nebivolol

ne-BI-vi-lol

Therapeutic Classification: antihypertensives

Pharmacologic Classification: beta blockers (selective)

REMS

Hypertension (alone or in combination with other antihypertensives).

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.

Absorption: Well absorbed following oral administration.

Distribution: Unknown.

Protein Binding: 98%.

Metabolism/Excretion: Mostly metabolized by the liver via the CYP2D6 isoenzyme; the CYP2D6 enzyme system exhibits genetic polymorphism; ∼7% of population may be poor metabolizers and may have significantly ↑ nebivolol concentrations and an ↑ risk of adverse effects.; minimal excretion of unchanged drug.

Half-Life: Extensive metabolizers: 12 hr; Poor metabolizers: 19 hr.

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
PO	unknown	1.5–4 hr	24 hr

Contraindicated in:

Hypersensitivity;
Severe bradycardia, heart block greater than first-degree cardiogenic shock, decompensated HF, or sick sinus syndrome (without pacemaker);
Severe hepatic impairment;
Bronchospastic disease;
Lactation: 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;
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);
OB: Use during pregnancy only if potential maternal benefit outweighs potential fetal risk;
Pedi: Safety and effectiveness not established in children;
Geri: Consider ↑ sensitivity, concurrent chronic diseases, medications, and presence of age-related ↓ in clearance in older adults.

Endo: hypoglycemia

Neuro: dizziness, fatigue, headache

Drug-drug:

CYP2D6 inhibitors, including fluoxetine, cimetidine, quinidine, propafenone, and paroxetine, may ↑ levels and risk of toxicity.
Anesthetic agents, including ether, trichloroethylene, and cyclopropane, as well as other myocardial depressants or inhibitors of AV conduction, such as diltiazem verapamil, digoxin, clonidine, and ivabradine, may ↑ risk of myocardial depression and bradycardia.

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

Hepatic/Renal Impairment

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

(Generic available)

Tablets: 2.5; 5 mg; 10 mg; 20 mg

Monitor BP, ECG, and HR prior to and periodically during therapy.
Monitor intake and output ratios and daily weights. Assess routinely for signs and symptoms of HF.
Monitor for signs and symptoms of hypoglycemia during therapy, especially in children, patients with diabetes, and patients who are fasting.

Lab Test Considerations:

May cause ↑ BUN, uric acid, and triglycerides and ↓ HDL cholesterol and platelet count.

PO: 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 develops, reinstitute nebivolol promptly, at least temporarily.

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, smoking cessation). Medication controls but does not cure hypertension.
Teach patient and family how to check HR and BP. Instruct them to check HR 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. Patients with diabetes 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 patient 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, ↑ shortness of 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.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy. Monitor neonates of mothers who used nebivolol during the 3rd trimester for hypotension, bradycardia, hypoglycemia, and respiratory depression.

Decrease in BP.

Bystolic

NDC Code

0456- Allergan, Inc.
- 0456-1402- Bystolic
  - 0456-1402-01- 100 TABLET in 1 BOTTLE (0456-1402-01)

0456- Allergan, Inc.
- 0456-1402- Bystolic
  - 0456-1402-30- 30 TABLET in 1 BOTTLE (0456-1402-30)

0456- Allergan, Inc.
- 0456-1402- Bystolic
  - 0456-1402-90- 90 TABLET in 1 BOTTLE (0456-1402-90)

0456- Allergan, Inc.
- 0456-1403-
  - 0456-1403-00- 1 BAG in 1 DRUM (0456-1403-00) / 90000 TABLET in 1 BAG

0456- Allergan, Inc.
- 0456-1405- Bystolic
  - 0456-1405-01- 100 TABLET in 1 BOTTLE (0456-1405-01)

0456- Allergan, Inc.
- 0456-1405- Bystolic
  - 0456-1405-30- 30 TABLET in 1 BOTTLE (0456-1405-30)

0456- Allergan, Inc.
- 0456-1405- Bystolic
  - 0456-1405-90- 90 TABLET in 1 BOTTLE (0456-1405-90)

0456- Allergan, Inc.
- 0456-1406-
  - 0456-1406-00- 1 BAG in 1 DRUM (0456-1406-00) / 50000 TABLET in 1 BAG

