Acebutolol (Monograph)

Brand name: Sectral
Drug class: alpha-Adrenergic Blocking Agents

Medically reviewed by Drugs.com on Apr 10, 2024. Written by ASHP.

Introduction

A short-acting β₁-selective adrenergic blocking agent (β-blocker).¹ ² ¹⁷ ¹⁸ ¹¹³

Uses for Acebutolol

Hypertension

Management of hypertension (alone or in combination with other classes of antihypertensive agents).¹ ²⁸⁰ ¹²⁰⁰

β-Blockers generally not preferred for first-line therapy of hypertension according to current evidence-based hypertension guidelines, but may be considered in patients who have a compelling indication (e.g., prior MI, ischemic heart disease, heart failure) for their use or as add-on therapy in those who do not respond adequately to the preferred drug classes (ACE inhibitors, angiotensin II receptor antagonists, calcium-channel blockers, or thiazide diuretics).³⁶¹ ⁵⁰¹ ⁵⁰² ⁵⁰³ ⁵⁰⁴ ⁵¹⁵ ⁵²³ ⁵²⁴ ⁵²⁷ ⁸⁰⁰ ¹²⁰⁰ A 2017 ACC/AHA multidisciplinary hypertension guideline states that β-blockers used for ischemic heart disease that are also effective in lowering BP include bisoprolol, carvedilol, metoprolol succinate, metoprolol tartrate, nadolol, propranolol, and timolol.¹²⁰⁰

Individualize choice of therapy; consider patient characteristics (e.g., age, ethnicity/race, comorbidities, cardiovascular risk) as well as drug-related factors (e.g., ease of administration, availability, adverse effects, cost).⁵⁰¹ ⁵⁰² ⁵⁰³ ⁵⁰⁴ ⁵¹⁵ ¹²⁰⁰ ¹²⁰¹

The 2017 ACC/AHA hypertension guideline classifies BP in adults into 4 categories: normal, elevated, stage 1 hypertension, and stage 2 hypertension.¹²⁰⁰ (See Table 1.)

Source: Whelton PK, Carey RM, Aronow WS et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA guideline for the prevention, detection, evaluation, and management of high blood pressure in adults: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018;71:e13-115.

Individuals with SBP and DBP in 2 different categories (e.g., elevated SBP and normal DBP) should be designated as being in the higher BP category (i.e., elevated BP).

Table 1. ACC/AHA BP Classification in Adults1200
Category	SBP (mm Hg)		DBP (mm Hg)
Normal	<120	and	<80
Elevated	120–129	and	<80
Hypertension, Stage 1	130–139	or	80–89
Hypertension, Stage 2	≥140	or	≥90

The goal of hypertension management and prevention is to achieve and maintain optimal control of BP.¹²⁰⁰ However, the BP thresholds used to define hypertension, the optimum BP threshold at which to initiate antihypertensive drug therapy, and the ideal target BP values remain controversial.⁵⁰¹ ⁵⁰³ ⁵⁰⁴ ⁵⁰⁵ ⁵⁰⁶ ⁵⁰⁷ ⁵⁰⁸ ⁵¹⁵ ⁵²³ ⁵²⁶ ⁵³⁰ ¹²⁰⁰ ¹²⁰¹ ¹²⁰⁷ ¹²⁰⁹ ¹²²² ¹²²³ ¹²²⁹

The 2017 ACC/AHA hypertension guideline generally recommends a target BP goal (i.e., BP to achieve with drug therapy and/or nonpharmacologic intervention) of <130/80 mm Hg in all adults regardless of comorbidities or level of atherosclerotic cardiovascular disease (ASCVD) risk.¹²⁰⁰ In addition, an SBP goal of <130 mm Hg generally is recommended for noninstitutionalized ambulatory patients ≥65 years of age with an average SBP of ≥130 mm Hg.¹²⁰⁰ These BP goals are based upon clinical studies demonstrating continuing reduction of cardiovascular risk at progressively lower levels of SBP.¹²⁰⁰ ¹²⁰² ¹²¹⁰

Other hypertension guidelines generally have based target BP goals on age and comorbidities.⁵⁰¹ ⁵⁰⁴ ⁵³⁶ Guidelines such as those issued by the JNC 8 expert panel generally have targeted a BP goal of <140/90 mm Hg regardless of cardiovascular risk and have used higher BP thresholds and target BPs in elderly patients⁵⁰¹ ⁵⁰⁴ compared with those recommended by the 2017 ACC/AHA hypertension guideline.¹²⁰⁰

