Monograph Details
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Urogenital System
> Overactive bladder/enuresis
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ENABLEX |
| Manufacturer |
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Novartis Pharmaceuticals Corp |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Antispasmodic/anticholinergic. |
| Generic Name |
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Darifenacin (as HBr) 7.5mg, 15mg; ext-rel tabs. |
| Indications |
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Overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. |
| Children |
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Not recommended. |
| Adults |
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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). |
| Contraindications |
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Urinary or gastric retention; uncontrolled narrow-angle glaucoma; or patients at risk for these. |
| Precautions |
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Severe hepatic impairment: not recommended. GI or GU obstruction. Severe constipation. Ulcerative colitis. Myasthenia gravis. Controlled narrow-angle glaucoma. High environmental temperatures. Pregnancy (Cat.C). Nursing mothers. |
| Interactions |
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Potentiated by CYP3A4 inhibitors (see Dose). May potentiate CYP2D6 or CYP3A4 substrates or those with narrow therapeutic indexes (eg, flecainide, thioridazine, antidepressants). Additive anticholinergic effects with other anticholinergics. |
| Adverse Reactions |
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Anticholinergic effects (eg, dry mouth, blurred vision), UTI, headache, GI upset, decreased GI motility (may affect absorption of other drugs). |
| How Supplied |
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Tabs—30, 90 |
| Additional Resources |
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• Related Prescribing Note |
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