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Acebutolol: Drug information

Acebutolol: Drug information
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For additional information see "Acebutolol: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: Canada
  • APO-Acebutolol;
  • TEVA-Acebutolol
Pharmacologic Category
  • Antiarrhythmic Agent, Class II;
  • Antihypertensive;
  • Beta-Blocker With Intrinsic Sympathomimetic Activity;
  • Beta-Blocker, Beta-1 Selective
Dosing: Adult
Hypertension

Hypertension (alternative agent): Oral: Initial: 200 to 400 mg daily in 1 to 2 divided doses; titrate as needed based on patient response; usual dosage range: 200 to 800 mg/day in 2 divided doses (Ref); maximum dose: 1,200 mg/day.

Thyrotoxicosis

Thyrotoxicosis (off-label use): Oral: 200 mg 2 to 3 times daily; treatment period in clinical trials was 7 to 10 days (Ref). Additional data may be necessary to further define the role of acebutolol in the treatment of this condition. Note: Other beta blockers (eg, propranolol) may be preferred in this setting (Ref).

Ventricular premature beats

Ventricular premature beats: Oral: Initial: 200 to 400 mg daily in 1 to 2 divided doses; titrate as needed up to a maximum dose of 1,200 mg/day (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl ≥50 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling.

CrCl 25 to 49 mL/minute: Reduce dose by 50%.

CrCl <25 mL/minute: Reduce dose by 75%.

Dosing: Liver Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing. Consider dose reduction due to age-related increase in bioavailability; do not exceed 800 mg/day.

In the management of hypertension, consider lower initial dose (eg, 200 to 400 mg/day) and titrate to response (Ref).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

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

1% to 10%:

Cardiovascular: Chest pain (2%), edema (2%), bradycardia (≤2%), cardiac failure (≤2%), hypotension (≤2%)

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

Dermatologic: Skin rash (2%), pruritus (≤2%)

Gastrointestinal: Constipation (4%), diarrhea (4%), dyspepsia (4%), nausea (4%), flatulence (3%), abdominal pain (≤2%), vomiting (≤2%)

Genitourinary: Urinary frequency (3%), dysuria (≤2%), impotence (≤2%), nocturia (≤2%)

Hepatic: Hepatic abnormality (≤2%)

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

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

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

<1%, postmarketing, and/or case reports: Increased ANA titer, psoriasis (Song 2021), systemic lupus erythematosus

Contraindications

Overt cardiac failure; cardiogenic shock; persistently severe bradycardia or second- and third-degree heart block (except in patients with a functioning artificial pacemaker)

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to acebutolol, beta-blockers, or any component of the formulation; sinus bradycardia; sick sinus syndrome; right ventricular failure secondary to pulmonary hypertension; pheochromocytoma; severe peripheral circulatory disorders; anesthesia with agents that produce myocardial depression

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse events:

• Anaphylactic reactions: Use caution with history of severe anaphylaxis to allergens; patients taking beta-blockers may become more sensitive to repeated challenges. Treatment of anaphylaxis (eg, epinephrine) in patients taking beta-blockers may be ineffective or promote undesirable effects.

Disease-related concerns:

• Bronchospastic disease: In general, patients with bronchospastic disease should not receive beta-blockers; for patients with bronchospastic disease who do not respond to or cannot tolerate other therapies, initial low doses of acebutolol may be employed and used cautiously with close monitoring. Ensure patient has an inhaled beta2-agonist immediately available.

• Conduction abnormality: Consider preexisting conditions such as sick sinus syndrome before initiating.

• Diabetes: Use with caution in patients with diabetes mellitus; may potentiate hypoglycemia and/or mask signs and symptoms.

• Heart failure (HF): Beta-blockers with intrinsic sympathomimetic activity (eg, acebutolol) are likely to worsen survival in patients with HF and should be avoided. Beta-blockers shown to improve survival in clinical trials should be used in these patients.

• Hepatic impairment: Use with caution in patients with hepatic impairment.

• Mesenteric vascular disease: Can precipitate or aggravate symptoms of arterial insufficiency in patients with mesenteric vascular disease. Use with caution in these patients. Observe closely for progression of arterial obstruction.

