Drug Monograph
VESIcare (Solifenacin)
solifenacin succinate
Pharmacokinetic Profile
Half-Life
45–68 h
Metabolism
Hepatic (CYP3A4 primary)
Protein Binding
~98%
Bioavailability
~90%
Volume of Distribution
600 L
Clinical Information
Drug Class
Muscarinic Antagonist
Available Doses
5 mg, 10 mg tablets; oral suspension
Route
Oral
Renal Adjustment
Max 5 mg if CrCl <30
Hepatic Adjustment
Max 5 mg (Child-Pugh B); CI in C
Pregnancy
No adequate human data
Lactation
Unknown excretion; caution advised
Schedule
Prescription only (not scheduled)
Generic Available
Yes
Indications
| Indication | Approved Population | Therapy Type | Status |
|---|---|---|---|
| Overactive bladder (OAB) — urge urinary incontinence, urgency, urinary frequency | Adults | Monotherapy | FDA Approved |
| Neurogenic detrusor overactivity (NDO) | Pediatric ≥2 years (oral suspension — VESIcare LS) | Monotherapy | FDA Approved |
Solifenacin is a selective muscarinic receptor antagonist used primarily for symptomatic management of overactive bladder in adults. The drug was initially approved by the FDA in 2004 for adult OAB. A separate oral suspension formulation (VESIcare LS) received approval for neurogenic detrusor overactivity in pediatric patients aged 2 years and older, providing a weight-based dosing option for this population. Across four pivotal 12-week trials involving over 3,000 patients, solifenacin consistently reduced micturition frequency, urgency episodes, and incontinence episodes compared with placebo.
Off-Label Uses
Neurogenic detrusor overactivity in adults: Used in adults with spinal cord injury or multiple sclerosis who have bladder overactivity; supported by extrapolation from pediatric NDO data and adult OAB trials, though formal adult NDO approval is lacking. Evidence quality: Moderate.
Pediatric idiopathic OAB (tablet formulation): Adjusted-dose regimens of solifenacin tablets (1.25–10 mg) have been studied in children with refractory idiopathic OAB unresponsive to oxybutynin or tolterodine, with open-label data showing significant improvement in continence and urodynamic parameters. Evidence quality: Moderate.
Dosing
Adult Dosing — Overactive Bladder
| Clinical Scenario | Starting Dose | Maintenance Dose | Maximum Dose | Notes |
|---|---|---|---|---|
| OAB — treatment-naive adult | 5 mg once daily | 5–10 mg once daily | 10 mg/day | Increase to 10 mg only if 5 mg well tolerated and symptoms persist Take with water; swallow whole; with or without food |
| OAB — severe renal impairment (CrCl <30 mL/min) | 5 mg once daily | 5 mg once daily | 5 mg/day | Do not exceed 5 mg; 2.1-fold AUC increase in severe renal impairment No adjustment needed for mild-moderate renal impairment |
| OAB — moderate hepatic impairment (Child-Pugh B) | 5 mg once daily | 5 mg once daily | 5 mg/day | 35% AUC increase; do not exceed 5 mg Contraindicated in severe hepatic impairment (Child-Pugh C) |
| OAB — concurrent strong CYP3A4 inhibitor | 5 mg once daily | 5 mg once daily | 5 mg/day | Ketoconazole increases AUC 2.7-fold Applies to ketoconazole, itraconazole, ritonavir, nelfinavir, etc. |
| OAB — elderly (≥65 years) | 5 mg once daily | 5–10 mg once daily | 10 mg/day | Cmax and AUC 20–25% higher than younger adults; no formal dose adjustment required Assess anticholinergic burden in polypharmacy |
Pediatric Dosing — Neurogenic Detrusor Overactivity (VESIcare LS Oral Suspension)
| Clinical Scenario | Starting Dose | Maintenance Dose | Maximum Dose | Notes |
|---|---|---|---|---|
| NDO — child ≥2 years, weight >60 kg | 5 mL (5 mg) once daily | 5–10 mL once daily | 10 mL (10 mg)/day | Weight-based dosing using oral suspension Titrate based on tolerability and clinical response |
| NDO — child ≥2 years, weight >45 to 60 kg | 4 mL (4 mg) once daily | 4–8 mL once daily | 8 mL (8 mg)/day | Adjust to lowest effective dose |
