Overactive bladder: Oral: Initial: 5 mg once daily; if tolerated, may increase to 10 mg once daily.
Missed doses: Oral suspension: Administer as soon as possible as long as ≤12 hours have passed. If >12 hours have passed, skip dose and administer next dose at usual time.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥30 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
CrCl <30 mL/minute: Maximum dose: 5 mg/day
Mild impairment (Child-Pugh class A): No dosage adjustment necessary; use with caution.
Moderate impairment (Child-Pugh class B): Maximum dose: 5 mg/day.
Severe impairment (Child-Pugh class C): Use is not recommended.
(For additional information see "Solifenacin: Pediatric drug information")
Neurogenic detrusor overactivity (Franco 2020; manufacturer's labeling): Children ≥2 years and Adolescents:
Oral suspension (1 mg/mL):
9 to 15 kg: Oral: Initial dose: 2 mg once daily; may titrate every 3 weeks to lowest effective dose. Maximum daily dose: 4 mg/day.
>15 to 30 kg: Oral: Initial dose: 3 mg once daily; may titrate every 3 weeks to lowest effective dose. Maximum daily dose: 5 mg/day.
>30 to 45 kg: Oral: Initial dose: 3 mg once daily; may titrate every 3 weeks to lowest effective dose. Maximum daily dose: 6 mg/day.
>45 to 60 kg: Initial dose: Oral: 4 mg once daily; may titrate every 3 weeks to lowest effective dose. Maximum daily dose: 8 mg/day.
>60 kg: Initial dose: Oral: 5 mg once daily; may titrate every 3 weeks to lowest effective dose. Maximum daily dose: 10 mg/day.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Altered kidney function: Children ≥2 years and Adolescents: Oral:
CrCl ≥30 mL/minute/1.73 m2: No dosage adjustment necessary.
CrCl <30 mL/minute/1.73 m2:
9 to 15 kg: Maximum daily dose: 2 mg/day.
>15 to 45 kg: Maximum daily dose: 3 mg/day.
>45 to 60 kg: Maximum daily dose: 4 mg/day.
>60 kg: Maximum daily dose: 5 mg/day.
Children ≥2 years and Adolescents: Oral:
Mild impairment (Child-Pugh class A): There are no dosage adjustments provided in manufacturer's labeling.
Moderate impairment (Child-Pugh class B):
9 to 15 kg: Maximum daily dose: 2 mg/day.
>15 to 45 kg: Maximum daily dose: 3 mg/day.
>45 to 60 kg: Maximum daily dose: 4 mg/day.
>60 kg: Maximum daily dose: 5 mg/day.
Severe impairment (Child-Pugh class C): Use is not recommended.
Angioedema and hypersensitivity reactions (eg, anaphylaxis): Discontinue therapy immediately with anaphylaxis or angioedema involving the tongue, hypopharynx, or larynx; initiate supportive care.
CNS effects: Consider decreasing dose or discontinuing therapy if CNS effects occur (eg, headache, confusion, hallucination, somnolence, dementia).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Oral, as succinate:
VESIcare LS: 5 mg/5 mL (150 mL) [contains methylparaben, propylene glycol, propylparaben; orange flavor]
Tablet, Oral, as succinate:
VESIcare: 5 mg, 10 mg [contains corn starch]
Generic: 5 mg, 10 mg
May be product dependent
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as succinate:
VESIcare: 5 mg, 10 mg
Generic: 5 mg, 10 mg
Oral:
Oral suspension: Shake well before use. Administer liquid (water or milk) after administration; simultaneous administration of food or liquid may result in bitter taste. Administer with an accurate measuring device, such as an oral syringe.
Tablet: Administer tablet with water without regard to food. Swallow whole. Do not crush or chew.
Oral suspension: Shake well before use. Administer liquid (water or milk) after administration; simultaneous administration of food or liquid may result in bitter taste. Administer with an accurate measuring device, such as an oral syringe.
Missed dose: Administer as soon as possible as long as ≤12 hours have passed. If >12 hours have passed, skip dose and administer next dose at usual time.