• Myasthenia gravis: Use with caution in patients with myasthenia gravis.

• Peripheral vascular disease (PVD) and Raynaud disease: May precipitate or aggravate symptoms of arterial insufficiency in patients with PVD and Raynaud disease. Use with caution and monitor for progression of arterial obstruction.

• Pheochromocytoma (untreated): Adequate alpha1-receptor blockade is required prior to use of any beta-blocker.

• Psoriasis: Beta-blocker use has been associated with induction or exacerbation of psoriasis, but cause and effect have not been firmly established.

• Renal impairment: Use with caution in patients with renal impairment, especially elderly patients. Elimination of the metabolite, diacetolol, is reduced resulting in a two- to threefold increase in its half-life.

• Thyroid disease: May mask signs of hyperthyroidism (eg, tachycardia). If hyperthyroidism is suspected, carefully manage and monitor; abrupt withdrawal may precipitate thyroid storm. Alterations in thyroid function tests may be observed.

• Vasospastic angina: Beta-blockers without alpha1-adrenergic receptor blocking activity should be avoided in patients with vasospastic angina since unopposed alpha1-adrenergic receptors mediate coronary vasoconstriction and can worsen anginal symptoms (Mayer 1998).

Special populations:

• Older adult: Use reduced doses in elderly patients; concentrations of acebutolol and diacetolol are significantly higher in elderly patients. Dose should not exceed 800 mg/day.

Other warnings/precautions:

• Abrupt withdrawal: Beta-blocker therapy should not be withdrawn abruptly (particularly in patients with CAD), but gradually tapered to avoid acute tachycardia, hypertension, and/or ischemia. Severe exacerbation of angina, ventricular arrhythmias, and myocardial infarction (MI) have been reported following abrupt withdrawal of beta-blocker therapy. Temporary but prompt resumption of beta-blocker therapy may be indicated with worsening of angina or acute coronary insufficiency.

• Major surgery: Chronic beta-blocker therapy should not be routinely withdrawn prior to major surgery.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral, as hydrochloride:

Generic: 200 mg, 400 mg

Generic Equivalent Available: US

Yes

Pricing: US

Capsules (Acebutolol HCl Oral)

200 mg (per each): $1.41 - $1.46

400 mg (per each): $1.88 - $1.93

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Generic: 100 mg, 200 mg, 400 mg

Administration: Adult

Oral: May be administered without regard to meals.

Use: Labeled Indications

Hypertension: Management of hypertension. Note: Beta-blockers are not recommended as first-line therapy (ACC/AHA [Whelton 2018]).

Ventricular premature beats: Management of ventricular premature beats

Use: Off-Label: Adult

Thyrotoxicosis

Medication Safety Issues
Sound-alike/look-alike issues:

Sectral may be confused with Seconal, Septra

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetylcholinesterase Inhibitors: May increase bradycardic effects of Beta-Blockers. Risk C: Monitor

Alfuzosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Alpha2-Agonists: Beta-Blockers may increase rebound hypertensive effects of Alpha2-Agonists. This effect can occur when the Alpha2-Agonist is abruptly withdrawn. Alpha2-Agonists may increase AV-blocking effects of Beta-Blockers. Sinus node dysfunction may also be enhanced. 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. Risk D: Consider Therapy Modification

Amifostine: Blood Pressure Lowering Agents may increase hypotensive effects of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider Therapy Modification

Amiodarone: May increase bradycardic effects of Beta-Blockers. Possibly to the point of cardiac arrest. Amiodarone may increase serum concentration of Beta-Blockers. Risk C: Monitor

Amphetamines: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Antidiabetic Agents: Beta-Blockers (Beta1 Selective) may increase adverse/toxic effects of Antidiabetic Agents. Specifically, beta-blockers may mask the hypoglycemic symptoms of antidiabetic agents. Risk C: Monitor

Antipsychotic Agents (Phenothiazines): May increase hypotensive effects of Beta-Blockers. Beta-Blockers may decrease metabolism of Antipsychotic Agents (Phenothiazines). Antipsychotic Agents (Phenothiazines) may decrease metabolism of Beta-Blockers. Risk C: Monitor

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may increase hypotensive effects of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor

Arginine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Barbiturates: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Benperidol: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

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

Bradycardia-Causing Agents: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor

Brigatinib: May decrease antihypertensive effects of Antihypertensive Agents. Brigatinib may increase bradycardic effects of Antihypertensive Agents. Risk C: Monitor

Brimonidine (Topical): May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Bromperidol: May decrease hypotensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase hypotensive effects of Bromperidol. Risk X: Avoid

Cafedrine: May increase bradycardic effects of Beta-Blockers. Beta-Blockers may decrease therapeutic effects of Cafedrine. Risk C: Monitor

Cannabis: Beta-Blockers may increase adverse/toxic effects of Cannabis. Specifically, the risk of hypoglycemia may be increased. Risk C: Monitor

Ceritinib: Bradycardia-Causing Agents may increase bradycardic effects 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. Risk D: Consider Therapy Modification

Cholinergic Agonists: Beta-Blockers may increase adverse/toxic effects of Cholinergic Agonists. Of particular concern are the potential for cardiac conduction abnormalities and bronchoconstriction. Risk C: Monitor

Dexmethylphenidate: May decrease therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Diazoxide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Dipyridamole: May increase bradycardic effects of Beta-Blockers. Risk C: Monitor

Disopyramide: May increase bradycardic effects of Beta-Blockers. Beta-Blockers may increase negative inotropic effects of Disopyramide. Risk C: Monitor

DOBUTamine: Beta-Blockers may decrease therapeutic effects of DOBUTamine. Risk C: Monitor

Dronedarone: May increase bradycardic effects of Beta-Blockers. Dronedarone may increase 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. Increase monitoring for clinical response and adverse effects. Risk D: Consider Therapy Modification

DULoxetine: Blood Pressure Lowering Agents may increase hypotensive effects of DULoxetine. Risk C: Monitor

EPHEDrine (Systemic): Beta-Blockers may decrease therapeutic effects of EPHEDrine (Systemic). Risk C: Monitor

EPINEPHrine (Nasal): Beta-Blockers (Beta1 Selective) may decrease therapeutic effects of EPINEPHrine (Nasal). Risk C: Monitor

EPINEPHrine (Oral Inhalation): Beta-Blockers (Beta1 Selective) may decrease therapeutic effects of EPINEPHrine (Oral Inhalation). Risk C: Monitor

EPINEPHrine (Systemic): Beta-Blockers (Beta1 Selective) may decrease therapeutic effects of EPINEPHrine (Systemic). Risk C: Monitor

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): Beta-Blockers may increase vasoconstricting effects of Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates). Risk C: Monitor

Etilefrine: Beta-Blockers may decrease therapeutic effects of Etilefrine. Etilefrine may increase bradycardic effects of Beta-Blockers. Risk C: Monitor

Etofylline: Beta-Blockers may decrease therapeutic effects of Etofylline. Risk X: Avoid

Etrasimod: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor

Fexinidazole: Bradycardia-Causing Agents may increase arrhythmogenic effects of Fexinidazole. Risk X: Avoid

Fingolimod: Bradycardia-Causing Agents may increase bradycardic effects of Fingolimod. Management: Consult with the prescriber of any bradycardia-causing agent to see if the agent could be switched to an agent that does not cause bradycardia prior to initiating fingolimod. If combined, perform continuous ECG monitoring after the first fingolimod dose. Risk D: Consider Therapy Modification

Flunarizine: May increase therapeutic effects of Antihypertensive Agents. Risk C: Monitor

Grass Pollen Allergen Extract (5 Grass Extract): Beta-Blockers may increase adverse/toxic effects 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. Management: Consider alternatives to either grass pollen allergen extract (5 grass extract) or beta-blockers in patients with indications for both agents. Canadian product labeling specifically lists this combination as contraindicated. Risk D: Consider Therapy Modification

Herbal Products with Blood Pressure Increasing Effects: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Herbal Products with Blood Pressure Lowering Effects: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Hypotension-Associated Agents: Blood Pressure Lowering Agents may increase hypotensive effects of Hypotension-Associated Agents. Risk C: Monitor

Iloperidone: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Indoramin: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Isocarboxazid: May increase antihypertensive effects of Antihypertensive Agents. Risk X: Avoid

