(sol i FEN a sin)
Treatment of overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence
Hypersensitivity to solifenacin or any component of the formulation; urinary retention; gastric retention; uncontrolled narrow-angle glaucoma.
Overactive bladder: Oral: 5 mg once daily; if tolerated, may increase to 10 mg once daily
Dosage adjustment with concomitant CYP3A4 inhibitors: Maximum solifenacin dose: 5 mg/day
Base dosing on renal/hepatic function.
Use with caution in reduced renal function; CrCl <30 mL/minute: Maximum dose: 5 mg/day
Use with caution in reduced hepatic function:
Moderate (Child-Pugh class B): Maximum dose: 5 mg/day
Severe (Child-Pugh class C): Use is not recommended
Swallow tablet whole; administer with liquids; may be administered without regard to meals.
May be taken without regard to meals.
Store at controlled room temperature of 25 ‚ °C (77 ‚ °F); excursions permitted to 15 ‚ °C to 30 ‚ °C (59 ‚ °F to 86 ‚ °F).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as succinate:
VESIcare: 5 mg, 10 mg
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy
Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of Solifenacin. Applicable Isavuconazonium considerations are addressed in separate monographs. Exceptions: Isavuconazonium Sulfate. Consider therapy modification
Aprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Exceptions: Cannabidiol. Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination
Conivaptan: May increase the serum concentration of CYP3A4 Substrates. Avoid combination
CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. 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. Monitor therapy
CYP3A4 Inhibitors (Strong): May decrease the metabolism of CYP3A4 Substrates. Consider therapy modification
Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. 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
Dasatinib: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination
Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates. 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
Fosaprepitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Fusidic Acid (Systemic): May increase the serum concentration of CYP3A4 Substrates. 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. Avoid combination
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination
Highest Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification
Idelalisib: May increase the serum concentration of CYP3A4 Substrates. 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
Ivacaftor: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination
Luliconazole: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
MiFEPRIStone: May increase the serum concentration of CYP3A4 Substrates. 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
MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification
Mirabegron: May enhance the adverse/toxic effect of Solifenacin. Specifically, the risk of acute urinary retention may be enhanced. Mirabegron may increase the serum concentration of Solifenacin. Monitor therapy
Mitotane: May decrease the serum concentration of CYP3A4 Substrates. Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification
Moderate Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy
Netupitant: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy
Osimertinib: May increase the serum concentration of CYP3A4 Substrates. Osimertinib may decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Palbociclib: May increase the serum concentration of CYP3A4 Substrates. 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
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification
Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy
Simeprevir: May increase the serum concentration of CYP3A4 Substrates. Monitor therapy
St Johns Wort: May decrease the serum concentration of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification
Stiripentol: May increase the serum concentration of CYP3A4 Substrates. 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. 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
Anticholinergic effects (eg, fixed and dilated pupils, blurred vision, tremors, or dry skin); creatinine clearance (prior to treatment for dosing adjustment); liver function
>10%: Gastrointestinal: Xerostomia (11% to 28%; dose-related), constipation (5% to 13%; dose-related)
1% to 10%:
Cardiovascular: Edema ( ≤1%), hypertension ( ≤1%)
Central nervous system: Fatigue (1% to 2%), depression ( ≤1%)
Gastrointestinal: Dyspepsia (1% to 4%), nausea (2% to 3%), upper abdominal pain (1% to 2%)
Genitourinary: Urinary tract infection (3% to 5%), urinary retention ( ≤1%)
Ophthalmic: Blurred vision (4% to 5%), dry eye syndrome ( ≤2%)
Respiratory: Cough ( ≤1%)
Miscellaneous: Influenza ( ≤2%)
<1% (Limited to important or life-threatening): Abnormal hepatic function tests, anaphylaxis, angioedema, atrial fibrillation, confusion, delirium, erythema multiforme, exfoliative dermatitis, fecal impaction, gastroesophageal reflux disease, gastrointestinal obstruction, glaucoma, hallucination, hyperkalemia, hypersensitivity reactions, intestinal obstruction, palpitations, prolonged Q-T interval on ECG, renal insufficiency, tachycardia, torsades de pointes, voice disorder
There is a 2.1-fold increase in AUC and 1.6-fold increase in half-life of solifenacin in patients with severe renal impairment.
There is a 2-fold increase in the half-life and 35% increase in AUC of solifenacin in patients with moderate hepatic impairment.
Elderly volunteers (65 to 80 y of age) showed that Cmax, AUC, and half-life values were 20% to 25% higher compared with younger volunteers (18 to 55 y of age).
Concerns related to adverse effects:
- Angioedema: Cases of angioedema involving the face, lips, tongue, and/or larynx have been reported during treatment; 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: Central nervous system effects have been reported (eg, headache, confusion, hallucinations, somnolence); monitor, 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 which require mental alertness (eg, operating machinery or 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 with solifenacin; immediately discontinue therapy if anaphylactic reaction develops. Do not use in patients with a known or suspected hypersensitivity.
Disease-related concerns:
- Bladder outflow obstruction: Use with caution in patients with bladder outflow obstruction; increased risk of urinary retention.
- Gastrointestinal disease: Use with caution in patients with gastrointestinal obstructive disorders or decreased gastrointestinal motility.
- 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 is 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 and/or 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:
- High potential for interactions: Patients on potent CYP3A4 inhibitors require the lower dose of solifenacin.
C
Adverse events were observed in some animal reproduction studies.
Inhibits muscarinic receptors resulting in decreased urinary bladder contraction, increased residual urine volume, and decreased detrusor muscle pressure.
Vd: ~600 L
Extensively hepatic; via N-oxidation and 4 R-hydroxylation, forms 1 active and 3 inactive metabolites; primary pathway for elimination is via CYP3A4
Urine (69%; <15% as unchanged drug); feces (23%)
Plasma: 3-8 hours
45-68 hours following chronic dosing; prolonged in severe renal (CrCl <30 mL/minute) or moderate hepatic (Child-Pugh class B) impairment
~98% bound primarily to alpha1-acid glycoprotein
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience dry eyes, blurred vision, nausea, dry mouth, or fatigue. Have patient report immediately to prescriber severe dizziness, passing out, severe loss of strength and energy, difficulty breathing, confusion, hallucinations, severe abdominal pain, severe constipation, lack of sweat, urinary retention, painful urination, bradycardia, tachycardia, arrhythmia, or severe headache (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.