Some clinicians continue to support previous target BPs recommended by JNC 8 due to concerns about the lack of generalizability of data from some clinical trials (e.g., SPRINT study) used to support the 2017 ACC/AHA hypertension guideline and potential harms (e.g., adverse drug effects, costs of therapy) versus benefits of BP lowering in patients at lower risk of cardiovascular disease.¹²²² ¹²²³ ¹²²⁴ ¹²²⁹

Consider potential benefits of hypertension management and drug cost, adverse effects, and risks associated with the use of multiple antihypertensive drugs when deciding a patient's BP treatment goal.¹²⁰⁰ ¹²²⁰ ¹²²⁹

For decisions regarding when to initiate drug therapy (BP threshold), the 2017 ACC/AHA hypertension guideline incorporates underlying cardiovascular risk factors.¹²⁰⁰ ¹²⁰⁷ ASCVD risk assessment is recommended by ACC/AHA for all adults with hypertension.¹²⁰⁰

ACC/AHA currently recommend initiation of antihypertensive drug therapy in addition to lifestyle/behavioral modifications at an SBP ≥140 mm Hg or DBP ≥90 mm Hg in adults who have no history of cardiovascular disease (i.e., primary prevention) and a low ASCVD risk (10-year risk <10%).¹²⁰⁰

For secondary prevention in adults with known cardiovascular disease or for primary prevention in those at higher risk for ASCVD (10-year risk ≥10%), ACC/AHA recommend initiation of antihypertensive drug therapy at an average SBP ≥130 mm Hg or an average DBP ≥80 mm Hg.¹²⁰⁰

Adults with hypertension and diabetes mellitus, chronic kidney disease (CKD), or age ≥65 years are assumed to be at high risk for cardiovascular disease; ACC/AHA state that such patients should have antihypertensive drug therapy initiated at a BP ≥130/80 mm Hg.¹²⁰⁰ Individualize drug therapy in patients with hypertension and underlying cardiovascular or other risk factors.⁵⁰² ¹²⁰⁰

In stage 1 hypertension, experts state that it is reasonable to initiate drug therapy using the stepped-care approach in which one drug is initiated and titrated and other drugs are added sequentially to achieve the target BP.¹²⁰⁰ Initiation of antihypertensive therapy with 2 first-line agents from different pharmacologic classes recommended in adults with stage 2 hypertension and average BP >20/10 mm Hg above BP goal.¹²⁰⁰

Black hypertensive patients generally tend to respond better to monotherapy with calcium-channel blockers or thiazide diuretics than to β-blockers.³⁵⁵ ³⁵⁹ ³⁶⁰ ⁵⁰¹ ⁵⁰⁴ ¹²⁰⁰ However, diminished response to β-blockers is largely eliminated when administered concomitantly with a thiazide diuretic.⁵⁰⁰

Cardiac Arrhythmias

Treatment of frequent ventricular premature complexes (VPCs), including uniform and multiform VPCs and/or coupled VPCs, and R-on-T complexes¹ ² ¹³⁷ ¹⁸⁵ ¹⁸⁶ ¹⁸⁷ ¹⁸⁸ ¹⁸⁹ ¹⁹⁰ ¹⁹³ ¹⁹⁴ ¹⁹⁵ ¹⁹⁶ ¹⁹⁷ ¹⁹⁸ ¹⁹⁹ ²⁰¹ ²⁰⁴ in patients with primary arrhythmias or arrhythmias secondary to various cardiac disorders (e.g., CAD,¹³⁷ ¹⁸⁵ ¹⁸⁶ ¹⁸⁷ ¹⁸⁸ ¹⁸⁹ ¹⁹⁴ acute MI,¹³⁷ ¹⁸⁶ ¹⁸⁷ ¹⁹³ ¹⁹⁴ ¹⁹⁵ ¹⁹⁶ valvular disease).¹⁸⁵ ¹⁸⁶ ¹⁸⁷ ¹⁸⁹ ¹⁹⁰

Management of various supraventricular tachyarrhythmias^{† [off-label]}.¹⁹¹ ¹⁹² ¹⁹⁶ ²⁰⁰ ²⁰² ²⁰³ ²⁵⁶ ²⁶⁶

Angina

Management of chronic stable angina pectoris^{† [off-label]}.²⁰⁵ ²⁰⁶ ²⁰⁷ ²⁰⁸ ²⁰⁹ ²¹⁰ ²¹¹ ²¹² ²¹³ ²¹⁴ ²²⁰ ²²¹ ²²² ²²³ ²²⁴ ²²⁵

