Acebutolol

Name: Acebutolol

What Is Acebutolol (Sectral)?

Acebutolol is the generic form of the brand-name medicine Sectral, which is used to treat high blood pressure and irregular heartbeat.

This prescription drug is also sometimes given to treat chest pain associated with coronary artery disease.

Acebutolol belongs to a class of drugs called beta blockers. It works by relaxing blood vessels and slowing the heart rate.

The U.S. Food and Drug Administration (FDA) approved acebutolol in 1984.

Acebutolol Warnings

Before taking acebutolol, tell your doctor if you have, or have ever had:

  • Heart failure, heart block, slow heartbeat, or other heart problems
  • Low blood pressure
  • Blood vessel problems
  • Circulation problems
  • Breathing disorders, such as bronchitis, asthma, sleep apnea, or chronic obstructive pulmonary disease (COPD)
  • Allergies to medication
  • Diabetes
  • Stroke
  • Overactive thyroid
  • Liver or kidney disease
  • Adrenal gland problems

If you have diabetes, this medicine may mask the symptoms of a low blood sugar episode. Monitor your blood sugar levels carefully while using acebutolol.

Let your healthcare provider know you're taking acebutolol before having any type of surgery, including a dental procedure.

Your doctor may recommend following a diet and exercise plan while taking acebutolol. Follow these instructions carefully.

Use caution in hot weather or when exercising. These activities can increase your risk of experiencing dizziness, lightheadedness, or fainting.

Continue to take acebutolol even if you feel well. You could experience serious heart problems, such as chest pain or a heart attack, if you stop using this medicine suddenly.

Your doctor will slowly lower your dose over several weeks if you need to stop treatment with acebutolol.

Keep all appointments with your doctor's office and laboratory while using this medicine. Your doctor will want to check your blood pressure often.

Pregnancy and Acebutolol

Acebutolol should only be used during pregnancy when clearly needed.

Tell your doctor if you're pregnant or plan to become pregnant. You'll have to discuss the risks and benefits of taking this medicine during pregnancy.

Acebutolol passes into breast milk. Don't breastfeed a baby while using this drug.

Brand names

  • Sectral®

What should I avoid while taking acebutolol?

Drinking alcohol with this medicine can cause side effects.

Ask a doctor or pharmacist before using any cough or cold medicine that contains a decongestant. Taking acebutolol together with a decongestant may raise your blood pressure to dangerous levels.

This medicine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Acebutolol side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;

  • new or worsening chest pain;

  • slow heartbeats;

  • a light-headed feeling, like you might pass out; or

  • dangerously high blood pressure--severe headache, blurred vision, pounding in your neck or ears, nosebleed, anxiety, confusion, severe chest pain, shortness of breath, irregular heartbeats.

Common side effects may include:

  • headache, dizziness;

  • feeling tired;

  • nausea, upset stomach;

  • diarrhea, constipation; or

  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Uses For acebutolol

Acebutolol is used alone or together with other medicines (such as hydrochlorothiazide) to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled .

Acebutolol is also used to treat certain heart rhythm problems (ventricular arrhythmia) .

acebutolol is a beta-blocker. It works by affecting the response to nerve impulses in certain parts of the body, like the heart. As a result, the heart beats slower and decreases the blood pressure. When the blood pressure is lowered, the amount of blood and oxygen is increased to the heart .

acebutolol is available only with your doctor's prescription .

Before Using acebutolol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For acebutolol, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to acebutolol or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of acebutolol in the pediatric population. Safety and efficacy have not been established .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of acebutolol in the elderly. However, elderly patients are more likely to have age-related liver or kidney problems, which may require an adjustment of dosage in patients receiving acebutolol .

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using acebutolol.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking acebutolol, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using acebutolol with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Clonidine
  • Crizotinib
  • Diltiazem
  • Dronedarone
  • Fenoldopam
  • Fingolimod
  • Lacosamide
  • Rivastigmine
  • Verapamil

