Acebutolol 200mg Capsules

Acebutolol is a cardioselective (beta-1) adrenergic receptor blocking agent with intrinsic sympathomimetic activity (ISA) and membrane-stabilizing activity. It selectively blocks beta-1 adrenergic receptors, primarily in the heart, reducing heart rate, myocardial contractility, and cardiac output. Its ISA means it can partially stimulate beta-receptors while blocking the effects of endogenous catecholamines, potentially leading to less bradycardia and bronchoconstriction compared to beta-blockers without ISA. The membrane-stabilizing activity is similar to quinidine, contributing to its antiarrhythmic 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. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms, which may indicate a serious reaction:

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
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Dizziness
Fatigue
Weakness
* Headache

Note: This is not an exhaustive list of possible 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:
+ 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 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.

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Stopping the Medication

Do not abruptly stop taking this medication, as this may lead to worsening chest pain and, in some cases, heart attack. The risk is higher if you have certain types of heart disease. To minimize 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.

Caution with Daily Activities

Avoid driving and engaging in activities that require alertness until you understand how this medication affects you. To reduce the risk of dizziness or fainting, rise slowly from a sitting or lying down position, and exercise caution when climbing stairs.

Monitoring and Follow-up

Regularly check your blood work as directed by your doctor and discuss the results with them. Additionally, monitor your blood pressure and heart rate as instructed by your doctor. Before consuming alcohol, consult with your doctor.

Low Blood Sugar and Diabetes

This medication may mask symptoms of low blood sugar, such as rapid heartbeat, which can increase the risk of severe or prolonged low blood sugar. 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, closely monitor your blood sugar levels.

Interactions with Other Medications

If you have high blood pressure, consult with your doctor before taking over-the-counter (OTC) products that may increase blood pressure, such as cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Thyroid Conditions

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.

Allergic Reactions

If you have a history of severe allergic reactions, inform your doctor. You may be at risk of a 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 epinephrine may be less effective while taking this medication.

Special Considerations

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.

• Fingolimod (risk of severe bradycardia)
• Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem) in patients with severe left ventricular dysfunction or AV conduction abnormalities (risk of severe bradycardia, heart block, heart failure exacerbation)

• Other antihypertensives (additive hypotensive effects)
• Class I antiarrhythmics (e.g., disopyramide, flecainide, quinidine) (additive negative inotropic and dromotropic effects)
• Digoxin (additive bradycardia, AV block)
• Insulin and oral hypoglycemics (masking of hypoglycemia symptoms, prolonged hypoglycemia)
• NSAIDs (e.g., ibuprofen, naproxen) (may reduce antihypertensive effect)
• Clonidine (risk of rebound hypertension upon clonidine withdrawal if beta-blocker is not tapered first)
• Sympathomimetics (e.g., epinephrine, norepinephrine, pseudoephedrine) (unopposed alpha-adrenergic stimulation leading to hypertension and bradycardia)

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

• Not available

• Bradycardia (slow heart rate)
• Hypotension (dizziness, lightheadedness, fainting)
• Fatigue or weakness
• Dyspnea (shortness of breath), especially in patients with asthma or COPD
• Peripheral edema or weight gain (signs of heart failure exacerbation)
• Cold extremities
• Masked symptoms of hypoglycemia in diabetic patients (e.g., sweating, tremors, tachycardia)

Acebutolol is classified as Pregnancy Category D. Use during pregnancy, especially in the second and third trimesters, has been associated with adverse fetal effects including intrauterine growth restriction, bradycardia, and hypoglycemia. Neonates exposed to beta-blockers in utero may experience bradycardia, hypoglycemia, and respiratory depression. Use only if the potential benefit justifies the potential risk to the fetus.

Acebutolol and its active metabolite, diacetolol, are excreted into breast milk. While the amount is relatively low, potential for adverse effects in the infant (e.g., bradycardia, hypoglycemia) exists. Monitor breastfed infants for signs of beta-blockade. Use with caution, or consider an alternative if possible, especially in premature or neonates with impaired renal function.

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 beta-blockers and may have reduced renal or hepatic function, requiring lower initial doses and careful titration. Increased risk of bradycardia and hypotension. Monitor closely.

• Acebutolol is a beta-1 selective beta-blocker with intrinsic sympathomimetic activity (ISA), which may result in less bradycardia and less bronchoconstriction compared to non-ISA beta-blockers.
• Due to its active metabolite (diacetolol) with a longer half-life, once-daily dosing is often effective despite the parent drug's shorter half-life.
• Always taper acebutolol gradually over 1-2 weeks when discontinuing, especially in patients with ischemic heart disease, to avoid rebound angina, myocardial infarction, or arrhythmias.
• Use with caution in patients with asthma, COPD, or other bronchospastic diseases, despite its beta-1 selectivity, as high doses can still affect beta-2 receptors.
• Monitor diabetic patients closely, as acebutolol can mask symptoms of hypoglycemia (e.g., tremor, tachycardia) and prolong hypoglycemic episodes.
• Patients with peripheral vascular disease may experience worsening symptoms due to reduced peripheral blood flow.

• Other beta-blockers (e.g., metoprolol, atenolol, carvedilol, bisoprolol)
• ACE inhibitors (e.g., lisinopril, enalapril)
• Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan)
• Calcium Channel Blockers (e.g., amlodipine, nifedipine, diltiazem, verapamil)
• Diuretics (e.g., hydrochlorothiazide, furosemide)
• Alpha-blockers (e.g., prazosin, doxazosin)

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. 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.