Generic Name and Formulations:
Darifenacin (as HBr) 7.5mg, 15mg; ext-rel tabs.
Indications for ENABLEX:
Overactive bladder with symptoms of urge urinary incontinence, urgency and frequency.
Swallow whole with liquid. Initially 7.5mg once daily; may increase to 15mg once daily after 2 weeks. Max 7.5mg once daily in moderate hepatic impairment or with potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, nefazadone).
Urinary or gastric retention; uncontrolled narrow-angle glaucoma; or patients at risk for these.
Severe hepatic impairment: not recommended. GI or GU obstruction. Severe constipation. Ulcerative colitis. Myasthenia gravis. Controlled narrow-angle glaucoma. High environmental temperatures. Discontinue if angioedema with upper airway swelling occurs. Pregnancy (Cat.C). Nursing mothers.
Potentiated by CYP3A4 inhibitors (see Dose). May potentiate CYP2D6 substrates with narrow therapeutic indexes (eg, flecainide, thioridazine, antidepressants). Additive anticholinergic effects with other anticholinergics.
Anticholinergic effects (eg, dry mouth, blurred vision), CNS effects (eg, headache, confusion, hallucinations, somnolence; consider reducing dose or discontinuing if occurs).UTI, headache, GI upset, accidental injury, flu symptoms, decreased GI motility (may affect absorption of other drugs).