Neurogenic detrusor overactivity (oral suspension): Treatment of neurogenic detrusor overactivity in pediatric patients ≥2 years of age.
Overactive bladder (tablet): Treatment of overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence in adults.
VESIcare may be confused with Vesanoid, Vessel Care (nutritional supplement)
Beers Criteria: Solifenacin is identified in the Beers Criteria as a potentially inappropriate medication in patients 65 years and older due to its strong anticholinergic properties (Beers Criteria [AGS 2019]).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Gastrointestinal: Constipation (5% to 13%, dose-dependent), xerostomia (11% to 28%, dose-dependent; children and adolescents: 3%)
1% to 10%:
Cardiovascular: Hypertension (1%), lower extremity edema (1%)
Gastrointestinal: Abdominal pain (1%), dyspepsia (4%), nausea (3%), upper abdominal pain (2%), vomiting (1%)
Genitourinary: Urinary retention (1%), urinary tract infection (2% to 5%)
Infection: Influenza (2%)
Nervous system: Depression (1%), drowsiness (1%), fatigue (2%)
Ophthalmic: Blurred vision (4% to 5%), dry eye syndrome (2%)
Respiratory: Cough (1%)
<1%, postmarketing, and/or case reports: Abnormal hepatic function tests, anaphylaxis, angioedema, atrial fibrillation, confusion, decreased appetite, delirium, dizziness, dry nose, dysgeusia, erythema multiforme, exfoliative dermatitis, fecal impaction, gastroesophageal reflux disease, gastrointestinal obstruction, glaucoma, hallucination, headache, hepatic disease, hyperkalemia, hypersensitivity reaction, increased gamma-glutamyl transferase, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, intestinal obstruction, myasthenia, palpitations, peripheral edema, pharyngitis, prolonged QT interval on ECG, renal insufficiency, sialadenitis, tachycardia, torsades de pointes, voice disorder, xeroderma
Hypersensitivity (eg, anaphylaxis, angioedema) to solifenacin or any component of the formulation; urinary retention (tablet only); gastric retention; uncontrolled narrow-angle glaucoma.
Canadian labeling: Additional contraindication (not in the US labeling): Dialysis
Concerns related to adverse effects:
• Angioedema: Potentially life-threatening angioedema involving the face, lips, tongue, and/or larynx have been reported; some cases have occurred after the first dose.
• CNS effects: CNS effects have been reported (eg, headache, confusion, hallucinations, somnolence, dementia) (Dantas 2022; Malcher 2022, manufacturer’s labeling). May cause drowsiness and/or blurred vision, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).
• Heat prostration: May occur in the presence of increased environmental temperature; use caution in hot weather and/or exercise.
• Hypersensitivity reactions: Anaphylactic reactions have been reported rarely; may be life-threatening.
Disease-related concerns:
• Alzheimer disease: Preliminary data suggest that long-term use of anticholinergics may potentially adversely affect the clinical course of Alzheimer disease in patients receiving cholinesterase inhibitors (Lu 2003; Sink 2008).
• Bladder outlet obstruction: Use not recommended in patients with significant bladder outlet obstruction (eg, BPH) being treated for overactive bladder; may increase the risk of urinary retention.
• Gastrointestinal disease: Use with caution in patients with decreased GI motility (severe constipation, ulcerative colitis) or GI obstructive disorders (pyloric stenosis); may increase the risk of gastric retention. Instruct patients to report severe abdominal pain or constipation that lasts longer than 3 days.
• Glaucoma: Use with caution in patients with controlled (treated) narrow-angle glaucoma; use is contraindicated in uncontrolled narrow-angle glaucoma.
• Hepatic impairment: Use with caution in patients with moderate hepatic impairment (Child-Pugh class B); dosage adjustment required; use is not recommended in patients with severe hepatic impairment (Child-Pugh class C).
• QT prolongation: Use with caution in patients with a known history of QT prolongation or other risk factors for QT prolongation (eg, concomitant use of medications known to prolong QT interval, electrolyte abnormalities). The risk for QT prolongation is dose-related.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment is required for severe renal impairment (CrCl <30 mL/minute).
