solifenacin (Rx)

Brand and Other Names:VESIcare, VESIcare LS
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 5mg (VESIcare)
  • 10mg (VESIcare)

Overactive Bladder

VESIcare only

Indicated for treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency

5 mg PO qDay, may increase to 10 mg/day if well tolerated

Dosing Modifications

Renal impairment

  • Mild-to-moderate (CrCl ≥30 mL/min): No dosage adjustment necessary
  • Severe (CrCl <30 mL/min): Not to exceed 5 mg/day

Hepatic impairment

  • Mild (Child-Pugh A): No dosage adjustment necessary
  • Moderate (Child-Pugh B): Not to exceed 5 mg/day
  • Severe (Child-Pugh class C): Not recommended

CYP3A4 inhibitors

  • Coadministration with strong CYP3A4 (eg, ketoconazole): Solifenacin dose not to exceed 5 mg/day

Dosage Forms & Strengths

oral suspension

  • 1mg/mL (VESIcare LS)

Neurogenic Detrusor Overactivity

VESIcare LS only

Indicated for treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged ≥2 years

<2 years: Safety and efficacy not established

≥2 years

  • Oral suspension concentration 1 mg/mL
  • 9 to 15 kg: 2 mL PO qDay initially; not to exceed 4 mL/day
  • >15 to 30 kg: 3 mL PO qDay initially; not to exceed 5 mL/day
  • >30 to 45 kg: 3 mL PO qDay initially; not to exceed 6 mL/day
  • >45 to 60 kg: 4 mL PO qDay initially; not to exceed 8 mL/day
  • >60 kg: 5 mL PO qDay initially; not to exceed 10 mL/day

Dosage Modifications

Renal impairment

  • Mild-to-moderate (CrCl ≥30 mL/min): No dosage adjustment necessary
  • Severe (CrCl <30 mL/min): Not to exceed starting dose for weight range

Hepatic impairment

  • Mild (Child-Pugh A): No dosage adjustment necessary
  • Moderate (Child-Pugh B): Not to exceed starting dose for weight range
  • Severe (Child-Pugh class C): Not recommended

Strong CYP3A4 inhibitors

  • Coadministration with strong CYP3A4 (eg, ketoconazole): Solifenacin dose not to exceed starting dose for weight range
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Interactions

Interaction Checker

and solifenacin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            tablets

            • Dry mouth (10.6-27.6%)
            • Constipation (5.4-13.4%)

            1-10%

            tablets

            • Blurred vision (3.8-4.8%)
            • Urinary tract infection NOS (2.8-4.8%)
            • Dyspepsia (1.4-3.9%)
            • Nausea (1.7-3.3%)
            • Influenza (0.9-2.2%)
            • Fatigue (1-2.1%)
            • Dizziness (1.8-1.9%)
            • Upper abdominal pain (1.2-1.9%)
            • Dry eyes NOS (0.3-1.6%)
            • Urinary retention (1.4%)
            • Hypertension NOS (0.5-1.4%)
            • Depression NOS (0.8-1.2%)
            • Edema lower limb (0.3-1.1%)
            • Vomiting (0.2-1.1%)
            • Cough (0.2-1.1%)

            Oral suspension

            • Constipation (7.4%)
            • Dry mouth (3.2%)
            • Urinary tract infection (2.1%)
            • Abdominal pain (1.1%)
            • Positive urinalysis bacterial test (1.1%)
            • Somnolence (1.1%)

            Postmarketing Reports

            General disorders and administration site conditions: Peripheral edema, hypersensitivity reactions (including angioedema with airway obstruction, rash, pruritus, urticaria, anaphylactic reaction)

            Nervous system disorders: Dizziness, headache, confusion, hallucinations, delirium, somnolence

            Cardiac disorders: QT prolongation, torsade de pointes, atrial fibrillation, tachycardia, palpitations

            Hepatobiliary disorders: Liver disorders mostly characterized by abnormal liver function tests (ie, AST, ALT, GGT)

            Renal and urinary disorders: renal impairment, urinary retention

            Metabolism and nutrition disorders: Decreased appetite, hyperkalemia

            Skin and subcutaneous tissue disorders: Exfoliative dermatitis, erythema multiforme, dry skin

            Eye disorders: Glaucoma

            Gastrointestinal disorders: Gastroesophageal reflux disease, ileus, vomiting, abdominal pain, dysgeusia, sialadenitis

            Respiratory, thoracic and mediastinal disorders: Dysphonia, nasal dryness

            Musculoskeletal and connective tissue disorders: Muscular weakness

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            Warnings

            Contraindications

            Hypersensitivity

            Gastric retention

            Uncontrolled narrow-angle glaucoma

            tablets only

            • Urinary retention

            Cautions

            Reports of angioedema of face, lips and/or larynx, in some cases occurring after the first dose, described; anaphylactic reactions reported rarely

            Administer with caution with clinically significant bladder outflow obstruction

            Caution with decreased gastrointestinal motility

            Somnolence reported; advise patients not to drive or operate heavy machinery until they know how therapy affects them

            Caution in patients being treated for narrow-angle glaucoma

            Caution with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval

            Associated with antimuscarinic CNS adverse reactions; monitor for signs of antimuscarinic CNS adverse reactions, particularly after beginning treatment or increasing the dose

            Drug interaction overview

            • Solifenacin is a CYP3A4 substrate
            • Coadministration of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin; modify solifenacin dose if coadministered with strong CYP3A4 inhibitors
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            Pregnancy & Lactation

            Pregnancy

            There are no studies on use in pregnant females

            Animal data

            • No adverse developmental outcomes were observed in animal reproduction studies with oral solifenacin succinate to pregnant mice during organogenesis at a 10 mg/day dose (1.2x the maximum recommended human dose [MRHD])
            • Administration of doses ≥3.6x the MRHD during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring

            Lactation

            No information available

            Solifenacin is present in mouse milk

            When a drug is present in animal milk, it is likely to be present in human milk

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Competitive muscarinic-receptor antagonist

            Absorption

            Peak plasma concentration

            • Tablets: 32.3 ng/mL (5-mg dose); 62.9 ng/mL (10-mg dose)
            • Solution: 2.5-29 ng/mL

            Peak plasma time

            • Tablets: 3 hr (5-mg dose); 8 hr (10-mg dose)
            • Solution: 2-6 hr

            Bioavailability

            • Tablets or solution: ~90%

            Distribution

            Protein bound: 98%

            Metabolism

            Extensively metabolized by the liver, primarily CYP3A4

            Metabolites: 4R-hydroxy solifenacin (active); N-glucuronide, N-oxide, and 4R-hydroxyN-oxide of solifenacin (inactive)

            Elimination

            Excretion: Urine (69%), feces (23%)

            Half-life

            • Adults: 45-68 hr
            • Children and adolescents: ~26 hr
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            Administration

            Oral Administration

            Tablets

            • May take with or without food
            • Administer with water and swallow whole

            Oral suspension

            • Shake bottle well before administration of each dose
            • Take once daily, followed by liquid (eg, water or milk) after each dose
            • Missed dose
              • Missed dose <12 hr: Take as soon as possible
              • Missed dose >12 hr: Skip dose and wait for next scheduled dose

            Storage

            Tablets

            • Store at 25ºC (68-77ºF) with excursions permitted to 15-30ºC (59-86ºF)

            Oral suspension

            • Store at 20-25ºC (68-77ºF) with excursions permitted to 15-30ºC (59-86ºF)
            • Store in original bottle to protect from degradation; discard any unused product 28 days after opening the original bottle
            • Dispense in a tight, light-resistant container
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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.