| NDO — child ≥2 years, weight >30 to 45 kg | 3 mL (3 mg) once daily | 3–6 mL once daily | 6 mL (6 mg)/day | Adjust to lowest effective dose |
| NDO — child ≥2 years, weight >15 to 30 kg | 3 mL (3 mg) once daily | 3–5 mL once daily | 5 mL (5 mg)/day | Adjust to lowest effective dose |
| NDO — child ≥2 years, weight 9 to 15 kg | 2 mL (2 mg) once daily | 2–4 mL once daily | 4 mL (4 mg)/day | Adjust to lowest effective dose |
Clinical Pearl: Dose Escalation Strategy
The SUNRISE trial demonstrated that approximately 47% of patients on solifenacin 5 mg requested a dose increase after 8 weeks, typically those with more severe baseline symptoms. Patients escalated to 10 mg showed statistically significant further reductions in urgency scores and micturition frequency. Clinicians should reassess symptom control at 4–8 weeks and consider uptitration if the 5 mg dose is well tolerated but insufficiently effective.
Pharmacology
Mechanism of Action
Solifenacin is a competitive antagonist at muscarinic acetylcholine receptors, with relative selectivity for the M3 receptor subtype predominantly expressed in detrusor smooth muscle. During the bladder filling phase, involuntary detrusor contractions are driven by acetylcholine binding to M3 receptors on the smooth muscle surface. By blocking these receptors, solifenacin suppresses uninhibited bladder contractions, increases functional bladder capacity, and raises the volume threshold at which urgency is perceived. The M3-preferring profile contributes to its bladder-selective activity, though some M2-mediated effects persist. Solifenacin does not appreciably cross the blood-brain barrier at therapeutic doses, which contributes to a lower incidence of central nervous system effects compared to lipophilic agents such as oxybutynin.
ADME Profile
| Parameter | Value | Clinical Implication |
|---|---|---|
| Absorption | Tmax 3–8 h; bioavailability ~90%; food has negligible effect (Cmax +4%, AUC +3%) | Reliable once-daily dosing; can be taken with or without meals |
| Distribution | Vd 600 L; ~98% protein-bound (primarily to alpha-1-acid glycoprotein); highly distributed to non-CNS tissues | Large volume of distribution supports once-daily dosing; limited CNS penetration reduces cognitive side effects |
| Metabolism | Extensively hepatic via CYP3A4 (primary); alternate pathways exist; active metabolite (4R-hydroxy) at low concentrations | Dose cap at 5 mg with strong CYP3A4 inhibitors; inducers may reduce efficacy; active metabolite unlikely to contribute clinically |
| Elimination | t½ 45–68 h; 69% urine, 23% feces; <15% excreted as unchanged drug | Long half-life supports once-daily dosing; steady state reached in approximately 10 days; dose reduction in severe renal impairment |
Side Effects
≥10%
Very Common
| Adverse Effect | Incidence | Clinical Note |
|---|---|---|
| Dry mouth | 10.9% (5 mg); 27.6% (10 mg) | Most common adverse effect; dose-related; typically mild-moderate; most frequent reason for discontinuation (1.5%); advise sugar-free lozenges and frequent water sips |
| Constipation | 5.4% (5 mg); 13.4% (10 mg) | Dose-dependent; can be managed with dietary fibre and adequate hydration; severe cases (fecal impaction, colonic obstruction) reported rarely at 10 mg dose |
1–10%
Common
| Adverse Effect | Incidence | Clinical Note |
|---|---|---|
| Blurred vision | 3.8% (5 mg); 4.8% (10 mg) | Accommodation disturbance secondary to antimuscarinic action; advise caution with driving until effects are known |
| Urinary tract infection | 2.8% (5 mg); 4.8% (10 mg) | More common at higher dose; may relate to residual urine volume changes; monitor for symptoms of UTI |
| Dyspepsia | 1.4% (5 mg); 3.9% (10 mg) | Upper GI discomfort; manageable with antacids if needed |
| Nausea | 1.7% (5 mg); 3.3% (10 mg) | Usually self-limiting; taking with food may help |
| Influenza-like illness | 2.2% (5 mg); 0.9% (10 mg) | Noted in clinical trials; not clearly dose-related |