Acute MI

Secondary prevention following acute MI^{† [off-label]} to reduce the risk of reinfarction and mortality.²⁸⁹ ²⁹⁰

Acebutolol Dosage and Administration

General

Individualize dosage according to patient response.¹ ² ⁴
β-Adrenergic blocking selectivity diminishes as dosage is increased.¹
If long-term therapy is discontinued, reduce dosage gradually over a period of about 2 weeks.¹ ² (See Abrupt Withdrawal of Therapy under Cautions.)
When substituting another β-blocker for acebutolol, initiate at a comparable dosage without interruption of β-blocker therapy.¹ ²

BP Monitoring and Treatment Goals

Monitor BP regularly (i.e., monthly) during therapy and adjust dosage of the antihypertensive drug until BP controlled.¹²⁰⁰
If unacceptable adverse effects occur, discontinue drug and initiate another antihypertensive agent from a different pharmacologic class.¹²¹⁶
If adequate BP response not achieved with a single antihypertensive agent, either increase dosage of single drug or add a second drug with demonstrated benefit and preferably a complementary mechanism of action (e.g., ACE inhibitor, angiotensin II receptor antagonist, calcium-channel blocker, thiazide diuretic).¹²⁰⁰ ¹²¹⁶ Many patients will require ≥2 drugs from different pharmacologic classes to achieve BP goal; if goal BP still not achieved, add a third drug.¹²⁰⁰ ¹²¹⁶

Administration

Acebutolol hydrochloride is administered orally.¹ ² Also been administered IV^{† [off-label]},²⁵ ²⁷ ²⁸ ²⁹ ⁴¹ ¹⁹¹ ¹⁹² ¹⁹⁶ ²⁰⁰ ²⁰² ²⁰³ ²⁶⁶ but a parenteral dosage form is currently not commercially available in the US.

Oral Administration

Hypertension

Usually administer as a single daily dose;¹ ²⁴⁵ however, for 24-hour BP control, some patients may require administration of the daily dose in 2 divided doses.¹ ¹⁴² ¹⁴³ ¹⁴⁴ ¹⁴⁵ ¹⁴⁹ ¹⁵⁵

Ventricular Arrhythmias

Twice-daily dosing of the drug appears to be more effective than once-daily dosing for the suppression and prevention of frequent VPCs.⁴ ¹⁸⁵ ¹⁸⁶ ¹⁸⁸ ¹⁸⁹ ¹⁹⁵ ¹⁹⁸ ¹⁹⁹ ²⁰³ ²⁰⁴ ²⁴⁸

Angina

Once-daily administration may be as effective as divided doses;⁴ ²⁰⁸ ²⁴⁹ however, further studies are needed.⁴

Dosage

Available as acebutolol hydrochloride; dosage expressed in terms of acebutolol.¹

Adults

Hypertension

Oral

Initially, 200–400 mg daily.¹ ²⁴⁵ ³²¹ Manufacturer and some clinicians state usual maintenance dosage is 400–800 mg daily, ¹ ¹⁴⁰ ¹⁴² ¹⁴³ ¹⁴⁴ ¹⁴⁵ ¹⁴⁹ ¹⁵⁰ ¹⁵¹ ¹⁵² ¹⁵³ ¹⁵⁴ ²⁴⁵ ²⁴⁶ ²⁴⁷ but some patients may achieve adequate BP control with dosages as low as 200 mg daily.¹ ⁴

Increase dosage up to 1.2 g daily in 2 divided doses in patients with more severe hypertension or if adequate reduction of BP does not occur;¹ ² ⁴ ¹⁴⁰ ¹⁴² ¹⁴³ ¹⁴⁴ ¹⁴⁵ ¹⁴⁹ ¹⁵⁰ ¹⁵¹ ¹⁵² ¹⁵⁴ ¹⁵⁵ alternatively, add another hypotensive agent (e.g., thiazide diuretic).¹ ² ⁴ ¹⁴² ¹⁴⁴ ¹⁵⁷ ¹⁵⁸ ¹⁶⁰ ¹⁶¹ ¹⁶⁵ ¹⁶⁶ ¹⁶⁸

Some experts state usual dosage range is 200–800 mg daily, administered in 2 divided doses.¹²⁰⁰

