Sectral 400mg Capsules
It is used to treat high blood pressure.It is used to treat certain types of abnormal heartbeats.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antihypertensive, Antiarrhythmic
Pharmacologic Class
Beta-adrenergic Blocker (Cardioselective with Intrinsic Sympathomimetic Activity)
Pregnancy Category
Category D
FDA Approved
Dec 1981
DEA Schedule
Not Controlled
Overview
What is this medicine?
Acebutolol is a type of medicine called a beta-blocker. It works by relaxing blood vessels and slowing your heart rate, which helps to lower high blood pressure and relieve chest pain (angina). It can also help to control irregular heartbeats.
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. Continue taking it even if you feel well, and take it at the same time every day.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Make sure the lid is tightly closed. Keep all medications in a safe location, out of the reach of children and pets.
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 a 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. Continue taking it even if you feel well, and take it at the same time every day.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Make sure the lid is tightly closed. Keep all medications in a safe location, out of the reach of children and pets.
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 a missed one.
Lifestyle & Tips
- Take medication exactly as prescribed, do not stop abruptly without consulting your doctor.
- Monitor your blood pressure and heart rate regularly as advised by your doctor.
- Maintain a healthy diet, low in sodium and saturated fats.
- Engage in regular physical activity as recommended by your doctor.
- Limit alcohol intake.
- Avoid smoking.
- Inform your doctor about all other medications, supplements, and herbal products you are taking.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Hypertension: Initial 200 mg once daily, maintenance 200-800 mg/day (typically 400 mg once daily or 200 mg twice daily). Angina Pectoris: Initial 200 mg twice daily, maintenance 300-800 mg/day (typically 400 mg twice daily). Ventricular Arrhythmias (PVCs): Initial 200 mg twice daily, maintenance 600-1200 mg/day.
Dose Range:
200 - 1200 mg
Condition-Specific Dosing:
hypertension:
Initial 200 mg once daily; maintenance 200-800 mg/day (max 1200 mg/day)
anginaPectoris:
Initial 200 mg twice daily; maintenance 300-800 mg/day (max 1200 mg/day)
ventricularArrhythmias:
Initial 200 mg twice daily; maintenance 600-1200 mg/day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
CrCl 25-50 mL/min: Reduce dose by 50%.
Moderate:
CrCl 25-50 mL/min: Reduce dose by 50%.
Severe:
CrCl < 25 mL/min: Reduce dose by 75%.
Dialysis:
Not significantly removed by hemodialysis; supplemental dose not typically needed after dialysis, but monitor patient response.
Hepatic Impairment:
Mild:
Use with caution, lower doses may be required.
Moderate:
Use with caution, lower doses may be required.
Severe:
Use with caution, lower doses may be required.
Pharmacology
Mechanism of Action
Acebutolol is a cardioselective (beta-1) adrenergic receptor blocking agent. It also possesses intrinsic sympathomimetic activity (ISA), meaning it can partially stimulate beta-adrenergic receptors while blocking the effects of catecholamines. Additionally, it has membrane-stabilizing activity (quinidine-like effect) at high doses.
Pharmacokinetics
Absorption:
Bioavailability:
35-50%
Tmax:
Acebutolol: 2-4 hours; Diacetolol (active metabolite): 3-8 hours
FoodEffect:
Food does not significantly alter absorption.
Distribution:
Vd:
Acebutolol: 1.2 L/kg; Diacetolol: 1.5 L/kg
ProteinBinding:
Acebutolol: ~25%; Diacetolol: ~15%
CnssPenetration:
Limited
Elimination:
HalfLife:
Acebutolol: 3-4 hours; Diacetolol: 8-13 hours
Clearance:
Not available
ExcretionRoute:
Renal (30-40% acebutolol, 50-60% diacetolol); Fecal (50-60% acebutolol, 30-40% diacetolol)
Unchanged:
Acebutolol: 30-40% (renal)
Pharmacodynamics
OnsetOfAction:
1-2 hours
PeakEffect:
2-4 hours
DurationOfAction:
12-24 hours (due to active metabolite)
Safety & Warnings
BLACK BOX WARNING
Abrupt cessation of therapy with beta-blocking agents in patients with coronary artery disease has been followed by exacerbations of angina pectoris and, in some cases, myocardial infarction and death. Therefore, when discontinuance of acebutolol is planned, the dosage should be gradually reduced over a period of about 2 weeks and the patient should be carefully observed. If angina worsens or acute coronary insufficiency develops, acebutolol administration should be reinstituted promptly, at least temporarily, and other measures appropriate for the management of unstable angina pectoris should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician's advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue acebutolol therapy abruptly even in patients treated only for hypertension.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while 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. 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:
Dizziness
Fatigue
Weakness
* Headache
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while 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. 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:
Dizziness
Fatigue
Weakness
* Headache
Note: This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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, wheezing, or new or worsening shortness of breath
- Swelling in your ankles or feet, or sudden weight gain
- Unusual fatigue or weakness
- Coldness or numbness in your hands or feet
- Symptoms of low blood sugar (e.g., sweating, shakiness) if you are diabetic, as acebutolol can mask typical symptoms like fast heartbeat.
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 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 drugs 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 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 drugs and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
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. 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.
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. 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 certain 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, it is crucial to 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 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. If you are pregnant or plan to become pregnant, discuss the benefits and risks of taking this medication with your doctor.
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. 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.
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. 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 certain 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, it is crucial to 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 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. If you are pregnant or plan to become pregnant, discuss the benefits and risks of taking this medication with your doctor.
