Nebivolol 10mg 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; Vasodilator
Pregnancy Category
Category C
FDA Approved
Dec 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nebivolol is a medication used to treat high blood pressure (hypertension) and sometimes heart failure. It works by relaxing blood vessels and slowing down your heart rate, which helps your heart pump blood more easily and lowers your blood pressure.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. It's essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or look into local drug take-back programs.
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 a missed one.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. It's essential to continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel well.
Storing and Disposing of Your Medication
To maintain the quality and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or look into local drug take-back programs.
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 a missed one.
Lifestyle & Tips
- Continue a heart-healthy diet (low in sodium, saturated fat).
- Engage in regular physical activity as advised by your doctor.
- Limit alcohol consumption.
- Quit smoking.
- Manage stress.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg orally once daily; may be increased to 10 mg after 2 weeks, then up to 40 mg once daily if needed.
Dose Range:
5 - 40 mg
Condition-Specific Dosing:
hypertension:
Initial 5 mg once daily, maximum 40 mg once daily.
heart_failure:
Initial 1.25 mg once daily, doubled at weekly or bi-weekly intervals to maximum tolerated dose, not exceeding 10 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:
Initial 2.5 mg once daily (CrCl 30-50 mL/min)
Severe:
Initial 2.5 mg once daily (CrCl < 30 mL/min)
Dialysis:
No additional dose needed after dialysis; use with caution.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Initial 2.5 mg once daily
Severe:
Contraindicated
Pharmacology
Mechanism of Action
Nebivolol is a beta-1 selective adrenergic receptor blocker. It competitively and selectively blocks beta-1 adrenergic receptors, leading to decreased heart rate, myocardial contractility, and cardiac output, thus lowering blood pressure. Unlike other beta-blockers, nebivolol also causes vasodilation, which is thought to be mediated by nitric oxide release from endothelial cells.
Pharmacokinetics
Absorption:
Bioavailability:
12% (poor metabolizers up to 96%)
Tmax:
1.5-4 hours
FoodEffect:
Increases absorption (AUC and Cmax increased by 1.5-fold)
Distribution:
Vd:
6.3 L/kg
ProteinBinding:
Approximately 98%
CnssPenetration:
Limited
Elimination:
HalfLife:
10-12 hours (extensive metabolizers); 27 hours (poor metabolizers)
Clearance:
Not available
ExcretionRoute:
Renal (approximately 38%), Fecal (approximately 48%)
Unchanged:
Less than 1% (renal)
Pharmacodynamics
OnsetOfAction:
Gradual, blood pressure reduction seen within 1-2 weeks
PeakEffect:
Full therapeutic effect typically achieved within 2-4 weeks
DurationOfAction:
24 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although 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 or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
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 about side effects, 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.
Although 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 or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
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 about side effects, 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)
- Difficulty breathing or worsening shortness of breath
- Swelling in your hands, ankles, or feet
- Unusual weight gain
- Chest pain
- Symptoms of depression (mood changes, loss of interest)
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 and breathing problems that cause shortness of breath or wheezing
+ Heart failure (a 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 if 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 and breathing problems that cause shortness of breath or wheezing
+ Heart failure (a 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 if 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 Precautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and exercise caution when climbing stairs.
Monitoring Your Condition
Follow your doctor's instructions for checking your blood pressure and heart rate. Additionally, have your blood work checked as directed by your doctor, and discuss the results with them.
Interference with Lab Tests
This medication may affect certain laboratory tests. Inform all your healthcare providers and lab personnel that you are taking this medication.
Alcohol Consumption and Low Blood Sugar
Consult your doctor before consuming alcohol, as this medication may mask symptoms of low blood sugar, such as a rapid heartbeat. This can increase the risk of severe or prolonged low blood sugar, particularly in individuals with diabetes, children, and those who are fasting or experiencing vomiting. This risk also applies to people undergoing surgery or experiencing abnormal eating habits.
Diabetes Management
If you have high blood sugar (diabetes), closely monitor your blood sugar levels while taking this medication.
Over-the-Counter Products and Blood Pressure
Before using over-the-counter 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 your doctor.
Stopping the Medication
Do not abruptly stop taking this medication, as this can lead to worsened chest pain and, in some cases, heart attack. The risk is higher in individuals with certain types of heart disease. To avoid side effects, your doctor will instruct you on how to gradually stop taking this medication. If you experience new or worsening chest pain or other heart problems, contact your doctor immediately.
Allergic Reactions and Epinephrine
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 use epinephrine to treat severe allergic reactions, inform your doctor, as this medication may reduce the effectiveness of epinephrine.
Overactive Thyroid
This medication may 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 abruptly, your condition may worsen and become life-threatening. Consult your doctor for guidance.
Pregnancy and Breastfeeding
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.
Caution with Daily Activities
Avoid driving and performing tasks that require alertness until you understand how this medication affects you. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and exercise caution when climbing stairs.
Monitoring Your Condition
Follow your doctor's instructions for checking your blood pressure and heart rate. Additionally, have your blood work checked as directed by your doctor, and discuss the results with them.
Interference with Lab Tests
This medication may affect certain laboratory tests. Inform all your healthcare providers and lab personnel that you are taking this medication.
Alcohol Consumption and Low Blood Sugar
Consult your doctor before consuming alcohol, as this medication may mask symptoms of low blood sugar, such as a rapid heartbeat. This can increase the risk of severe or prolonged low blood sugar, particularly in individuals with diabetes, children, and those who are fasting or experiencing vomiting. This risk also applies to people undergoing surgery or experiencing abnormal eating habits.
Diabetes Management
If you have high blood sugar (diabetes), closely monitor your blood sugar levels while taking this medication.