Using acebutolol with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acarbose
  • Aceclofenac
  • Acemetacin
  • Acetyldigoxin
  • Albiglutide
  • Alfuzosin
  • Alogliptin
  • Amiodarone
  • Amtolmetin Guacil
  • Arbutamine
  • Aspirin
  • Bromfenac
  • Bufexamac
  • Bunazosin
  • Canagliflozin
  • Celecoxib
  • Chlorpropamide
  • Choline Salicylate
  • Clonixin
  • Dapagliflozin
  • Deslanoside
  • Dexibuprofen
  • Dexketoprofen
  • Diclofenac
  • Diflunisal
  • Digitoxin
  • Digoxin
  • Dipyrone
  • Doxazosin
  • Droxicam
  • Dulaglutide
  • Empagliflozin
  • Etodolac
  • Etofenamate
  • Etoricoxib
  • Exenatide
  • Felbinac
  • Fenoprofen
  • Fepradinol
  • Feprazone
  • Floctafenine
  • Flufenamic Acid
  • Flurbiprofen
  • Glimepiride
  • Glipizide
  • Glyburide
  • Ibuprofen
  • Indomethacin
  • Insulin Aspart, Recombinant
  • Insulin Degludec
  • Insulin Detemir
  • Insulin Glargine, Recombinant
  • Insulin Glulisine
  • Insulin Human Inhaled
  • Insulin Human Isophane (NPH)
  • Insulin Human Regular
  • Insulin Lispro, Recombinant
  • Ketoprofen
  • Ketorolac
  • Linagliptin
  • Liraglutide
  • Lixisenatide
  • Lornoxicam
  • Loxoprofen
  • Lumiracoxib
  • Meclofenamate
  • Mefenamic Acid
  • Meloxicam
  • Metformin
  • Metildigoxin
  • Mibefradil
  • Miglitol
  • Morniflumate
  • Moxisylyte
  • Nabumetone
  • Naproxen
  • Nateglinide
  • Nepafenac
  • Niflumic Acid
  • Nimesulide
  • Nimesulide Beta Cyclodextrin
  • Oxaprozin
  • Oxyphenbutazone
  • Parecoxib
  • Phenoxybenzamine
  • Phentolamine
  • Phenylbutazone
  • Piketoprofen
  • Pioglitazone
  • Piroxicam
  • Pramlintide
  • Pranoprofen
  • Prazosin
  • Proglumetacin
  • Propyphenazone
  • Proquazone
  • Repaglinide
  • Rofecoxib
  • Rosiglitazone
  • Salicylic Acid
  • Salsalate
  • Saxagliptin
  • Sitagliptin
  • Sodium Salicylate
  • St John's Wort
  • Sulindac
  • Tamsulosin
  • Tenoxicam
  • Terazosin
  • Tiaprofenic Acid
  • Tolazamide
  • Tolbutamide
  • Tolfenamic Acid
  • Tolmetin
  • Trimazosin
  • Urapidil
  • Valdecoxib
  • Vildagliptin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of acebutolol. Make sure you tell your doctor if you have any other medical problems, especially:

  • Angina (severe chest pain)—May provoke chest pain if stopped too quickly .
  • Blood vessel disease—Use with caution. acebutolol may worsen this condition .
  • Bradycardia (slow heartbeat) or
  • Heart block or
  • Heart failure—Should not use in patients with these conditions .
  • Diabetes or
  • Hyperthyroidism (overactive thyroid) or
  • Hypoglycemia (low blood sugar)—May cover up some of the signs and symptoms of these diseases, such as a fast heartbeat .
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .
  • Lung disease (e.g., asthma, bronchitis, emphysema)—May cause difficulty with breathing in patients with this condition .

Contraindications

Acebutolol HCl, USP is contraindicated in: 1) persistently severe bradycardia; 2) second-and third-degree hear t block; 3) over t cardiac failure; and 4) cardiogenic shock. (See Warnings.)

Index Terms

  • Acebutolol HCl
  • Acebutolol Hydrochloride

Pharmacology

Competitively blocks beta1-adrenergic receptors with little or no effect on beta2-receptors except at high doses; exhibits membrane stabilizing and intrinsic sympathomimetic activity

Absorption

Oral: 40%

Distribution

Vd: 1.2 L/kg

Metabolism

Extensive first-pass effect to equipotent and cardioselective diacetolol metabolite

Excretion

Feces (50% to 60%); urine (30% to 40%); diacetolol eliminated primarily in the urine

Use Labeled Indications

Treatment of hypertension; management of ventricular arrhythmias

The 2014 guideline for the management of high blood pressure in adults (Eighth Joint National Committee [JNC 8; James, 2013]) recommends initiation of pharmacologic treatment to lower blood pressure for the following patients:

• Patients ≥60 years of age with systolic blood pressure (SBP) ≥150 mm Hg or diastolic blood pressure (DBP) ≥90 mm Hg. Goal of therapy is SBP <150 mm Hg and DBP <90 mm Hg.

• Patients <60 years of age with SBP ≥140 mm Hg or DBP ≥90 mm Hg. Goal of therapy is SBP <140 mm Hg and DBP <90 mm Hg.

• Patients ≥18 years of age with diabetes and SBP ≥140 mm Hg or DBP ≥90 mm Hg. Goal of therapy is SBP <140 mm Hg and DBP <90 mm Hg.