| Fatigue | 1.0% (5 mg); 2.1% (10 mg) | Mild; consider dose reduction if persistent |
| Dizziness | 1.9% (5 mg); 1.8% (10 mg) | Not clearly dose-related; advise caution with hazardous activities |
| Upper abdominal pain | 1.9% (5 mg); 1.2% (10 mg) | Usually mild; differentiate from constipation-related discomfort |
| Dry eyes | 0.3% (5 mg); 1.6% (10 mg) | Antimuscarinic class effect; artificial tears may be helpful |
| Urinary retention | 0% (5 mg); 1.4% (10 mg) | Risk higher at 10 mg and in patients with bladder outlet obstruction; monitor post-void residual if symptoms arise |
| Hypertension | 1.4% (5 mg); 0.5% (10 mg) | Observed in trials; unclear causal relationship; monitor blood pressure at routine visits |
| Depression | 1.2% (5 mg); 0.8% (10 mg) | Observed in trials at rates comparable to placebo (0.8%); monitor mood in susceptible individuals |
| Lower limb oedema | 0.3% (5 mg); 1.1% (10 mg) | Peripheral oedema reported primarily at higher dose; evaluate for other causes |
Serious
Serious Adverse Effects (Regardless of Frequency)
| Adverse Effect | Estimated Frequency | Typical Onset | Required Action |
|---|---|---|---|
| Angioedema | Rare | Hours after first dose or after multiple doses | Immediately discontinue solifenacin; provide emergency airway management; permanent discontinuation required |
| Anaphylaxis | Very rare | Minutes to hours after administration | Emergency treatment (epinephrine, supportive care); permanent discontinuation; do not rechallenge |
| QT prolongation / Torsade de Pointes | Rare (postmarketing) | Variable; more likely with supratherapeutic doses | Discontinue drug; correct electrolytes; cardiology review; avoid in patients with known QT prolongation |
| Severe urinary retention | Rare | Days to weeks after initiation | Discontinue or reduce dose; catheterisation may be required; assess for bladder outlet obstruction |
| Fecal impaction / colonic obstruction | Rare (<1%) | Weeks after initiation, particularly at 10 mg | Discontinue solifenacin; surgical consultation if obstructed; manage aggressively with laxatives |
| CNS effects (hallucinations, confusion, delirium) | Rare (postmarketing) | Days to weeks; more common in elderly | Reduce dose or discontinue; assess total anticholinergic burden; monitor cognitive function in elderly |
| Acute angle-closure glaucoma exacerbation | Very rare | Variable | Emergency ophthalmology referral; discontinue solifenacin; contraindicated in uncontrolled narrow-angle glaucoma |
Discontinuation
Discontinuation Rates
Adults — 12-Week Trials
~10% vs ~90% completion rate
Top reason for discontinuation: Dry mouth (1.5% overall); approximately 90% of patients completed the 12-week pivotal studies
Long-Term Extension (52 Weeks)
81% completion of extension enrollees
Tolerability: Incidence and severity of adverse effects during the 40-week extension were similar to the initial 12-week period
| Reason for Discontinuation | Incidence | Context |
|---|---|---|
| Dry mouth | 1.5% | Most common reason across all doses; dose-related severity |
| Constipation | <1% | Severe cases (fecal impaction, obstruction) reported only at 10 mg dose in pivotal trials |
| Blurred vision | <1% | Accommodation disturbance; typically mild |
Managing Dry Mouth and Constipation
Dry mouth is the adverse effect most likely to limit treatment. Practical strategies include frequent water sips, sugar-free gum or lozenges, and saliva substitutes. For constipation, recommend increased dietary fibre and fluid intake before starting treatment. If constipation becomes bothersome, a stimulant laxative or osmotic agent may be considered. Instruct patients to seek medical attention promptly if they experience severe abdominal pain or more than 3 days without a bowel movement, as rare cases of fecal impaction and colonic obstruction have been reported.
