Acebutolol

Name: Acebutolol

Acebutolol Interactions

Tell your doctor about all prescription, nonprescription, illegal, recreational, herbal, nutritional, or dietary drugs you're taking, especially:

  • Drugs for allergies, asthma, colds, diabetes, or migraines
  • Diet pills
  • Other medicines for high blood pressure or heart problems, such as reserpine
  • Nonsteroidal anti-inflammatory drugs (NSAIDs), such as Advil or Motrin (ibuprofen) and Indocin or Indo-Lemmon (indomethacin)

Acebutolol and Other Interactions

Acebutolol may cause dizziness or lightheadedness.

Don't drive, operate machinery, or perform other tasks that require alertness until you know how this medicine affects you.

Acebutolol and Alcohol

Alcohol may worsen certain side effects of acebutolol.

Talk to your doctor before drinking alcoholic beverages while taking this drug.

What brand names are available for acebutolol?

Sectral

Why is this medication prescribed?

Acebutolol is used to treat high blood pressure. Acebutolol also is used to treat an irregular heartbeat. Acebutolol is in a class of medications called beta blockers. It works by relaxing blood vessels and slowing heart rate to improve blood flow and decrease blood pressure.

High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include very slow heartbeats, trouble breathing, severe dizziness, fainting, or seizure (convulsions).

Uses of Acebutolol

  • 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.

Pronunciation

(a se BYOO toe lole)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral, as hydrochloride:

Sectral: 200 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), fd&c yellow #6 (sunset yellow)]

Sectral: 400 mg [DSC] [contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #6 (sunset yellow)]

Generic: 200 mg, 400 mg

Brand Names U.S.

  • Sectral [DSC]

Duration of Action

12 to 24 hours

Half-Life Elimination

Parent drug: 3 to 4 hours; Metabolite: 8 to 13 hours

Protein Binding

~26%

Special Populations Renal Function Impairment

Decreased elimination of diacetolol resulting in a 2- to 3-fold increase in its half-life.

Dosing Adult

Angina, ventricular arrhythmia: Oral: 400 mg daily in 2 divided doses; maintenance: 600 to 1,200 mg daily in divided doses; maximum: 1,200 mg daily

Hypertension: Oral: Initial: 400 mg in 1 to 2 divided doses; optimal response usually seen at 400 to 800 mg daily (larger doses may be divided) although some patients may respond to as little as 200 mg daily; usual dose range (ASH/ISH [Weber 2014]): 200 to 400 mg daily; maximum dose: 1,200 mg in 2 divided doses

Chronic stable angina (off-label use): Oral: Usual dose: 400 to 1200 mg daily in 2 divided doses (Gibbons 2003); low doses (ie, 400 mg daily) may also be given as once daily (Pina 1988)

Thyrotoxicosis (off-label use): Oral: 200 mg 2 to 3 times daily. The treatment period in clinical trials was 7 to 10 days (Perret 1984). Additional data may be necessary to further define the role of acebutolol in the treatment of this condition.

Storage

Store at controlled room temperature of 20°C to 25°C (68°F to 77°F). Protect from light and dispense in a light-resistant, tight container.

Drug Interactions

Acetylcholinesterase Inhibitors: May enhance the bradycardic effect of Beta-Blockers. Monitor therapy

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Alpha-/Beta-Agonists (Direct-Acting): Beta-Blockers may enhance the vasopressor effect of Alpha-/Beta-Agonists (Direct-Acting). Epinephrine used as a local anesthetic for dental procedures will not likely cause clinically relevant problems. Some beta-adrenoceptor mediated effects of Alpha-/Beta-Agonists (Direct-Acting), including anti-anaphylactic effects of epinephrine, may be diminished by Beta-Blockers. Management: Cardioselective beta-blockers and lower doses of epinephrine may confer a more limited risk. Patients who may require acute subcutaneous epinephrine (e.g., bee sting kits) should probably avoid beta blockers. Exceptions: Dipivefrin. Consider therapy modification

