Bisoprolol Fumarate 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, Beta-blocker
Pharmacologic Class
Beta-1 selective adrenergic blocker
Pregnancy Category
Category C
FDA Approved
Jul 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bisoprolol is a type of medicine called a beta-blocker. It works by slowing down your heart rate and relaxing blood vessels, which helps to lower your blood pressure and reduce the strain on your heart. It's used to treat high blood pressure and sometimes for heart failure.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue taking it even if you feel well. It's essential to follow your doctor's or healthcare provider's advice on dosage and duration of treatment.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms. Keep all medications in a safe location, out of reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal methods. You may also want to explore drug take-back programs 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. Avoid taking two doses at the same time or taking extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication as directed, with or without food, and continue taking it even if you feel well. It's essential to follow your doctor's or healthcare provider's advice on dosage and duration of treatment.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, avoiding bathrooms. Keep all medications in a safe location, out of reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult your pharmacist for guidance on proper disposal methods. You may also want to explore drug take-back programs 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. Avoid taking two doses at the same time or taking extra doses.
Lifestyle & Tips
- Take bisoprolol exactly as prescribed, usually once a day, with or without food.
- Do not stop taking this medication suddenly, as it can worsen your condition. If you need to stop, your doctor will gradually reduce your dose.
- Monitor your blood pressure and heart rate regularly as advised by your doctor.
- Maintain a healthy lifestyle, including a balanced diet (low in sodium), regular exercise, and limiting alcohol intake.
- Avoid activities requiring alertness until you know how the medication affects you, as it may cause dizziness or fatigue.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg once daily, titrated to 10 mg once daily for hypertension. For stable chronic heart failure, initial 1.25 mg once daily, titrated slowly over weeks to target 10 mg once daily.
Dose Range:
1.25 - 20 mg
Condition-Specific Dosing:
hypertension:
Initial 5 mg once daily, may increase to 10 mg once daily. Maximum 20 mg once daily.
stable_chronic_heart_failure:
Initial 1.25 mg once daily, doubled every 2 weeks as tolerated to a maximum of 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:
No adjustment needed (CrCl 20-50 mL/min)
Severe:
Maximum 10 mg once daily (CrCl < 20 mL/min)
Dialysis:
No additional dose needed; not significantly dialyzable.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Maximum 10 mg once daily
Severe:
Maximum 10 mg once daily
Pharmacology
Mechanism of Action
Bisoprolol is a highly selective beta1-adrenergic receptor blocking agent. It decreases heart rate, myocardial contractility, and cardiac output, leading to a reduction in blood pressure. It also reduces renin release from the kidneys.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 90%
Tmax:
2-4 hours
FoodEffect:
Food does not significantly affect the rate or extent of absorption.
Distribution:
Vd:
Approximately 3.5 L/kg
ProteinBinding:
Approximately 30%
CnssPenetration:
Limited
Elimination:
HalfLife:
9-12 hours
Clearance:
Approximately 15 L/hour
ExcretionRoute:
Renal (approximately 50% unchanged), Hepatic (approximately 50% as inactive metabolites, followed by renal excretion)
Unchanged:
Approximately 50%
Pharmacodynamics
OnsetOfAction:
Within 2-4 hours
PeakEffect:
2-4 hours
DurationOfAction:
24 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
Severe dizziness or fainting
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Slow heartbeat
Feeling cold in the arms or legs
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor if they bother you or do not go away:
Headache
Feeling tired or weak
Signs of a common cold
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
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
Severe dizziness or fainting
Shortness of breath, sudden weight gain, or swelling in the arms or legs
Slow heartbeat
Feeling cold in the arms or legs
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor if they bother you or do not go away:
Headache
Feeling tired or weak
Signs of a common cold
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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, wheezing, or shortness of breath
- Swelling in your ankles, feet, or hands (signs of worsening heart failure)
- Unusual fatigue or weakness
- Coldness or numbness in your fingers and toes
- Symptoms of depression
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:
+ Breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD)
+ Heart block or heart failure (weak heart)
+ Shock caused by heart problems
+ Slow heartbeat
* If you are currently using another medication similar to this one. If you are unsure, consult your doctor or pharmacist.
