Pregnancy Category: C
ClassificationTherapeutic: urinary tract antispasmodics
Treatment of overactive bladder function that results in urinary frequency, urgency, or urge incontinence.
Acts as a competitive muscarinic receptor antagonist resulting in inhibition of cholinergically mediated bladder contraction.
Decreased urinary frequency, urgency, and urge incontinence.
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. 16% of active metabolite is excreted in urine, most of the remainder of inactive metabolites are renally excreted. 7% excreted in feces.
Metabolism and Excretion: Rapidly converted by esterases to active metabolite.
Half-life: 7 hr (following oral administration).
Time/action profile (active metabolite)
|PO||rapid||5 hr||24 hr|
Contraindicated in: Hypersensitivity;Urinary retention;Gastric retention;Severe hepatic impairment;Uncontrolled narrow-angle glaucoma.
Use Cautiously in: Significant bladder outlet obstruction (↑ risk of retention);Severe renal insufficiency (dose adjustment required);↓ GI motility including severe constipation;Treated narrow-angle glaucoma (use only if benefits outweigh risks);Myasthenia gravis;Severe renal impairment (dose should not exceed 4 mg/day); Geriatric: ↑ risk of anticholinergic side effects in patients >75 yr; Obstetric / Lactation: Avoid using unless potential benefits outweighs potential risk to fetus/neonate; Pediatric: Safety not established.
Adverse Reactions/Side Effects
Central nervous system
- tachycardia (dose related)
- dry mouth (most frequent)
- upper abdominal pain
- urinary retention
- back pain
- angioedema (life-threatening)
Drug-Drug interactionConcurrent use of potent CYP3A4 enzyme inhibitors including ketoconazole, itraconazole, and clarithromycin ↑ blood levels and risk of toxicity; daily dose should not exceed 4 mg.Use less potent inhibitors of CYP3A4 (such as erythromycin ) with caution; escalate dose carefully.Anticholinergic effects may alter the GI absorption of other drugs.
Oral (Adults) 4 mg once daily initially may be ↑ to 8 mg/daily; Concurrent potent CYP3A4 inhibitors or CCr <30 mL/min—dose should not exceed 4 mg/day.
Extended-release tablets: 4 mg, 8 mg
- Assess for urinary urgency, frequency, and urge incontinence periodically throughout therapy.
- Monitor for signs and symptoms of angioedema (swelling of face, lips, tongue, and/or larynx). May occur with first or subsequent doses. Discontinue therapy and prove supportive therapy. Have epinephrine, corticosteroids, and resuscitation equipment available.
- Lab Test Considerations: May cause ↑ ALT and GGT.
Potential Nursing DiagnosesImpaired urinary elimination (Indications)
Urinary retention (Indications)
- Oral: Administer without regard to food.
- Extended-release tablets should be swallowed whole; do not break, crush, or chew.
- Instruct patient to take fesoterodine as directed. If a dose is missed, omit and begin taking again the next day; do not take 2 doses the same day. Advise patient to read the Patient Information sheet prior to initiation of therapy and with each Rx refill.
- May cause drowsiness, dizziness, and blurred vision. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
- Advise patient to avoid alcohol; may increase drowsiness.
- Advise patient to use caution in hot environments; may cause decreased sweating and severe heat illness.
- Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
- Advise patient to stop medication and notify health care professional if signs and symptoms of angioedema occur.
- Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.
- Decreased urinary frequency, urgency, and urge incontinence.