENABLEX® should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention. ENABLEX® may decrease gastrointestinal motility and should be used with caution in patients with conditions such as severe constipation, ulcerative colitis, and myasthenia gravis.
  • Controlled Narrow-Angle Glaucoma: In patients being treated for narrow-angle glaucoma, ENABLEX® should be used with caution and only where the potential benefits outweigh the risks.
  • Angioedema:Angioedema of the face, lips, tongue, and/or larynx have been reported with ENABLEX®, and in some cases, occurring 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.
  • Central Nervous System (CNS) Effects: 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. Dose reduction or drug discontinuation should be considered if a patient experiences anticholinergic CNS effects. Advise patients not to drive or operate heavy machinery until they know how ENABLEX® affects them.
  • Patients with Hepatic Impairment: Daily dose should not exceed 7.5 mg when used for patients with moderate hepatic impairment (Child-Pugh B). ENABLEX® is not recommended for use in patients with severe hepatic impairment (Child-Pugh C).

Adverse Reactions

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

Drug Interactions

  • CYP3A4 Inhibitors: Daily dose of ENABLEX® should not exceed 7.5 mg when co-administered with potent CYP3A4 inhibitors (for example, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin and nefazadone).
  • CYP2D6 Substrates: Caution should be taken when ENABLEX® is used concomitantly with medications that are predominantly metabolized by CYP2D6 and which have a narrow therapeutic window (for example, flecainide, thioridazine and tricyclic antidepressants).
  • Other Anticholinergic Agents: The concomitant use of ENABLEX® with other anticholinergic agents may increase the frequency and/or severity of dry mouth, constipation, blurred vision and other anticholinergic pharmacological effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to effects on gastrointestinal motility.

Please see full Prescribing Information, which includes the Patient Information.

  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).

The information provided in this site is intended for US healthcare professionals only. The products described on this site may have different producct labeling in countries outside of the United States.

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