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:
+ Breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD)
+ Heart block or heart failure (weak heart)
+ Shock caused by heart problems
+ Slow heartbeat
* If you are currently using another medication similar to this one. If you are unsure, consult your doctor or pharmacist.
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
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Do not abruptly stop taking this medication, as this can lead to worsened chest pain and potentially even a heart attack, especially if you have certain types of heart disease. To minimize the risk of 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.
Until you understand how this medication affects you, avoid driving and other activities that require your full attention. To reduce the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.
Follow your doctor's instructions for monitoring your blood pressure and heart rate. Be aware that this medication may affect the results of certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication.
This medication may mask some symptoms of low blood sugar, such as a rapid heartbeat, which can increase the risk of severe or prolonged low blood sugar episodes. This is particularly concerning for individuals with diabetes, children, and those who are fasting, undergoing surgery, or experiencing nausea and vomiting. If you have questions or concerns, discuss them with your doctor.
If you have diabetes, it is crucial to closely monitor your blood sugar levels. Before taking any 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 with your doctor.
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 abruptly, your condition may worsen and become life-threatening. Discuss this with your doctor.
If you have a history of severe allergic reactions, inform your doctor, as you may be at a higher risk of an even more severe reaction if you are exposed to the allergen again. Additionally, if you use epinephrine to treat severe allergic reactions, consult with your doctor, as this medication may reduce the effectiveness of epinephrine.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
It is essential to discuss the benefits and risks of this medication with your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.
Do not abruptly stop taking this medication, as this can lead to worsened chest pain and potentially even a heart attack, especially if you have certain types of heart disease. To minimize the risk of 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.
Until you understand how this medication affects you, avoid driving and other activities that require your full attention. To reduce the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.
Follow your doctor's instructions for monitoring your blood pressure and heart rate. Be aware that this medication may affect the results of certain laboratory tests, so inform all your healthcare providers and laboratory personnel that you are taking this medication.
This medication may mask some symptoms of low blood sugar, such as a rapid heartbeat, which can increase the risk of severe or prolonged low blood sugar episodes. This is particularly concerning for individuals with diabetes, children, and those who are fasting, undergoing surgery, or experiencing nausea and vomiting. If you have questions or concerns, discuss them with your doctor.
If you have diabetes, it is crucial to closely monitor your blood sugar levels. Before taking any 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 with your doctor.
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 abruptly, your condition may worsen and become life-threatening. Discuss this with your doctor.
If you have a history of severe allergic reactions, inform your doctor, as you may be at a higher risk of an even more severe reaction if you are exposed to the allergen again. Additionally, if you use epinephrine to treat severe allergic reactions, consult with your doctor, as this medication may reduce the effectiveness of epinephrine.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
It is essential to discuss the benefits and risks of this medication with your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.
Overdose Information
Overdose Symptoms:
- Severe bradycardia (very slow heart rate)
- Profound hypotension (very low blood pressure)
- Bronchospasm (difficulty breathing, wheezing)
- Acute heart failure
- Hypoglycemia (low blood sugar)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment may involve atropine for bradycardia, glucagon, vasopressors for hypotension, and bronchodilators for bronchospasm.
Drug Interactions
Major Interactions
- Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) - risk of severe bradycardia, heart block, and heart failure.
- Clonidine - risk of rebound hypertension upon clonidine withdrawal if beta-blocker is not tapered.
- Digoxin - additive bradycardic effects.
- Amiodarone - increased risk of bradycardia, AV block, and myocardial depression.
Moderate Interactions
- NSAIDs (e.g., ibuprofen, naproxen) - may reduce the antihypertensive effect of bisoprolol.
- Insulin and oral hypoglycemics - may mask symptoms of hypoglycemia (e.g., tachycardia).
- Other antihypertensives - additive hypotensive effects.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine) - may slightly increase bisoprolol plasma concentrations (minor clinical significance).
Minor Interactions
- Alpha-1 blockers (e.g., prazosin) - increased risk of orthostatic hypotension.
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide dosing.
Timing: Prior to initiation
Heart Rate (HR)
Rationale: To establish baseline and assess risk of bradycardia.