0456- Allergan, Inc.
- 0456-1410- Bystolic
  - 0456-1410-01- 100 TABLET in 1 BOTTLE (0456-1410-01)

0456- Allergan, Inc.
- 0456-1410- Bystolic
  - 0456-1410-30- 30 TABLET in 1 BOTTLE (0456-1410-30)

0456- Allergan, Inc.
- 0456-1410- Bystolic
  - 0456-1410-63- 100 TABLET in 1 BOX, UNIT-DOSE (0456-1410-63)

0456- Allergan, Inc.
- 0456-1410- Bystolic
  - 0456-1410-90- 90 TABLET in 1 BOTTLE (0456-1410-90)

0456- Allergan, Inc.
- 0456-1411-
  - 0456-1411-00- 1 BAG in 1 DRUM (0456-1411-00) / 30000 TABLET in 1 BAG

0456- Allergan, Inc.
- 0456-1420- Bystolic
  0456-1420-01- 100 TABLET in 1 BOTTLE (0456-1420-01)

0456- Allergan, Inc.
- 0456-1420- Bystolic
  - 0456-1420-63- 100 TABLET in 1 BOX, UNIT-DOSE (0456-1420-63)

0456- Allergan, Inc.
- 0456-1420- Bystolic
  - 0456-1420-90- 90 TABLET in 1 BOTTLE (0456-1420-90)

0456- Allergan, Inc.
- 0456-1421-
  - 0456-1421-00- 1 BAG in 1 DRUM (0456-1421-00) / 50000 TABLET in 1 BAG

0904- Major Pharmaceuticals
- 0904-7226- nebivolol
  0904-7226-04- 30 BLISTER PACK in 1 CARTON (0904-7226-04) / 1 TABLET in 1 BLISTER PACK

0904- Major Pharmaceuticals
- 0904-7497- NEBIVOLOL
  - 0904-7497-04- 30 BLISTER PACK in 1 CARTON (0904-7497-04) / 1 TABLET in 1 BLISTER PACK

0904- Major Pharmaceuticals
- 0904-7498- NEBIVOLOL
  - 0904-7498-04- 30 BLISTER PACK in 1 CARTON (0904-7498-04) / 1 TABLET in 1 BLISTER PACK

0904- Major Pharmaceuticals
- 0904-7499- NEBIVOLOL
  - 0904-7499-04- 30 BLISTER PACK in 1 CARTON (0904-7499-04) / 1 TABLET in 1 BLISTER PACK

13668- Torrent Pharmaceuticals Limited
- 13668-353- nebivolol
  - 13668-353-01- 100 TABLET in 1 BOTTLE (13668-353-01)

13668- Torrent Pharmaceuticals Limited
- 13668-353- nebivolol
  - 13668-353-05- 500 TABLET in 1 BOTTLE (13668-353-05)

13668- Torrent Pharmaceuticals Limited
- 13668-353- nebivolol
  - 13668-353-30- 30 TABLET in 1 BOTTLE (13668-353-30)

13668- Torrent Pharmaceuticals Limited
- 13668-353- nebivolol
  - 13668-353-90- 90 TABLET in 1 BOTTLE (13668-353-90)

13668- Torrent Pharmaceuticals Limited
- 13668-354- nebivolol
  - 13668-354-01- 100 TABLET in 1 BOTTLE (13668-354-01)

13668- Torrent Pharmaceuticals Limited
- 13668-354- nebivolol
  - 13668-354-05- 500 TABLET in 1 BOTTLE (13668-354-05)

13668- Torrent Pharmaceuticals Limited
- 13668-354- nebivolol
  - 13668-354-30- 30 TABLET in 1 BOTTLE (13668-354-30)

13668- Torrent Pharmaceuticals Limited
- 13668-354- nebivolol
  - 13668-354-90- 90 TABLET in 1 BOTTLE (13668-354-90)

13668- Torrent Pharmaceuticals Limited
- 13668-355- nebivolol
  - 13668-355-01- 100 TABLET in 1 BOTTLE (13668-355-01)

13668- Torrent Pharmaceuticals Limited
- 13668-355- nebivolol
  - 13668-355-05- 500 TABLET in 1 BOTTLE (13668-355-05)

