nebivolol

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nebivolol

(ne-bi-vi-lole) ,

Bystolic

(trade name)

Classification

Therapeutic: antihypertensives
Pharmacologic: beta blockers
Pregnancy Category: C

Indications

Hypertension (alone and with other antihypertensives).

Action

Blocks stimulation of beta adrenergic receptor sites; selective for beta1 (myocardial) receptors in most patients. In some patients (poor metabolizers, higher blood levels may result in some beta2 [pulmonary, vascular, uterine] adrenergic) blockade.

Therapeutic effects

Lowering of BP.

Pharmacokinetics

Absorption: Well absorbed following oral administration.
Distribution: Unknown.
Protein Binding: 98%.
Metabolism and Excretion: Mostly metabolized by the liver, including the CYP2D6 enzyme system; some have antihypertensive action; minimal excretion of unchanged drug.
Half-life: Extensive metabolizers—12 hr; poor metabolizers—19 hr.

Time/action profile (blood levels)

ROUTEONSETPEAKDURATION
POunknown1.5–4 hr24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Severe bradycardia, heart block greater than first degree cardiogenic shock, decompensated heart failure, or sick sinus syndrome (without pacemaker);Severe hepatic impairment (Child-Pugh >B);Bronchospastic disease; Obstetric: Lactation.
Use Cautiously in: Coronary artery disease (rapid cessation should be avoided);Compensated HF;Major surgery (anesthesia may augment myocardial depression);Diabetes mellitus (may mask signs of hypoglycemia);Thyrotoxicosis (may mask symptoms);Moderate hepatic impairment (↓ metabolism);Severe renal impairment (↓ initial dose if CCr <30 mL/min);History of severe allergic reactions (↑ intensity of reactions);Pheochromocytoma (alpha blockers required prior to beta blockers); Geriatric: Consider increased sensitivity, concurrent chronic diseases, medications and presence of age-related decrease in clearance; Obstetric: Use in pregnancy only if maternal benefit outweighs fetal risk; Pediatric: Safe use in children <18 yr not established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • fatigue
  • headache

Interactions

Drug-Drug interaction

Drugs that affect the CYP2D6 enzyme system are expected to alter levels and possibly effects of nebivolol; dose alterations may be required.Fluoxetine, a known inhibitor of CYP2D6, ↑ levels and effects; similar effects may be expected from quinidine, propafenone, and paroxetine.Blood levels are also ↑ by cimetine.Anesthetic agents including ether, trichloroethylene, and cyclopropane as well as other myocardial depressants or inhibitors of AV conduction, such as diltiazem and verapamil may ↑ risk of myocardial depression and bradycardia.Avoid concurrent use with beta blockers.Concurrent use with reserpine may excessively reduce sympathetic activity.If used concurrently with clonidine, nebivolol should be tapered and discontinued several days prior to gradual withdrawal of clonidine.

Route/Dosage

Oral (Adults) 5 mg once daily initially, may increase at 2 wk intervals up to 40 mg/day.

Hepatic/Renal Impairment

Oral (Adults) 2.5 mg once daily initially; titrate upward cautiously.

Availability

Tablets: 2.5, 5 mg, 10 mg

Nursing implications

Nursing assessment

  • Monitor BP, ECG, and pulse prior to and periodically during therapy.
  • Monitor intake and output ratios and daily weights. Assess routinely for signs and symptoms of HF (dyspnea, rales/crackles, weight gain, peripheral edema, jugular venous distention).
  • Lab Test Considerations: May cause ↑ BUN, uric acid, triglycerides and ↓ HDL cholesterol and platelet court.

Potential Nursing Diagnoses

Decreased cardiac output (Side Effects)

Implementation

  • Oral: May be administered without regard to food.
    • When discontinuation is planned, observe patient carefully and advise to minimize physical activity. Taper over 1–2 wk when possible. If angina worsens or acute coronary insufficiency develops, reinstitute nebivolol promptly, at least temporarily.

