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Nebivolol: Drug information

Nebivolol: Drug information
(For additional information see "Nebivolol: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Bystolic
Brand Names: Canada
  • Bystolic
Pharmacologic Category
  • Antihypertensive;
  • Beta-Blocker, Beta-1 Selective
Dosing: Adult
Hypertension

Hypertension (alternative agent):

Note : Not recommended in the absence of specific comorbidities (eg, ischemic heart disease or arrhythmia) (Ref).

Oral: Initial: 5 mg once daily; titrate as needed at 2-week intervals based on patient response to a maximum dose of 40 mg once daily (Ref).

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

Dosing: Kidney Impairment: Adult

CrCl 50 to 80 mL/minute: There are no dosage adjustments provided in the manufacturer’s labeling; however, dose adjustment does not appear necessary.

CrCl 30 to 50 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling; however, dose adjustment is likely not necessary. Following a single 5 mg dose in patients with CrCl 30 to 50 mL/minute, reduction in nebivolol clearance was negligible (~17%) (Ref).

CrCl <30 mL/minute: Initial: 2.5 mg once daily; if initial response is inadequate, may increase cautiously.

Hemodialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

Mild impairment (Child-Pugh class A): There are no dosage adjustments provided in the manufacturer's labeling; use caution.

Moderate impairment (Child-Pugh class B): Initial: 2.5 mg once daily; if initial response is inadequate, may increase cautiously

Severe impairment (Child-Pugh class C): Use is contraindicated.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Cardiovascular: Peripheral edema (1%), bradycardia (≤1%), chest pain (≤1%)

Central nervous system: Headache (6% to 9%), fatigue (dose-related; 2% to 5%), dizziness (2% to 4%), insomnia (1%), paresthesia

Dermatologic: Skin rash (≤1%)

Endocrine & metabolic: Decreased HDL cholesterol, hypercholesterolemia, increased serum triglycerides, increased uric acid

Gastrointestinal: Diarrhea (dose-related; 2% to 3%), nausea (1% to 3%), abdominal pain

Hematologic & oncologic: Decreased platelet count

Neuromuscular & skeletal: Weakness

Renal: Increased blood urea nitrogen

Respiratory: Dyspnea (≤1%)

<1%, postmarketing, and/or case reports: Acute pulmonary edema, acute renal failure, angioedema, atrioventricular block (second and third degree), bronchospasm, claudication, dermatological disease, drowsiness, erectile dysfunction, hepatic insufficiency, hypersensitivity angiitis, hypersensitivity reaction, increased serum ALT, increased serum AST, increased serum bilirubin, myocardial infarction, peripheral ischemia, pruritus, psoriasis, Raynaud's phenomenon, syncope, thrombocytopenia, urticaria, vertigo, vomiting

Contraindications

Hypersensitivity to nebivolol or any component of the formulation; severe bradycardia; heart block greater than first-degree (except in patients with a functioning artificial pacemaker); cardiogenic shock; decompensated heart failure; sick sinus syndrome (unless a permanent pacemaker is in place); severe hepatic impairment (Child-Pugh class C)

Canadian labeling: Additional contraindications (not in US labeling): Severe peripheral arterial circulatory disorders; sinoatrial block; rare hereditary conditions of Galactose intolerance, congenital lactase deficiency or glucose-galactose malabsorption.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylactic reactions: Use caution with history of severe anaphylaxis to a variety of allergens; patients taking beta-blockers may become more sensitive to repeated challenges. Treatment of anaphylaxis (eg, epinephrine) in patients taking beta-blockers may be ineffective or promote undesirable effects.

• Hypoglycemia: Beta-blockers may mask early warning signs of hypoglycemia (eg, tachycardia) and increase the risk of severe or prolonged hypoglycemia. Patients with diabetes mellitus, children, and patients who are fasting (eg, surgery, not eating regularly, vomiting) may be at increased risk. If hypoglycemia occurs, advise patients to seek emergency medical treatment.

Disease-related concerns:

• Bronchospastic disease: In general, patients with bronchospastic disease should not receive beta-blockers; for patients with bronchospastic disease who do not respond to or cannot tolerate other therapies, initial low doses of beta1-selective nebivolol may be employed and used cautiously with close monitoring. Ensure patient has an inhaled beta2-agonist immediately available.