Alpha1-Blockers: Beta-Blockers may enhance the orthostatic hypotensive effect of Alpha1-Blockers. The risk associated with ophthalmic products is probably less than systemic products. Monitor therapy

Alpha2-Agonists: May enhance the AV-blocking effect of Beta-Blockers. Sinus node dysfunction may also be enhanced. Beta-Blockers may enhance the rebound hypertensive effect of Alpha2-Agonists. This effect can occur when the Alpha2-Agonist is abruptly withdrawn. Management: Closely monitor heart rate during treatment with a beta blocker and clonidine. Withdraw beta blockers several days before clonidine withdrawal when possible, and monitor blood pressure closely. Recommendations for other alpha2-agonists are unavailable. Exceptions: Apraclonidine. Consider therapy modification

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Aminoquinolines (Antimalarial): May decrease the metabolism of Beta-Blockers. Monitor therapy

Amiodarone: May enhance the bradycardic effect of Beta-Blockers. Possibly to the point of cardiac arrest. Amiodarone may increase the serum concentration of Beta-Blockers. Monitor therapy

Amphetamines: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Anilidopiperidine Opioids: May enhance the bradycardic effect of Beta-Blockers. Anilidopiperidine Opioids may enhance the hypotensive effect of Beta-Blockers. Monitor therapy

Antipsychotic Agents (Phenothiazines): May enhance the hypotensive effect of Beta-Blockers. Beta-Blockers may decrease the metabolism of Antipsychotic Agents (Phenothiazines). Antipsychotic Agents (Phenothiazines) may decrease the metabolism of Beta-Blockers. Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy

Barbiturates: May decrease the serum concentration of Beta-Blockers. Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Beta2-Agonists: Beta-Blockers (Beta1 Selective) may diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Monitor therapy

Bradycardia-Causing Agents: May enhance the bradycardic effect of other Bradycardia-Causing Agents. Monitor therapy

Bretylium: May enhance the bradycardic effect of Bradycardia-Causing Agents. Bretylium may also enhance atrioventricular (AV) blockade in patients receiving AV blocking agents. Monitor therapy

Brigatinib: May diminish the antihypertensive effect of Antihypertensive Agents. Brigatinib may enhance the bradycardic effect of Antihypertensive Agents. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Bupivacaine: Beta-Blockers may increase the serum concentration of Bupivacaine. Monitor therapy

Calcium Channel Blockers (Nondihydropyridine): May enhance the hypotensive effect of Beta-Blockers. Bradycardia and signs of heart failure have also been reported. Calcium Channel Blockers (Nondihydropyridine) may increase the serum concentration of Beta-Blockers. Exceptions: Bepridil. Monitor therapy

Cardiac Glycosides: Beta-Blockers may enhance the bradycardic effect of Cardiac Glycosides. Monitor therapy

Ceritinib: Bradycardia-Causing Agents may enhance the bradycardic effect of Ceritinib. Management: If this combination cannot be avoided, monitor patients for evidence of symptomatic bradycardia, and closely monitor blood pressure and heart rate during therapy. Avoid combination

Cholinergic Agonists: Beta-Blockers may enhance the adverse/toxic effect of Cholinergic Agonists. Of particular concern are the potential for cardiac conduction abnormalities and bronchoconstriction. Management: Administer these agents in combination with caution, and monitor for conduction disturbances. Avoid methacholine with any beta blocker due to the potential for additive bronchoconstriction. Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Dipyridamole: May enhance the bradycardic effect of Beta-Blockers. Monitor therapy

Disopyramide: May enhance the bradycardic effect of Beta-Blockers. Beta-Blockers may enhance the negative inotropic effect of Disopyramide. Monitor therapy

Dronedarone: May enhance the bradycardic effect of Beta-Blockers. Dronedarone may increase the serum concentration of Beta-Blockers. This likely applies only to those agents that are metabolized by CYP2D6. Management: Use lower initial beta-blocker doses; adequate tolerance of the combination, based on ECG findings, should be confirmed prior to any increase in beta-blocker dose. Consider therapy modification

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Ergot Derivatives: Beta-Blockers may enhance the vasoconstricting effect of Ergot Derivatives. Exceptions: Nicergoline. Consider therapy modification

