Acebutolol 400mg Capsules

Acebutolol is a cardioselective beta-1 adrenergic receptor blocker. It selectively blocks beta-1 receptors in the heart, reducing heart rate and myocardial contractility, leading to decreased cardiac output and blood pressure. It also possesses intrinsic sympathomimetic activity (ISA), meaning it can partially stimulate beta-receptors while blocking the effects of catecholamines, which may result in less bradycardia and less adverse lipid effects compared to beta-blockers without ISA. Additionally, it has membrane-stabilizing activity (quinidine-like effect) at high doses.

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 or seek immediate medical attention:

Signs of an allergic reaction, including:
+ 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
Abnormal 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 unusual symptoms that bother you or persist, contact your doctor for advice:

Dizziness
Fatigue
Weakness
* Headache

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.

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:
+ Respiratory problems like asthma or chronic obstructive pulmonary disease (COPD)
+ Heart block or heart failure (weak heart)
+ Shock caused by heart problems
+ Slow heartbeat
* If you are breastfeeding, as you should not breastfeed 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 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, stand up slowly after sitting or lying down, and exercise caution when navigating stairs.

Regular blood tests, as directed by your doctor, are crucial to monitor your condition. Also, follow your doctor's instructions for checking your blood pressure and heart rate. Before consuming alcohol, discuss the potential risks 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 questions or concerns, consult your doctor. If you have diabetes, it is vital to closely monitor your blood sugar levels.

If you have high blood pressure and are taking this medication, consult your doctor 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, and certain natural products or aids.

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 risk with your doctor.

If you have a history of severe allergic reactions, inform your doctor, as you may be at increased risk of a more severe reaction if you are exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, consult 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 or plan to become pregnant, discuss the benefits and risks of using this medication with your doctor.

• Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) in patients with impaired ventricular function or AV conduction abnormalities (risk of severe bradycardia, heart block, heart failure exacerbation)
• MAO inhibitors (risk of severe hypertension)

• Other antiarrhythmics (e.g., amiodarone, disopyramide, flecainide, quinidine) - additive negative inotropic and dromotropic effects
• Digoxin - additive bradycardia, increased AV block risk
• Insulin and oral hypoglycemics - may mask symptoms of hypoglycemia (tachycardia, palpitations)
• Clonidine - risk of rebound hypertension upon clonidine withdrawal if beta-blocker is not tapered first
• Sympathomimetics (e.g., epinephrine, norepinephrine, phenylephrine) - may cause hypertension followed by bradycardia
• NSAIDs (e.g., ibuprofen, naproxen) - may reduce antihypertensive effect

• Alpha-1 blockers (e.g., prazosin, doxazosin) - increased risk of first-dose hypotension
• Antipsychotics (e.g., thioridazine) - increased risk of QT prolongation
• Cimetidine - may increase acebutolol levels
• Alcohol - additive hypotensive effects

• Antacids (aluminum/magnesium hydroxide) - may decrease acebutolol absorption

• Bradycardia (slow pulse)
• Hypotension (dizziness, lightheadedness, fainting)
• Fatigue, lethargy
• Dyspnea, wheezing (especially in patients with reactive airway disease)
• Peripheral edema, weight gain (signs of heart failure exacerbation)
• Cold extremities
• Depression, sleep disturbances

Acebutolol is Pregnancy Category B in the first trimester and Category D in the second and third trimesters. Use during pregnancy should only be considered 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 experience bradycardia, hypoglycemia, and respiratory depression.

Acebutolol and its active metabolite, diacetolol, are excreted into breast milk. The American Academy of Pediatrics considers acebutolol to be compatible with breastfeeding, but caution is advised. Monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, hypotension, lethargy, hypoglycemia).

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

Elderly patients may be more sensitive to the effects of acebutolol, particularly regarding bradycardia and hypotension. Lower initial doses and careful titration are recommended. Renal function should be monitored, as age-related decline in renal function may necessitate dose adjustments.

• Acebutolol is a cardioselective beta-1 blocker with intrinsic sympathomimetic activity (ISA). This ISA may result in less bradycardia and less adverse effects on lipid profiles compared to beta-blockers without ISA.
• Due to its ISA, acebutolol may be preferred in patients who develop significant bradycardia or peripheral vasoconstriction with other beta-blockers, but it may be less effective in reducing heart rate during exercise.
• Abrupt discontinuation of acebutolol, like other beta-blockers, can lead to rebound hypertension, angina exacerbation, myocardial infarction, or arrhythmias, especially in patients with ischemic heart disease. Taper dose gradually over 1-2 weeks.
• Acebutolol is primarily eliminated renally, so dose adjustments are crucial in patients with renal impairment.
• While cardioselective, acebutolol can still cause bronchospasm at higher doses or in susceptible patients with asthma or COPD. Use with caution in such patients.

• Other beta-blockers (e.g., metoprolol, atenolol, carvedilol, bisoprolol)
• Calcium channel blockers (e.g., amlodipine, nifedipine, diltiazem, verapamil)
• ACE inhibitors (e.g., lisinopril, enalapril)
• Angiotensin receptor blockers (ARBs) (e.g., losartan, valsartan)
• Diuretics (e.g., hydrochlorothiazide, furosemide)
• Other antiarrhythmics (e.g., amiodarone, flecainide, sotalol)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. 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 for more information. 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.