Acebutolol

What is Acebutolol?

• Acebutolol (Sectral; Monitan) is a selective, hydrophilic beta-adrenoreceptor blocking agent used for the treatment of hypertension and arrhythmias.

Acebutolol

Acebutolol 3d-model-bonds

What are the uses of this medicine?

Acebutolol (Sectral) is used: Hypertension:

• For the management of hypertension in adults.
• It may be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics.

Ventricular Arrhythmias:

• Acebutolol hydrochloride capsules, USP are indicated in the management of ventricular premature beats.

How does this medicine work?

• Acebutolol (a" se bue' toe lol) is considered a “selective” beta-adrenergic receptor blocker in that it has potent activity against beta-1 adrenergic receptors which are found in cardiac muscle, but has little or no activity against beta-2 adrenergic receptors found on bronchial and vascular smooth muscle.
• Acebutolol also has mild sympathomimetic activity (a partial adrenergic agonist, similar to pinolol).

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• severe bradycardia
• second- and third-degree heart block
• overt cardiac failure
• cardiogenic shock

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention if you are taking any of the following:

• medications for migraine headaches, diabetes, asthma, allergies, colds, or pain; other medications for high blood pressure or heart disease; and reserpine.

Is this medicine FDA approved?

• Acebutolol was approved for use in the United States in 1985 and is currently used in the therapy of hypertension alone or in combination with other agents.
• It is also used for cardiac arrhythmias.

How should this medicine be used?

Recommended dosage: Hypertension:

• The initial dosage of acebutolol in uncomplicated mild-to-moderate hypertension is 400 mg.
• This can be given as a single daily dose, but in occasional patients twice daily dosing may be required for adequate 24-hour blood-pressure control.
• Patients with more severe hypertension or who have demonstrated inadequate control may respond to a total of 1200 mg daily (administered b.i.d.), or to the addition of a second antihypertensive agent.

Ventricular Arrhythmia:

• The usual initial dose of acebutolol is 400 mg daily given as 200 mg b.i.d. Dosage should be increased gradually until an optimal clinical response is obtained, generally at 600 to 1200 mg per day.

Use in Older Patients:

• Doses above 800 mg/day should be avoided in the elderly.

Administration:

• Acebutolol comes as a capsule to take by mouth.
• It usually is taken once or twice a day. To help you remember to take acebutolol, take it around the same time(s) every day.
• Acebutolol controls your condition but does not cure it.
• Continue to take acebutolol even if you feel well.
• Do not stop taking acebutolol without talking to your doctor.
• If you suddenly stop taking acebutolol, you may experience serious heart problems such as angina (chest pain) or heart attack.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Acebutolol hydrochloride capsules, USP are available as 200 mg,400 mg.

This medicine is available in fallowing brand namesː

• Sectral; Monitan

What side effects can this medication cause?

The most common side effects of this medicine include:

• bradycardia, hypotension, fatigue, dizziness, depression, insomnia, memory loss and impotence. In high doses, acebutolol is less cardioselective and can induced acute bronchospasm.
• As with other beta-blockers, sudden withdrawal can trigger rebound hypertension.

Some side effects can be serious which may include:

• shortness of breath or wheezing
• swelling of the feet and lower legs
• chest pain

What special precautions should I follow?

• Acebutolol can be used with caution in patients with a history of heart failure who are controlled with digitalis and/or diuretics. Both digitalis and acebutolol impair AV conduction. If cardiac failure persists, therapy with acebutolol should be withdrawn.
• Following abrupt cessation of therapy with certain β-blocking agents in patients with coronary artery disease, exacerbation of angina pectoris and, in some cases, myocardial infarction and death have been reported. Therefore, such patients should be cautioned against interruption of therapy without a physician’s advice.
• Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery.
• β-blockers may potentiate insulin-induced hypoglycemia and mask some of its manifestations such as tachycardia; however, dizziness and sweating are usually not significantly affected. Diabetic patients should be warned of the possibility of masked hypoglycemia.
• β-adrenergic blockade may mask certain clinical signs (tachycardia) of hyperthyroidism. Abrupt withdrawal of β-blockade may precipitate a thyroid storm; therefore, patients suspected of developing thyrotoxicosis from whom acebutolol therapy.
• Acebutolol has been linked to several instances of clinically apparent drug induced liver injury.
• Patients, especially those with evidence of coronary artery disease, should be warned against interruption or discontinuation of acebutolol therapy without a physician’s supervision.
• Patients should also be warned of possible severe hypertensive reactions from concomitant use of α-adrenergic stimulants, such as the nasal decongestants commonly used in OTC cold preparations and nasal drops.
• Acebutolol, like other β-blockers, has been associated with the development of antinuclear antibodies (ANA).
• Acebutolol and diacetolol also appear in breast milk. Use in nursing mothers is not recommended.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• bradycardia, advanced atrioventricular block, intraventricular conduction defects, hypotension, severe congestive heart failure, seizures, bronchospasm and hypoglycemia.

Management of overdosage:

• Empty stomach by emesis or lavage.
• For Bradycardia: IV atropine (1 to 3 mg in divided doses). If antivagal response is inadequate, administer isoproterenol cautiously since larger than usual doses of isoproterenol may be required.
• For Persistent hypotension in spite of correction of bradycardia: Administer vasopressor (e.g., epinephrine, norepinephrine, dopamine, or dobutamine) with frequent monitoring of blood pressure and pulse rate.
• For Bronchospasm: A theophylline derivative, such as aminophylline and/or parenteral β2-stimulant, such as terbutaline.
• For Cardiac failure: Digitalize the patient and/or administer a diuretic. It has been reported that glucagon is useful in this situation.
• Acebutolol is dialyzable.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are no adequate and well-controlled trials in pregnant women.
• Because animal teratology studies are not always predictive of the human response, acebutolol should be used during pregnancy only if the potential benefit justifies the risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• ACEBUTOLOL HYDROCHLORIDE

Inactive ingredient:

• FD&C BLUE NO. 1

Who manufactures and distributes this medicine?

Distributed by:

• Amneal Pharmaceuticals
• Bridgewater, NJ

What should I know about storage and disposal of this medication?

• Store at 20° to 25°C (68° to 77°F).
• Protect from light.
• Keep tightly closed.
• Dispense in a tight, light-resistant container.

Antihypertensive agents

• Dailymed label info on Acebutolol
• FDA Acebutolol

Acebutolol Resources
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