• Diabetes: Use with caution in patients with diabetes mellitus; may potentiate hypoglycemia and/or mask signs and symptoms.

• Heart failure: Nebivolol has not been shown to reduce morbidity or mortality in the general heart failure population; only beta-blockers proven to reduce mortality (ie, bisoprolol, carvedilol, or ER metoprolol succinate) should be used in the treatment of heart failure.

• Hepatic impairment: Use with caution in patients with hepatic impairment; dosage adjustment required with moderate impairment (Child-Pugh class B).

• Kidney impairment: Use with caution in patients with renal impairment; dosage adjustment required with severe renal impairment (CrCl <30 mL/minute). Nebivolol has not been evaluated in dialysis-dependent patients.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis.

• Peripheral vascular disease (PVD) and Raynaud disease: May precipitate or aggravate symptoms of arterial insufficiency in patients with PVD and Raynaud disease. Use with caution and monitor for progression of arterial obstruction.

• Pheochromocytoma (untreated): Adequate alpha-blockade is required prior to use of any beta-blocker.

• Psoriasis: Beta-blocker use has been associated with induction or exacerbation of psoriasis, but cause and effect have not been firmly established.

• Thyroid disease: May mask signs of hyperthyroidism (eg, tachycardia). If hyperthyroidism is suspected, carefully manage and monitor; abrupt withdrawal may exacerbate symptoms of hyperthyroidism or precipitate thyroid storm.

Special populations:

• Older adult: Bradycardia may be observed more frequently in elderly patients (>65 years of age); dosage reductions may be necessary.

Other warnings/precautions:

• Abrupt withdrawal: Beta-blocker therapy should not be withdrawn abruptly (particularly in patients with coronary artery disease), but gradually tapered over 1-2 weeks to avoid acute tachycardia, hypertension, and/or ischemia. Severe exacerbation of angina, ventricular arrhythmias, and myocardial infarction (MI) have been reported following abrupt withdrawal of beta-blocker therapy. Temporary but prompt resumption of beta-blocker therapy may be indicated with worsening of angina or acute coronary insufficiency.

• Major surgery: Chronic beta-blocker therapy should not be routinely withdrawn prior to major surgery.

Dosage Forms: US

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

Tablet, Oral:

Bystolic: 2.5 mg, 5 mg, 10 mg, 20 mg [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]

Generic: 2.5 mg, 5 mg, 10 mg, 20 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Bystolic Oral)

2.5 mg (per each): $7.10

5 mg (per each): $7.31

10 mg (per each): $7.31

20 mg (per each): $7.31

Tablets (Nebivolol HCl Oral)

2.5 mg (per each): $3.19 - $5.75

5 mg (per each): $3.36 - $5.75

10 mg (per each): $3.77 - $5.75

20 mg (per each): $3.77 - $5.75

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

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

Tablet, Oral:

Bystolic: 2.5 mg, 5 mg, 10 mg, 20 mg [contains fd&c blue #2 (indigo carm) aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]

Administration: Adult

Oral: May be administered with or without food.

Use: Labeled Indications

Hypertension: Management of hypertension. Note: Beta-blockers are not recommended as first-line therapy (ACC/AHA [Whelton 2018]).

Metabolism/Transport Effects

Substrate of CYP2D6 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetylcholinesterase Inhibitors: May enhance the bradycardic effect of Beta-Blockers. Risk C: Monitor therapy

Ajmaline: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Alpha2-Agonists: May enhance the AV-blocking effect of Beta-Blockers. Sinus node dysfunction may also be enhanced. Beta-Blockers may enhance the rebound hypertensive effect of Alpha2-Agonists. This effect can occur when the Alpha2-Agonist is abruptly withdrawn. Management: Closely monitor heart rate during treatment with a beta blocker and clonidine. Withdraw beta blockers several days before clonidine withdrawal when possible, and monitor blood pressure closely. Recommendations for other alpha2-agonists are unavailable. Risk D: Consider therapy modification

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider therapy modification

Amiodarone: May enhance the bradycardic effect of Beta-Blockers. Possibly to the point of cardiac arrest. Amiodarone may increase the serum concentration of Beta-Blockers. Risk C: Monitor therapy

Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Antidiabetic Agents: Beta-Blockers (Beta1 Selective) may enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Antipsychotic Agents (Phenothiazines): May enhance the hypotensive effect of Beta-Blockers. Beta-Blockers may decrease the metabolism of Antipsychotic Agents (Phenothiazines). Antipsychotic Agents (Phenothiazines) may decrease the metabolism of Beta-Blockers. Risk C: Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy

Arginine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Artemether and Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Beta2-Agonists: Beta-Blockers (Beta1 Selective) may diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor therapy

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Risk C: Monitor therapy

Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination

Cannabis: Beta-Blockers may enhance the adverse/toxic effect of Cannabis. Specifically, the risk of hypoglycemia may be increased. Risk C: Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Risk D: Consider therapy modification

Cholinergic Agonists: Beta-Blockers may enhance the adverse/toxic effect of Cholinergic Agonists. Of particular concern are the potential for cardiac conduction abnormalities and bronchoconstriction. Risk C: Monitor therapy

CYP2D6 Inhibitors (Moderate): May increase the serum concentration of Nebivolol. Risk C: Monitor therapy

CYP2D6 Inhibitors (Strong): May increase the serum concentration of Nebivolol. Risk C: Monitor therapy

Dexmethylphenidate: May diminish the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Dipyridamole: May enhance the bradycardic effect of Beta-Blockers. Risk C: Monitor therapy

Disopyramide: May enhance the bradycardic effect of Beta-Blockers. Beta-Blockers may enhance the negative inotropic effect of Disopyramide. Risk C: Monitor therapy

DOBUTamine: Beta-Blockers may diminish the therapeutic effect of DOBUTamine. Risk C: Monitor therapy

Dronedarone: May enhance the bradycardic effect of Beta-Blockers. Dronedarone may increase the serum concentration of Beta-Blockers. This likely applies only to those agents that are metabolized by CYP2D6. Management: Use lower initial beta-blocker doses; adequate tolerance of the combination, based on ECG findings, should be confirmed prior to any increase in beta-blocker dose. Increase monitoring for clinical response and adverse effects. Risk D: Consider therapy modification

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy

EPHEDrine (Systemic): Beta-Blockers may diminish the therapeutic effect of EPHEDrine (Systemic). Risk C: Monitor therapy

EPINEPHrine (Nasal): Beta-Blockers (Beta1 Selective) may diminish the therapeutic effect of EPINEPHrine (Nasal). Risk C: Monitor therapy

EPINEPHrine (Oral Inhalation): Beta-Blockers (Beta1 Selective) may diminish the therapeutic effect of EPINEPHrine (Oral Inhalation). Risk C: Monitor therapy

Epinephrine (Racemic): Beta-Blockers (Beta1 Selective) may diminish the therapeutic effect of Epinephrine (Racemic). Risk C: Monitor therapy

EPINEPHrine (Systemic): Beta-Blockers (Beta1 Selective) may diminish the therapeutic effect of EPINEPHrine (Systemic). Risk C: Monitor therapy

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): Beta-Blockers may enhance the vasoconstricting effect of Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates). Risk C: Monitor therapy

Etilefrine: May enhance the bradycardic effect of Beta-Blockers. Beta-Blockers may diminish the therapeutic effect of Etilefrine. Risk C: Monitor therapy

Etofylline: Beta-Blockers may diminish the therapeutic effect of Etofylline. Risk X: Avoid combination

Etrasimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Fexinidazole: Bradycardia-Causing Agents may enhance the arrhythmogenic effect of Fexinidazole. Risk X: Avoid combination

Fingolimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider therapy modification

Flunarizine: May enhance the therapeutic effect of Antihypertensive Agents. Risk C: Monitor therapy

Grass Pollen Allergen Extract (5 Grass Extract): Beta-Blockers may enhance the adverse/toxic effect of Grass Pollen Allergen Extract (5 Grass Extract). More specifically, Beta-Blockers may inhibit the ability to effectively treat severe allergic reactions to Grass Pollen Allergen Extract (5 Grass Extract) with epinephrine. Some other effects of epinephrine may be unaffected or even enhanced (e.g., vasoconstriction) during treatment with Beta-Blockers. Management: Consider alternatives to either grass pollen allergen extract (5 grass extract) or beta-blockers in patients with indications for both agents. Canadian product labeling specifically lists this combination as contraindicated. Risk D: Consider therapy modification

