• Overactive bladder with symptoms of urinary frequency, urgency, and urge incontinence.
• Neurogenic detrusor overactivity.

Contraindicated in:

• Hypersensitivity
• Urinary retention
• Significant bladder outlet obstruction (↑ risk of retention)
• Gastric retention
• ↓ GI motility including severe constipation
• Severe hepatic impairment
• Uncontrolled narrow-angle glaucoma
• Pedi: eGFR <15 mL/min/1.73 m² or requiring dialysis (children ≥6 yr and >35 kg)
• Pedi: eGFR <30 mL/min/1.73 m² or requiring dialysis (children ≥6 yr and 25–35 kg).

Use Cautiously in:

• CCr <30 mL/min (dose adjustment required in adults)
• Treated narrow-angle glaucoma (use only if benefits outweigh risks)
• Myasthenia gravis
• OB: Safety not established in pregnancy
• Lactation: Safety not established in breastfeeding
• Pedi: Safety and effectiveness not established in children <18 yr (overactive bladder) or <6 yr or <25 kg (neurogenic detrusor overactivity)
• Geri: ↑ risk of anticholinergic side effects in patients >75 yr.

CV: tachycardia (dose related).

GI: dry mouth, constipation, nausea, upper abdominal pain.

GU: dysuria, urinary retention.

MS: back pain.

Neuro: dizziness, drowsiness, headache.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANGIOEDEMA).

Drug-Drug:

• Strong CYP3A4 inhibitors, including ketoconazole, itraconazole, and clarithromycin, ↑ levels and risk of toxicity; daily dose should not exceed 4 mg in adults and children ≥6 yr and >35 kg; avoid concurrent use in children ≥6 yr and 25–35 kg.
• Additive anticholinergic effects with other anticholinergic drugs, including antihistamines, phenothiazines, quinidine, disopyramide, and tricyclic antidepressants.
• May ↓ GI absorption of other drugs.

(Generic available)

• Extended-release tablets: 4 mg; 8 mg;

Overactive Bladder

• PO (Adults): 4 mg once daily initially; may ↑ to 8 mg/daily, if needed based on response and tolerability; Concurrent use of strong CYP3A4 inhibitors: Do not exceed 4 mg/day.

Neurogenic Detrusor Overactivity

• PO (Children ≥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.
• PO (Children ≥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.

Toviaz

• Acts as a competitive muscarinic receptor antagonist resulting in inhibition of cholinergically mediated bladder contraction.

• Decreased urinary frequency, urgency, and urge incontinence in overactive bladder.
• Increase in maximum cystometric bladder capacity in neurogenic detrusor overactivity.

Therapeutic Classification: urinary tract antispasmodics

Pharmacologic Classification: anticholinergics

Absorption: Rapidly absorbed following oral administration, but is rapidly converted to its active metabolite (bioavailability of metabolite 52%).

Distribution: Unknown.

Metabolism/Excretion: Primarily metabolized in the liver via the CYP2D6 and CYP3A4 isoenzymes; the CYP2D6 enzyme system exhibits genetic polymorphism; 7% of population may be poor metabolizers 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.

Half-life: 7 hr (following oral administration).

(plasma concentrations of active metabolite)

• 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 in case of changes.
• 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.
• Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

fes-oh-TER-o-deen

NDC Code^*

• 0069- Pfizer Laboratories Div Pfizer Inc
  • 0069-0242- Toviaz
    • 0069-0242-30- 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0242-30)

• 0069- Pfizer Laboratories Div Pfizer Inc
  • 0069-0244- Toviaz
    • 0069-0244-30- 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0069-0244-30)

• 55154- Cardinal Health
  • 55154-2737- Toviaz
    • 55154-2737-8- 960 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55154-2737-8)

• 55154- Cardinal Health
  • 55154-2738- Toviaz
    • 55154-2738-8- 960 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (55154-2738-8)

• 63539- U.S. Pharmaceuticals
  • 63539-183- Toviaz
    • 63539-183-05- 5 BLISTER PACK in 1 CARTON (63539-183-05) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (63539-183-03)

• 63539- U.S. Pharmaceuticals
  • 63539-242- Toviaz
    • 63539-242-05- 5 BLISTER PACK in 1 CARTON (63539-242-05) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (63539-242-03)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-479- fesoterodine fumarate
    • 68382-479-06- 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-479-06)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-479- fesoterodine fumarate
    • 68382-479-16- 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-479-16)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-479- fesoterodine fumarate
    • 68382-479-77- 10 BLISTER PACK in 1 CARTON (68382-479-77) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-479-30)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-480- fesoterodine fumarate
    • 68382-480-06- 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-480-06)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-480- fesoterodine fumarate
    • 68382-480-16- 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68382-480-16)

• 68382- Zydus Pharmaceuticals (USA) Inc.
  • 68382-480- fesoterodine fumarate
    • 68382-480-77- 10 BLISTER PACK in 1 CARTON (68382-480-77) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68382-480-30)

• 70771- Cadila Healthcare Limited
  • 70771-1168- fesoterodine fumarate
    • 70771-1168-3- 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1168-3)

• 70771- Cadila Healthcare Limited
  • 70771-1168- fesoterodine fumarate
    • 70771-1168-4- 10 BLISTER PACK in 1 CARTON (70771-1168-4) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1168-2)

• 70771- Cadila Healthcare Limited
  • 70771-1168- fesoterodine fumarate
    • 70771-1168-9- 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1168-9)

• 70771- Cadila Healthcare Limited
  • 70771-1169- fesoterodine fumarate
    • 70771-1169-3- 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1169-3)

• 70771- Cadila Healthcare Limited
  • 70771-1169- fesoterodine fumarate
    • 70771-1169-4- 10 BLISTER PACK in 1 CARTON (70771-1169-4) > 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (70771-1169-2)

• 70771- Cadila Healthcare Limited
  • 70771-1169- fesoterodine fumarate
    • 70771-1169-9- 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (70771-1169-9)