Nebivolol 20mg Tablets
It is used to treat high blood pressure.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antihypertensive
Pharmacologic Class
Beta-1 Selective Adrenergic Blocker with Vasodilating Properties
Pregnancy Category
Not available
FDA Approved
Dec 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nebivolol is a medication used to treat high blood pressure (hypertension). It works by relaxing blood vessels and slowing down your heart rate, which helps your heart pump blood more easily throughout your body.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. Take your medication as directed, with or without food, and continue taking it even if you start feeling well. It's essential to follow your doctor's or healthcare provider's advice on the dosage and duration of treatment.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, avoiding storage in bathrooms. Ensure that all medications are kept in a safe location, out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method or check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. Take your medication as directed, with or without food, and continue taking it even if you start feeling well. It's essential to follow your doctor's or healthcare provider's advice on the dosage and duration of treatment.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, avoiding storage in bathrooms. Ensure that all medications are kept in a safe location, out of reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on the best disposal method or check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take your medication exactly as prescribed, usually once daily, with or without food.
- Do not stop taking nebivolol suddenly, as this can lead to serious heart problems. Your doctor will tell you how to slowly reduce your dose if needed.
- Continue to follow a heart-healthy diet (low in salt and saturated fats).
- Engage in regular physical activity as advised by your doctor.
- Limit alcohol intake.
- Monitor your blood pressure and heart rate regularly at home if advised by your doctor.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg orally once daily, may be increased at 2-week intervals to 10 mg, then 20 mg, up to a maximum of 40 mg once daily.
Dose Range:
5 - 40 mg
Condition-Specific Dosing:
hypertension:
Initial 5 mg once daily, maintenance 5-20 mg once daily. Max 40 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 50 mL/min)
Moderate:
No adjustment needed (CrCl 30-50 mL/min)
Severe:
Initial 2.5 mg once daily (CrCl < 30 mL/min)
Dialysis:
Not extensively studied; use with caution. Initial 2.5 mg once daily.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Initial 2.5 mg once daily
Severe:
Not recommended
Pharmacology
Mechanism of Action
Nebivolol is a highly selective beta-1 adrenergic receptor blocker. It also causes vasodilation primarily through an endothelium-derived nitric oxide-dependent mechanism, which contributes to its antihypertensive effects.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (12% in extensive metabolizers, 96% in poor metabolizers)
Tmax:
1.5-4 hours
FoodEffect:
Food increases absorption slightly but is not clinically significant; can be taken with or without food.
Distribution:
Vd:
6.3 L/kg
ProteinBinding:
~98%
CnssPenetration:
Limited
Elimination:
HalfLife:
10-12 hours (extensive metabolizers), 20-30 hours (poor metabolizers)
Clearance:
Not available
ExcretionRoute:
Urine (38%), feces (48%)
Unchanged:
<1% in urine
Pharmacodynamics
OnsetOfAction:
Within 2 hours
PeakEffect:
1-4 hours
DurationOfAction:
24 hours
Safety & Warnings
BLACK BOX WARNING
Abrupt Cessation of Therapy: Do not abruptly discontinue nebivolol therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction, and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of beta-blocker therapy. When discontinuing chronically administered nebivolol, particularly in patients with coronary artery disease, the dosage should be gradually reduced over 1 to 2 weeks and the patient should be carefully monitored. If angina worsens or acute coronary insufficiency develops, nebivolol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of angina pectoris should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue nebivolol therapy abruptly even in patients treated only for hypertension.
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Dizziness or fainting
Shortness of breath, significant weight gain, or swelling in the arms or legs
Slow heartbeat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
* Feeling tired or weak
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of low blood sugar, including:
+ Dizziness
+ Headache
+ Feeling sleepy
+ Feeling weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating
Dizziness or fainting
Shortness of breath, significant weight gain, or swelling in the arms or legs
Slow heartbeat
Other Possible Side Effects
Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
* Feeling tired or weak
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting
- Very slow heart rate (e.g., less than 50 beats per minute)
- Shortness of breath, especially with activity or lying down
- Swelling in your ankles or feet
- Unusual weight gain
- Chest pain or discomfort that is new or worsening
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Asthma or other lung or breathing problems that cause shortness of breath or wheezing
+ Heart failure (weak heart)
+ Abnormal heartbeats, such as heart block or sick sinus syndrome
+ A slow heartbeat
Liver disease
Use of another medication similar to this one. If you are unsure, consult your doctor or pharmacist.