Herbal Products with Blood Pressure Increasing Effects: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy

Indoramin: May enhance the hypotensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Isoproterenol: Beta-Blockers may diminish the therapeutic effect of Isoproterenol. Risk C: Monitor therapy

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Risk C: Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Risk C: Monitor therapy

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Foslevodopa. Risk C: Monitor therapy

Loop Diuretics: May enhance the hypotensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Mavacamten: Beta-Blockers may enhance the adverse/toxic effect of Mavacamten. Specifically, negative inotropic effects may be increased. Risk C: Monitor therapy

Methacholine: Beta-Blockers may enhance the adverse/toxic effect of Methacholine. Risk C: Monitor therapy

Methoxyflurane: May enhance the hypotensive effect of Beta-Blockers. Risk C: Monitor therapy

Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Risk C: Monitor therapy

Midodrine: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Mivacurium: Beta-Blockers may enhance the therapeutic effect of Mivacurium. Risk C: Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

NIFEdipine: May enhance the hypotensive effect of Beta-Blockers. NIFEdipine may enhance the negative inotropic effect of Beta-Blockers. Risk C: Monitor therapy

Nitrendipine: May enhance the therapeutic effect of Beta-Blockers. Risk C: Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May diminish the antihypertensive effect of Beta-Blockers. Risk C: Monitor therapy

Nonsteroidal Anti-Inflammatory Agents (Topical): May diminish the therapeutic effect of Beta-Blockers. Risk C: Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification

Ozanimod: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Patiromer: May decrease the serum concentration of Nebivolol. Management: Administer nebivolol at least 3 hours before or 3 hours after patiromer. Risk D: Consider therapy modification

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Ponesimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider therapy modification

Prazosin: Antihypertensive Agents may enhance the hypotensive effect of Prazosin. Risk C: Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Reserpine: May enhance the bradycardic effect of Beta-Blockers. Reserpine may enhance the hypotensive effect of Beta-Blockers. Risk C: Monitor therapy

Rivastigmine: May enhance the bradycardic effect of Beta-Blockers. Risk X: Avoid combination

Silodosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy

Siponimod: Bradycardia-Causing Agents may enhance the bradycardic effect of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider therapy modification

Succinylcholine: Beta-Blockers may enhance the neuromuscular-blocking effect of Succinylcholine. Risk C: Monitor therapy

Tasimelteon: Beta-Blockers may diminish the therapeutic effect of Tasimelteon. Management: Consider avoiding nighttime administration of beta-blockers during tasimelteon therapy due to the potential for reduced tasimelteon efficacy. Risk D: Consider therapy modification

Terazosin: Antihypertensive Agents may enhance the hypotensive effect of Terazosin. Risk C: Monitor therapy

Theophylline Derivatives: Beta-Blockers (Beta1 Selective) may diminish the bronchodilatory effect of Theophylline Derivatives. Risk C: Monitor therapy

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Risk C: Monitor therapy

Urapidil: Antihypertensive Agents may enhance the hypotensive effect of Urapidil. Risk C: Monitor therapy

White Birch Allergen Extract: Beta-Blockers may enhance the adverse/toxic effect of White Birch Allergen Extract. Specifically, beta-blockers may reduce the effectiveness of beta-agonists that may be required to treat systemic reactions to white birch allergen extract. Risk X: Avoid combination

Reproductive Considerations

Medications considered acceptable for the treatment of chronic hypertension during pregnancy may generally be used in patients trying to conceive. Nebivolol is not considered a preferred agent for use in pregnant patients; consider transitioning to a preferred agent in patients planning to become pregnant (ACC/AHA [Whelton 2018]; ACOG 2019; NICE 2019).