13668- Torrent Pharmaceuticals Limited
- 13668-355- nebivolol
  - 13668-355-30- 30 TABLET in 1 BOTTLE (13668-355-30)

13668- Torrent Pharmaceuticals Limited
- 13668-355- nebivolol
  - 13668-355-90- 90 TABLET in 1 BOTTLE (13668-355-90)

13668- Torrent Pharmaceuticals Limited
- 13668-356- nebivolol
  - 13668-356-01- 100 TABLET in 1 BOTTLE (13668-356-01)

13668- Torrent Pharmaceuticals Limited
- 13668-356- nebivolol
  - 13668-356-05- 500 TABLET in 1 BOTTLE (13668-356-05)

13668- Torrent Pharmaceuticals Limited
- 13668-356- nebivolol
  - 13668-356-30- 30 TABLET in 1 BOTTLE (13668-356-30)

13668- Torrent Pharmaceuticals Limited
- 13668-356- nebivolol
  - 13668-356-90- 90 TABLET in 1 BOTTLE (13668-356-90)

24689- Apnar Pharma LP
- 24689-159- nebivolol
  - 24689-159-01- 30 TABLET in 1 BOTTLE (24689-159-01)

24689- Apnar Pharma LP
- 24689-159- nebivolol
  - 24689-159-02- 90 TABLET in 1 BOTTLE (24689-159-02)

24689- Apnar Pharma LP
- 24689-160- nebivolol
  - 24689-160-01- 30 TABLET in 1 BOTTLE (24689-160-01)

24689- Apnar Pharma LP
- 24689-160- nebivolol
  - 24689-160-02- 90 TABLET in 1 BOTTLE (24689-160-02)

24689- Apnar Pharma LP
- 24689-161- nebivolol
  - 24689-161-01- 30 TABLET in 1 BOTTLE (24689-161-01)

24689- Apnar Pharma LP
- 24689-161- nebivolol
  - 24689-161-02- 90 TABLET in 1 BOTTLE (24689-161-02)

24689- Apnar Pharma LP
- 24689-162- nebivolol
  - 24689-162-01- 30 TABLET in 1 BOTTLE (24689-162-01)

24689- Apnar Pharma LP
- 24689-162- nebivolol
  - 24689-162-02- 90 TABLET in 1 BOTTLE (24689-162-02)

27241- Ajanta Pharma USA Inc.
- 27241-179- Nebivolol
  - 27241-179-30- 30 TABLET in 1 BOTTLE (27241-179-30)

27241- Ajanta Pharma USA Inc.
- 27241-180- Nebivolol
  - 27241-180-30- 30 TABLET in 1 BOTTLE (27241-180-30)

27241- Ajanta Pharma USA Inc.
- 27241-180- Nebivolol
  - 27241-180-90- 90 TABLET in 1 BOTTLE (27241-180-90)

27241- Ajanta Pharma USA Inc.
- 27241-181- Nebivolol
  - 27241-181-30- 30 TABLET in 1 BOTTLE (27241-181-30)

27241- Ajanta Pharma USA Inc.
- 27241-181- Nebivolol
  - 27241-181-90- 90 TABLET in 1 BOTTLE (27241-181-90)

27241- Ajanta Pharma USA Inc.
- 27241-182- Nebivolol
  - 27241-182-30- 30 TABLET in 1 BOTTLE (27241-182-30)

27241- Ajanta Pharma USA Inc.
- 27241-182- Nebivolol
  - 27241-182-90- 90 TABLET in 1 BOTTLE (27241-182-90)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-375- Nebivolol Hydrochloride
  - 29300-375-05- 500 TABLET in 1 BOTTLE (29300-375-05)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-375- Nebivolol Hydrochloride
  - 29300-375-13- 30 TABLET in 1 BOTTLE (29300-375-13)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-375- Nebivolol Hydrochloride
  - 29300-375-19- 90 TABLET in 1 BOTTLE (29300-375-19)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-376- Nebivolol Hydrochloride
  - 29300-376-05- 500 TABLET in 1 BOTTLE (29300-376-05)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-376- Nebivolol Hydrochloride
  - 29300-376-13- 30 TABLET in 1 BOTTLE (29300-376-13)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-376- Nebivolol Hydrochloride
  - 29300-376-19- 90 TABLET in 1 BOTTLE (29300-376-19)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-377- Nebivolol Hydrochloride
  - 29300-377-05- 500 TABLET in 1 BOTTLE (29300-377-05)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-377- Nebivolol Hydrochloride
  - 29300-377-13- 30 TABLET in 1 BOTTLE (29300-377-13)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-377- Nebivolol Hydrochloride
  - 29300-377-19- 90 TABLET in 1 BOTTLE (29300-377-19)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-378- Nebivolol Hydrochloride
  - 29300-378-05- 500 TABLET in 1 BOTTLE (29300-378-05)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-378- Nebivolol Hydrochloride
  - 29300-378-13- 30 TABLET in 1 BOTTLE (29300-378-13)