Isoproterenol: Beta-Blockers may decrease therapeutic effects of Isoproterenol. Risk C: Monitor

Ivabradine: Bradycardia-Causing Agents may increase bradycardic effects of Ivabradine. Risk C: Monitor

Lacosamide: Bradycardia-Causing Agents may increase AV-blocking effects of Lacosamide. Risk C: Monitor

Landiolol: Bradycardia-Causing Agents may increase bradycardic effects of Landiolol. Risk X: Avoid

Levodopa-Foslevodopa: Blood Pressure Lowering Agents may increase hypotensive effects of Levodopa-Foslevodopa. Risk C: Monitor

Loop Diuretics: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Lormetazepam: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Mavacamten: Beta-Blockers may increase adverse/toxic effects of Mavacamten. Specifically, negative inotropic effects may be increased. Risk C: Monitor

Metergoline: May decrease antihypertensive effects of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may increase orthostatic hypotensive effects of Metergoline. Risk C: Monitor

Methacholine: Beta-Blockers may increase adverse/toxic effects of Methacholine. Risk C: Monitor

Methylphenidate: May decrease antihypertensive effects of Antihypertensive Agents. Risk C: Monitor

Midodrine: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor

Mivacurium: Beta-Blockers may increase therapeutic effects of Mivacurium. Risk C: Monitor

Molsidomine: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Naftopidil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicergoline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Nicorandil: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

NIFEdipine (Topical): May increase adverse/toxic effects of Beta-Blockers. Risk C: Monitor

NIFEdipine: May increase hypotensive effects of Beta-Blockers. NIFEdipine may increase negative inotropic effects of Beta-Blockers. Risk C: Monitor

Nitrendipine: May increase therapeutic effects of Beta-Blockers. Risk C: Monitor

Nitroprusside: Blood Pressure Lowering Agents may increase hypotensive effects of Nitroprusside. Risk C: Monitor

Nonsteroidal Anti-Inflammatory Agents (Topical): May decrease therapeutic effects of Beta-Blockers. Risk C: Monitor

Nonsteroidal Anti-Inflammatory Agents: May decrease antihypertensive effects of Beta-Blockers. Risk C: Monitor

Obinutuzumab: May increase hypotensive effects 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. Risk D: Consider Therapy Modification

Opipramol: Beta-Blockers may increase serum concentration of Opipramol. Opipramol may increase serum concentration of Beta-Blockers. Risk C: Monitor

Ozanimod: May increase bradycardic effects of Bradycardia-Causing Agents. Risk C: Monitor

Pentoxifylline: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Perazine: May increase hypotensive effects of Antihypertensive Agents. Risk C: Monitor

Pholcodine: Blood Pressure Lowering Agents may increase hypotensive effects of Pholcodine. Risk C: Monitor

Phosphodiesterase 5 Inhibitors: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Ponesimod: Bradycardia-Causing Agents may increase bradycardic effects of Ponesimod. Management: Avoid coadministration of ponesimod with drugs that may cause bradycardia when possible. If combined, monitor heart rate closely and consider obtaining a cardiology consult. Do not initiate ponesimod in patients on beta-blockers if HR is less than 55 bpm. Risk D: Consider Therapy Modification

Prazosin: Antihypertensive Agents may increase hypotensive effects of Prazosin. Risk C: Monitor

Prostacyclin Analogues: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Quinagolide: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Reserpine: May increase hypotensive effects of Beta-Blockers. Reserpine may increase bradycardic effects of Beta-Blockers. Risk C: Monitor

Rivastigmine: May increase bradycardic effects of Beta-Blockers. Risk X: Avoid

Silodosin: May increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor

Siponimod: Bradycardia-Causing Agents may increase bradycardic effects of Siponimod. Management: Avoid coadministration of siponimod with drugs that may cause bradycardia. If combined, consider obtaining a cardiology consult regarding patient monitoring. Risk D: Consider Therapy Modification

Succinylcholine: Beta-Blockers may increase neuromuscular-blocking effects of Succinylcholine. Risk C: Monitor