Erectile dysfunction is noted in product labeling following use of nebivolol. As a class, outcomes from available studies evaluating beta-blockers and sexual dysfunction are inconsistent, and the negative effects on erectile function are considered controversial. A clear relationship between use of beta-blockers and erectile dysfunction has not been established. Some reports suggest nebivolol has a lower incidence of sexual dysfunction and may be beneficial for use in patients who report this adverse event with other beta-blockers. Hypertension itself is associated with erectile dysfunction. Patients on a beta-blocker presenting with sexual dysfunction should be evaluated for underlying disease (Farmakis 2021; Levine 2012; Semet 2017; Terentes-Printzios 2022; Viigimaa 2020).

Pregnancy Considerations

Outcome data following maternal use of nebivolol in pregnancy are limited (Humenna 2019; Sullo 2015).

Exposure to beta-blockers during pregnancy may increase the risk for adverse events in the neonate. If maternal use of a beta-blocker is needed, monitor fetal growth during pregnancy; monitor the newborn for 48 hours after delivery for bradycardia, hypoglycemia, and respiratory depression (ESC [Regitz-Zagrosek 2018]).

Chronic maternal hypertension is also associated with adverse events in the fetus/infant. Chronic maternal hypertension may increase the risk of birth defects, low birth weight, premature delivery, stillbirth, and neonatal death. Actual fetal/neonatal risks may be related to the duration and severity of maternal hypertension. Untreated chronic hypertension may also increase the risks of adverse maternal outcomes, including gestational diabetes, preeclampsia, delivery complications, stroke, and myocardial infarction (ACOG 2019).

Patients with preexisting hypertension may continue their medication during pregnancy unless contraindications exist (ESC [Regitz-Zagrosek 2018]). When treatment of hypertension is initiated during pregnancy, agents other than nebivolol may be preferred (ACOG 2019; ESC [Cífková 2020]; ESC [Regitz-Zagrosek 2018]; SOGC [Magee 2022]).

Breastfeeding Considerations

It is not known if nebivolol is present in breast milk.

Breastfeeding is not recommended by the manufacturer due to the potential for beta-blockers to produce serious effects on breastfed infants, especially bradycardia. Use of a beta-blocker other than nebivolol may be preferred in lactating patients (ESC [Cífková 2020]).

Monitoring Parameters

BP, heart rate, ECG; serum glucose (in diabetic patients); signs and symptoms of bronchospasm in patients with existing bronchospastic disease; mental alertness.

Reference Range

BP goal: May vary depending on clinical conditions, different clinical practice guidelines, and expert opinion. Refer to "Clinical Practice Guidelines" for specific treatment goals.

Mechanism of Action

Highly-selective inhibitor of beta1-adrenergic receptors; at doses ≤10 mg nebivolol preferentially blocks beta1-receptors. Nebivolol, unlike other beta-blockers, also produces an endothelium-derived nitric oxide-dependent vasodilation resulting in a reduction of systemic vascular resistance.

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Rapid

Distribution: Vd: 8 to 12 L/kg

Protein binding: ~98%, primarily to albumin

Metabolism: Hepatic; via glucuronidation and CYP2D6; extensive first-pass metabolism to multiple active metabolites with variable activity

Bioavailability: ~12% (extensive metabolizers); 96% (poor metabolizers) (Mangrella 1998)

Half-life elimination: Terminal: 12 hours (extensive metabolizers) or 19 hours (poor metabolizers); up to 32 hours has been reported in poor metabolizers (Mangrella 1998)

Time to peak, plasma: 1.5 to 4 hours

Excretion: Urine (extensive metabolizers: 38%; poor metabolizers: 67%; <0.5% of total dose as unchanged drug); feces (extensive metabolizers: 44%; poor metabolizers: 13%; <0.5% of total dose as unchanged drug)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Clearance was unchanged in patients with mild renal impairment and was reduced negligibly in patients with moderate renal impairment. However, clearance was reduced by 53% in patients with severe renal impairment.