29300- Unichem Pharmaceuticals (USA), Inc.
- 29300-378- Nebivolol Hydrochloride
  - 29300-378-19- 90 TABLET in 1 BOTTLE (29300-378-19)

31722- Camber Pharmaceuticals, Inc.
- 31722-585- Nebivolol
  - 31722-585-01- 100 TABLET in 1 BOTTLE (31722-585-01)

31722- Camber Pharmaceuticals, Inc.
- 31722-585- Nebivolol
  - 31722-585-30- 30 TABLET in 1 BOTTLE (31722-585-30)

31722- Camber Pharmaceuticals, Inc.
- 31722-585- Nebivolol
  - 31722-585-32- 12 BLISTER PACK in 1 CARTON (31722-585-32) / 10 TABLET in 1 BLISTER PACK (31722-585-31)

31722- Camber Pharmaceuticals, Inc.
- 31722-585- Nebivolol
  - 31722-585-34- 15 BLISTER PACK in 1 CARTON (31722-585-34) / 10 TABLET in 1 BLISTER PACK (31722-585-33)

31722- Camber Pharmaceuticals, Inc.
- 31722-586- Nebivolol
  - 31722-586-01- 100 TABLET in 1 BOTTLE (31722-586-01)

31722- Camber Pharmaceuticals, Inc.
- 31722-586- Nebivolol
  - 31722-586-30- 30 TABLET in 1 BOTTLE (31722-586-30)

31722- Camber Pharmaceuticals, Inc.
- 31722-586- Nebivolol
  - 31722-586-32- 10 BLISTER PACK in 1 CARTON (31722-586-32) / 10 TABLET in 1 BLISTER PACK (31722-586-31)

31722- Camber Pharmaceuticals, Inc.
- 31722-586- Nebivolol
  - 31722-586-34- 18 BLISTER PACK in 1 CARTON (31722-586-34) / 7 TABLET in 1 BLISTER PACK (31722-586-33)

31722- Camber Pharmaceuticals, Inc.
- 31722-586- Nebivolol
  - 31722-586-90- 90 TABLET in 1 BOTTLE (31722-586-90)

31722- Camber Pharmaceuticals, Inc.
- 31722-587- Nebivolol
  - 31722-587-01- 100 TABLET in 1 BOTTLE (31722-587-01)

31722- Camber Pharmaceuticals, Inc.
- 31722-587- Nebivolol
  - 31722-587-30- 30 TABLET in 1 BOTTLE (31722-587-30)

31722- Camber Pharmaceuticals, Inc.
- 31722-587- Nebivolol
  - 31722-587-32- 10 BLISTER PACK in 1 CARTON (31722-587-32) / 10 TABLET in 1 BLISTER PACK (31722-587-31)

31722- Camber Pharmaceuticals, Inc.
- 31722-587- Nebivolol
  - 31722-587-34- 18 BLISTER PACK in 1 CARTON (31722-587-34) / 7 TABLET in 1 BLISTER PACK (31722-587-33)

31722- Camber Pharmaceuticals, Inc.
- 31722-587- Nebivolol
  - 31722-587-90- 90 TABLET in 1 BOTTLE (31722-587-90)

31722- Camber Pharmaceuticals, Inc.
- 31722-588- Nebivolol
  - 31722-588-01- 100 TABLET in 1 BOTTLE (31722-588-01)