Ventricular Arrhythmias

Oral

Initially, 200 mg twice daily.¹ ¹⁸⁷ ¹⁹⁶ Increase gradually until optimum effect is achieved.¹ ¹⁸⁵ ¹⁸⁶ ¹⁹⁵ ¹⁹⁸ ²⁰⁴ Usual maintenance dosage is 600–1200 mg daily.¹ ² ⁴ ¹⁸⁵ ¹⁸⁶ ¹⁸⁹ ¹⁹⁰ ¹⁹⁵ ¹⁹⁹ ²⁰⁴

Angina

Oral

Initially, 200 mg twice daily.⁴ ²⁰⁵ ²⁰⁸ Increase dosage gradually until optimum effect is achieved.⁴ ²⁰⁵ Usual maintenance dosage is 800 mg or less daily,⁴ ²⁰⁶ ²⁰⁷ ²⁰⁸ ²⁰⁹ ²¹⁰ ²¹¹ ²¹² ²¹³ ²¹⁴ but patients with severe angina may require higher dosages.⁴ ²⁰⁵ ²⁰⁹ ²¹¹

Adjust dosage of β-blockers according to clinical response⁴ ²⁰⁵ and to maintain a resting heart rate of 55–60 bpm.²¹¹ ²¹⁶

Prescribing Limits

Adults

Hypertension

Oral

Maximum 1.2 g daily.¹ ² ⁴ ¹⁴⁰ ¹⁴² ¹⁴³ ¹⁴⁴ ¹⁴⁵ ¹⁴⁹ ¹⁵⁰ ¹⁵¹ ¹⁵² ¹⁵⁴ ¹⁵⁵

Special Populations

Renal Impairment

Active metabolite (diacetolol) eliminated principally by the kidneys;¹ ¹²³ ¹²⁵ dosage and/or frequency of administration must be modified in response to the degree of renal impairment.¹ ² ⁸⁶ ¹²³ ¹²⁴ ¹²⁵ ¹²⁶ ¹²⁷

Dosage Reductions in Patients with Renal Impairment
Reduction in Usual Daily Dosage	Cl_cr (mL/min)
50%	25–49 mL/minute
75%	<25 mL/minute

Acebutolol and diacetolol removed by hemodialysis;¹ ¹²⁵ ¹²⁷ individualize dosage carefully in patients with severe renal impairment who undergo chronic intermittent hemodialysis.¹²⁴ ¹²⁵

Geriatric Patients

Consider reduction in maintenance dosage.¹ ² Avoid dosages >800 mg daily.¹ ²

Cautions for Acebutolol

Contraindications

Patients with heart block greater than first degree, severe bradycardia, cardiogenic shock, or overt cardiac failure.¹

Warnings/Precautions

Warnings

Heart Failure

Possible precipitation of heart failure.¹

Avoid use in patients with decompensated heart failure; use cautiously in patients with inadequate myocardial function and, if necessary, in patients with well-compensated heart failure (e.g., those controlled with cardiac glycosides and/or diuretics).¹

Adequate treatment (e.g., with a cardiac glycoside and/or diuretic) and close observation recommended if signs or symptoms of impending cardiac failure occur; if cardiac failure continues, discontinue therapy, gradually if possible.¹

Abrupt Withdrawal of Therapy

Possible exacerbated angina symptoms or precipitation of MI in patients with CAD.¹ Abrupt discontinuance of therapy is not recommended.¹ ²⁷⁶ Gradually decrease dosage over a period of about 2 weeks; monitor patients carefully and advise to temporarily limit their physical activity.¹ ²⁷⁶ If exacerbation of angina occurs, reinstitute therapy promptly and initiate appropriate measures for the management of unstable angina pectoris.¹

Peripheral Vascular Disease

Possible reduction in cardiac output and precipitation or aggravation of symptoms of arterial insufficiency.¹ Use with caution; observe for evidence of disease progression.¹

Bronchospastic Disease

Possible bronchoconstriction.¹

Use with caution in patients with bronchospastic disease; administer the lowest effective dosage (initially in divided doses). A bronchodilator (e.g., a β₂-adrenergic agonist, theophylline) should be available for immediate use, if necessary.¹

Major Surgery

Possible risks associated with general anesthesia (e.g., severe hypotension, maintenance of heart beat) due to decreased ability of the heart to respond to reflex β-adrenergic stimuli.¹ Use with caution in patients undergoing major surgery involving general anesthesia; anesthetics used should not cause myocardial depression.¹