Drug Interactions
Solifenacin is primarily metabolised by CYP3A4. It does not significantly inhibit CYP1A2, 2C9, 2C19, 2D6, or 3A4 at therapeutic concentrations, so the risk of solifenacin affecting levels of co-administered drugs is low. However, drugs that modulate CYP3A4 activity can substantially alter solifenacin exposure.
Major
Ketoconazole (and other strong CYP3A4 inhibitors)
MechanismStrong CYP3A4 inhibition blocks primary metabolic pathway
EffectCmax increased 1.5-fold and AUC increased 2.7-fold with ketoconazole 400 mg daily
ManagementDo not exceed solifenacin 5 mg/day; applies to itraconazole, ritonavir, nelfinavir, clarithromycin, and similar potent CYP3A4 inhibitors
FDA PI
Major
QT-prolonging agents
MechanismAdditive QT prolongation; solifenacin 30 mg (3x max dose) associated with mean QTcF increase of 8 msec
EffectIncreased risk of cardiac arrhythmias including torsade de pointes
ManagementAvoid combination in patients with known QT prolongation, uncorrected hypokalaemia, or concurrent Class IA/III antiarrhythmics; obtain baseline ECG if clinically indicated
FDA PI
Moderate
Other anticholinergic drugs
MechanismPharmacodynamic: additive antimuscarinic effects across multiple organ systems
EffectIncreased risk of dry mouth, constipation, urinary retention, cognitive impairment, heat intolerance, and anticholinergic toxicity
ManagementReview total anticholinergic burden; minimise concurrent anticholinergics especially in elderly; consider Anticholinergic Cognitive Burden scale
Lexicomp
Moderate
CYP3A4 inducers (rifampicin, phenytoin, carbamazepine)
MechanismEnhanced CYP3A4 activity accelerates solifenacin metabolism
EffectReduced solifenacin plasma concentrations and potentially diminished efficacy
ManagementMonitor for reduced bladder symptom control; dose increase may be considered clinically but no formal guidance exists
FDA PI
Minor
Digoxin
MechanismPossible P-glycoprotein interaction
EffectDigoxin Cmax increased by 13% and AUC increased by 4% when co-administered with solifenacin 10 mg
ManagementChanges not clinically significant at standard digoxin doses; routine monitoring sufficient
FDA PI
Minor
Warfarin
MechanismNo significant CYP-mediated interaction demonstrated
EffectR-warfarin AUC decreased by 2%; S-warfarin AUC increased by 1% — clinically insignificant
ManagementNo dose adjustment needed; standard INR monitoring
FDA PIMonitoring
-
Post-Void Residual
Baseline; repeat if symptoms suggest retention
Trigger-based Measure PVR before initiation in patients with suspected bladder outlet obstruction or weak urinary stream; repeat if urinary hesitancy, straining, or incomplete emptying develop during treatment -
Renal Function
Baseline; annually in at-risk patients
Routine Serum creatinine and estimated CrCl before starting therapy; dose capped at 5 mg/day if CrCl <30 mL/min; periodic reassessment in elderly or patients with progressive renal disease -
Hepatic Function
Baseline
Routine Assess hepatic function before initiation; do not exceed 5 mg/day in moderate hepatic impairment (Child-Pugh B); contraindicated in severe hepatic impairment (Child-Pugh C) -
Symptom Response
4–8 weeks after initiation; then every 6–12 months
Routine Reassess OAB symptoms using voiding diary or validated questionnaire at each visit; consider dose escalation to 10 mg if 5 mg is well tolerated but inadequately effective; periodically reassess continued need for treatment -
Cognitive Function
