Bisoprolol Fumarate 2.5mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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 start feeling 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 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, which may include 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. Do not take two doses at the same time or take extra doses to make up for a missed one.
Lifestyle & Tips
- Take medication exactly as prescribed, do not stop abruptly.
- Monitor your blood pressure and heart rate regularly at home if advised by your doctor.
- Maintain a healthy diet, low in sodium and saturated fats.
- Engage in regular physical activity as recommended by your doctor.
- Avoid smoking and limit alcohol consumption.
- Report any new or worsening symptoms to your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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 immediate 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 significant weight gain
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 do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Headache
Feeling tired or weak
Symptoms 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, contact your doctor for medical advice. 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 heartbeat (e.g., less than 50 beats per minute)
- Difficulty breathing or wheezing
- Swelling in your ankles, feet, or legs
- Unusual weight gain
- Chest pain or discomfort that worsens after stopping the medication
Before Using This Medicine
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:
+ Respiratory problems, such as asthma or chronic obstructive pulmonary disease (COPD)
+ Heart conditions, including heart block, heart failure (weak heart), or shock caused by heart problems
+ Slow heartbeat
If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist for clarification.
Please note that this is not an exhaustive list of all potential interactions between this medication and other drugs or health conditions. Therefore, it is crucial to discuss the following with your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including any health problems you have
To ensure your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in combination with all your other medications and health conditions.
Precautions & Cautions
Do not abruptly stop taking this medication, as this can lead to worsened chest pain and, in some cases, heart attack. This risk is particularly higher if you have certain types of heart disease. To minimize 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 alertness. To reduce the risk of dizziness or fainting, rise slowly from a sitting or lying position, and exercise caution when navigating stairs.
Regularly monitor your blood pressure and heart rate as directed by your doctor. Be aware that this medication may affect 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 rapid heartbeat, which can increase the risk of severe or prolonged hypoglycemia, especially in individuals with diabetes, children, and those who are fasting or undergoing surgery. 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 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 risk of an even more severe reaction if you are exposed to the allergen again. 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.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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)
- Cardiogenic shock
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment is supportive and may include atropine for bradycardia, glucagon, vasopressors, and bronchodilators.
Drug Interactions
Contraindicated Interactions
- Acute decompensated heart failure
- Severe bradycardia (< 45-50 bpm)
- Second- or third-degree AV block (without a pacemaker)
- Cardiogenic shock
- Sick sinus syndrome (without a pacemaker)
Major Interactions
- Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) - risk of severe bradycardia, AV block, heart failure
- Clonidine (risk of rebound hypertension upon clonidine withdrawal)
- Other beta-blockers (additive effects)
- Fingolimod (risk of severe bradycardia)
Moderate Interactions
- NSAIDs (may reduce antihypertensive effect)
- Alpha-1 blockers (e.g., prazosin, doxazosin) - additive hypotensive effects
- Insulin and oral hypoglycemics (may mask symptoms of hypoglycemia)
- Rifampin (may decrease bisoprolol levels)
- CYP2D6 inhibitors (e.g., fluoxetine, paroxetine, quinidine) - minor increase in bisoprolol levels
Minor Interactions
- Alcohol (additive hypotensive effect)
- Antacids (minor effect on absorption)
Monitoring
Baseline Monitoring
Rationale: To establish baseline and guide dosing
Timing: Prior to initiation
Rationale: To establish baseline and assess for bradycardia
Timing: Prior to initiation
Rationale: To assess for pre-existing conduction abnormalities
Timing: Prior to initiation (especially in patients with cardiac history)
Rationale: To assess kidney function and guide dose adjustments in severe impairment
Timing: Prior to initiation
Rationale: To assess liver function and guide dose adjustments in severe impairment
Timing: Prior to initiation
Routine Monitoring
Frequency: Regularly (e.g., weekly during titration, then monthly or as clinically indicated)
Target: <130/80 mmHg (or individualized target)
Action Threshold: Systolic >140 mmHg or Diastolic >90 mmHg (consider dose increase); Systolic <90 mmHg or symptomatic hypotension (consider dose decrease)
Frequency: Regularly (e.g., weekly during titration, then monthly or as clinically indicated)
Target: 50-70 bpm (or individualized target)
Action Threshold: <50 bpm or symptomatic bradycardia (consider dose decrease/discontinuation)
Frequency: Regularly
Target: Absence of worsening symptoms
Action Threshold: Worsening dyspnea, edema, weight gain (evaluate for heart failure exacerbation)
Frequency: Regularly (especially in patients with reactive airway disease)
Target: Absence of wheezing, shortness of breath
Action Threshold: New or worsening respiratory symptoms (consider discontinuation)
Symptom Monitoring
- Dizziness
- Lightheadedness
- Fatigue
- Shortness of breath
- Wheezing
- Swelling in ankles/feet
- Unusual weight gain
- Slow or irregular heartbeat
- Cold hands/feet
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 growth restriction. Monitor neonates for signs of beta-blockade for several days after birth.
Trimester-Specific Risks:
Lactation
Bisoprolol is excreted in breast milk in small amounts. The risk to the infant is generally considered low, but monitor the infant for signs of beta-blockade (e.g., bradycardia, lethargy, hypoglycemia). Use with caution, especially in preterm or unstable infants.
Pediatric Use
Safety and efficacy have not been established in pediatric patients for hypertension or angina. Use in pediatric heart failure is off-label and requires specialized care and monitoring.
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 (e.g., 2.5 mg) and titrate slowly due to potential for increased sensitivity to effects and adverse reactions.
Clinical Information
Clinical Pearls
- Do not abruptly discontinue bisoprolol, especially in patients with ischemic heart disease, as it can exacerbate angina, lead to myocardial infarction, or cause arrhythmias. Taper the dose gradually over 1-2 weeks.
- Use with caution in patients with reactive airway disease (e.g., asthma, COPD), as even beta-1 selective agents can cause bronchospasm at higher doses or in susceptible individuals.
- Bisoprolol can mask the signs and symptoms of hypoglycemia (e.g., tachycardia) in diabetic patients.
- May worsen symptoms of peripheral artery disease due to reduced peripheral blood flow.
- Effective for both hypertension and chronic stable heart failure, but dosing strategies differ significantly for these indications.
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)
- Loop diuretics (e.g., furosemide) for heart failure