Fingolimod: Beta-Blockers may enhance the bradycardic effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and beta-blockers if possible. If coadministration is necessary, patients should have overnight continuous ECG monitoring conducted after the first dose of fingolimod. Monitor patients for bradycardia. Consider therapy modification

Floctafenine: May enhance the adverse/toxic effect of Beta-Blockers. Avoid combination

Grass Pollen Allergen Extract (5 Grass Extract): Beta-Blockers may enhance the adverse/toxic effect of Grass Pollen Allergen Extract (5 Grass Extract). More specifically, Beta-Blockers may inhibit the ability to effectively treat severe allergic reactions to Grass Pollen Allergen Extract (5 Grass Extract) with epinephrine. Some other effects of epinephrine may be unaffected or even enhanced (e.g., vasoconstriction) during treatment with Beta-Blockers. Consider therapy modification

Herbs (Hypertensive Properties): May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Insulin: Beta-Blockers may enhance the hypoglycemic effect of Insulin. Monitor therapy

Ivabradine: Bradycardia-Causing Agents may enhance the bradycardic effect of Ivabradine. Monitor therapy

Lacosamide: Bradycardia-Causing Agents may enhance the AV-blocking effect of Lacosamide. Monitor therapy

Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy

Lidocaine (Systemic): Beta-Blockers may increase the serum concentration of Lidocaine (Systemic). Monitor therapy

Lidocaine (Topical): Beta-Blockers may increase the serum concentration of Lidocaine (Topical). Monitor therapy

Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Mepivacaine: Beta-Blockers may increase the serum concentration of Mepivacaine. Monitor therapy

Methacholine: Beta-Blockers may enhance the adverse/toxic effect of Methacholine. Avoid combination

Methoxyflurane: May enhance the hypotensive effect of Beta-Blockers. Monitor therapy

Methylphenidate: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

Midodrine: Beta-Blockers may enhance the bradycardic effect of Midodrine. Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

NIFEdipine: May enhance the hypotensive effect of Beta-Blockers. NIFEdipine may enhance the negative inotropic effect of Beta-Blockers. Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy

Nonsteroidal Anti-Inflammatory Agents: May diminish the antihypertensive effect of Beta-Blockers. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Propafenone: May increase the serum concentration of Beta-Blockers. Propafenone possesses some independent beta blocking activity. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Regorafenib: May enhance the bradycardic effect of Beta-Blockers. Monitor therapy

Reserpine: May enhance the hypotensive effect of Beta-Blockers. Monitor therapy

Rifamycin Derivatives: May decrease the serum concentration of Beta-Blockers. Exceptions: Rifabutin. Monitor therapy

Rivastigmine: May enhance the bradycardic effect of Beta-Blockers. Avoid combination

Ruxolitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Management: Ruxolitinib Canadian product labeling recommends avoiding use with bradycardia-causing agents to the extent possible. Monitor therapy

Sulfonylureas: Beta-Blockers may enhance the hypoglycemic effect of Sulfonylureas. Cardioselective beta-blockers (eg, acebutolol, atenolol, metoprolol, and penbutolol) may be safer than nonselective beta-blockers. All beta-blockers appear to mask tachycardia as an initial symptom of hypoglycemia. Ophthalmic beta-blockers are probably associated with lower risk than systemic agents. Monitor therapy

Theophylline Derivatives: Beta-Blockers (Beta1 Selective) may diminish the bronchodilatory effect of Theophylline Derivatives. Management: Monitor for reduced theophylline efficacy during concomitant use with any beta-blocker. Beta-1 selective agents are less likely to antagonize theophylline than nonselective agents, but selectivity may be lost at higher doses. Monitor therapy

Tofacitinib: May enhance the bradycardic effect of Bradycardia-Causing Agents. Monitor therapy

Yohimbine: May diminish the antihypertensive effect of Antihypertensive Agents. Monitor therapy

How supplied

Sectral® (acebutolol HCl) is available in the following dosage strengths:

200 mg, opaque purple and orange capsule marked “RP 700” and “Sectral 200”

NDC 67857-700-01, in bottles of 100 capsules.