Periodically in elderly patients
Trigger-based Monitor for confusion, hallucinations, or cognitive decline, particularly in patients over 65 years or those taking other medications with anticholinergic properties; consider total anticholinergic burden -
Intraocular Pressure
Baseline if narrow-angle glaucoma treated
Trigger-based Use with caution in patients being treated for narrow-angle glaucoma; contraindicated in uncontrolled narrow-angle glaucoma; coordinate with ophthalmology -
Bowel Function
Each clinic visit
Routine Ask about constipation at each visit; counsel patients to seek attention if ≥3 days without bowel movement or if they develop severe abdominal pain; rare cases of fecal impaction and intestinal obstruction reported
Contraindications & Cautions
Absolute Contraindications
- Urinary retention: Solifenacin may worsen urinary retention and cause kidney injury in patients with pre-existing retention
- Gastric retention: Antimuscarinic action can further impair gastric emptying in patients with gastroparesis or gastric outlet obstruction
- Uncontrolled narrow-angle glaucoma: Mydriatic effect may precipitate an acute angle-closure crisis
- Known hypersensitivity: Hypersensitivity to solifenacin succinate or any excipient; prior angioedema or anaphylaxis with solifenacin
- Severe hepatic impairment (Child-Pugh C): Drug has not been studied in this population; significant accumulation expected
Relative Contraindications (Specialist Input Recommended)
- Clinically significant bladder outlet obstruction without urinary retention: Risk of precipitating urinary retention; urodynamic assessment recommended before initiation; coordinate with urology
- Known QT prolongation or concurrent QT-prolonging drugs: At supratherapeutic doses (30 mg), solifenacin was associated with a mean QTcF increase of 8 msec; avoid in high-risk patients
- Severe renal impairment (CrCl <30 mL/min) requiring >5 mg: Do not exceed 5 mg/day due to 2.1-fold AUC increase
- Concurrent strong CYP3A4 inhibitor therapy: Do not exceed 5 mg/day if concurrent use cannot be avoided
Use with Caution
- Controlled narrow-angle glaucoma: Use only under ophthalmologic supervision
- Decreased gastrointestinal motility: May exacerbate constipation and reduce GI transit; not recommended in patients with conditions associated with decreased GI motility
- Elderly patients: Higher plasma levels (Cmax and AUC 20–25% increased); increased sensitivity to anticholinergic CNS effects; assess cognitive function and total anticholinergic burden
- Myasthenia gravis: Antimuscarinic agents may theoretically reduce acetylcholine availability at the neuromuscular junction; use with vigilance
- Hot environments: Decreased sweating from antimuscarinic action increases heat prostration risk; advise patients exercising or working in heat
FDA Class-Wide Safety Advisory
Antimuscarinic Agents — Cognitive and Fall Risk in Elderly
Anticholinergic medications as a class are associated with an increased risk of cognitive impairment, confusion, and falls in older adults. The Beers Criteria (AGS 2023) recommend avoiding strong anticholinergic agents in patients aged 65 and older when alternatives exist. While solifenacin has lower CNS penetration than oxybutynin, clinicians should assess total anticholinergic burden, monitor cognitive function, and consider non-pharmacological OAB interventions or beta-3 agonists (mirabegron, vibegron) in elderly patients at risk of cognitive decline.
