solifenacin (Rx)

Brand and Other Names:VESIcare
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 5mg
  • 10mg

Overactive Bladder

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

Monotherapy

  • 5 mg PO qDay; may be increased to 10 mg PO qDay

Combination with beta3 agonists

  • Indicated in combination with mirabegron for treatment of OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency
  • Combination regimen: 5 mg PO qDay in combination with mirabegron 25 mg PO qDay

Dosing Modifications

Renal impairment

  • CrCl <30 mL/min: Not to exceed 5 mg/day

Hepatic impairment

  • Moderate: Not to exceed 5 mg/day
  • Severe (Child-Pugh class C): Not recommended

CYP3A4 inhibitors

  • Strong CYP3A4 (eg, ketoconazole): Not to exceed 5 mg/day

Safety and efficacy not established

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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%

            Dry mouth

            Constipation

            1-10%

            Abdominal pain

            Blurred vision

            Constipation (with 5 mg)

            Cough (with 10 mg)

            Depression (with 5 mg)

            Dizziness

            Dry eyes

            Dyspepsia

            Edema (with 10 mg)

            Fatigue

            Hypertension (with 5 mg)

            Influenza (with 5 mg)

            Nausea

            Pharyngitis (with 10 mg)

            Urinary retention (with 10 mg)

            Urinary tract infection

            Vomiting (with 10 mg)

            <1%

            Cough (with 5 mg)

            Depression (with 10 mg)

            Dry eyes (with 5 mg)

            Hypertension (with 10 mg)

            Influenza (with 10 mg)

            Lower-limb edema (with 5 mg)

            Pharyngitis (with 5 mg)

            Vomiting (with 5 mg)

            Postmarketing Reports

            General: Peripheral edema, hypersensitivity reactions (including angioedema with airway obstruction, rash, pruritus, urticaria, anaphylactic reaction)

            Neurologic: Headache, confusion, hallucinations, delirium, somnolence

            Cardiovascular: QT prolongation, torsades de pointes, atrial fibrillation, tachycardia, palpitations

            Dermatologic: Exfoliative dermatitis, erythema multiforme, dry skin

            Hepatic: Liver disorders, mostly characterized by abnormal liver function test (LFT) results (aspartate aminotransferase [AST], alanine aminotransferase [ALT], gamma-glutamyl transpeptidase [GGT])

            Renal: Renal impairment

            Metabolic and nutritional: Decreased appetite, hyperkalemia

            Musculoskeletal: Muscular weakness

            Ophthalmologic: Glaucoma

            Gastrointestinal (GI): Gastroesophageal reflux disease, ileus, dysgeusia

            Respiratory, thoracic, and mediastinal disorders: Dysphonia, nasal dryness

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            Warnings

            Contraindications

            Hypersensitivity

            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 to patients with clinically significant bladder outflow obstruction

            Use with caution in patients with decreased gastrointestinal motility

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

            Use with caution in patients being treated for narrow-angle glaucoma

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

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Avoid using drug, or do not nurse

            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

            Bioavailability: 90%

            Peak plasma time: 3-8 hr

            Distribution

            Protein bound: 98%

            Metabolism

            Metabolized in liver, primarily by CYP3A4

            Elimination

            Half-life: 45-68 hr

            Excretion: Urine (69.2%), feces (22.5%)

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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.
            OR Other Restrictions
            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.