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Solifenacin

Medically reviewed by Drugs.com. Last updated on May 27, 2020.

Pronunciation

(sol i FEN a sin)

Index Terms

  • Solifenacin Succinate
  • Vesicare LS
  • YM905

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as succinate:

VESIcare: 5 mg, 10 mg [contains corn starch]

Generic: 5 mg, 10 mg

Brand Names: U.S.

  • VESIcare

Pharmacologic Category

  • Anticholinergic Agent

Pharmacology

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.

Metabolism

Extensively hepatic; via N-oxidation and 4 R-hydroxylation, forms 1 active and 3 inactive metabolites; primary pathway for elimination is via CYP3A4

Excretion

Urine (69.2%; <15% as unchanged drug); feces (22.5%)

Time to Peak

Plasma:

Children ≥2 years and Adolescents ≤17 years: Oral suspension: 2 to 6 hours.

Adults: Tablets: 3 to 8 hours.

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.

Protein Binding

~98%, primarily to alpha1-acid glycoprotein

Special Populations: Renal Function Impairment

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).

Special Populations: 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).

Special Populations: Elderly

In elderly patients (65 to 80 years), Cmax, AUC, and half-life values were 20% to 25% higher.

Use: Labeled Indications

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.

Contraindications

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

Dosing: Adult

Overactive bladder: Oral: Initial: 5 mg once daily; if tolerated, may increase to 10 mg once daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Pediatric

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.

Administration

Oral: Administer tablet with water without regard to food. Swallow whole. Do not crush or chew.

Storage

Suspension: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F); store in original bottle and dispense in a tight, light-resistant container. Discard unused product 28 days after opening.

Tablet: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Drug Interactions

Abametapir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Acetylcholinesterase Inhibitors: Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Acetylcholinesterase Inhibitors may diminish the therapeutic effect of Anticholinergic Agents. Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy

Aprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination

Clofazimine: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). 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. Consider therapy modification

Conivaptan: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates (High risk with Inducers). Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

CYP3A4 Inhibitors (Moderate): May decrease the metabolism of CYP3A4 Substrates (High risk with Inhibitors). 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. Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Duvelisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Erdafitinib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Erdafitinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fosnetupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Monitor therapy

Idelalisib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Avoid combination

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. 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. Consider therapy modification

Ivosidenib: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Larotrectinib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Minimize doses of CYP3A4 substrates, and monitor for increased concentrations/toxicity, during and 2 weeks following treatment with mifepristone. Avoid cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Consider therapy modification

Mirabegron: May enhance the adverse/toxic effect of Solifenacin. Specifically, the risk of acute urinary retention may be enhanced. Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Netupitant: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). 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. 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. Monitor therapy

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Palbociclib: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

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. Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. 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. Monitor therapy

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Avoid combination

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

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. Consider therapy modification

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Simeprevir: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Monitor therapy

Stiripentol: May increase the serum concentration of CYP3A4 Substrates (High risk with Inhibitors). Management: Use of stiripentol with CYP3A4 substrates that are considered to have a narrow therapeutic index should be avoided due to the increased risk for adverse effects and toxicity. Any CYP3A4 substrate used with stiripentol requires closer monitoring. Consider therapy modification

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates (High risk with Inducers). Monitor therapy

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination

Adverse Reactions

>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

Warnings/Precautions

Concerns related to adverse effects:

• Angioedema: Angioedema involving the face, lips, tongue, and/or larynx have been reported; some cases have occurred after the first dose. May be life-threatening. Immediately discontinue and institute supportive care if tongue, hypopharynx, or larynx is involved.

• CNS effects: CNS effects have been reported (eg, headache, confusion, hallucinations, somnolence); monitor for CNS effects, particularly at treatment initiation or dose increase; reduce dose or discontinue, if necessary. 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. Immediately discontinue therapy if anaphylactic reaction develops.

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). Additional monitoring for decreases in cognition and functional abilities and increased problematic behaviors should be considered in patients with dementia receiving dual therapy with an acetylcholinesterase inhibitor and a bladder anticholinergic, such as solifenacin.

• 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. Contact health care provider for 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).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

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.

Monitoring Parameters

Anticholinergic effects (eg, CNS effects [headache, confusion, hallucinations, somnolence], fixed and dilated pupils, blurred vision, tremors, dry skin); creatinine clearance; hepatic function; post-void residuals when added to alpha-blocker therapy for BPH.

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies.

Patient Education

What is this drug used for?

Tablets:

• It is used to treat an overactive bladder.

Liquid (suspension):

• It is used in some children to treat a bladder problem called neurogenic detrusor overactivity (NDO).

All products:

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Constipation

• Headache

• Blurred vision

• Dry mouth

• Fatigue

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Urinary tract infection like blood in the urine, burning or painful urination, passing a lot of urine, fever, lower stomach pain, or pelvic pain

• Fast heartbeat

• Abnormal heartbeat

• Severe dizziness

• Passing out

• Feeling very tired or weak

• Confusion

• Sensing things that seem real but are not

• Severe stomach pain

• Lack of sweat

• Trouble urinating

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.