Classes
DEA Class; Rx
Common Brand Names; Enablex
- Anticholinergics, Genitourinary
Description
Oral competitive selective antimuscarinic (M3); reduces incontinence episodes and urinary urgency
Used for treatment of overactive bladder (OAB) in adults; used as monotherapy or in combination with a beta-3 adrenoreceptor agonist if needed
Comparable to oxybutynin in efficacy; less dry mouth and CNS side effects
Indications
Indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urinary urgency, and urinary frequency.
Contraindications
Urinary retention
Gastric retention
Uncontrolled narrow-angle glaucoma
Hypersensitivity
Adverse Effects
>10%
- Dry mouth (19-35%)
- Constipation (15-21%)
1-10%
- Abdominal pain (2-4%)
- Dizziness (2%)
- Dry eyes (2%)
- Dyspepsia (3-8%)
- Nausea (2-4%)
- UTI (4-5%)
- Vaginitis (>1%)
- Back pain (>1%)
- Rhinitis (>1%)
- Abnormal vision (>2%)
- Vomiting (>1%)
- Weight gain (>1%)
- Flu-like syndrome (1-3%)
- Peripheral edema (>1%)
Warnings
Heat prostration may occur in the presence of increased environmental temperature
Use caution in patients with decreased GI motility, hiatal hernia, reflux esophagitis, and ulcerative colitis
Administer with caution to patients with clinically significant bladder outflow, obstruction because of the risk of urinary retention
Administer with caution to patients with gastrointestinal obstructive disorders because of risk of gastric retention; like other anticholinergic drugs, this drug may decrease gastrointestinal motility and should be used with caution in patients with conditions such as severe constipation, ulcerative colitis, and myasthenia gravis
Use with caution in patients being treated for narrow-angle glaucoma and only where potential benefits outweigh risk
Pregnancy and Lactation
There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
There are no data on presence of drug in human milk, effects on breastfed infant, or on milk production
The drug is present in rat milk; when a drug is present in animal milk, it is likely that the drug will be present in human milk
Maximum Dosage
15 mg/day PO.
15 mg/day PO.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
Not indicated.
