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. Moderate hepatic impairment (Child-Pugh B), concomitant potent CYP3A4 inhibitors: max 7.5mg once daily.
Patients with or at risk for: urinary or gastric retention, uncontrolled narrow-angle glaucoma.
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 (Cat.C). Nursing mothers.
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.
Constipation, dry mouth, headache, dyspepsia, nausea, UTI, accidental injury, flu symptoms; angioedema (discontinue if occurs), CNS effects (eg, confusion, hallucination, somnolence).