Treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.
Apply one 3.9mg/day system to dry, intact skin on the abdomen, hip, or buttock twice weekly (every 3 or 4 days)
Apply immediately after removal from the protective pouch
Select a new application site w/ each new system to avoid reapplication to the same site w/in 7 days
Patch: 3.9mg/day [8s]
Urinary retention, gastric retention, uncontrolled narrow-angle glaucoma.
Caution with bladder outflow obstruction, GI obstructive disorders, gastroesophageal reflux disease (GERD), and myasthenia gravis. May decrease GI motility; caution with ulcerative colitis (UC) or intestinal atony. CNS anticholinergic effects reported; consider discontinuation if these occur. May impair mental/physical abilities. Angioedema may occur; d/c and provide appropriate therapy if this occurs. D/C if skin hypersensitivity develops.
Application-site reactions (pruritus, erythema, vesicles, rash), dry mouth, diarrhea, constipation.
Concomitant use with other anticholinergic drugs may increase the frequency and/or severity of dry mouth, constipation, somnolence, and/or other anticholinergic-like effects. May alter the absorption of other drugs due to anticholinergic effects on GI motility. Caution with drugs that can cause or exacerbate esophagitis (eg, bisphosphonates).
PREGNANCY AND LACTATION
Category B, caution in nursing.
MECHANISM OF ACTION
Muscarinic antagonist; acts as a competitive antagonist of acetylcholine at postganglionic muscarinic receptors, resulting in relaxation of bladder smooth muscle.
Absorption: Administration of variable doses resulted in different parameters. Distribution: (IV) Vd=193L. Metabolism: Liver (extensive) via CYP3A4; N-desethyloxybutynin (active metabolite). Elimination: Urine (<0.1% unchanged, <0.1% N-desethyloxybutynin); T1/2=7-8 hrs following patch removal.
Assess for urinary/gastric retention, uncontrolled narrow-angle glaucoma, bladder outflow obstruction, GI obstructive disorders, UC, intestinal atony, GERD, myasthenia gravis, pregnancy/nursing status, and possible drug interactions.
Monitor for urinary retention, gastric retention, anticholinergic CNS effects (particularly after beginning treatment), angioedema, skin hypersensitivity, exacerbation of symptoms of myasthenia gravis, and other adverse reactions.
Instruct to discard used patch in household trash in a manner that prevents accidental application or ingestion by children, pets, or others. Inform that drug may produce adverse reactions related to anticholinergic activity (eg, urinary retention, constipation, dizziness, blurred vision). Advise that heat prostration may occur when the drug is used in a hot environment. Instruct to avoid driving or operating heavy machinery until effects have been determined. Inform that drowsiness may be worsened by alcohol. Advise to promptly d/c therapy and seek immediate medical attention if symptoms consistent with angioedema occur.
20-25°C (68-77°F). Protect from moisture and humidity. Do not store outside the sealed pouch.
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