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(dar-i-fen-a-sin) ,


(trade name)


Therapeutic: urinary tract antispasmodics
Pharmacologic: anticholinergics
Pregnancy Category: C


Overactive bladder with symptoms (urge incontinence, urgency, frequency).


Acts as a muscarinic (cholinergic) receptor antagonist; antagonizes bladder smooth muscle contraction.

Therapeutic effects

Decreased symptoms of overactive bladder.


Absorption: 15–19% absorbed.
Distribution: Unknown.
Protein Binding: 98%.
Metabolism and Excretion: Extensively metabolized by the CYP2D6 enzyme system in most individuals; genetic implication poor metabolizers (7% of Caucasians, 2% of African Americans) have less CYP2D6 activity with less metabolism occurring. Some metabolism via CYP3A4 enzyme system. 60% excreted renally as metabolites, 40% in feces as metabolites.
Half-life: 13–19 hr.

Time/action profile

POunknown7 hr24 hr


Contraindicated in: Hypersensitivity;Urinary retention;Gastric retention;Uncontrolled angle-closure glaucoma;Severe hepatic impairment.
Use Cautiously in: Concurrent use of CYP3A4 inhibitors (use lower dose/clinical monitoring may be necessary);Moderate hepatic impairment (lower dose recommended);Bladder outflow obstruction;GI obstructive disorders, ↓ GI motility, severe constipation or ulcerative colitis;Myasthenia gravis;Angle-closure glaucoma; Lactation / Pediatric: Safety not established; Obstetric: Use only if maternal benefit outweighs fetal risk.

Adverse Reactions/Side Effects

Central nervous system

  • confusion
  • dizziness
  • drowsiness
  • hallucinations
  • headache

Ear, Eye, Nose, Throat

  • blurred vision


  • constipation (most frequent)
  • dry mouth (most frequent)
  • dyspepsia
  • nausea


  • heat intolerance


  • angioedema (life-threatening)


Drug-Drug interaction

Blood levels and risk of toxicity are ↑ by concurrent use of strong CYP3A4 inhibitors including ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, and nefazodone ; daily dose should not exceed 7.5 mg.Concurrent use of moderate inhibitors of CYP3A4, especially those with narrow therapeutic indices, including flecainide, thioridazine, and tricyclic antidepressants, should be undertaken with caution.


Oral (Adults) 7.5 mg once daily, may be ↑ after 2 wk to 15 mg once daily.


Extended-release tablets: 7.5 mg, 15 mg Cost: All strengths $599.48 / 90

Nursing implications

Nursing assessment

  • Monitor voiding pattern and assess symptoms of overactive bladder (urinary urgency, urinary incontinence, urinary frequency) to and periodically during therapy.

Potential Nursing Diagnoses

Impaired urinary elimination (Indications)


  • Oral: Administer once daily without regard to food. Extended-release tablets must be swallowed whole; do not break, crush, or chew.

Patient/Family Teaching

  • Instruct patient to take darifenacin as directed. Advise patient to read the Patient Information before starting therapy and with each prescription refill. If a dose is missed, skip dose and take next day; do not take 2 doses in same day.
  • Do not share darifenacin with others; may be dangerous.
  • Inform patient of potential anticholinergic side effects (constipation, urinary retention, blurred vision, heat prostration in a hot environment).
  • May cause dizziness, drowsiness, confusion, and blurred vision. Caution patient to avoid driving and other activities that require alertness until response to medication is known.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Decrease in symptoms of overactive bladder (urge urinary incontinence, urgency, frequency).


Therapeutics An agent in clinical trials for treating irritable bowel syndrome and overactive bladder
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The impending patent expiries of Detrol and Enablex are the major reasons for the slow market growth expected from 2012 onwards.
It also bolsters Actavis Specialty Brands' Urology business with the addition of the Enablex franchise and establishes a platform for continued expansion into the fast-growing areas of Gastroenterology and Dermatology.
The market is segmented by product: Detrol, Detrol LA, Ditropan, Ditropan XL, Enablex, Oxytrol, Sanctura, Sanctura XR, VESIcare, and others.
To make matters more difficult, Warner Chilcott's acne treatment drug Doryx is facing generic competition, while Enablex and oral contraceptive Loestrin could both lose their patents by 2015.
Presently the therapeutic regimen for UI is dominated by a range of muscarinic receptor antagonists (anticholinergic drugs) which include Detrol LA, Dirtopan, Enablex, Toviaz, Sanctura XR and VESIcare.
0 million of costs related to licensing Enablex from Novartis.
9 million of costs related to licensing Enablex from Novartis, increased headcount and salary-related expenses, as well as Sarbanes Oxley consulting fees and stock compensation expense.
Lifecycle management strategies, novel formulations and follow-on products will drive the majority of this growth, with key brands expected to be Pfizer's Detrol LA (tolterodine) and Toviaz (fesoterodine), GSKs Vesicare (solifenacin), and Novartis Enablex (darifenacin).
Gao continued, "The potential sales opportunity for Enablex is extremely compelling in China.
Warner Chilcott Purchases US Rights of Enablex from Novartis 24
The market will expand with the introduction of new generation anticholinergics such as Astella Pharma's Vesicare and Enablex by Novartis.