Acebutolol HCl

What is Acebutolol Hydrochloride?

• Acebutolol HCl is a selective, hydrophilic beta-adrenoreceptor blocking agent with mild intrinsic sympathomimetic activity.

What are the uses of this medicine?

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

How does this medicine work?

• Acebutolol is a cardioselective, β-adrenoreceptor blocking agent, which possesses mild intrinsic sympathomimetic activity (ISA) in its therapeutically effective dose range.

Who Should Not Use this medicine?

This medicine should not be used in patients with:

• Persistently severe bradycardia
• Second- and third-degree heart block
• Overt cardiac failure
• Cardiogenic shock

Is this medicine FDA approved?

• It was approved for use in United States in 1995.

How should this medicine be used?

• 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.
• 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.
• In older patients: Older patients have an approximately 2-fold increase in bioavailability and may require lower maintenance doses. Doses above 800 mg/day should be avoided in the elderly.

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

This medicine is available in the following dosage forms:

• 200 mg hard gelatin capsules
• 400 mg hard gelatin capsules

This medicine is available in the following brand names: SECTRAL

What side effects can this medicine cause?

Common side effects of this medicine include:

• fatigue
• headache
• dizziness
• diarrhea
• nausea
• dyspnea

What special precautions should I follow?

• Risk of anaphylactic reaction: Patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.
• Impaired Renal or Hepatic function: The daily dose of acebutolol should be reduced by 50% when the creatinine clearance is less than 50 mL/min and by 75% when it is less than 25 mL/min. Acebutolol should be used cautiously in patients with impaired hepatic function.
• Use in nursing mothers is not recommended.

What to do in case of emergency/overdose?

Although specific information on the emergency treatment of acebutolol overdose is not available, on the basis of the pharmacological actions and the observations in treating overdoses with other β-blockers, the following general measures should be considered

• Empty stomach by emesis or lavage.
• Bradycardia: IV atropine (1 to 3 mg in divided doses).
• 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.
• Bronchospasm: A theophylline derivative, such as aminophylline and/or parenteral β2-stimulant, such as terbutaline.
• Cardiac failure: Digitalize the patient and/or administer a diuretic. It has been reported that glucagon is useful in this situation.

Can this medicine be used in pregnancy?

• Teratogenic effects: 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.
• Non-teratogenic effects: Studies in humans have shown that both acebutolol and diacetolol cross the placenta. Neonates of mothers who have received acebutolol during pregnancy have reduced birth weight, decreased blood pressure, and decreased heart rate. Adequate facilities for monitoring these infants at birth should be available.

Can this medicine be used in children?

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

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.
• Dispose unused medication via a take-back option if available; otherwise follow FDA instructions for disposal in the household trash.

• Dailymed label info on Acebutolol HCl
• FDA Acebutolol HCl

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