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.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function:
Oral:
CrCl ≥30 mL/minute: No dosage adjustment necessary (Ref).
CrCl <30 mL/minute: Maximum dose: 5 mg/day (Ref).
Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2): Note: Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Younger patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).
Oral: No dosage adjustment necessary (Ref).
Hemodialysis, intermittent (thrice weekly): Unlikely to be significantly dialyzable (large Vd and highly protein bound): Oral: Maximum dose: 5 mg/day (Ref).
Peritoneal dialysis: Unlikely to be significantly dialyzable (large Vd and highly protein bound: Oral: Maximum dose: 5 mg/day (Ref).
CRRT: Oral: Maximum dose: 5 mg/day (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): Oral: Maximum dose: 5 mg/day (Ref).
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.
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).
(For additional information see "Solifenacin: Pediatric drug information")
Neurogenic detrusor overactivity (Ref): 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: There are no dosage adjustments provided in manufacturer's labeling.
Moderate impairment:
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: Use is not recommended.
Anticholinergic agents, including solifenacin, may cause reversible, dose-dependent anticholinergic effects, including, but not limited to CNS effects (eg, confusion, dizziness, drowsiness, hallucinations), GI effects (eg, constipation, xerostomia), ophthalmic effects (eg, blurred vision), cardiovascular effects (eg, prolonged QT interval on ECG) in adult and pediatric patients (Ref). Heat prostration due to decreased sweating can also occur in a hot environment.
Risk factors:
• Kidney or hepatic impairment
• Use of multiple concurrent medications with anticholinergic effects (Ref)
• Preexisting or undiagnosed dementia (Ref)
• Preexisting decreased GI motility or GI obstructive disorders
• Preexisting narrow-angle closure glaucoma
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults, unless otherwise noted.
>10%: Gastrointestinal: Constipation (children, adolescents, and adults: 5% to 13%) (table 1) , xerostomia (children and adolescents: 3%; adults: 11% to 28%) (table 2)
Drug (Solifenacin) |
Placebo |
Population |
Dose |
Dosage Form |
Indication |
Number of Patients (Solifenacin) |
Number of Patients (Placebo) |
---|---|---|---|---|---|---|---|
7% |
N/A |
Children and adolescents |
N/A |
Oral suspension |
Neurogenic detrusor overactivity |
95 |
N/A |
13% |
3% |
Adults |
10 mg once daily |
Oral tablets |
Overactive bladder |
1,233 |
1,216 |
5% |
3% |
Adults |
5 mg once daily |
Oral tablets |
Overactive bladder |
578 |
1,216 |
Drug (Solifenacin) |
Placebo |
Population |
Dose |
Dosage Form |
Indication |
Number of Patients (Solifenacin) |
Number of Patients (Placebo) |
---|---|---|---|---|---|---|---|
3% |
N/A |
Children and adolescents |
N/A |
Oral suspension |
Neurogenic detrusor overactivity |
95 |
N/A |
28% |
4% |
Adults |
10 mg once daily |
Oral tablets |
Overactive bladder |
1,233 |
1,216 |
11% |
4% |
Adults |
5 mg once daily |
Oral tablets |
Overactive bladder |
578 |
1,216 |
1% to 10%:
Cardiovascular: Hypertension (1%), lower extremity edema (1%)
Gastrointestinal: Abdominal pain (children and adolescents: 1%), dyspepsia (4%), nausea (3%), upper abdominal pain (2%), vomiting (1%)
Genitourinary: Urinary retention (1%), urinary tract infection (children, adolescents, and adults: 2% to 5%)
Infection: Influenza (2%)
Nervous system: Depression (1%), drowsiness (children and adolescents: 1%), fatigue (2%)
Ophthalmic: Blurred vision (4% to 5%) (table 3) , dry eye syndrome (2%)
Drug (Solifenacin) |
Placebo |
Population |
Dose |
Dosage Form |
Indication |
Number of Patients (Solifenacin) |
Number of Patients (Placebo) |
---|---|---|---|---|---|---|---|
5% |
2% |
Adults |
10 mg once daily |
Oral tablets |
Overactive bladder |
1,233 |
1,216 |
4% |
2% |
Adults |
5 mg once daily |
Oral tablets |
Overactive bladder |
578 |
1,216 |
Respiratory: Cough (1%)
<1%: Gastrointestinal: Fecal impaction, gastrointestinal obstruction, intestinal obstruction
Postmarketing (any population):
Cardiovascular: Peripheral edema, prolonged QT interval on ECG (Bray 2017), tachyarrhythmia (including atrial fibrillation, increased heart rate, palpitations, and tachycardia) (Gratzke 2018), torsades de pointes (Bray 2017)
Dermatologic: Erythema multiforme, exfoliative dermatitis, urticaria (Younas 2022), xeroderma
Endocrine & metabolic: Hyperkalemia
Gastrointestinal: Decreased appetite, dysgeusia, gastroesophageal reflux disease, sialadenitis
Hepatic: Abnormal hepatic function tests, hepatic disease, increased gamma-glutamyl transferase, increased serum alanine aminotransferase, increased serum aspartate aminotransferase
Hypersensitivity: Anaphylaxis, angioedema (Younas 2022)