Hepatic function impairment: Cmax increases 3-fold, AUC increases 10-fold, and apparent clearance decreases 86% in patients with moderate hepatic impairment.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Nebicor | Nebilet | Nebistar;
  • (AR) Argentina: Corpres | Gadocor | Moban | Nabila | Nebibloc | Nebicor | Nebilet | Nebivolol denver farma | Nebix | Neoblock | Nidib | Nirpol | Syncrocor;
  • (AT) Austria: Hypoloc | Nebacop | Nebilan | Nebivolol | Nebivolol 1a pharma | Nebivolol actavis | Nebivolol G.L. | Nebivolol genericon | Nebivolol ratiopharm | Nebivolol sandoz | Nebivolol stada | Nomexor;
  • (AU) Australia: Apo nebivolol | Nebilet | Nebivolol sandoz | Nepiten;
  • (BD) Bangladesh: Bipinor | Cardoneb | Ivolol | Maxineb | Nebicard | Nebifast | Nebilol | Nebinor | Nebipres | Nebita | Vasocor;
  • (BE) Belgium: Hypoloc | Nebivolol ab | Nebivolol actavis | Nebivolol Apotex | Nebivolol EG | Nebivolol krka | Nebivolol Mylan | Nebivolol ratiopharm | Nebivolol sandoz | Nebivolol Teva | Nobiten;
  • (BG) Bulgaria: Bivolet | Bravylol | Cardiostad | Dublock | Nebacop | Nebicard | Nebicor | Nebilan | Nebilet | Nebivocon | Nebivolol | Nebivolol actavis | Nebivolol ratiopharm | Nebivolol Teva | Nebizita | Nevolen;
  • (BR) Brazil: Bivolet | Cloridrato de nebivolol | Lobeat | Lobivon | Nebic | Nebilet | Nebipre | Nebitah | Neblock | Teubiliv;
  • (CH) Switzerland: Nebilet | Nebivolol actavis | Nebivolol Axapharm | Nebivolol Helvepharm | Nebivolol mepha | Nebivolol sandoz | Nebivolol spirig | Nebivolol Streuli | Nebivolol Teva | Nebivolol zentiva;
  • (CI) Côte d'Ivoire: Nebilong | Nebinox | Temerit;
  • (CL) Chile: Anfibol | Doox | Nabila | Nebilet | Nebivitae | Nevobi | Pertium;
  • (CO) Colombia: Carvolol | Nabila | Nebilet | Nebilol | Nebivolol | Nebivolol mk | Neviten;
  • (CZ) Czech Republic: Nebilet | Nebivolol aurovitas | Nebivolol sandoz | Nolibeta;
  • (DE) Germany: Lobivon | Nebilet | Nebivolol Acino | Nebivolol actavis | Nebivolol AL | Nebivolol Glenmark | Nebivolol Heumann | Nebivolol puren | Nebivolol ratiopharm | Nebivolol stada;
  • (DO) Dominican Republic: Anfibol | Cipres | Nabila | Nabudol | Nebibrit | Nebilet | Nebipres | Nebiv | Nebivitae | Nebivolol sandoz | Pertium;
  • (EC) Ecuador: Anfibol | Nabila | Nebicor | Pertium;
  • (EE) Estonia: Lovispes | Nebicard | Nebilet | Nebiphar | Nebispes | Nebiten | Nebivolol Orion | Nebivolol Portfarma | Nebivolol ratiopharm | Nebivolol stada | Nebivolol Teva;
  • (EG) Egypt: Mavilor | Modulol | Nebasco | Nebicard | Nebilet | Nebimoun | Nepvol | Nevilob | Symbian;
  • (ES) Spain: Insucor | Lobivon | Nebivolol Apotex | Nebivolol aurovitas | Nebivolol Cinfa | Nebivolol combix | Nebivolol Edigen | Nebivolol kern pharma | Nebivolol krka | Nebivolol Mylan | Nebivolol Normon | Nebivolol Pensa | Nebivolol ratiopharm | Nebivolol sandoz | Nebivolol stada | Nebivolol tarbis | Nebivolol Tevagen | Nebivolol viso farmaceutica | Nebivolol Winthrop | Silostar;
  • (ET) Ethiopia: Nebivolol;