Diabetes and Hypoglycemia

Possible decreased signs and symptoms of hypoglycemia (e.g., tachycardia, palpitation, BP changes, tremor, feelings of anxiety, but not sweating or dizziness) and increased insulin-induced hypoglycemia.¹

Use with caution in patients with diabetes mellitus.¹

Thyrotoxicosis

Signs of hyperthyroidism (e.g., tachycardia) may be masked.¹ Possible thyroid storm if therapy is abruptly withdrawn; carefully monitor patients having or suspected of developing thyrotoxicosis.¹

Sensitivity Reactions

Anaphylactic Reactions

Patients with a history of anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenges with such allergens while taking β-blocking agents.¹ Such patients may be unresponsive to usual doses of epinephrine.¹

Specific Populations

Pregnancy

Category B.¹

Lactation

Distributed into milk in higher concentrations than in maternal plasma.¹ ² ¹⁰⁵ Use not recommended by manufacturer.¹

Pediatric Use

Safety and efficacy not established in children <12 years of age.¹ ²⁶⁸

Geriatric Use

Insufficient experience in patients >65 years of age to determine whether geriatric patients respond differently than younger adults.¹ However, reduction of maintenance dosage may be necessary,¹ ² since bioavailability of acebutolol and diacetolol (active metabolite) may be increased compared with that in younger adults.¹ ² ¹²² (See Geriatric Patients under Dosage and Administration.)

Hepatic Impairment

Use with caution.¹ ² Cirrhosis does not appear to substantially affect the pharmacokinetics of acebutolol or diacetolol; however, the effects of hepatic impairment on elimination of the drug have not been fully evaluated.¹²⁸

Renal Impairment

Use with caution; dosage should be reduced based on the degree of renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

Fatigue, dizziness, headache, dyspnea, constipation, diarrhea, dyspepsia, nausea, flatulence, insomnia, increased micturition, chest pain, edema, depression, abnormal dreams, rash, arthralgia, myalgia, cough, rhinitis, abnormal vision.¹

Drug Interactions

Specific Drugs

Drug	Interaction	Comments
α-Adrenergic agonists¹	Possible exaggerated hypertensive reactions¹	Warn patients of potential hazard¹
Calcium-channel blockers	Potential additive depressant effects on SA or AV nodal conduction³¹⁸ ³¹⁹
Cardiac glycosides (digoxin)	Potential additive depressant effects on SA or AV nodal conduction³¹⁸ ³¹⁹ Pharmacokinetic interaction unlikely¹
Diuretics	Possible increased hypotensive effect¹ ² ¹⁴² ¹⁴⁴ ¹⁵⁷ ¹⁵⁸ ¹⁶⁰	Careful dosage adjustment recommended¹ ² ¹⁴⁴ ¹⁵⁷ ¹⁵⁸ ¹⁶⁰
Glyburide	Possible decreased hypoglycemic action in type II diabetic patients, presumably by decreasing insulin secretion²⁴⁴
Hydralazine	Pharmacokinetic interaction unlikely¹
Hydrochlorothiazide	Pharmacokinetic interaction unlikely¹
Hypotensive agents	Possible increased hypotensive effect¹ ² ¹⁴² ¹⁴⁴ ¹⁵⁷ ¹⁵⁸ ¹⁶⁰	Careful dosage adjustment recommended¹ ² ¹⁴⁴ ¹⁵⁷ ¹⁵⁸ ¹⁶⁰
NSAIAs	Potential blunting of hypotensive effects¹
Oral contraceptives	Pharmacokinetic interaction unlikely¹
Reserpine	Possible additive pharmacologic effects¹	Observe closely for evidence of marked bradycardia or hypotension (e.g., vertigo, presyncope or syncope, or orthostatic changes in BP without compensatory tachycardia)¹
Sulfinpyrazone	Pharmacokinetic interaction unlikely¹
Sympathomimetic agents	Antagonism of β₁-adrenergic stimulating effects (e.g., bronchodilation)¹ ² ⁵⁷ ⁵⁸ ⁵⁹ ⁶²	Increased dosage of β-adrenergic agonist bronchodilators may be required ²⁶⁸ ²⁷⁷
Tolbutamide	Interaction unlikely¹
Warfarin	Interaction unlikely¹

Acebutolol Pharmacokinetics

Absorption

Bioavailability

Well absorbed from the GI tract following oral administration;¹ ² ⁴ ¹¹ ⁹¹ ¹⁰⁹ undergoes extensive first-pass metabolism in the liver.¹ ² ⁹⁷ ⁹⁹ ¹⁰⁹ ¹²² ¹²⁴

