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ENABLEX
Overactive bladder/enuresis
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Drug Name:

ENABLEX Rx

Generic Name and Formulations:
Darifenacin (as HBr) 7.5mg, 15mg; ext-rel tabs.

Company:
Allergan

Therapeutic Use:

Indications for ENABLEX:

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

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.

Contraindications:

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

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 (Cat.C). Nursing mothers.

Pharmacological Class:

Muscarinic antagonist.

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.

Adverse Reactions:

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

How Supplied:

Tabs—30, 90

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