Bisoprolol Fumarate 5mg 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, Antianginal
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 (hypertension) and chest pain (angina).
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 and areas where children and pets can access it. Keep all medications in a safe location and 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, check with your pharmacist for guidance on proper disposal or participate in a drug take-back program 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 dose, skip the missed dose and resume your regular 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. 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 and areas where children and pets can access it. Keep all medications in a safe location and 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, check with your pharmacist for guidance on proper disposal or participate in a drug take-back program 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 dose, skip the missed dose and resume your regular 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.
- Do not stop taking bisoprolol suddenly, as this can worsen your condition. If you need to stop, your doctor will gradually reduce your dose.
- Monitor your blood pressure and heart rate regularly at home, if advised by your doctor.
- Maintain a healthy lifestyle, including a balanced diet, regular exercise, limiting sodium intake, and avoiding smoking and excessive alcohol.
- Report any new or worsening symptoms, especially shortness of breath, swelling, or very slow heart rate, to your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Hypertension: Initially 5 mg orally once daily. May increase to 10 mg once daily. Maximum 20 mg once daily. Angina: Initially 5 mg orally once daily. May increase to 10 mg once daily. Maximum 20 mg once daily.
Dose Range:
2.5 - 20 mg
Condition-Specific Dosing:
heartFailure:
Initially 1.25 mg orally once daily, titrated slowly over weeks to months to a target of 10 mg once daily, as tolerated.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established for routine use; limited data for hypertension (e.g., 0.2 mg/kg/day, max 10 mg/day).
Adolescent:
Not established for routine use; limited data for hypertension (e.g., 0.2 mg/kg/day, max 10 mg/day).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 50 mL/min)
Moderate:
No adjustment needed (CrCl 30-50 mL/min)
Severe:
Initial dose 2.5 mg once daily; maximum 10 mg once daily (CrCl < 30 mL/min)
Dialysis:
No additional dose needed after dialysis; initial dose 2.5 mg once daily, max 10 mg once daily.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
Initial dose 2.5 mg once daily; maximum 10 mg once daily
Pharmacology
Mechanism of Action
Bisoprolol is a highly selective beta1-adrenergic receptor blocking agent. It competitively blocks beta1-adrenergic receptors, primarily in the heart, leading to decreased heart rate, decreased myocardial contractility, and reduced cardiac output. This results in a reduction in blood pressure. It also reduces renin release from the kidneys.
Pharmacokinetics
Absorption:
Bioavailability:
80-90%
Tmax:
2-4 hours
FoodEffect:
Not significantly affected by food
Distribution:
Vd:
Approximately 2.8 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)
Unchanged:
Approximately 50%
Pharmacodynamics
OnsetOfAction:
1-2 hours
PeakEffect:
2-4 hours
DurationOfAction:
24 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 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
Severe dizziness or fainting
Shortness of breath, significant 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. 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
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 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
Severe dizziness or fainting
Shortness of breath, significant 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. 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
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 or wheezing
- Swelling in your hands, ankles, or feet
- Unusual weight gain
- Chest pain or discomfort that worsens
- Coldness or numbness in your fingers and toes
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 allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD)
+ Heart block or heart failure (a weak heart)
+ Shock caused by heart problems
+ A slow heartbeat
* If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine if there are any potential interactions.
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 you 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 allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, including:
+ Breathing problems, such as asthma or chronic obstructive pulmonary disease (COPD)
+ Heart block or heart failure (a weak heart)
+ Shock caused by heart problems
+ A slow heartbeat
* If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine if there are any potential interactions.
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 you 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 discontinue the 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 alertness. To reduce the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
As directed by your doctor, regularly monitor your blood pressure and heart rate. Be aware that this medication may influence 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 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 have undergone surgery, are not eating normally, or are experiencing 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 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 with your doctor.
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 suddenly stop taking this medication, 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.
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to both you and your baby.
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 discontinue the 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 alertness. To reduce the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.
As directed by your doctor, regularly monitor your blood pressure and heart rate. Be aware that this medication may influence 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 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 have undergone surgery, are not eating normally, or are experiencing 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 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 with your doctor.
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 suddenly stop taking this medication, 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.
Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe bradycardia (very slow heart rate)
- Hypotension (very low blood pressure)
- Acute cardiac insufficiency (heart failure)
- Bronchospasm (difficulty breathing)
- 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
Contraindicated Interactions
- Acute decompensated heart failure
- Cardiogenic shock
- Second or third-degree AV block without a pacemaker
- Sick sinus syndrome without a pacemaker
- Severe bradycardia (<45-50 bpm)
- Severe asthma or severe COPD
Major Interactions
- Other beta-blockers (additive effects)
- Calcium channel blockers (e.g., verapamil, diltiazem - increased risk of bradycardia, AV block, heart failure)
- Class I antiarrhythmics (e.g., disopyramide, quinidine, flecainide - increased risk of myocardial depression, AV conduction disturbances)
- Clonidine (risk of rebound hypertension upon clonidine withdrawal if beta-blocker not stopped first)
- MAO inhibitors (risk of significant hypertension)
Moderate Interactions
- NSAIDs (may reduce antihypertensive effect)
- Alpha-1 blockers (e.g., prazosin - increased risk of first-dose hypotension)
- Insulin and oral hypoglycemics (may mask symptoms of hypoglycemia, prolong hypoglycemic response)
- Digitalis glycosides (additive bradycardia, AV block)
- Rifampin (may decrease bisoprolol levels)
- Cimetidine (may increase bisoprolol levels)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide dosing for hypertension/angina.
Timing: Before initiation
Heart Rate (HR)
Rationale: To establish baseline and assess for bradycardia.
Timing: Before initiation
Electrocardiogram (ECG)
Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block).
Timing: Before initiation, especially in patients with cardiac history
Renal Function (SCr, eGFR)
Rationale: To guide initial dosing in patients with renal impairment.
Timing: Before initiation
Liver Function Tests (LFTs)
Rationale: To guide initial dosing in patients with severe hepatic impairment.
Timing: Before initiation
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly (e.g., weekly during titration, then monthly/quarterly)
Target: <130/80 mmHg (general hypertension target, may vary by patient)
Action Threshold: Persistent BP above target or symptomatic hypotension
Heart Rate (HR)
Frequency: Regularly (e.g., weekly during titration, then monthly/quarterly)
Target: 50-70 bpm (resting)
Action Threshold: Persistent HR <50 bpm or symptomatic bradycardia
Symptoms of Heart Failure
Frequency: Regularly (at each visit)
Target: Not applicable
Action Threshold: Worsening shortness of breath, edema, weight gain
Symptoms of Bronchospasm
Frequency: Regularly (at each visit)
Target: Not applicable
Action Threshold: New or worsening wheezing, dyspnea
Symptom Monitoring
- Dizziness or lightheadedness (especially upon standing)
- Fatigue or weakness
- Shortness of breath or wheezing
- Swelling in ankles, feet, or legs
- Unusual weight gain
- Slow or irregular heartbeat
- Cold hands or feet
- Depression
Special Patient Groups
Pregnancy
Bisoprolol is 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/neonatal bradycardia, hypoglycemia, and respiratory depression. Growth retardation has been reported.
Trimester-Specific Risks:
First Trimester:
Limited data, but generally avoided if possible due to potential for fetal growth restriction and other adverse effects seen with beta-blockers.
Second Trimester:
Potential for fetal growth restriction, bradycardia, and hypoglycemia.
Third Trimester:
Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression. Monitor neonates for 24-48 hours after birth.
Lactation
Bisoprolol is excreted in human milk in small amounts. The amount ingested by the infant is low, and adverse effects are unlikely. However, monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, hypotension, lethargy). Considered L3 (Moderately Safe).
Infant Risk:
Low risk, but monitor for bradycardia, hypotension, and hypoglycemia.
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Use is generally not recommended for routine hypertension or angina in children. Limited off-label use for specific conditions (e.g., certain arrhythmias, hypertrophic cardiomyopathy) under specialist supervision.
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 the lowest effective dose (e.g., 2.5 mg) and titrate slowly due to potential for decreased renal/hepatic function and increased sensitivity to adverse effects.
Clinical Information
Clinical Pearls
- Bisoprolol is a highly beta1-selective beta-blocker, making it a preferred choice for patients with concomitant respiratory conditions (e.g., mild asthma, COPD) compared to non-selective beta-blockers, though caution is still advised.
- Abrupt discontinuation of bisoprolol, especially in patients with ischemic heart disease, can precipitate angina, myocardial infarction, or ventricular arrhythmias. Taper the dose gradually over 1-2 weeks.
- Used in the management of stable chronic heart failure (NYHA Class II-IV) in addition to ACE inhibitors and diuretics, starting at a very low dose and titrating slowly.
- May mask symptoms of hypoglycemia in diabetic patients and hyperthyroidism (e.g., tachycardia).
- Patients should be advised to report any signs of worsening heart failure (e.g., increasing shortness of breath, weight gain, edema).
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, Nifedipine, Diltiazem, Verapamil)
- Diuretics (e.g., Hydrochlorothiazide, Furosemide)
- Alpha-blockers (e.g., Doxazosin, Prazosin)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$30 per 30 tablets (5mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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.