Dosing and uses of VESIcare (solifenacin)
Adult dosage forms and strengths
tablet
- 5mg
- 10mg
Overactive Bladder, Urge Incontinence
5 mg PO once daily; may be increased to 10 mg PO once daily
Dosing Modifications
Renal impairment
- CrCl <30 mL/min: Not to exceed 5 mg/day
Hepatic impairment
- Moderate: Not to exceed 5 mg/day
- Severe (Child-Pugh class C): Do not use
CYP3A4 inhibitors
- Not to exceed 5 mg/day
Pediatric dosage forms and strengths
Safety and efficacy not established
VESIcare (solifenacin) adverse (side) effects
>10%
Dry mouth
Constipation
1-10%
Abdominal pain
Blurred vision
Constipation (with 5 mg)
Cough (with 10 mg)
Depression (with 5 mg)
Dizziness
Dry eyes
Dyspepsia
Edema (with 10 mg)
Fatigue
Hypertension (with 5 mg)
Influenza (with 5 mg)
Nausea
Pharyngitis (with 10 mg)
Urinary retention (with 10 mg)
Urinary tract infection
Vomiting (with 10 mg)
<1%
Cough (with 5 mg)
Depression (with 10 mg)
Dry eyes (with 5 mg)
Hypertension (with 10 mg)
Influenza (with 10 mg)
Lower-limb edema (with 5 mg)
Pharyngitis (with 5 mg)
Vomiting (with 5 mg)
Postmarketing Reports
General: Peripheral edema, hypersensitivity reactions (including angioedema with airway obstruction, rash, pruritus, urticaria, anaphylactic reaction)
Neurologic: Headache, confusion, hallucinations, delirium, somnolence
Cardiovascular: QT prolongation, torsades de pointes, atrial fibrillation, tachycardia, palpitations
Dermatologic: Exfoliative dermatitis, erythema multiforme
Hepatic: Liver disorders, mostly characterized by abnormal liver function test (LFT) results (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transpeptidase [GGT])
Renal: Renal impairment
Metabolic and nutritional: Decreased appetite, hyperkalemia
Musculoskeletal: Muscular weakness
Ophthalmologic: Glaucoma
Gastrointestinal (GI): Gastroesophageal reflux disease, ileus
Respiratory, thoracic, and mediastinal: Dysphonia
Warnings
Contraindications
Urinary or gastric retention
Uncontrolled narrow-angle glaucoma
Severe hepatic impairment
Hypersensitivity
Cautions
Bladder outflow obstruction, controlled narrow-angle glaucoma, decreased GI motility, renal or hepatic impairment
Monitor for signs of anticholinergic central nervous system effects (especially after treatment initiation or dosage adjustment), such as headache, confusion, hallucinations, and somnolence
Pregnancy and lactation
Pregnancy category: C
Lactation: Avoid using drug, or do not nurse
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of VESIcare (solifenacin)
Mechanism of action
Competitive muscarinic-receptor antagonist
Absorption
Bioavailability: 90%
Peak plasma time: 3-8 hr
Distribution
Protein bound: 98%
Metabolism
Metabolized in liver, primarily by CYP3A4
Elimination
Half-life: 45-68 hr
Excretion: Urine (69.2%), feces (22.5%)