  • (FI) Finland: Hypoloc | Nebilet | Nebivolol Orion;
  • (FR) France: Hypoloc | Nebilox | Nebivolol actavis | Nebivolol almus | Nebivolol Arrow | Nebivolol Biogaran | Nebivolol cristers | Nebivolol Dci | Nebivolol EG | Nebivolol evolugen | Nebivolol isomed | Nebivolol krka | Nebivolol Mylan | Nebivolol Qualimed | Nebivolol Ranbaxy | Nebivolol ratiopharm | Nebivolol sandoz | Nebivolol Teva | Nebivolol Winthrop | Nebivolol Zydus | Nevibolol Dci | Temerit;
  • (GB) United Kingdom: Hypoloc | Nebilet | Nebivolol | Nebivolol Pliva | Nebivolol sandoz | Nebivolol Teva;
  • (GR) Greece: Bivol | Hypoloc | Lobibeta | Lobivon | Nebicur | Nebivolol Teva | Nebivolol/Generics | Nozac;
  • (HK) Hong Kong: Nebilet;
  • (HR) Croatia: Nebilet | Nebivolol Pliva | Nebyol | Nibel | Vibolol | Volone;
  • (HU) Hungary: Esteban | Ezocem | Nebacop | Nebaletor | Nebibeta | Nebiblock | Nebilet | Nebispes | Nebitrix | Nebivep | Nebivogen | Nebivolol 1 A Pharma | Nebivolol Ratiopham | Nebivolol sandoz | Nebivolol Teva | Nevotens;
  • (ID) Indonesia: Nebilet | Nevodio;
  • (IE) Ireland: Nebilet | Nebimel | Nebivolol accord | Nebivolol Teva | Nebol | Nelet;
  • (IN) India: Betalol | Endolol | Nebesel | Nebest | Nebi | Nebicard | Nebicip | Nebilife | Nebilol | Nebilong | Nebimax | Nebinex | Nebinorm | Nebipil | Nebiring | Nebistar | Nebitab | Nebiten | Nebitime | Nebitroy | Nebizok | Nebrol | Nebula | Nebycare | Nevelol | Nevol | Niavas | Nodon | Nubeta | Nuxol | Pine | Zinebi;
  • (IT) Italy: Lobivon | Nebilox | Nebiscon | Nebivololo | Nebivololo actavis | Nebivololo Agenerico | Nebivololo Alter | Nebivololo angenerico | Nebivololo awp | Nebivololo doc generici | Nebivololo dr reddy's | Nebivololo eg | Nebivololo Germed | Nebivololo KRKA | Nebivololo myl | Nebivololo Pensa | Nebivololo Ranbaxy | Nebivololo Ratiopharm | Nebivololo sandoz | Nebivololo teva | Nebivololo Winthrop | Nivolon | Nobistar;
  • (JO) Jordan: Nebilet;
  • (KE) Kenya: Nebi | Nebibio | Nebicard | Nebiem | Nebilet | Nebiloc | Nebilong | Nebiring | Nebiton | Nebivi | Nebtas | Nevol | Nodon;
  • (KR) Korea, Republic of: Nebibeta | Nebilet | Nebilol | Nebistar | Nebistol | Nebitlol | Nevetrol | Nevican | Neviolet | Nevolmin | Nevotron;
  • (KW) Kuwait: Nebilet;
  • (LB) Lebanon: Nebicip n | Nebilet | Nebivolol Biogaran;
  • (LT) Lithuania: Nebilet | Nebinorm | Nebiphar | Nebispes | Nebiten | Nebivolol Aconitum | Nebivolol Orion | Nebivolol Portfarma | Nebivolol ratiopharm | Nebivolol stada | Nebivolol Teva | Nebivolol Torrent | Nemirostad | Nemont | Nerose;
  • (LU) Luxembourg: Nebivolol EG | Nebivolol Hexal | Nobiten;
  • (LV) Latvia: Nebilet | Nebiphar | Nebiten | Nebivolol actavis | Nebivolol krka | Nebivolol Orion | Nebivolol Portfarma | Nebivolol Ratiopharma | Nebivolol stada;
  • (MA) Morocco: Nebilet;
  • (MX) Mexico: Batensiar | Coretel n | Dubila | Lobivon | Nebivolol | Temerit | Temitev;
  • (MY) Malaysia: Nebicard | Nebilet | Nodon;
  • (NG) Nigeria: Nebivolol | Nodon;