Peak plasma acebutolol and diacetolol concentrations occur within 2–2.5 hours (range: 1–4 hours) and 4 hours (range: 2.4–5 hours), respectively, in healthy individuals¹ ² ⁹⁴ ⁹⁵ ⁹⁷ ⁹⁸ ⁹⁹ ¹²⁶ ¹³⁵ or patients with hypertension⁹¹ or arrhythmias.² ⁹⁰ ¹³⁷

Absolute bioavailability is approximately 35–50%.¹ ⁴ ⁹⁴ ⁹⁷ ¹⁰²

Food

Food may slightly decrease the rate of absorption and peak plasma concentrations of acebutolol and its major metabolite (diacetolol), but the extent of absorption is not substantially affected.¹ ² ¹⁰¹

Onset

Effect on resting, reflex, or exercise-induced heart rate and systolic BP begins within 1–1.5 hours,¹ ³ ²¹ ⁹¹ ¹⁰⁰ in healthy¹ ²¹ ⁹⁸ ¹⁰⁰ or hypertensive⁹¹ individuals.

Duration

Effect may persist for up to 24 hours or longer.¹ ³ ⁹¹ ⁹⁸ ¹⁰⁰

Special Populations

In geriatric patients, peak plasma concentrations and AUCs of acebutolol and diacetolol are increased twofold compared with those observed in younger patients.¹ ² ¹²²

Distribution

Extent

Acebutolol and diacetolol readily cross the placenta¹ ² ¹⁰⁵ ¹⁰⁶ ¹⁰⁷ and can accumulate in the fetus.¹⁰⁵ ¹⁰⁶ ¹⁰⁷

Acebutolol and diacetolol are distributed into milk at concentrations higher than those in maternal plasma. (See Lactation under Cautions.)¹ ² ¹⁰⁵ ¹⁰⁶

Plasma Protein Binding

Approximately 11–25% (acebutolol) and 6–9% (diacetolol).² ⁹³ ¹⁰³ Approximately 50% bound to erythrocytes.⁴ ¹²⁵

Elimination

Metabolism

Rapidly and extensively metabolized in the liver² ¹¹⁰ ¹¹³ to metabolites (acetolol and diacetolol).² ⁴ ⁶ ⁹⁹ ¹⁰⁸ ¹⁰⁹ ¹¹⁰ ¹¹³

Elimination Route

Acebutolol and its metabolites are excreted in feces and urine.¹ ⁸⁷ ⁹² ¹⁰⁹ ¹¹¹ ¹²³

Half-life

About 3 hours in the initial distribution phase (t_½α) ⁹⁵ and about 11 hours (range: 6–12 hours) in the terminal phase (t_½β).⁹⁵ ¹²⁵ About 7.5 (range: 7–11 hours) and 3 hours, respectively, for diacetolol and acetolol following a single oral dose.¹⁰¹ ¹⁰⁸ ¹²⁵

Special Populations

Renal impairment may reduce clearances of acebutolol and diacetolol.¹²⁵ Acebutolol and diacetolol are removed by hemodialysis.¹ ¹²⁵ ¹²⁷