* Breast-feeding. It is recommended that you do not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
Certain health conditions, including:
+ Asthma or other lung or breathing problems that cause shortness of breath or wheezing
+ Heart failure (weak heart)
+ Abnormal heartbeats, such as heart block or sick sinus syndrome
+ A slow heartbeat
Liver disease
Use of another medication similar to this one. If you are unsure, consult your doctor or pharmacist.
* Breast-feeding. It is recommended that you do not breast-feed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.
Regularly monitor your blood pressure and heart rate as directed by your doctor. Additionally, have your blood work checked as instructed by your doctor, and discuss the results with them.
Please note that this medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Before consuming alcohol, consult with your doctor. This medication may mask symptoms of low blood sugar, such as a rapid heartbeat, which can increase the risk of severe or prolonged hypoglycemia, particularly in individuals with diabetes, children, and those who are fasting or undergoing surgery.
If you have diabetes, it is crucial to closely monitor your blood sugar levels. Before taking any over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products, consult with your doctor.
Do not abruptly stop taking this medication, as this may lead to worsened chest pain or even a heart attack, especially in individuals with certain types of heart disease. To minimize the risk of side effects, your doctor will instruct you on how to gradually discontinue the medication. If you experience new or worsening chest pain or other heart problems, contact your doctor immediately.
If you have a history of severe allergic reactions, discuss this with your doctor, as you may be at risk of an even more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, inform your doctor, as this medication may reduce the effectiveness of epinephrine.
This medication may also make it more challenging to recognize symptoms of an overactive thyroid, such as a rapid heartbeat. If you have an overactive thyroid and stop taking this medication suddenly, your condition may worsen and become life-threatening. Consult with your doctor before making any changes to your medication regimen.
If you are pregnant or plan to become pregnant, discuss the benefits and risks of taking this medication with your doctor.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To ensure your safety, avoid driving and other activities that require alertness until you understand how this medication affects you. When changing positions, such as standing up from a sitting or lying down position, do so slowly to minimize the risk of dizziness or fainting. Be cautious when navigating stairs.
Regularly monitor your blood pressure and heart rate as directed by your doctor. Additionally, have your blood work checked as instructed by your doctor, and discuss the results with them.
Please note that this medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this medication.
Before consuming alcohol, consult with your doctor. This medication may mask symptoms of low blood sugar, such as a rapid heartbeat, which can increase the risk of severe or prolonged hypoglycemia, particularly in individuals with diabetes, children, and those who are fasting or undergoing surgery.
If you have diabetes, it is crucial to closely monitor your blood sugar levels. Before taking any over-the-counter (OTC) products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, or certain natural products, consult with your doctor.
Do not abruptly stop taking this medication, as this may lead to worsened chest pain or even a heart attack, especially in individuals with certain types of heart disease. To minimize the risk of side effects, your doctor will instruct you on how to gradually discontinue the medication. If you experience new or worsening chest pain or other heart problems, contact your doctor immediately.
If you have a history of severe allergic reactions, discuss this with your doctor, as you may be at risk of an even more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, inform your doctor, as this medication may reduce the effectiveness of epinephrine.
This medication may also make it more challenging to recognize symptoms of an overactive thyroid, such as a rapid heartbeat. If you have an overactive thyroid and stop taking this medication suddenly, your condition may worsen and become life-threatening. Consult with your doctor before making any changes to your medication regimen.
If you are pregnant or plan to become pregnant, discuss the benefits and risks of taking this medication with your doctor.
Overdose Information
Overdose Symptoms:
- Severe bradycardia (very slow heart rate)
- Hypotension (very low blood pressure)
- Acute cardiac insufficiency (heart failure)
- Cardiogenic shock
- Bronchospasm
- Vomiting
- Impaired consciousness
- Generalized seizures
What to Do:
Seek immediate medical attention or call 911. For poison control, call 1-800-222-1222. Treatment is supportive and symptomatic, including atropine for bradycardia, vasopressors for hypotension, glucagon, and possibly cardiac pacing.