Overdose Information
Overdose Symptoms:
- Severe bradycardia (very slow heart rate)
- Hypotension (low blood pressure)
- Acute cardiac failure
- Cardiogenic shock
- Bronchospasm
- Hypoglycemia
- Seizures
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Treatment is supportive and symptomatic, and may include atropine, glucagon, vasopressors, and bronchodilators.
Drug Interactions
Contraindicated Interactions
- Patients with overt cardiac failure
- Second and third degree AV block
- Cardiogenic shock
- Sinus bradycardia
- Hypersensitivity to acebutolol or other beta-blockers
Major Interactions
- Non-dihydropyridine calcium channel blockers (e.g., verapamil, diltiazem): Increased risk of bradycardia, AV block, and heart failure.
- Digoxin: Increased risk of bradycardia and AV block.
- Clonidine: Potentiation of rebound hypertension upon clonidine withdrawal.
- Fingolimod: Increased risk of severe bradycardia and AV block.
- Other beta-blockers: Additive effects.
Moderate Interactions
- 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.
- Sympathomimetics (e.g., epinephrine, norepinephrine): May cause paradoxical hypertension and bradycardia.
- Class I antiarrhythmics (e.g., disopyramide, quinidine): Additive negative inotropic effects.
- Alpha-1 blockers (e.g., prazosin): Increased risk of first-dose hypotension.
Minor Interactions
- Alcohol: May enhance hypotensive effect.
- Antacids (aluminum/magnesium hydroxide): May decrease acebutolol absorption (separate administration).
Monitoring
Baseline Monitoring
Blood Pressure (BP)
Rationale: To establish baseline and guide initial dosing.
Timing: Prior to initiation
Heart Rate (HR)
Rationale: To establish baseline and assess for bradycardia.
Timing: Prior to initiation
Electrocardiogram (ECG)
Rationale: To assess for pre-existing conduction abnormalities (e.g., AV block).
Timing: Prior to initiation, especially in patients with cardiac history
Renal Function (CrCl)
Rationale: To guide dose adjustments in patients with renal impairment.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated)
Target: Individualized based on treatment goals (e.g., <130/80 mmHg for hypertension)
Action Threshold: Hypotension (e.g., SBP <90 mmHg or symptomatic), uncontrolled hypertension
Heart Rate (HR)
Frequency: Regularly (e.g., weekly initially, then monthly or as clinically indicated)
Target: Typically >50-60 bpm (unless lower target is desired for specific conditions like angina)
Action Threshold: Bradycardia (<50 bpm or symptomatic)
Symptoms of Heart Failure
Frequency: At each visit
Target: Absence of new or worsening symptoms
Action Threshold: Dyspnea, edema, weight gain, fatigue
Peripheral Pulses/Perfusion
Frequency: Periodically
Target: Normal
Action Threshold: Worsening claudication, cold extremities
Symptom Monitoring
- Bradycardia (slow pulse)
- Hypotension (dizziness, lightheadedness, fainting)
- Fatigue, weakness
- Dyspnea (shortness of breath)
- Peripheral edema (swelling in ankles/feet)
- Bronchospasm (wheezing, difficulty breathing)
- Cold extremities
- Masked symptoms of hypoglycemia (in diabetics)
Special Patient Groups
Pregnancy
Acebutolol is classified as Pregnancy Category D. Use during the second and third trimesters has been associated with adverse effects in the fetus/neonate (e.g., bradycardia, hypoglycemia, intrauterine growth restriction). Use in the first trimester is generally considered Category B, but overall risk outweighs benefit in later trimesters unless absolutely necessary and safer alternatives are not available.
Trimester-Specific Risks:
First Trimester:
Category B (no evidence of risk in animal studies, but no adequate human studies).
Second Trimester:
Category D (evidence of fetal risk, e.g., bradycardia, hypoglycemia, growth restriction).
Third Trimester:
Category D (evidence of fetal risk, e.g., bradycardia, hypoglycemia, growth restriction, respiratory depression).
Lactation
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. L3 (Moderately Safe) according to Hale's.
Infant Risk:
Low to moderate risk; monitor for bradycardia, hypotension, hypoglycemia, and respiratory distress.
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.
Geriatric Use
Lower initial doses may be appropriate due to potential for decreased renal function and increased sensitivity to beta-blockade. Monitor closely for adverse effects such as bradycardia, hypotension, and CNS effects.
Clinical Information
Clinical Pearls
- Acebutolol is a cardioselective beta-blocker with intrinsic sympathomimetic activity (ISA), which may result in less bradycardia and less adverse effect on lipid profiles compared to beta-blockers without ISA.
- Due to its ISA, acebutolol may be preferred in patients who develop significant bradycardia with other beta-blockers, or in those with mild bradycardia at baseline.
- It is important to gradually taper the dose over 1-2 weeks when discontinuing acebutolol, especially in patients with coronary artery disease, to avoid rebound angina, myocardial infarction, or arrhythmias.
- Monitor diabetic patients closely, as acebutolol can mask the adrenergic symptoms of hypoglycemia (e.g., tachycardia, tremors).
- Use with caution in patients with bronchospastic disease (e.g., asthma, COPD), although its beta-1 selectivity may offer some advantage over non-selective beta-blockers, it is not absolute.
- The active metabolite, diacetolol, has a longer half-life than acebutolol, contributing to its once-daily dosing potential.
Alternative Therapies
- Other beta-blockers (e.g., metoprolol, atenolol, carvedilol, bisoprolol, propranolol)
- 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)
Cost & Coverage
Average Cost:
Varies, typically low per 30 capsules
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (Generic)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your 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 check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for guidance and support. 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 name of the medication taken, the amount, and the time it occurred.