Timing: Prior to initiation
Electrocardiogram (ECG)
Rationale: To assess for pre-existing conduction abnormalities (e.g., heart block).
Timing: Prior to initiation, especially in patients with cardiac history
Renal Function (SCr, eGFR)
Rationale: To assess baseline kidney function and guide dose adjustments in severe impairment.
Timing: Prior to initiation
Hepatic Function (ALT, AST)
Rationale: To assess baseline liver function and guide dose adjustments in severe impairment.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly (e.g., daily at home, at each clinic visit)
Target: <130/80 mmHg (general hypertension target, individualized)
Action Threshold: Systolic >140 mmHg or Diastolic >90 mmHg (consider dose increase); Systolic <90 mmHg or symptomatic hypotension (consider dose decrease)
Heart Rate (HR)
Frequency: Regularly (e.g., daily at home, at each clinic visit)
Target: 50-70 bpm (resting, individualized)
Action Threshold: <50 bpm or symptomatic bradycardia (consider dose decrease or discontinuation)
Symptoms of Heart Failure Exacerbation
Frequency: Regularly (patient self-monitoring)
Target: Not applicable
Action Threshold: Worsening dyspnea, edema, weight gain (requires medical evaluation)
Renal Function (SCr, eGFR)
Frequency: Periodically (e.g., every 6-12 months, or more frequently if renal impairment or concomitant nephrotoxic drugs)
Target: Stable
Action Threshold: Significant decline in eGFR (consider dose adjustment or alternative)
Hepatic Function (ALT, AST)
Frequency: Periodically (e.g., every 6-12 months, or more frequently if hepatic impairment)
Target: Stable
Action Threshold: Significant elevation (consider dose adjustment or alternative)
Symptom Monitoring
- Bradycardia (slow heart rate)
- Hypotension (dizziness, lightheadedness, fainting)
- Fatigue, weakness
- Shortness of breath, wheezing (especially in patients with asthma/COPD)
- Peripheral edema (swelling in ankles/feet)
- Cold extremities
- Depression
- Insomnia
- Masked symptoms of hypoglycemia (in diabetics)
Special Patient Groups
Pregnancy
Bisoprolol is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Beta-blockers can cause fetal growth restriction, bradycardia, and hypoglycemia. Neonates exposed to beta-blockers in utero may be at risk for these effects for several days after birth.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally avoided unless essential due to potential for fetal effects.
Second Trimester:
Risk of fetal growth restriction, bradycardia, and hypoglycemia.
Third Trimester:
Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression. Monitor neonate for several days post-delivery.
Lactation
Bisoprolol is excreted in human milk in small amounts. The amount ingested by the infant is generally low. Monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, hypotension, hypoglycemia). Use with caution.
Infant Risk:
Low to moderate risk (L3). Potential for bradycardia, hypotension, and hypoglycemia in the infant, especially in preterm or sick infants.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not recommended for routine use in children.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and titrate slowly due to increased risk of adverse effects like bradycardia and orthostatic hypotension.
Clinical Information
Clinical Pearls
- Bisoprolol is a highly beta-1 selective beta-blocker, which may be advantageous in patients with mild to moderate obstructive airway disease, but caution is still advised.
- Abrupt discontinuation can lead to rebound hypertension, angina exacerbation, or myocardial infarction, especially in patients with coronary artery disease. Taper dose gradually over 1-2 weeks.
- In heart failure, bisoprolol should be initiated at a very low dose (1.25 mg) and titrated slowly over several weeks to months, only in stable patients.
- Monitor for signs of worsening heart failure during initiation or dose titration in heart failure patients.
- May mask symptoms of hypoglycemia in diabetic patients and hyperthyroidism (tachycardia).
Alternative Therapies
- Other beta-blockers (e.g., metoprolol, carvedilol, atenolol)
- ACE inhibitors (e.g., lisinopril, enalapril)
- Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
- Calcium Channel Blockers (e.g., amlodipine, nifedipine)
- Thiazide diuretics (e.g., hydrochlorothiazide)
- Alpha-blockers (e.g., prazosin, doxazosin)
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (generic 10mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
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 substance taken, the amount, and the time it occurred.