nebivolol (Rx)

Brand and Other Names:Bystolic
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

tablet

  • 2.5mg
  • 5mg
  • 10mg
  • 20mg
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Hypertension

5 mg/day PO; may be increased every 2 weeks; not to exceed 40 mg/day

Dosing Modifications

Renal impairment

  • CrCl >30-80 mL/min: Dose adjustment not listed by the manufacturer
  • CrCl <30 mL/min: 2.5 mg/day PO initially; increased cautiously

Hepatic impairment

  • Mild impairment (Child-Pugh A): Dose adjustment not listed by the manufacturer
  • Moderate Impairment (Child-Pugh Class B): 2.5 mg PO once daily; increase cautiously if initial response inadequate
  • Severe impairment (Child-Pugh Class C): Contraindicated

Safety and efficacy not established

Hypertension

5 mg/day PO; may be increased every 2 weeks; not to exceed 40 mg/day

Heart Failure

<70 years: Not established

>70 years: 1.25 mg/day PO; may be increased by 2.5 mg/day every 1 or 2 weeks; not to exceed 10 mg/day

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Interactions

Interaction Checker

and nebivolol

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Headache (6-9%)

            Fatigue (2-5%)

            Dizziness (2-4%)

            Diarrhea (2-3%)

            Nausea (1-3%)

            Increased triglyceride levels and insulin resistance, decreased high-density lipoprotein (HDL) levels (1%)

            Insomnia (1%)

            Peripheral edema (1%)

            Weakness (1%)

            <1%

            Bradycardia

            Chest pain

            Dyspnea

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            Warnings

            Contraindications

            Hypersensitivity

            Severe hepatic impairment

            Cardiogenic shock

            Sick sinus syndrome (if no pacemaker)

            2°/3° heart block (if no pacemaker)

            Bradycardia (HR <50 beats/min)

            Decompensated heart failure

            Severe hepatic impairment (Child-Pugh Class C)

            Cautions

            Anesthetics that cause myocardial depression, bradycardia, 1° heart block, ischemic heart disease, Prinzmetal angina, untreated congestive heart failure (CHF)

            Patients with bronchospastic disease should not receive beta-blockers; patients with bronchospastic disease who do not respond to other therapies, initial low doses may be employed and used cautiously; monitor closely; patient should have immediate access to beta2-agonist

            May mask hyperthyroidism, including tachycardia; abrupt withdrawal may exacerbate symptoms of hyperthyroidism or precipitate thyroid storm; if thyrotoxicosis suspected, carefully manage and treat

            Severe renal impairment decreases clearance; adjust dose in severe renal failure

            Moderate hepatic impairment decreases metabolism ; adjust dose in moderate hepatic impairment (Child-Pugh class B); contraindicated in severe hepatic impairment (Child-Pugh class C)

            May potentiate hypoglycemia in patients with hypoglycemia and/or mask signs and symptoms

            Sudden discontinuance can exacerbate angina and lead to MI; to discontinue therapy, taper gradually over 1-2 weeks to avoid acute tachycardia, ischemia, and/or hypertension; temporary but prompt resumption of beta-blocker therapy may be necessary if angina symptoms or acute coronary insufficiency symptoms worsen

            Can precipitate or worsen symptoms of arterial insufficiency in patients with peripheral and Raynaud disease (intermittent claudication); use caution; monitor for progression of arterial obstruction

            Renal disease, cerebrovascular insufficiency, use in pheochromocytoma (alpha blocker should be started before beta blocker)

            Increased risk of stroke after surgery; routine withdrawal of chronic beta-blocker therapy not recommended prior to major surgery

            Use with caution in patients with myasthenia gravis

            Use with caution in patients taking calcium-channel blockers or cardiac glycosides or using inhaled anesthetics

            Drug loses receptor selectivity in poor metabolizers and in high doses (blocks both beta1 and beta2)

            Excerbation or induction of psoriasis associated with psoriasis; use caution

            Not shown to reduce morbidity or mortality in heart failure population; bisoprolol, carvedilol, and extended release metoprolol only beta blockers proven to reduce mortality; use caution in patients with compensated heart failure and monitor for worsening of condition; temporarily discontinue or reduce dose if condition worsens; stabilize patients on heart failure regimen before initiating beta-blocker therapy; initiate therapy at very low doses; may require adjustment of other medications, including ACE inhibitors and/or diuretics

            May cause or exacerbate CNS depression; use caution in patient with psychiatric disorder

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Not known whether drug is excreted into breast milk; use not recommended

            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 and selective beta1-receptor antagonist; has little or no effect on beta2 receptors at doses <10 mg; possesses mild vasodilating properties; reduces systemic vascular resistance

            Absorption

            Bioavailability: Extensive metabolizers, 12%; poor metabolizers, 96%

            Peak plasma time: 1.5-4 hr

            Distribution

            Protein bound: 98%

            Vd: 8-12 L/kg

            Metabolism

            Metabolized by CYP2D6 via alicyclic and aromatic hydroxylation, N-dealkylation, glucuronidation

            Elimination

            Half-life: Extensive metabolizers, 10-12 hr; poor metabolizers, 19-32 hr

            Excretion: Urine (38-67%), feces (13-44%)

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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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