Tasimelteon: Beta-Blockers may decrease therapeutic effects of Tasimelteon. Management: Consider avoiding nighttime administration of beta-blockers during tasimelteon therapy due to the potential for reduced tasimelteon efficacy. Risk D: Consider Therapy Modification

Terazosin: Antihypertensive Agents may increase hypotensive effects of Terazosin. Risk C: Monitor

Theodrenaline: May increase bradycardic effects of Beta-Blockers. Beta-Blockers may decrease therapeutic effects of Theodrenaline. Risk C: Monitor

Theophylline Derivatives: Beta-Blockers (Beta1 Selective) may decrease bronchodilatory effects of Theophylline Derivatives. Risk C: Monitor

Urapidil: Antihypertensive Agents may increase hypotensive effects of Urapidil. Risk C: Monitor

White Birch Allergen Extract: Beta-Blockers may increase adverse/toxic effects of White Birch Allergen Extract. Specifically, beta-blockers may reduce the effectiveness of beta-agonists that may be required to treat systemic reactions to white birch allergen extract. Risk X: Avoid

Food Interactions

Peak serum acebutolol levels may be slightly decreased if taken with food. Management: Administer without regard to meals.

Reproductive Considerations

Medications considered acceptable for the treatment of chronic hypertension during pregnancy may generally be continued in patients trying to conceive. Acebutolol is generally not a preferred agent for use in pregnant patients (ACC/AHA [Whelton 2018]; ACOG 2019; NICE 2019); however, use may be considered (SOGC [Magee 2022]).

Impotence is noted in product labeling following use of acebutolol. As a class, outcomes from available studies evaluating beta-blockers and sexual dysfunction are inconsistent, and the negative effects on erectile function are considered controversial. A clear relationship between use of beta-blockers and erectile dysfunction has not been established. Hypertension itself is associated with erectile dysfunction. Patients on a beta-blocker presenting with sexual dysfunction should be evaluated for underlying disease (Farmakis 2021; Levine 2012; Semet 2017; Terentes-Printzios 2022; Viigimaa 2020).

Pregnancy Considerations

Acebutolol and diacetolol (active metabolite) cross the placenta.

Following maternal use of acebutolol during pregnancy, acebutolol and diacetolol can be detected in newborn serum and urine for at least 3 days after birth (Bianchetti 1981b; Boutroy 1982). Decreases in birth weight, BP, and heart rate have been observed in neonates following maternal use of acebutolol during pregnancy. If maternal use of a beta-blocker is needed, monitor fetal growth during pregnancy; monitor the newborn for 48 hours after delivery for bradycardia, hypoglycemia, and respiratory depression (ESC [Regitz-Zagrosek 2018]).

Chronic maternal hypertension is also associated with adverse events in the fetus/infant. Chronic maternal hypertension may increase the risk of birth defects, low birth weight, premature delivery, stillbirth, and neonatal death. Actual fetal/neonatal risks may be related to the duration and severity of maternal hypertension. Untreated chronic hypertension may also increase the risks of adverse maternal outcomes, including gestational diabetes, preeclampsia, delivery complications, stroke, and myocardial infarction (ACOG 2019).

Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of acebutolol may be altered. The plasma elimination half-life of acebutolol is longer in pregnant patients at term (Bianchetti 1981a; Boutroy 1982).

Patients with preexisting hypertension may continue their medication during pregnancy unless contraindications exist (ESC [Regitz-Zagrosek 2018]). When treatment of hypertension is initiated during pregnancy, agents other than acebutolol may be preferred (ACOG 2019; ESC [Cífková 2020]; ESC [Regitz-Zagrosek 2018]); however, use may be considered (SOGC [Magee 2022]).

Breastfeeding Considerations

Acebutolol and diacetolol (active metabolite) are present in breast milk.

Both acebutolol and diacetolol are present in breast milk in higher concentrations than those in the maternal serum (per the manufacturer, acebutolol M/P ratio 7.1; diacetolol M/P ratio 12.2). Acebutolol and diacetolol can be detected in infant serum following exposure via breast milk (Bianchetti 1981b; Boutroy 1986). Bradycardia, hypotension, and tachypnea (transient) were observed in a breastfeeding infant (Boutroy 1986).

