Therapeutic Classification: urinary tract antispasmodics
Pharmacologic Classification: anticholinergics
Absorption: 90% absorbed following oral administration.
Distribution: Extensively distributed to tissues.
Protein Binding: 98%.
Metabolism/Excretion: Extensively metabolized by liver via the CYP3A4 isoenzyme. 69% excreted in urine as metabolites, 22% in feces.
Half-life: Tablets: 45–68 hr; Suspension: 26 hr.
CV: QT interval prolongation, palpitations, tachycardia.
EENT: blurred vision.
GI: constipation, dry mouth, abdominal pain, dyspepsia, nausea.
GU: urinary tract infection.
MS: muscle weakness.
Neuro: confusion, drowsiness, hallucinations, headache.
Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).
Overactive Bladder
- PO (Adults): Tablets: 5 mg once daily, may ↑ to 10 mg once daily; Concurrent use of strong CYP3A4 inhibitors: Tablets: Not to exceed 5 mg once daily.
Renal Impairment
- PO (Adults): CCr <30 mL/min: Tablets: Not to exceed 5 mg once daily.
Hepatic Impairment
- PO (Adults): Moderate hepatic impairment: Tablets: Not to exceed 5 mg once daily.
Neurogenic Detrusor Overactivity
- PO (Children ≥2 yr and >60 kg): Suspension: 5 mg once daily, may ↑ to 10 mg once daily; Concurrent use of strong CYP3A4 inhibitors: Suspension: Not to exceed 5 mg once daily.
- PO (Children ≥2 yr and 46–60 kg): Suspension: 4 mg once daily, may ↑ to 8 mg once daily; Concurrent use of strong CYP3A4 inhibitors: Suspension: Not to exceed 4 mg once daily.
- PO (Children ≥2 yr and 31–45 kg): Suspension: 3 mg once daily, may ↑ to 6 mg once daily; Concurrent use of strong CYP3A4 inhibitors: Suspension: Not to exceed 3 mg once daily.
- PO (Children ≥2 yr and 16–30 kg): Suspension: 3 mg once daily, may ↑ to 5 mg once daily; Concurrent use of strong CYP3A4 inhibitors: Suspension: Not to exceed 3 mg once daily.
- PO (Children ≥2 yr and 9–15 kg): Suspension: 2 mg once daily, may ↑ to 4 mg once daily; Concurrent use of strong CYP3A4 inhibitors: Suspension: Not to exceed 2 mg once daily.
Renal Impairment
- PO (Children ≥2 yr): CCr <30 mL/min: >60 kg: Not to exceed 5 mg once daily (suspension); 46–60 kg: Not to exceed 4 mg once daily (suspension); 16–45 kg: Not to exceed 3 mg once daily (suspension); 9–15 kg: Not to exceed 2 mg once daily (suspension).
Hepatic Impairment
- PO (Children ≥2 yr): Moderate hepatic impairment: >60 kg: Not to exceed 5 mg once daily (suspension); 46–60 kg: Not to exceed 4 mg once daily (suspension); 16–45 kg: Not to exceed 3 mg once daily (suspension); 9–15 kg: Not to exceed 2 mg once daily (suspension).