Nervous system: Behavioral changes (Raman 2023), confusion, delirium, dizziness (Raman 2023), hallucination, headache (Gratzke 2018), myasthenia, voice disorder
Ophthalmic: Glaucoma
Renal: Kidney impairment
Respiratory: Dry nose
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.
• 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).
• 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.
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
Suspension (VESIcare LS Oral)
5 mg/5 mL (per mL): $2.06
Tablets (Solifenacin Succinate Oral)
5 mg (per each): $12.35 - $14.65
10 mg (per each): $12.35 - $14.65
Tablets (VESIcare Oral)
5 mg (per each): $15.42
10 mg (per each): $15.42
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
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. The manufacturer's labeling recommends to swallow whole. If necessary, the tablet may be crushed, but bitterness may impact palatability (Ref).
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)
The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs (pediatric liquid medications requiring measurement) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care Settings).
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 2023]).
Substrate of CYP3A4 (Major with inhibitors), CYP3A4 (Minor with inducers); 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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Acetylcholinesterase Inhibitors: May decrease therapeutic effects of Agents with Clinically Relevant Anticholinergic Effects. Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Acetylcholinesterase Inhibitors. Risk C: Monitor
Aclidinium: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Acrivastine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Amantadine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Benperidol: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Benperidol. Risk C: Monitor
Benztropine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Benztropine. Risk C: Monitor
Biperiden: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Biperiden. Risk C: Monitor
Bornaprine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Bornaprine. Risk C: Monitor
Botulinum Toxin-Containing Products: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Bromperidol: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Bromperidol. Risk C: Monitor
Buclizine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Buclizine. Risk C: Monitor
Cannabinoid-Containing Products: Agents with Clinically Relevant Anticholinergic Effects may increase tachycardic effects of Cannabinoid-Containing Products. Risk C: Monitor
Chlorprothixene: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Chlorprothixene. Risk C: Monitor
Cimetropium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Cimetropium. Risk X: Avoid
Clofazimine: May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Risk C: Monitor
CloZAPine: Agents with Clinically Relevant Anticholinergic Effects may increase constipating effects 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
Cyclizine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
CYP3A4 Inducers (Strong): May decrease serum concentration of Solifenacin. Risk C: Monitor
CYP3A4 Inhibitors (Moderate): May increase serum concentration of Solifenacin. Risk C: Monitor
CYP3A4 Inhibitors (Strong): May increase 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
Darifenacin: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Darifenacin. Risk C: Monitor
Dicyclomine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Dicyclomine. Risk C: Monitor
Dimethindene (Systemic): Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Dimethindene (Systemic). Risk C: Monitor
DroNABinol: Agents with Clinically Relevant Anticholinergic Effects may increase tachycardic effects of DroNABinol. Risk X: Avoid
Eluxadoline: Agents with Clinically Relevant Anticholinergic Effects may increase constipating effects of Eluxadoline. Risk X: Avoid
Fesoterodine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Fesoterodine. Risk C: Monitor
FluPHENAZine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Fusidic Acid (Systemic): May increase serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Consider avoiding this combination if possible. If required, monitor patients closely for increased adverse effects of the CYP3A4 substrate. Risk D: Consider Therapy Modification
Gastrointestinal Agents (Prokinetic): Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Gastrointestinal Agents (Prokinetic). Risk C: Monitor
Gepotidacin: May decrease anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Glucagon: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor
Glycopyrrolate (Oral Inhalation): Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Glycopyrrolate (Oral Inhalation). Risk X: Avoid
Glycopyrrolate (Systemic): Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Glycopyrrolate (Systemic). Risk C: Monitor
Glycopyrronium (Topical): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Grapefruit Juice: May increase serum concentration of Solifenacin. Risk C: Monitor
Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor
Ipratropium (Nasal): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Ipratropium (Oral Inhalation): May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Itopride: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Itopride. Risk C: Monitor
Itraconazole: May increase 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: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Levosulpiride. Risk X: Avoid
Maprotiline: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Maprotiline. Risk C: Monitor
Melperone: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Methotrimeprazine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Methotrimeprazine. Risk C: Monitor
Methscopolamine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Methscopolamine. Risk C: Monitor
Mirabegron: May increase adverse/toxic effects of Solifenacin. Specifically, the risk of acute urinary retention may be enhanced. Risk C: Monitor
Nitroglycerin: Agents with Clinically Relevant Anticholinergic Effects may decrease absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor
OLANZapine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of OLANZapine. Risk C: Monitor
Opioid Agonists: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Opioid Agonists. Specifically, the risk for constipation and urinary retention may be increased with this combination. Risk C: Monitor
Opipramol: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Oxatomide: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
OxyBUTYnin: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of OxyBUTYnin. Risk C: Monitor
Perazine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Perphenazine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Perphenazine. Risk C: Monitor
Potassium Chloride: Agents with Clinically Relevant Anticholinergic Effects may increase ulcerogenic effects 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
Potassium Citrate: Agents with Clinically Relevant Anticholinergic Effects may increase ulcerogenic effects of Potassium Citrate. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium citrate. Risk X: Avoid
Pramlintide: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. These effects are specific to the GI tract. Risk X: Avoid
Promethazine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Promethazine. Risk C: Monitor
Propantheline: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Propantheline. Risk C: Monitor
Propiverine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects 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
QuiNIDine: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk C: Monitor
Ramosetron: Agents with Clinically Relevant Anticholinergic Effects may increase constipating effects of Ramosetron. Risk C: Monitor
Revefenacin: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Revefenacin. Risk X: Avoid
Rivastigmine: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Rivastigmine. Rivastigmine may decrease therapeutic effects of Agents with Clinically Relevant Anticholinergic Effects. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider Therapy Modification
Scopolamine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Scopolamine. Risk C: Monitor
Secretin: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects 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
Sofpironium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Sofpironium. Risk X: Avoid
Thiazide and Thiazide-Like Diuretics: Agents with Clinically Relevant Anticholinergic Effects may increase serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor
Thiothixene: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Thiothixene. Risk C: Monitor
Tiapride: Agents with Clinically Relevant Anticholinergic Effects may decrease therapeutic effects of Tiapride. Risk C: Monitor
Tiotropium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Tiotropium. Risk X: Avoid
Tolterodine: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Tolterodine. Risk C: Monitor
Topiramate: Agents with Clinically Relevant Anticholinergic Effects may increase adverse/toxic effects of Topiramate. Risk C: Monitor
Tricyclic Antidepressants: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Tricyclic Antidepressants. Risk C: Monitor
Trimethobenzamide: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Trimethobenzamide. Risk C: Monitor
Trospium: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Trospium. Risk C: Monitor
Umeclidinium: May increase anticholinergic effects of Agents with Clinically Relevant Anticholinergic Effects. Risk X: Avoid
Zuclopenthixol: Agents with Clinically Relevant Anticholinergic Effects may increase anticholinergic effects of Zuclopenthixol. Risk C: Monitor
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]); anticholinergic effects (eg, mental alertness, dizziness, constipation, blurred vision).
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.