Stability

Storage

Oral

Capsules

Tight containers¹ ²⁵³ at room temperature (approximately 25°C).¹ ² ³

Protect from light.¹ ³⁰⁵

Actions

Pharmacologic effects result from both the unchanged drug and diacetolol, ¹ ² ¹¹⁴ ¹¹⁵ ¹¹⁶ ¹¹⁷ which is equipotent to acebutolol.¹ ² ¹¹⁴ ¹¹⁵ ¹¹⁶ ¹¹⁷
Inhibits response to adrenergic stimuli by competitively blocking β₁-adrenergic receptors within the myocardium.¹ ² ⁴ ⁵ ⁶ ⁷ ⁸ ⁹ ¹⁰ ¹¹ ¹² ¹³ ¹⁴ ¹⁵ ¹⁶ ¹⁷ ¹⁸ ¹⁹ ²⁰ ²¹ ²² ²³ ²⁴ ²⁵ ²⁶ ²⁷ ²⁸ ³⁴ ³⁵ ³⁶ ³⁷ ³⁸ Blocks β₂-adrenergic receptors within bronchial and vascular smooth muscle only at high doses.⁴ ²⁴ ³⁵ ¹⁷⁸
Decreases exercise-induced heart rate,¹ ² ⁴ ¹¹ ¹² ¹³ ²³ ²⁴ ²⁵ ²⁷ inhibits reflex orthostatic tachycardia,¹ ² ⁴ ¹¹ ¹² ¹³ ²³ ²⁴ and may decrease¹ ² ²⁵ ²⁸ ²⁹ ¹⁴⁰ ¹⁹³ or leave unchanged ²⁶ ¹⁴⁰ cardiac output at rest² ²⁵ ¹⁴⁰ ¹⁹³ or during exercise.¹ ²⁸ ²⁹ Decreases systolic and diastolic BP at rest¹ ² ¹³ ¹⁹ ²³ ⁵⁶ ⁵⁷ ¹³⁹ and during exercise.¹ ² ¹⁵⁵ ¹⁶⁰ ¹⁷¹
Precise mechanism of hypotensive action has not been determined.⁷ ²² ²⁶ ³⁴ ³⁵ ¹³⁹ ¹⁷⁸ May reduce BP by blocking peripheral (especially cardiac) adrenergic receptors (decreasing cardiac output), by decreasing sympathetic outflow from the CNS, and/or by suppressing renin release.⁷ ²⁶ ³⁴ ³⁵ ¹⁴⁰
Exhibits antiarrhythmic activity;¹ ² ¹³⁷ ¹⁸⁵ ¹⁸⁶ ¹⁸⁷ ¹⁸⁸ ¹⁸⁹ ¹⁹⁰ ¹⁹³ ¹⁹⁴ ¹⁹⁵ ¹⁹⁶ ¹⁹⁹ ²⁰⁴ considered a class II antiarrhythmic agent.²⁵⁴
Can produce nervous system effects,¹ ² ⁴ ⁶ ¹⁵⁰ ¹⁵² ¹⁵⁴ ¹⁵⁸ ¹⁷⁰ ¹⁹⁸ although the frequency and/or severity of such effects may be less than those observed with some other β-blockers.¹⁵² ¹⁵⁴ ¹⁵⁶ ²⁶²
Unlike some β-blockers,¹⁴⁷ ¹⁴⁸ does not consistently suppress plasma renin activity (PRA).²⁶ ⁷¹ ¹³⁹ ¹⁴⁰ ¹⁴¹ ¹⁴² ¹⁴³
May increase airway resistance and decrease ventilatory capacity,⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁷ ⁵⁸ ⁵⁹ ⁶⁰ ⁶¹ ⁶² ⁶³ ⁶⁴ ¹⁵⁵ ¹⁵⁸ especially in patients with asthma and/or COPD or when high dosages are used.⁵² ⁵³ ⁵⁷ ⁵⁸ ⁵⁹ ⁶⁰ ⁶¹ ⁶² ⁶³ ⁶⁴ ¹⁵⁸ ²⁶⁸
Does not appear to substantially affect glucose metabolism;⁷³ ⁷⁵ however, the drug may potentiate insulin-induced hypoglycemia in diabetic patients receiving oral hypoglycemic agents.⁷⁴ (See Interactions.)

Advice to Patients

Importance of taking acebutolol exactly as prescribed.¹
Importance of not interrupting or discontinuing therapy without consulting clinician; patients should temporarily limit physical activity when discontinuing therapy.¹ ²⁷⁶
Importance of immediately informing clinician at the first sign or symptom of impending cardiac failure (e.g., weight gain, increased shortness of breath) or if any difficulty in breathing occurs.¹
In patients with heart failure, importance of informing clinician of signs or symptoms of exacerbation (e.g., weight gain, difficulty in breathing).¹
Importance of patients informing anesthesiologist or dentist that they are receiving acebutolol therapy prior to undergoing major surgery.¹
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.¹
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹
Importance of informing patients of other important precautionary information.¹ (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Acebutolol Hydrochloride
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	200 mg (of acebutolol)*	Acebutolol Hydrochloride Capsules
			Sectral	Promius
		400 mg (of acebutolol)*	Acebutolol Hydrochloride Capsules
			Sectral	Promius

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Wyeth-Ayerst Laboratories. Sectral (acebutolol hydrochloride) prescribing information. In: Physicians’ desk reference. 53rd ed. Montvale, NJ: Medical Economics Company Inc; 1999:3381-3.

2. Ives Laboratories Inc. Sectral product monograph. New York, NY; 1985 Mar.

3. Ives Laboratories Inc. Sectral product information form for American Hospital Formulary Service. Philadelphia, PA; 1985 Jan.

