ENABLEX

Enablex Generic Name & Formulations

Legal Class

General Description

Darifenacin (as HBr) 7.5mg, 15mg; ext-rel tabs.

Pharmacological Class

Muscarinic antagonist.

How Supplied

Tabs—30, 90

Manufacturer

AbbVie

Generic Availability

YES

Enablex Indications

Indications

Overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.

Enablex Dosage and Administration

Adult

Swallow whole with liquid. Initially 7.5mg once daily; may increase to 15mg once daily after 2 weeks. Moderate hepatic impairment (Child-Pugh B), concomitant potent CYP3A4 inhibitors: max 7.5mg once daily.

Children

Not established.

Enablex Contraindications

Contraindications

Patients with or at risk for: urinary or gastric retention, uncontrolled narrow-angle glaucoma.

Enablex Boxed Warnings

Not Applicable

Enablex Warnings/Precautions

Warnings/Precautions

Severe hepatic impairment: not recommended. Bladder outflow obstruction. GI obstruction. Severe constipation. Ulcerative colitis. Myasthenia gravis. Controlled narrow-angle glaucoma. Monitor for CNS effects esp. after initiation or dose increases; consider reducing dose or discontinue if occurs. High environmental temperatures. Pregnancy. Nursing mothers.

Enablex Pharmacokinetics

Metabolism

Hepatic. ~98% serum protein bound.

Elimination

Renal (60%), fecal (40%). Half-life: 13–19 hours.

Enablex Interactions

Interactions

Potentiated by potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, nefazadone); see Adult. May potentiate CYP2D6 substrates with narrow therapeutic indexes (eg, flecainide, thioridazine, TCAs). Additive anticholinergic effects with other anticholinergics.

Enablex Adverse Reactions

Adverse Reactions

Constipation, dry mouth, headache, dyspepsia, nausea, UTI, accidental injury, flu symptoms; angioedema (discontinue if occurs), CNS effects (eg, confusion, hallucination, somnolence).

Enablex Clinical Trials

See Literature

Enablex Note