Absorption: Rapidly absorbed following oral administration, but is rapidly converted to its active metabolite (bioavailability of metabolite 52%); further metabolism occurs in the liver via CYP2D6 and CYP3A4 enzyme systems; the CYP2D6 enzyme system exhibits genetic polymorphism; 7% of population may be poor metabolizers (PMs) and may have significantly ↑ fesoterodine concentrations and an ↑ risk of adverse effects. 16% of active metabolite is excreted in urine, most of the remainder of inactive metabolites are renally excreted. 7% excreted in feces.
Distribution: Unknown.
Metabolism/Excretion: Rapidly converted by esterases to active metabolite.
Half-life: 7 hr (following oral administration).
Contraindicated in:
Use Cautiously in:
CV: tachycardia (dose related).
GI: dry mouth, constipation, nausea, upper abdominal pain.
GU: dysuria, urinary retention.
MS: back pain.
Neuro: dizziness, drowsiness, headache.
Drug-Drug:
6 yr and >35 kg; avoid concurrent use in children 6 yr and 25–35 kg.Overactive Bladder
Renal Impairment
Neurogenic Detrusor Overactivity
6 yr and >35 kg): 4 mg once daily, then ↑ to 8 mg once daily after 1 wk; Concurrent use of strong CYP3A4 inhibitors — Do not exceed 4 mg/day.6 yr and 25–35 kg): 4 mg once daily; ↑ to 8 mg once daily, if needed; Concurrent use of strong CYP3A4 inhibitors — Use not recommended.Renal Impairment
6 yr and >35 kg): eGFR 15–29 mL/min/1.73 m2 — Do not exceed 4 mg/day; eGFR <15 mL/min/1.73 m2 or requiring dialysis — Use not recommended.Renal Impairment
6 yr and 25–35 kg): eGFR 30–89 mL/min/1.73 m2 — Do not exceed 4 mg/day; eGFR <30 mL/min/1.73 m2 or requiring dialysis — Use not recommended.Therapeutic Classification: urinary tract antispasmodics
Pharmacologic Classification: anticholinergics
NDC Code*