4. Singh BN, Thoden WR, Ward A. Acebutolol: a review of its pharmacological properties and therapeutic efficacy in hypertension, angina pectoris and arrhythmia. Drugs. 1985; 29:531-69. http://www.ncbi.nlm.nih.gov/pubmed/3891306?dopt=AbstractPlus

5. Cowling CGD, Leary WP. Acebutolol: a review. Curr Ther Res. 1981; 30:765-74.

6. De Bono G, Kaye CM, Roland E et al. Acebutolol: ten years of experience. Am Heart J. 1985; 109(5 Part 2):1211-24. http://www.ncbi.nlm.nih.gov/pubmed/2859785?dopt=AbstractPlus

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503. Go AS, Bauman MA, Coleman King SM et al. An effective approach to high blood pressure control: a science advisory from the American Heart Association, the American College of Cardiology, and the Centers for Disease Control and Prevention. Hypertension. 2014; 63:878-85. http://www.ncbi.nlm.nih.gov/pubmed/24243703?dopt=AbstractPlus

504. Weber MA, Schiffrin EL, White WB et al. Clinical practice guidelines for the management of hypertension in the community: a statement by the American Society of Hypertension and the International Society of Hypertension. J Clin Hypertens (Greenwich). 2014; 16:14-26. http://www.ncbi.nlm.nih.gov/pubmed/24341872?dopt=AbstractPlus

505. Wright JT, Fine LJ, Lackland DT et al. Evidence supporting a systolic blood pressure goal of less than 150 mm Hg in patients aged 60 years or older: the minority view. Ann Intern Med. 2014; 160:499-503. http://www.ncbi.nlm.nih.gov/pubmed/24424788?dopt=AbstractPlus

506. Mitka M. Groups spar over new hypertension guidelines. JAMA. 2014; 311:663-4. http://www.ncbi.nlm.nih.gov/pubmed/24549531?dopt=AbstractPlus

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515. Thomas G, Shishehbor M, Brill D et al. New hypertension guidelines: one size fits most?. Cleve Clin J Med. 2014; 81:178-88. http://www.ncbi.nlm.nih.gov/pubmed/24591473?dopt=AbstractPlus

523. Fihn SD, Gardin JM, Abrams J et al. 2012 ACCF/AHA/ACP/AATS/PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. Circulation. 2012; 126:e354-471.

524. WRITING COMMITTEE MEMBERS, Yancy CW, Jessup M et al. 2013 ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation. 2013; 128:e240-327.

526. Kernan WN, Ovbiagele B, Black HR et al. Guidelines for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2014; :. http://www.ncbi.nlm.nih.gov/pubmed/24788967?dopt=AbstractPlus

527. O'Gara PT, Kushner FG, Ascheim DD et al. 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Circulation. 2013; 127:e362-425. http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=3695607&blobtype=pdf

530. Myers MG, Tobe SW. A Canadian perspective on the Eighth Joint National Committee (JNC 8) hypertension guidelines. J Clin Hypertens (Greenwich). 2014; 16:246-8. http://www.ncbi.nlm.nih.gov/pubmed/24641124?dopt=AbstractPlus

536. Kidney Disease: Improving Global Outcomes (KDIGO) Blood Pressure Work Group. KDIGO clinical practice guideline for the management of blood pressure in chronic kidney disease. Kidney Int Suppl. 2012: 2: 337-414.

800. Yancy CW, Jessup M, Bozkurt B et al. 2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. Circulation. 2016; :.

1200. Whelton PK, Carey RM, Aronow WS et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension. 2018; 71:el13-e115. http://www.ncbi.nlm.nih.gov/pubmed/29133356?dopt=AbstractPlus

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1209. Qaseem A, Wilt TJ, Rich R et al. Pharmacologic treatment of hypertension in adults aged 60 years or older to higher versus lower blood pressure targets: a clinical practice guideline from the American College of Physicians and the American Academy of Family Physicians. Ann Intern Med. 2017; 166:430-437. http://www.ncbi.nlm.nih.gov/pubmed/28135725?dopt=AbstractPlus

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1235. Mann SJ. Redefining beta-blocker use in hypertension: selecting the right beta-blocker and the right patient. J Am Soc Hypertens. 2017; 11(1):54-65. http://www.ncbi.nlm.nih.gov/pubmed/28057444?dopt=AbstractPlus

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