Dosage forms specific issues:
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer's labeling.
Substrate of CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Risk C: Monitor therapy
Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy
Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination
Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor therapy
CloZAPine: Anticholinergic Agents may enhance the constipating effect of CloZAPine. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Risk D: Consider therapy modification
CYP3A4 Inducers (Strong): May decrease the serum concentration of Solifenacin. Risk C: Monitor therapy
CYP3A4 Inhibitors (Moderate): May increase the serum concentration of Solifenacin. Risk C: Monitor therapy
CYP3A4 Inhibitors (Strong): May increase the serum concentration of Solifenacin. Management: Limit adult solifenacin doses to 5 mg daily and limit doses in pediatric patients to the recommended weight-based starting dose (and do not increase the dose) when combined with strong CYP3A4 inhibitors. Risk D: Consider therapy modification
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination
Fexinidazole: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk X: Avoid combination
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination
Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy
Itraconazole: May increase the serum concentration of Solifenacin. Management: Limit adult solifenacin doses to 5 mg daily and limit pediatric doses to the starting dose. Do not use with itraconazole, or for 2 weeks after itraconazole discontinuation, in patients with moderate to severe hepatic impairment or severe renal impairment. Risk D: Consider therapy modification
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy
Mirabegron: May enhance the adverse/toxic effect of Solifenacin. Specifically, the risk of acute urinary retention may be enhanced. Risk C: Monitor therapy
Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy
Opioid Agonists: Anticholinergic Agents may enhance the adverse/toxic effect of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination
Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Risk X: Avoid combination
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy
Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination
Grapefruit juice may increase the serum level effects of solifenacin. Management: Monitor closely with concurrent use.
Adverse events were observed in some animal reproduction studies.
It is not known if solifenacin is present in breast milk.
According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.
Mini Mental State exam (MMSE) (periodically) (Dantas 2022); creatinine clearance; hepatic function; postvoid residual urine volume (at baseline and as clinically indicated thereafter) (AUA [Lerner 2021]).
Inhibits muscarinic receptors resulting in decreased urinary bladder contraction, increased residual urine volume, and decreased detrusor muscle pressure.
Distribution: Vdss:
Children ≥2 years to Adolescents ≤17 years: Median: 211 L.
Adults: Mean: 600 L.
Protein binding: ~98%, primarily to alpha1-acid glycoprotein.
Metabolism: Extensively hepatic; via N-oxidation and 4 R-hydroxylation, forms 1 active and 3 inactive metabolites; primary pathway for elimination is via CYP3A4.
Bioavailability: ~90%.
Half-life elimination:
Children ≥2 years and Adolescents ≤17 years: Oral suspension: Median: 26 hours; prolonged in severe kidney impairment (CrCl <30 mL/minute/1.73 m2) or moderate hepatic impairment.
Adults: 45 to 68 hours following chronic dosing; prolonged in severe renal (CrCl <30 mL/minute) or moderate hepatic (Child-Pugh class B) impairment.
Time to peak, plasma:
Children ≥2 years and Adolescents ≤17 years: Oral suspension: 2 to 6 hours.
Adults: Tablets: 3 to 8 hours.
Excretion: Urine (69%; <15% as unchanged drug); feces (23%).
Altered kidney function: There is a 2.1-fold increase in AUC and 1.6-fold increase in half-life of solifenacin in patients with severe impairment (CrCl <30 mL/minute).
Hepatic function impairment: There is a 2-fold increase in the half-life and 35% increase in AUC of solifenacin in patients with moderate impairment (Child-Pugh class B).
Older adult: In elderly patients (65 to 80 years), Cmax, AUC, and half-life values were 20% to 25% higher.
Suspension (VESIcare LS Oral)
5 mg/5 mL (per mL): $2.06
Tablets (Solifenacin Succinate Oral)
5 mg (per each): $0.57 - $14.65
10 mg (per each): $0.57 - $14.65
Tablets (VESIcare Oral)
5 mg (per each): $15.42
10 mg (per each): $15.42
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