Classes
DEA Class; Rx
Common Brand Names; Toviaz
- Anticholinergics, Genitourinary
Description
Oral competitive selective antimuscarinic (M3); reduces incontinence episodes and urinary urgency
Used for treatment of overactive bladder (OAB) in adults and for neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older weighing more than 25 kg
Active metabolite is the therapeutic entity
Indications
Indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urinary urgency, and urinary frequency.
For the treatment of neurogenic detrusor overactivity (neurogenic bladder).
Contraindications
Hypersensitivity to drug or ingredients
Urinary or gastric retention
Uncontrolled narrow-angle glaucoma
Adverse Effects
>10%
Adult overactive bladder
Dry mouth (18.8-34.6%)
Pediatric neurogenic detrusor overactivity
Diarrhea (7.1-11.9%)
1-10%
Adult overactive bladder
Constipation (4.2-6%)
Dyspepsia (1.6-2.3%)
Urinary tract infection (3.2-4.2%)
Xerophthalmia (1.4-3.7%)
Upper respiratory tract infection (1.8-2.5%)
Dysuria (1.3-1.6%)
Urinary retention (1.1-1.4%)
Dry throat (0.9-2.3%)
Insomnia (0.4-1.3%)
Back pain (0.9-2%)
Nausea (0.7-1.9%)
ncreased ALT (0.5-1.2%)
Increased GGT (0.4-1.2%)
Peripheral edema (0.7-1.2%)
Upper abdominal pain (0.5-1.1%)
Rash (0.7-1.1%)
Pediatric neurogenic detrusor overactivity
Urinary tract infection (2.4-9.5%)
Dry mouth (7.1-9.5%)
Constipation (7.1-7.1%)
Abdominal pain (4.8-2.4%)
Weight increased (0-4.8%)
Headache (4.8-7.1%)
Ophthalmological reactions (6.1%)
Increased heart rate compared to baseline (8.1-12.2%, week 4; 7.6-11.4%, week 12; 3.3-2.7% week 24)
Warnings
Use caution in reduced hepatic/renal function, and autonomic neuropathy
Therapy can worsen controlled narrow-angle glaucoma; contraindicated in patients with uncontrolled narrow-angle glaucoma; should be used with caution in patients being treated for narrow-angle glaucoma; use only when potential benefits outweigh risks
Anticholinergic CNS effects (eg, headache, dizziness, somnolence) reported; monitor for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing dose; advise patients not to drive or operate heavy machinery until they adjust to therapy; consider dose reduction or drug discontinuation if a patient experiences anticholinergic CNS effects
Caution with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction, bladder flow obstruction; therapy may worsen symptoms
Heat prostration may occur in the presence of increased environmental temperature
Pregnancy and Lactation
There are no data with fesoterodine use in pregnant women to inform a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
There is no information on the presence of fesoterodine in human milk, the effects on the breastfed child, or the effects on milk production
Maximum Dosage
8 mg/day PO.
8 mg/day PO.
8 mg/day PO.
6 to 12 years weighing more than 25 kg: 8 mg/day PO.
6 to 12 years weighing 25 kg or less: Safety and efficacy have not been established.
1 to 5 years: Safety and efficacy have not been established.