31722- Camber Pharmaceuticals, Inc.
- 31722-588- Nebivolol
  - 31722-588-30- 30 TABLET in 1 BOTTLE (31722-588-30)

31722- Camber Pharmaceuticals, Inc.
- 31722-588- Nebivolol
  - 31722-588-32- 10 BLISTER PACK in 1 CARTON (31722-588-32) / 10 TABLET in 1 BLISTER PACK (31722-588-31)

31722- Camber Pharmaceuticals, Inc.
- 31722-588- Nebivolol
  - 31722-588-34- 18 BLISTER PACK in 1 CARTON (31722-588-34) / 7 TABLET in 1 BLISTER PACK (31722-588-33)

31722- Camber Pharmaceuticals, Inc.
- 31722-588- Nebivolol
  - 31722-588-90- 90 TABLET in 1 BOTTLE (31722-588-90)

33342- Macleods Pharmaceuticals Limited
- 33342-457- Nebivolol
  - 33342-457-07- 30 TABLET in 1 BOTTLE (33342-457-07)

33342- Macleods Pharmaceuticals Limited
- 33342-457- Nebivolol
  - 33342-457-10- 90 TABLET in 1 BOTTLE (33342-457-10)

33342- Macleods Pharmaceuticals Limited
- 33342-457- Nebivolol
  - 33342-457-25- 12 BLISTER PACK in 1 CARTON (33342-457-25) / 10 TABLET in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
- 33342-458- Nebivolol
  - 33342-458-07- 30 TABLET in 1 BOTTLE (33342-458-07)

33342- Macleods Pharmaceuticals Limited
- 33342-458- Nebivolol
  - 33342-458-10- 90 TABLET in 1 BOTTLE (33342-458-10)

33342- Macleods Pharmaceuticals Limited
- 33342-458- Nebivolol
  - 33342-458-25- 12 BLISTER PACK in 1 CARTON (33342-458-25) / 10 TABLET in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
- 33342-459- Nebivolol
  - 33342-459-07- 30 TABLET in 1 BOTTLE (33342-459-07)

33342- Macleods Pharmaceuticals Limited
- 33342-459- Nebivolol
  - 33342-459-10- 90 TABLET in 1 BOTTLE (33342-459-10)

33342- Macleods Pharmaceuticals Limited
- 33342-459- Nebivolol
  - 33342-459-25- 12 BLISTER PACK in 1 CARTON (33342-459-25) / 10 TABLET in 1 BLISTER PACK

33342- Macleods Pharmaceuticals Limited
- 33342-460- Nebivolol
  - 33342-460-07- 30 TABLET in 1 BOTTLE (33342-460-07)

33342- Macleods Pharmaceuticals Limited
- 33342-460- Nebivolol
  - 33342-460-10- 90 TABLET in 1 BOTTLE (33342-460-10)

33342- Macleods Pharmaceuticals Limited
- 33342-460- Nebivolol
  - 33342-460-25- 12 BLISTER PACK in 1 CARTON (33342-460-25) / 10 TABLET in 1 BLISTER PACK

42291- AvKARE
- 42291-871- nebivolol
  - 42291-871-30- 30 TABLET in 1 BOTTLE (42291-871-30)

42291- AvKARE
- 42291-872- nebivolol
  - 42291-872-90- 90 TABLET in 1 BOTTLE (42291-872-90)

42291- AvKARE
- 42291-873- nebivolol
  - 42291-873-90- 90 TABLET in 1 BOTTLE (42291-873-90)

42291- AvKARE
- 42291-874- nebivolol
  - 42291-874-90- 90 TABLET in 1 BOTTLE (42291-874-90)

43547- Solco Healthcare US, LLC
- 43547-524- NEBIVOLOL
  - 43547-524-03- 30 TABLET in 1 BOTTLE (43547-524-03)

43547- Solco Healthcare US, LLC
- 43547-524- NEBIVOLOL
  - 43547-524-09- 90 TABLET in 1 BOTTLE (43547-524-09)

section name header

Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇

Availability ⬆ ⬇

Assessment ⬆ ⬇

Implementation ⬆ ⬇

Patient/Family Teaching ⬆ ⬇

Evaluation/Desired Outcomes ⬆ ⬇

US Brand Names ⬆ ⬇

Code ⬆