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Indications

REMS


Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects

EENT: blurred vision

GI: constipation, dry mouth, dyspepsia, nausea

Metab: heat intolerance

Neuro: confusion, dizziness, drowsiness, hallucinations, headache

Misc: ANGIOEDEMA

Interactions

Drug-drug:

Availability

(Generic available)

Route/Dosage

Hepatic Impairment

Action

  • Acts as a muscarinic (cholinergic) receptor antagonist; antagonizes bladder smooth muscle contraction.
Therapeutic effects:
  • Decreased symptoms of overactive bladder.

Classifications

Therapeutic Classification: urinary tract antispasmodics

Pharmacologic Classification: anticholinergics

Pharmacokinetics

Absorption: 15–19% absorbed.

Distribution: Unknown.

Protein Binding: 98%.

Metabolism/Excretion: Extensively metabolized in the liver by the CYP2D6 isoenzyme, with some metabolism by the CYP3A4 isoenzyme; the CYP2D6 isoenzyme exhibits genetic polymorphism (7% of population may be poor metabolizers and may have significantly darifenacin concentrations and an risk of adverse effects). 60% excreted by the kidneys as metabolites, 40% in feces as metabolites.

Half-Life: 13–19 hr.

Canadian Brand Names

Enablex

Time/Action Profile

ROUTEONSETPEAKDURATION
POunknown7 hr24 hr

Patient/Family Teaching

  • Instruct patient to take darifenacin as directed. If dose is missed, omit and take next day; do not take two doses in same day. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
  • 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.
  • Inform patient that darifenacin may cause heat stroke in hot environments. Notify health care professional for sweating, dizziness, fatigue, nausea, fever.
  • Advise patient to immediately notify emergency health care professional for symptoms of angioedema (swelling of face, lips, tongue, or throat).
  • 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.
  • Rep: Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Pronunciation

dar-i-FEN-a-sin

Code

NDC Code