400 mg, opaque brown and orange capsule marked “RP 701” and “Sectral 400”

NDC 67857-701-01, in bottles of 100 capsules.

Keep tightly closed

Store at controlled room temperature 20° to 25°C (68° to 77°F)

Protect from light

Dispense in a light-resistant, tight container

Us e carton to protect contents from light

Distributed by: Promius Pharma, LLC, Bridgewater, NJ 08807. Manufactured by: PATHEON, Puerto Rico, Inc., Manatí, Puerto Rico 00674, USA. Revised: April 2008

Inform MD

Before taking acebutolol, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

  • are allergic to any ingredient in acebutolol
  • have persistently severe bradycardia
  • have second- and third-degree heart block
  • have diabetes
  • are pregnant or breastfeeding
  • have asthma or other lung disease

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

 

Acebutolol and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Acebutolol falls into category B. There are no well-done studies that have been done in humans with acebutolol. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

 

Dosing & Uses

Dosage Forms & Strengths

capsule

  • 200mg
  • 400mg

Hypertension

400-1200 mg/day divided PO q12hr; not to exceed 1200 mg/day

Ventricular Arrhythmias

400-1200 mg/day divided PO q12hr; not to exceed 1200 mg/day  

Angina

400-1200 mg/day divided PO q12hr; not to exceed 1200 mg/day  

Renal Impairment

CrCl 25-49 mL/min: Reduce dose by 50%

CrCl < 25 mL/min: Reduce dose by 75%

Hepatic Impairment

Dose adjustment not necessary

Other Indications & Uses

Off-label: ventricular tachycardia, angina, essential tremor

Also used to control ventricular premature beats

Safety and efficacy not established

Hypertension

Initial dose: 200-400 mg PO daily; not to exceed 800 mg/day  

Ventricular Arrhythmias

Initial dose: 200-400 mg PO daily; not to exceed 800 mg/day  

Angina

Initial dose: 200-400 mg PO daily; not to exceed 800 mg/day  

Patient Handout

Print without Office InfoPrint with Office Info

Where can i get more information?

Your pharmacist can provide more information about acebutolol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 8.05. Revision date: 12/15/2010.

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For the Consumer

Applies to acebutolol: oral capsule, oral tablet

Along with its needed effects, acebutolol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking acebutolol:

Less common
  • Changes in vision
  • chest pain
  • difficult or labored breathing
  • shortness of breath
  • swelling of face, fingers, feet, or lower legs
  • tightness in chest
  • wheezing

Get emergency help immediately if any of the following symptoms of overdose occur while taking acebutolol:

Symptoms of overdose
  • Anxiety
  • blurred vision
  • chest discomfort
  • chills
  • cold sweats
  • coma
  • confusion
  • convulsions
  • cool, pale skin
  • cough
  • decreased urine output
  • depression
  • dilated neck veins
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • extreme fatigue
  • headache
  • increased hunger
  • irregular breathing
  • loss of bladder control
  • muscle spasm or jerking of all extremities
  • nausea
  • nervousness
  • nightmares
  • noisy breathing
  • pain in the shoulders, back, neck, or jaw
  • shakiness
  • slow, fast, pounding, or irregular heartbeat
  • slurred speech
  • sudden loss of consciousness
  • sweating
  • troubled breathing
  • unusual tiredness or weakness
  • weight gain

Some side effects of acebutolol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Acid or sour stomach
  • belching
  • bloated
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty in moving
  • discouragement
  • excess air or gas in stomach or intestines
  • feeling sad or empty
  • full feeling
  • heartburn
  • indigestion
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • muscle aching or cramping
  • muscle pain or stiffness
  • pain in joints
  • passing gas
  • problems in urination or increase in amount of urine
  • rash
  • sleeplessness
  • stomach discomfort, upset, or pain
  • swollen joints
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unable to sleep
  • unusual dreams

Acebutolol Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: B

Animal studies have revealed evidence of embryolethality and fetotoxicity at doses that produced maternal toxicity. There are no controlled data in human pregnancy. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

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