Drug Interactions
Major Interactions
- Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, propafenone): May significantly increase nebivolol plasma concentrations, increasing risk of bradycardia and other adverse effects. Consider lower nebivolol dose.
- Other beta-blockers: Additive effects on heart rate and blood pressure.
- Calcium channel blockers (e.g., verapamil, diltiazem): Increased risk of bradycardia, AV block, and heart failure. Monitor closely.
Moderate Interactions
- Clonidine: May potentiate rebound hypertension upon clonidine withdrawal. Discontinue nebivolol several days before clonidine withdrawal.
- Digitalis glycosides: Increased risk of bradycardia.
- NSAIDs (e.g., ibuprofen, naproxen): May reduce the antihypertensive effect of nebivolol.
- Antidiabetic agents (insulin, oral hypoglycemics): Beta-blockers may mask symptoms of hypoglycemia (e.g., tachycardia).
- Anesthetics (general): May potentiate hypotensive effects and myocardial depression.
Minor Interactions
- Alcohol: May cause additive hypotensive effects.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation
Heart Rate (HR)
Rationale: To establish baseline and assess for bradycardia.
Timing: Prior to initiation
Renal Function (e.g., CrCl)
Rationale: To assess need for dose adjustment in renal impairment.
Timing: Prior to initiation
Hepatic Function (e.g., LFTs)
Rationale: To assess need for dose adjustment in hepatic impairment.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially during dose titration and periodically thereafter (e.g., monthly, then every 3-6 months)
Target: <130/80 mmHg (individualized based on guidelines and patient comorbidities)
Action Threshold: Persistent elevation above target or symptomatic hypotension
Heart Rate (HR)
Frequency: Regularly, especially during dose titration and periodically thereafter
Target: 50-90 bpm (avoid symptomatic bradycardia <50 bpm)
Action Threshold: HR <50 bpm or symptomatic bradycardia
Signs/Symptoms of Heart Failure
Frequency: Periodically
Target: Absence of new or worsening symptoms (e.g., dyspnea, edema, weight gain)
Action Threshold: Development or worsening of heart failure symptoms
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fatigue
- Shortness of breath
- Swelling in ankles/feet
- Bradycardia (slow heart rate)
- Cold extremities
Special Patient Groups
Pregnancy
Use during pregnancy is generally not recommended unless the potential benefit justifies the potential risk to the fetus. Based on animal data, nebivolol may cause fetal harm. Neonates exposed to beta-blockers in utero may be at risk for bradycardia, hypoglycemia, and respiratory depression.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show some risk.
Second Trimester:
Potential for fetal growth restriction, bradycardia, and hypoglycemia.
Third Trimester:
Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression. Monitor neonates for signs of beta-blockade for several days after birth.
Lactation
It is unknown if nebivolol is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Risk cannot be ruled out. Monitor infant for signs of beta-blockade (e.g., bradycardia, lethargy, poor feeding).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for use in children.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Consider starting with a lower dose (2.5 mg) in elderly patients.
Clinical Information
Clinical Pearls
- Nebivolol is unique among beta-blockers due to its additional vasodilatory effect mediated by nitric oxide release, which may lead to a lower incidence of common beta-blocker side effects like fatigue and erectile dysfunction.
- It is highly beta-1 selective, but selectivity is dose-dependent and may decrease at higher doses.
- Patients who are poor CYP2D6 metabolizers will have significantly higher plasma concentrations of nebivolol and its active metabolites, requiring lower doses.
- Always taper nebivolol slowly over 1-2 weeks when discontinuing, especially in patients with coronary artery disease, to avoid rebound hypertension, angina, or myocardial infarction.
- Monitor heart rate closely, especially in patients with pre-existing bradycardia or those taking other medications that slow heart rate (e.g., verapamil, diltiazem, digoxin).
Alternative Therapies
- Other beta-blockers (e.g., metoprolol, carvedilol, atenolol)
- ACE inhibitors (e.g., lisinopril, enalapril)
- Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan)
- Calcium Channel Blockers (e.g., amlodipine, nifedipine)
- Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 for generic 30 tablets per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. It is also important to note that some medications may have additional patient information leaflets, so be sure to consult with your pharmacist if you have any questions. If you are unsure about any aspect of your medication, do not hesitate to discuss your concerns with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication, the amount taken, and the time it was taken.