Patient Counselling
Purpose of Therapy
Solifenacin helps manage overactive bladder symptoms by relaxing the bladder muscle, allowing it to hold more urine before the urge to void arises. This reduces the frequency of urination, the intensity of urgency, and episodes of incontinence. It does not cure the underlying bladder condition but provides symptomatic relief that improves daily function and quality of life.
How to Take
Take one tablet once daily, swallowed whole with water. The tablet can be taken at any time of day, with or without food, but taking it at the same time each day helps maintain consistent drug levels. If a dose is missed, skip it and take the next dose at the usual time the following day; do not double the dose.
Dry Mouth
Tell patient
Dry mouth is the most common side effect and is usually manageable. Sip water frequently throughout the day, use sugar-free gum or lozenges to stimulate saliva, and maintain good oral hygiene. It is typically worst in the first few weeks and may improve over time.
Call prescriber
If dry mouth becomes severe enough to interfere with eating, sleeping, or wearing dentures, or if mouth sores or dental problems develop.
Constipation
Tell patient
Constipation can occur, especially at the higher 10 mg dose. Increase dietary fibre (fruits, vegetables, whole grains), drink plenty of water, and maintain regular physical activity. An over-the-counter osmotic laxative (e.g., polyethylene glycol) may be used if needed.
Call prescriber
If you have not had a bowel movement for 3 or more days, develop severe abdominal pain or bloating, or notice blood in stools.
Blurred Vision & Drowsiness
Tell patient
Solifenacin may cause blurred vision or drowsiness. Do not drive, operate heavy machinery, or engage in hazardous activities until you know how the medication affects you. These effects are usually mild and tend to settle as your body adjusts.
Call prescriber
If vision problems persist beyond the first week or worsen, or if you experience significant drowsiness that affects your daily functioning.
Heat Sensitivity
Tell patient
This medication can reduce sweating, making you more susceptible to overheating. In hot weather or during vigorous exercise, stay well hydrated, take breaks in shaded or cool areas, and wear light clothing. Watch for signs of heat-related illness such as dizziness, nausea, or a rapid increase in body temperature.
Call prescriber
If you experience symptoms of heat exhaustion such as feeling faint, confused, or developing a very high temperature.
Allergic Reactions
Tell patient
Rarely, solifenacin can cause serious allergic reactions including swelling of the face, lips, tongue, or throat, and severe difficulty breathing. These reactions can occur after the first dose or after multiple doses.
Call prescriber
Stop the medication immediately and seek emergency medical attention if you experience swelling of the tongue or throat, difficulty breathing, widespread rash, or hives.
Difficulty Urinating
Tell patient
Although solifenacin treats bladder overactivity, in some people it can make it harder to empty the bladder completely. This is more likely if you already have trouble with urine flow or have an enlarged prostate.
Call prescriber
If you notice difficulty starting urination, a weak stream, incomplete emptying, or inability to urinate at all — seek prompt medical attention.
Sources
Regulatory (PI / SmPC)
- VESIcare (solifenacin succinate) tablets — Full Prescribing Information. Astellas Pharma US, Inc. Revised May 2020. FDA Label Primary regulatory source for adult OAB indication, dosing, adverse reactions (Table 1), pharmacokinetics, and contraindications.
- VESIcare LS (solifenacin succinate) oral suspension — Full Prescribing Information. Astellas Pharma US, Inc. 2020. FDA Label Regulatory source for pediatric NDO indication with weight-based dosing tables for the oral suspension formulation.
- Solifenacin succinate tablets — DailyMed label. National Library of Medicine. DailyMed Generic label confirming dosing, renal and hepatic adjustment thresholds, and CYP3A4 interaction guidance.
Key Clinical Trials
- Chapple CR, Rechberger T, Al-Shukri S, et al. Randomized, double-blind placebo- and tolterodine-controlled trial of the once-daily antimuscarinic agent solifenacin in patients with symptomatic overactive bladder. BJU Int. 2004;93(3):303–310. PubMed: 14764127 Pivotal phase III trial (YM-905 Study) in 1,077 OAB patients demonstrating efficacy of solifenacin 5 mg and 10 mg versus placebo and tolterodine.