Breastfeeding is not recommended by the manufacturer. Use of a beta-blocker other than acebutolol may be preferred in lactating patients (ESC [Cífková 2020]).

Monitoring Parameters

Blood pressure, heart rate, ECG; serum glucose (in patients with diabetes); mental alertness; signs and symptoms of bronchospasm in patients with existing bronchospastic disease.

Reference Range

Blood pressure goal: May vary depending on clinical conditions, different clinical practice guidelines, and expert opinion. Refer to "Clinical Practice Guidelines" for specific treatment goals.

Mechanism of Action

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

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: 1 to 2 hours

Duration: 12 to 24 hours

Absorption: Oral: 40%

Distribution: Vd: 1.2 L/kg

Protein binding: ~26%

Metabolism: Extensive first-pass effect to equipotent and cardioselective diacetolol metabolite

Bioavailability: Acebutolol: 40%

Half-life elimination: Parent drug: 3 to 4 hours; Metabolite: 8 to 13 hours

Time to peak: 2 to 4 hours

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

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

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

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Sectral;
  • (AR) Argentina: Rhodiasectral;
  • (BD) Bangladesh: Sectral;
  • (BE) Belgium: Abutophar | Acebutolol Ips | Sectral;
  • (BG) Bulgaria: Sectral;
  • (CH) Switzerland: Prent;
  • (CI) Côte d'Ivoire: Acebutolol;
  • (CL) Chile: Beloc | Grifobutol;
  • (CZ) Czech Republic: Acebirex | Acebutolol Aurovitas | Acecor | Apo acebutol | Sectral;
  • (DE) Germany: Acebutolol | Prent;
  • (EE) Estonia: Sectral;
  • (EG) Egypt: Sectral;
  • (ES) Spain: Sectral;
  • (FI) Finland: Acebutolol Alternova | Diasectral | Espesil;
  • (FR) France: Acebutolol | Acebutolol almus | Acebutolol Alter | Acebutolol arrow | Acebutolol biogaran | Acebutolol g gam | Acebutolol irex | Acebutolol ivax | Acebutolol merck | Acebutolol Qualimed | Acebutolol ranbaxy | Acebutolol rpg | Acebutolol teva | Acebutolol Zydus | Sectral | Sectral lp;
  • (GB) United Kingdom: Acebutolol | Acebutolol Kent | Sectral;
  • (HK) Hong Kong: Sectral;
  • (ID) Indonesia: Sectral;
  • (IE) Ireland: Sectral;
  • (IL) Israel: Sectral;
  • (IT) Italy: Prent | Sectral;
  • (JO) Jordan: Sectral;
  • (JP) Japan: Acetanol | Sectral;
  • (KR) Korea, Republic of: Prent | Sectral;
  • (LB) Lebanon: Acebutolol biogaran | Sectral;
  • (LT) Lithuania: Sectral;
  • (LU) Luxembourg: Sectral;
  • (LV) Latvia: Sectral;
  • (MA) Morocco: Sectral;
  • (MX) Mexico: Diasectral;
  • (MY) Malaysia: Sectral;
  • (NL) Netherlands: Acebutolol | Acebutolol aurobindo | Acebutolol ratiopharm | Sectral;
  • (NZ) New Zealand: Acb | Sectral;
  • (PL) Poland: Abutol | Acebutolol | Acebutolol Aurovitas | Acecor;
  • (PR) Puerto Rico: Acebutolol HCL | Sectral;
  • (PT) Portugal: Prent;
  • (RU) Russian Federation: Sectral;
  • (SG) Singapore: Acb | Apo-Acebutolol | Sectral;
  • (SK) Slovakia: Sectral;
  • (TH) Thailand: Sectral;
  • (TN) Tunisia: Cebutol | Cebutral | Sectral | Tensiol;
  • (TR) Turkey: Prent;
  • (TW) Taiwan: Abutol | Acebol | Acebutolol | Acelor | Acepin | Apo-Acebutolol | Gentolol | Sectral | Sincer | Wincetol;
  • (UA) Ukraine: Sectral;
  • (VE) Venezuela, Bolivarian Republic of: Flebutol | Lupar;
  • (ZA) South Africa: Sectral
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