darifenacin

dar-i-FEN-a-sin

Therapeutic Classification: urinary tract antispasmodics

Pharmacologic Classification: anticholinergics

REMS

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/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.

ROUTE	ONSET	PEAK	DURATION
PO	unknown	7 hr	24 hr

Contraindicated in:

Hypersensitivity;
Urinary retention;
Gastric retention;
Uncontrolled angle-closure glaucoma;
Severe hepatic impairment.

Use Cautiously in:

Moderate hepatic impairment (↓ dose);
Bladder outflow obstruction;
GI obstructive disorders, ↓ GI motility, severe constipation, or ulcerative colitis;
Myasthenia gravis;
Angle-closure glaucoma;
OB: Safety not established in pregnancy;
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.

EENT: blurred vision

GI: constipation, dry mouth, dyspepsia, nausea

Metab: heat intolerance

Neuro: confusion, dizziness, drowsiness, hallucinations, headache

Misc: ANGIOEDEMA

Drug-drug:

Strong CYP3A4 inhibitors, including ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, and nefazodone may ↑ levels and risk of toxicity; do not exceed dose of 7.5 mg/day.
Concurrent use of moderate CYP3A4 inhibitors, especially those with narrow therapeutic indices, including flecainide, thioridazine, and tricyclic antidepressants, should be undertaken with caution.

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

Hepatic Impairment

PO (Adults ): Moderate hepatic impairment: Not to exceed 7.5 mg once daily.

(Generic available)

Extended-release tablets: 7.5 mg; 15 mg

Monitor voiding pattern and assess symptoms of overactive bladder (urinary urgency, incontinence, frequency) before and periodically during therapy.
Monitor for anticholinergic effects (constipation, urinary retention, blurred vision), including CNS effects (headache, confusion, hallucinations, somnolence), especially with therapy initiation or dose ↑. If CNS effects occur, consider dose ↓ or discontinue darifenacin.

PO: Administer once daily with water, without regard to food. DNC: Swallow extended-release tablets whole; do not break, crush, or chew.

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.

Decreased symptoms of overactive bladder.

Enablex

NDC Code

13668- Torrent Pharmaceuticals Limited
- 13668-202- Darifenacin
  - 13668-202-05- 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-05)

13668- Torrent Pharmaceuticals Limited
- 13668-202- Darifenacin
  - 13668-202-30- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-30)

13668- Torrent Pharmaceuticals Limited
- 13668-202- Darifenacin
  - 13668-202-90- 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-202-90)

13668- Torrent Pharmaceuticals Limited
- 13668-203- Darifenacin
  - 13668-203-05- 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-203-05)

13668- Torrent Pharmaceuticals Limited
- 13668-203- Darifenacin
  - 13668-203-30- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-203-30)

13668- Torrent Pharmaceuticals Limited
- 13668-203- Darifenacin
  - 13668-203-90- 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (13668-203-90)

16571- Rising Pharma Holdings, Inc.
- 16571-767- Darifenacin
  - 16571-767-03- 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-767-03)

16571- Rising Pharma Holdings, Inc.
- 16571-767- Darifenacin
  - 16571-767-09- 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-767-09)

16571- Rising Pharma Holdings, Inc.
- 16571-768- Darifenacin
  - 16571-768-03- 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-768-03)

16571- Rising Pharma Holdings, Inc.
- 16571-768- Darifenacin
  - 16571-768-09- 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16571-768-09)

33342- Macleods Pharmaceuticals Limited
- 33342-276- Darifenacin
  - 33342-276-07- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-276-07)

33342- Macleods Pharmaceuticals Limited
- 33342-276- Darifenacin
  - 33342-276-10- 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-276-10)

33342- Macleods Pharmaceuticals Limited
- 33342-276- Darifenacin
  - 33342-276-12- 10 BLISTER PACK in 1 CARTON (33342-276-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
- 33342-277- Darifenacin
  - 33342-277-07- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-277-07)

33342- Macleods Pharmaceuticals Limited
- 33342-277- Darifenacin
  - 33342-277-10- 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (33342-277-10)

33342- Macleods Pharmaceuticals Limited
- 33342-277- Darifenacin
  - 33342-277-12- 10 BLISTER PACK in 1 CARTON (33342-277-12) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK

46708- Alembic Pharmaceuticals Limited
- 46708-223- DARIFENACIN
  - 46708-223-08- 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46708-223-08)

46708- Alembic Pharmaceuticals Limited
- 46708-223- DARIFENACIN
  - 46708-223-30- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-30)

46708- Alembic Pharmaceuticals Limited
- 46708-223- DARIFENACIN
  - 46708-223-90- 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-90)

46708- Alembic Pharmaceuticals Limited
- 46708-223- DARIFENACIN
  - 46708-223-91- 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-223-91)

46708- Alembic Pharmaceuticals Limited
- 46708-224- DARIFENACIN
  - 46708-224-08- 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (46708-224-08)

46708- Alembic Pharmaceuticals Limited
- 46708-224- DARIFENACIN
  - 46708-224-30- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-30)

46708- Alembic Pharmaceuticals Limited
- 46708-224- DARIFENACIN
  - 46708-224-90- 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-90)

46708- Alembic Pharmaceuticals Limited
- 46708-224- DARIFENACIN
  - 46708-224-91- 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-224-91)

62332- Alembic Pharmaceuticals Inc.
- 62332-223- DARIFENACIN
  - 62332-223-08- 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (62332-223-08)

62332- Alembic Pharmaceuticals Inc.
- 62332-223- DARIFENACIN
  - 62332-223-30- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-223-30)

62332- Alembic Pharmaceuticals Inc.
- 62332-223- DARIFENACIN
  - 62332-223-90- 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-223-90)

62332- Alembic Pharmaceuticals Inc.
- 62332-223- DARIFENACIN
  - 62332-223-91- 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-223-91)

62332- Alembic Pharmaceuticals Inc.
- 62332-224- DARIFENACIN
  - 62332-224-08- 8 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (62332-224-08)

62332- Alembic Pharmaceuticals Inc.
- 62332-224- DARIFENACIN
  - 62332-224-30- 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-224-30)

62332- Alembic Pharmaceuticals Inc.
- 62332-224- DARIFENACIN
  - 62332-224-90- 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-224-90)

62332- Alembic Pharmaceuticals Inc.
- 62332-224- DARIFENACIN
  - 62332-224-91- 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (62332-224-91)

65862- Aurobindo Pharma Limited
- 65862-861- Darifenacin
  - 65862-861-05- 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-861-05)

65862- Aurobindo Pharma Limited
- 65862-861- Darifenacin
  - 65862-861-30- 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-861-30)

65862- Aurobindo Pharma Limited
- 65862-861- Darifenacin
  - 65862-861-90- 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-861-90)

65862- Aurobindo Pharma Limited
- 65862-861- Darifenacin
  - 65862-861-99- 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-861-99)

65862- Aurobindo Pharma Limited
- 65862-862- Darifenacin
  - 65862-862-05- 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-05)

65862- Aurobindo Pharma Limited
- 65862-862- Darifenacin
  - 65862-862-30- 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-30)

65862- Aurobindo Pharma Limited
- 65862-862- Darifenacin
  - 65862-862-90- 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-90)

65862- Aurobindo Pharma Limited
- 65862-862- Darifenacin
  - 65862-862-99- 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (65862-862-99)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

Canadian Brand Names ⬆ ⬇

Code ⬆