- Chapple CR, Martinez-Garcia R, Selvaggi L, et al. A comparison of the efficacy and tolerability of solifenacin succinate and extended release tolterodine at treating overactive bladder syndrome: results of the STAR trial. Eur Urol. 2005;48(3):464–470. PubMed: 15990220 Head-to-head comparative trial showing solifenacin 5/10 mg provided a 44% greater reduction in incontinence episodes versus tolterodine ER 4 mg at 4 weeks.
- Cardozo L, Hessdörfer E, Milani R, et al. Solifenacin in the treatment of urgency and other symptoms of overactive bladder: results from a randomized, double-blind, placebo-controlled, rising-dose trial (SUNRISE). BJU Int. 2008;102(9):1120–1127. PubMed: 18990175 SUNRISE trial evaluating flexible 5-to-10 mg dosing in 863 patients; demonstrated that dose escalation further improved urgency and micturition frequency.
- Cardozo L, Amarenco G, Pushkar D, et al. Severity of overactive bladder symptoms and response to dose escalation in a randomized, double-blind trial of solifenacin (SUNRISE). BJU Int. 2013;111(5):804–810. PubMed: 23294801 SUNRISE subanalysis confirming that patients with more severe baseline symptoms benefit most from dose escalation to 10 mg.
Guidelines
- Lightner DJ, Gomelsky A, Souter L, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline amendment 2019. J Urol. 2019;202(3):558–563. PubMed: 31039103 AUA/SUFU guideline positioning antimuscarinics as second-line pharmacotherapy for OAB after behavioural interventions, with dose modification guidance.
- American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2023 updated AGS Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2023;71(7):2052–2081. PubMed: 37139824 Lists antimuscarinics as potentially inappropriate in older adults due to cognitive impairment and fall risk; informs risk-benefit discussions for solifenacin in elderly.
Mechanistic / Basic Science
- Abrams P, Andersson KE. Muscarinic receptor antagonists for overactive bladder. BJU Int. 2007;100(5):987–1006. PubMed: 17922784 Comprehensive review of muscarinic receptor pharmacology underlying antimuscarinic OAB therapy, including M3 receptor selectivity of solifenacin.
- Solifenacin — LiverTox entry. National Institute of Diabetes and Digestive and Kidney Diseases. Last updated July 2023. LiverTox Confirms solifenacin has not been implicated in clinically significant hepatotoxicity despite nearly two decades of widespread use.
Pharmacokinetics / Special Populations
- Franco I, Hoebeke P, Baka-Ostrowska M, et al. Long-term efficacy and safety of solifenacin in pediatric patients aged 6 months to 18 years with neurogenic detrusor overactivity: results from two phase 3 prospective open-label studies. J Pediatr Urol. 2020;16(2):180.e1–180.e8. PubMed: 32007426 Phase 3 data (MONKEY/MARMOSET trials) supporting solifenacin efficacy and tolerability in pediatric NDO with clinically meaningful increases in maximum cystometric capacity.
- Tannenbaum S, den Adel M, Krauwinkel W, et al. Pharmacokinetics of solifenacin in pediatric populations with overactive bladder or neurogenic detrusor overactivity. Pharmacol Res Perspect. 2020;8(6):e00684. PMC7685239 Population pharmacokinetic analysis from three phase III pediatric trials confirming similar PK characteristics across OAB and NDO populations.
- Bolduc S, Upadhyay J, Payton J, et al. Prospective open label study of solifenacin for overactive bladder in children. J Urol. 2010;184(4 Suppl):1668–1673. PubMed: 20728124 Early prospective data on adjusted-dose solifenacin (1.25–10 mg) in 72 children with refractory OAB demonstrating significant urodynamic improvement.