• Patients ≥18 years of age with chronic kidney disease (CKD) and SBP ≥140 mm Hg or DBP ≥90 mm Hg. Goal of therapy is SBP <140 mm Hg and DBP <90 mm Hg.

In patients with CKD, regardless of race or diabetes status, the use of an ACE inhibitor (ACEI) or angiotensin receptor blocker (ARB) as initial therapy is recommended to improve kidney outcomes. In the general nonblack population (without CKD), including those with diabetes, initial antihypertensive treatment should consist of a thiazide-type diuretic, calcium channel blocker, ACEI, or ARB. In the general black population (without CKD), including those with diabetes, initial antihypertensive treatment should consist of a thiazide-type diuretic or a calcium channel blocker instead of an ACEI or ARB.

Dosing Hepatic Impairment

There are no dosage adjustments provided in manufacturer's labeling; use with caution.

Test Interactions

May lead to false-positive aldosterone/renin ratio (ARR) (Funder 2016)

Adverse Reactions

>10%: Central nervous system: Fatigue (11%)

1% to 10%:

Cardiovascular: Chest pain (2%), edema (2%), bradycardia, congestive heart failure, hypotension

Central nervous system: Dizziness (6%), headache (6%), insomnia (3%), abnormal dreams (2%), depression (2%), anxiety, hyperesthesia, hypoesthesia

Dermatologic: Skin rash (2%), pruritus

Gastrointestinal: Constipation (4%), diarrhea (4%), dyspepsia (4%), nausea (4%), flatulence (3%), abdominal pain, vomiting

Genitourinary: Urinary frequency (3%), dysuria, impotence, nocturia

Neuromuscular & skeletal: Myalgia (2%), arthralgia, back pain

Ophthalmic: Visual disturbance (2%), conjunctivitis, dry eye syndrome, eye pain

Respiratory: Dyspnea (4%), rhinitis (2%), cough (1%), pharyngitis, wheezing

<1% (Limited to important or life-threatening): Anorexia, atrioventricular block, cold extremities, facial edema, hepatotoxicity, increased serum alkaline phosphatase, increased serum bilirubin, increased serum transaminases, lichen planus, lupus-like syndrome, palpitations, pleurisy, pneumonitis, pulmonary granuloma, renal insufficiency, urinary retention, ventricular arrhythmia, xerostomia

Description

Sectral (acebutolol HCl) is a selective, hydrophilic beta-adrenoreceptor blocking agent with mild intrinsic sympathomimetic activity for use in treating patients with hypertension and ventricular arrhythmias. It is marketed in capsule form for oral administration. Sectral capsules are provided in two dosage strengths which contain 200 or 400 mg of acebutolol as the hydrochloride salt. The inactive ingredients present are D&C Red 22, FD&C Blue 1, FD&C Yellow 6, gelatin, povidone, starch, stearic acid, and titanium dioxide. The 200 mg dosage strength also contains D&C Red 28 and the 400 mg dosage strength also contains FD&C Red 40. Acebutolol HCl has the following structural formula:

Acebutolol HCl is a white or slightly off-white powder freely soluble in water, and less soluble in alcohol. Chemically it is defined as the hydrochloride salt of (±)N-[3-Acetyl-4-[2- hydroxy-3-[(1- methylethyl)amino]propoxy]phenyl] butanamide.

Uses of Acebutolol

Acebutolol is a prescription medication used to treat high blood pressure and irregular heartbeat (known medically as ventricular arrhythmia). 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Side Effects of Acebutolol

Common side effects include:

  • dizziness
  • lightheadedness
  • excessive tiredness
  • headache
  • constipation
  • diarrhea
  • upset stomach
  • muscle aches

Tell your doctor if you have any side effect that bothers you or does not go away.

Serious side effects have been reported. See "Drug Precautions" section.

These are not all the possible side effects of acebutolol. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Acebutolol Usage

  • Take acebutolol exactly as prescribed.
  • Acebutolol comes in capsule form and is taken once or twice daily.
  • Take with or without food.
  • Do not chew, divide, or break acebutolol capsules. Swallow capsule whole.
  • If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Sectral at the same time.

 

What happens if i miss a dose (sectral)?

Take the missed dose as soon as you remember. If your next dose is less than 4 hours away, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

Acebutolol Breastfeeding Warnings

Acebutolol and diacetolol, a renally excreted and equipotent metabolite, appear in breast milk with a milk:plasma ratio of 7:1 and 12:2, respectively.

Use is not recommended. Excreted into human milk: Yes

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