  • (NL) Netherlands: Lobivon | Nebilet | Nebivolol | Nebivolol accord | Nebivolol actavis | Nebivolol Apotex | Nebivolol aurobindo | Nebivolol Glenmark | Nebivolol Mylan | Nebivolol PCH | Nebivolol ratiopharm | Nebivolol sandoz;
  • (NO) Norway: Hypoloc | Nebivolol;
  • (PE) Peru: Anfibol | Nabila | Nebiem | Nebilet | Nebipress | Pertium | Viboloxx;
  • (PH) Philippines: Bivolol | Nebicar | Nebicard | Nebil | Nebilet | Toricard;
  • (PK) Pakistan: Anvol | Betanorm | Bevis | Bistolic | Bmiv | Bynevol | Byvas | Byvol | Danlol | Nabiloc | Nabilox | Nebicare | Nebicor | Nebifix | Nebil | Nebilol | Nebimap | Nebiv | Nebivol | Nebiwrd | Nebix | Nebmax | Nebol | Neobiv | Nevo | Nib | Nibovo | Nobu | Voloxo;
  • (PL) Poland: Daneb | Ebivol | Emzok | Ezocem | Ivineb | Nebicard | Nebicon | Nebilenin | Nebilet | Nebinad | Nebispes | Nebivas | Nebivolek | Nebivolol aurovitas | Nebivolol genoptim | Nebivolol krka | Nebivor | Nedal;
  • (PR) Puerto Rico: Bystolic | Nebivolol;
  • (PT) Portugal: Blokat | Hypoloc | Nebilet | Nebivolol | Nebivolol actavis | Nebivolol ciclum | Nebivolol generis | Nebivolol germed | Nebivolol gp | Nebivolol krka | Nebivolol labesfal | Nebivolol mepha | Nebivolol ratiopharm | Nebivolol sandoz | Nebivolol tecnigen | Nebivolol Teva | Nebivolol tolife;
  • (PY) Paraguay: Anfibol | Antalgico | Betadine | Binest | Doox | Etibloker | Nabila | Nebivolol bioteng | Nebivolol dallas | Nebivolol heisecke | Nebivolol pasteur | Nebivolol prosalud | Nebivolol quimfa | Neblix | Nebuterol | Nevicar | Nirpol | Pertium;
  • (QA) Qatar: Nebilet;
  • (RO) Romania: Ezocem | Nebivolol aurobindo | Nebivolol Teva | Nolet | Voxnebin | X Pressol;
  • (RU) Russian Federation: Binelol | Bivotenz | Nebicor | Nebicor adipharm | Nebilan lannacher | Nebilet | Nebilong | Nebivator | Nebivolol | Nebivolol canon | Nebivolol chaikafarma | Nebivolol nanolek | Nebivolol sandoz | Nebivolol stada | Nebivolol Teva | Nevotens | Od Neb;
  • (SA) Saudi Arabia: Nebilet;
  • (SE) Sweden: Hypoloc;
  • (SG) Singapore: Nebilet;
  • (SI) Slovenia: Massido | Nebispes | Nebivolol Teva | Neldivex;
  • (SK) Slovakia: Nebilet | Nebitrix | Nebivolol krka | Tevaneb;
  • (TH) Thailand: Bilkate | Nebilet;
  • (TN) Tunisia: Nebicard | Nebicor | Nebilet | Nebilus | Nebipress;
  • (TR) Turkey: Bivol | Bloxer | Naksen | Nevimol | Nexivol | Valende | Vascura | Vasilol | Vasoxen;
  • (TW) Taiwan: Nebilet | Nebipress | Synbeta;
  • (UA) Ukraine: Nebiar | Nebilet | Nebilong | Nebitens | Nebitrend | Nebival | Nebivolol | Nebivolol sandoz | Nebivolol-darnitsa | Nebiworld;
  • (UG) Uganda: Nebi | Nebiem | Nebilet | Nebilong | Nebivolol sandoz | Nodon;
  • (UY) Uruguay: Nebibloc | Neblic | Syncrocor;
  • (VE) Venezuela, Bolivarian Republic of: Anfibol | Nebicard | Nebilet | Relnex | Tonervol | Vanzel;
  • (VN) Viet Nam: Bivolcard | Khouma | Smabelol;
  • (ZA) South Africa: Lovispes | Nebilet;
  • (ZM) Zambia: Nebicard | Nebilong | Nodon;
  • (ZW) Zimbabwe: Nebicard | Nebiem
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