Over-the-Counter Products and Blood Pressure
Before using over-the-counter 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 your doctor.
Stopping the Medication
Do not abruptly stop taking this medication, as this can lead to worsened chest pain and, in some cases, heart attack. The risk is higher in individuals with certain types of heart disease. To avoid side effects, your doctor will instruct you on how to gradually stop taking this medication. If you experience new or worsening chest pain or other heart problems, contact your doctor immediately.
Allergic Reactions and Epinephrine
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 use epinephrine to treat severe allergic reactions, inform your doctor, as this medication may reduce the effectiveness of epinephrine.
Overactive Thyroid
This medication may 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 abruptly, your condition may worsen and become life-threatening. Consult your doctor for guidance.
Pregnancy and Breastfeeding
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 failure
- Cardiogenic shock
- Bronchospasm
- Hypoglycemia
- Loss of consciousness
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and may include atropine for bradycardia, vasopressors for hypotension, glucagon, and bronchodilators for bronchospasm.
Drug Interactions
Contraindicated Interactions
- Severe hepatic impairment
Major Interactions
- Strong CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine, propafenone): Significantly increase nebivolol plasma concentrations, increasing risk of bradycardia and hypotension.
- 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.
- Antiarrhythmics (e.g., amiodarone, disopyramide): Increased risk of bradycardia and AV block.
- Clonidine: Risk of rebound hypertension upon clonidine withdrawal if nebivolol is not discontinued first.
Moderate Interactions
- Digitalis glycosides (e.g., digoxin): Increased risk of bradycardia and AV block.
- NSAIDs (e.g., ibuprofen, naproxen): May reduce the antihypertensive effect of nebivolol.
- Insulin and oral hypoglycemics: Beta-blockers may mask symptoms of hypoglycemia (e.g., tachycardia) and prolong hypoglycemic episodes.
- Sympathomimetics (e.g., epinephrine, norepinephrine): May antagonize the effects of nebivolol and lead to hypertension and bradycardia.
Minor Interactions
- Not typically categorized for minor interactions with nebivolol.
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 risk of bradycardia.
Timing: Prior to initiation
Renal Function (SCr, eGFR)
Rationale: To assess need for dose adjustment in renal impairment.
Timing: Prior to initiation
Hepatic Function (ALT, AST, Bilirubin)
Rationale: To assess need for dose adjustment or contraindication in hepatic impairment.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially after dose adjustments (e.g., weekly for first month, then monthly/quarterly)
Target: <130/80 mmHg (general hypertension target, individualized)
Action Threshold: >130/80 mmHg (consider dose increase or add therapy); <90/60 mmHg or symptomatic hypotension (consider dose decrease)
Heart Rate (HR)
Frequency: Regularly, especially after dose adjustments
Target: 50-70 bpm (individualized)
Action Threshold: <50 bpm or symptomatic bradycardia (consider dose decrease or discontinuation)
Symptoms of Heart Failure
Frequency: Regularly
Target: N/A
Action Threshold: Worsening dyspnea, edema, weight gain (evaluate for heart failure exacerbation)
Blood Glucose (for diabetics)
Frequency: Regularly
Target: Individualized
Action Threshold: Frequent or severe hypoglycemic episodes (adjust antidiabetic therapy or consider alternative antihypertensive)
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fatigue
- Shortness of breath
- Swelling in ankles/feet
- Slow heart rate
- Cold hands/feet
- Depression
Special Patient Groups
Pregnancy
Nebivolol is Pregnancy Category C. Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Beta-blockers can cause fetal/neonatal bradycardia, hypoglycemia, and respiratory depression. Neonates should be monitored for these effects.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally considered low risk for major malformations.
Second Trimester:
Potential for fetal growth restriction, bradycardia, and hypoglycemia.
Third Trimester:
Increased risk of neonatal bradycardia, hypoglycemia, respiratory depression, and prolonged labor. Withdrawal symptoms may occur in the neonate.
Lactation
Nebivolol is excreted into human milk. Due to the potential for serious adverse reactions in breastfed infants (e.g., bradycardia, hypotension, hypoglycemia), 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 level L3 (Moderately Safe - Possible risk to infant; use only if benefit outweighs risk).
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. Start with lower doses (e.g., 2.5 mg) and titrate slowly.
Clinical Information
Clinical Pearls
- Nebivolol is unique among beta-blockers due to its additional nitric oxide-mediated vasodilatory properties, which may contribute to its efficacy and potentially reduce some beta-blocker side effects like peripheral vasoconstriction.
- Abrupt discontinuation of nebivolol, especially in patients with ischemic heart disease, should be avoided as it can exacerbate angina, myocardial infarction, or ventricular arrhythmias. Taper dose gradually over 1-2 weeks.
- Patients who are poor CYP2D6 metabolizers will have significantly higher plasma concentrations of nebivolol and its active metabolites, requiring lower doses and careful monitoring for adverse effects.
- Nebivolol can mask symptoms of hypoglycemia (e.g., tachycardia) in diabetic patients and hyperthyroidism (e.g., tachycardia).
- Use with caution in patients with bronchospastic disease (e.g., asthma, COPD), although its beta-1 selectivity may offer some advantage over non-selective beta-blockers, it is not absolutely safe.
Alternative Therapies
- Other Beta-blockers (e.g., Metoprolol, Atenolol, Carvedilol)
- ACE Inhibitors (e.g., Lisinopril, Enalapril)
- Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
- Calcium Channel Blockers (e.g., Amlodipine, Diltiazem)
- Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
Cost & Coverage
Average Cost:
$15 - $50 per 30 tablets (generic 10mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (generic) or Tier 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them 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 medication taken, the amount, and the time it occurred.