Sectral 200mg Capsules

Acebutolol is a cardioselective (beta-1 selective) beta-adrenergic receptor blocking agent with intrinsic sympathomimetic activity (ISA) and membrane-stabilizing activity. It competitively 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 catecholamines, potentially leading to less bradycardia and bronchoconstriction compared to beta-blockers without ISA. The membrane-stabilizing activity is similar to quinidine, but only at doses higher than those used therapeutically.

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, 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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:

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 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 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 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.

Important Warnings and Precautions

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 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 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 have your blood work checked as directed by your doctor, and discuss the results with them. Additionally, monitor your blood pressure and heart rate as instructed by your doctor.

Interactions with Other Substances

Before consuming alcohol, consult with your doctor. 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.

Diabetes Management

If you have high blood sugar (diabetes), closely monitor your blood sugar levels while taking this medication.

High Blood Pressure

If you have high blood pressure and are taking this medication, consult with 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.

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 a higher 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 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.

Pregnancy

If you are pregnant or plan to become pregnant, discuss the benefits and risks of taking this medication with your doctor.

• Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem): Increased risk of bradycardia, AV block, heart failure.
• Clonidine: Potentially severe rebound hypertension upon clonidine withdrawal if beta-blocker is not tapered first.
• Digoxin: Increased risk of bradycardia and AV block.
• Fingolimod: Additive bradycardic effects.

• NSAIDs (e.g., ibuprofen, naproxen): May reduce antihypertensive effect.
• Insulin and oral hypoglycemics: May mask symptoms of hypoglycemia (e.g., tachycardia) and prolong hypoglycemic episodes.
• Other antihypertensives: Additive hypotensive effects.
• Class I antiarrhythmics (e.g., disopyramide, quinidine): Increased risk of myocardial depression and bradycardia.
• Sympathomimetics (e.g., epinephrine, norepinephrine): Reduced beta-agonist effect, potential for unopposed alpha-adrenergic effects (hypertension, bradycardia).

• Alcohol: May enhance hypotensive effect.

• Bradycardia (slow pulse)
• Hypotension (dizziness, lightheadedness, fainting)
• Fatigue or weakness
• Shortness of breath or wheezing (especially in patients with asthma/COPD)
• Cold hands and feet
• Depression or mood changes
• Sleep disturbances
• New or worsening symptoms of heart failure (e.g., swelling in ankles/feet, sudden weight gain, increased shortness of breath)

Acebutolol is Pregnancy Category B. Studies in animals have shown no evidence of harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if clearly needed.

Acebutolol and its active metabolite, diacetolol, are excreted into human 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.

Lower initial doses (e.g., 200 mg once daily) are recommended in elderly patients due to potential for increased sensitivity to beta-blockers and reduced renal function. Titrate dose carefully based on response and tolerability. Increased risk of adverse effects such as bradycardia and hypotension.

• Acebutolol is a cardioselective beta-blocker with intrinsic sympathomimetic activity (ISA), which may result in less bradycardia and less adverse effects on lipid profiles or bronchoconstriction compared to non-ISA beta-blockers.
• Due to its active metabolite (diacetolol) with a longer half-life, once-daily dosing is effective.
• 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 bronchospastic disease (e.g., asthma, COPD), although its beta-1 selectivity and ISA may offer a slight advantage over non-selective beta-blockers, it is not without risk.
• Monitor for signs of heart failure exacerbation, especially in patients with pre-existing cardiac dysfunction.
• May mask symptoms of hypoglycemia in diabetic patients and hyperthyroidism (e.g., tachycardia).

• Other Beta-blockers (e.g., metoprolol, atenolol, carvedilol, bisoprolol, propranolol)
• Calcium Channel Blockers (e.g., amlodipine, nifedipine, verapamil, diltiazem)
• 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)

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.