Patient/Family Teaching

  • Instruct patient to take nebivolol as directed, at the same time each day, even if feeling well. If a dose is missed, skip missed dose and take next scheduled dose; do not double doses. Do not discontinue without consulting health care professional. Abrupt withdrawal may precipitate life-threatening arrhythmias, hypertension, or myocardial ischemia.
  • Advise patient to ensure that enough medication is available for weekends, holidays, and vacations. A written prescription may be kept in the wallet for emergencies.
  • Reinforce the need to continue additional therapies for hypertension (weight loss, sodium restriction, stress reduction, regular exercise, moderation of alcohol consumption, and smoking cessation). Medication controls but does not cure hypertension.
  • Teach patient and family how to check pulse and BP. Instruct them to check pulse daily and BP biweekly and to report significant changes to health care professional.
  • Instruct patient to consult health care professional before taking any Rx, OTC, or herbal products, especially cold preparations, concurrently with this medication. Patients on antihypertensive therapy should also avoid excessive amounts of coffee, tea, and cola.
  • May mask some signs of hypoglycemia, especially tachycardia. Diabetics should closely monitor blood sugar, especially if weakness, malaise, irritability, or fatigue occurs. Medication does not block dizziness or sweating as signs of hypoglycemia.
  • May cause dizziness. Caution patients to avoid driving or other activities requiring alertness until response to medication is known.
  • Advise patient to notify health care professional if difficulty breathing or signs and symptoms of worsening HF (weight gain, increasing shortness or breath, excessive bradycardia) occur.
  • Instruct patient to inform health care professional of medication regimen before treatment or surgery.
  • Advise patient to carry identification describing disease process and medication regimen at all times.
  • Advise female patients that breast feeding should be avoided during nebivolol therapy.

Evaluation/Desired Outcomes

  • Decrease in BP.

nebivolol

an antihypertensive.
indication This drug is used to treat hypertension.
contraindications Cardiogenic shock, sick sinus syndrome, acute bronchospasm, atrioventricular heart block, and hypersensitivity to this agent or beta blockers prohibit its use. This drug should not be abruptly discontinued.
adverse effects Adverse effects of this drug include drowsiness, headache, atrioventricular heart block, edema, vomiting, abdominal pain, rash, pruritus, vasculitis, urticaria, psoriasis, hyperuricemia, hypercholesterolemia, and dyspnea. Life-threatening side effects include bradycardia, MI, thrombocytopenia, angioedema, renal failure, pulmonary edema, and bronchospasm. Common side effects include insomnia, fatigue, dizziness, mental changes, nausea, diarrhea, and impotence.
References in periodicals archive ?
Mylan sold rights to Bystolic to Forest Laboratories Inc.
For example, Bystolic, which was launched in a highly genericized market in 2008, is growing strongly, and in combination with valsartan, it could achieve blockbuster status.
This expense includes funding continued competitive levels of support behind currently promoted products including Bystolic, Savella, Teflaro, Daliresp and Viibryd.
Howard Solomon, Chairman and Chief Executive Officer of Forest Laboratories said, "We are pleased with the success of Bystolic and we look forward to the product's continued growth.
We successfully introduced Bystolic in 2008 and Savella in 2009 and are currently in the process of launching Teflaro, Daliresp and Viibryd.
Forest Labs entered into a collaboration and distribution agreement with Janssen to commercialize Bystolic and Savella in Canada.
Bystolic and Savella continued with their strong performance, and the recent launch of Teflaro has been very satisfactory.
Importantly, Bystolic, Savella, Teflaro, Viibryd and Daliresp, key long-term profit contributors, were launched successfully:
Lastly, we entered into a collaboration and distribution agreement with Janssen Pharmaceutica, NV for the commercialization of Bystolic and Savella in Canada where we will also have the opportunity to co-promote these products.
Bystolic appears to inhibit the uncoupling of endothelial nitric oxide synthetase, which reduces the formation of free oxygen radicals and increases the generation of nitric oxide, effects that "could [potentially] be associated with target organ protection," Dr.
The FDA has approved Bystolic (nebivolol) for the treatment of high blood pressure.