Acebutolol is an active pharmaceutical ingredient in the Beta Blocking Agents, Selective group (C07AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised March 22, 2025[1]
AND CLINICAL USE......................................................................................................................... 3 CONTRAINDICATIONS ..............................................................................................................................................
4 WARNINGS AND PRECAUTIONS ............................................................................................................................ 4 ADVERSE REACTIONS ..............................................................................................................................................
9 DRUG INTERACTIONS............................................................................................................................................. 11 DOSAGE AND ADMINISTRATION .........................................................................................................................
15 OVERDOSAGE ........................................................................................................................................................... 16 ACTION AND CLINICAL PHARMACOLOGY .......................................................................................................
GBUnited Kingdom· MHRA
3 products
Uses
GBOfficial regulatory label· revised March 6, 2026[2]
The management of hypertension, angina pectoris and the control of tachyarrhythmias.
How to take
GBOfficial regulatory label
Drug interactions
Known interactions involving Acebutolol. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 517. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]Health Canada (DPD) · 02147602 · revised March 22, 2025
[2]MHRA (UK) · PL163630521 · revised March 6, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
17 STORAGE AND STABILITY .................................................................................................................................... 19 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................................................................
19 PART II: SCIENTIFIC INFORMATION ........................................................................................................................ 20 PHARMACEUTICAL INFORMATION ....................................................................................................................
23 REFERENCES ............................................................................................................................................................. 30 PART III: CONSUMER INFORMATION ......................................................................................................................
32 APO-ACEBUTOLOL Product Monograph Page 3 of 34 Pr APO-ACEBUTOLOL (acebutolol hydrochloride) Apotex Standard 100 mg, 200 mg and 400 mg Tablets PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY PRODUCT INFORMATION Route of Administration Dosage Form / Strength All Nonmedicinal Ingredients Oral Tablet 100, 200, and 400 mg carnauba wax, colloidal silicon dioxide, dextrates, hydroxypropyl methylcellulose, magnesium stearate, polyethylene glycol and titanium dioxide.
INDICATIONS AND CLINICAL USE APO-ACEBUTOLOL is indicated for the following: Treatment of mild to moderate hypertension. Long-term management of patients with angina pectoris due to ischemic heart disease.
Treatment of mild to moderate hypertension:
APO-ACEBUTOLOL is usually used in combination with other drugs, particularly a thiazide diuretic. However, it may be tried alone as an initial agent in those patients in whom, in the judgment of the physician, treatment should be started with a β-blocker rather than a diuretic.
In patients with severe hypertension a β-adrenergic blocking agent may be used as part of a multiple drug regimen which would normally include a diuretic and a vasodilator. The combination of acebutolol with a diuretic or peripheral vasodilator has been found to be compatible and generally more effective than acebutolol alone.
Limited experience with other antihypertensive agents has not shown evidence of incompatibility. APO-ACEBUTOLOL is not indicated in the emergency treatment of hypertensive crises.
Geriatrics:
Acebutolol has been used in the elderly without specific adjustment of dosage. APO-ACEBUTOLOL Product Monograph Page 4 of 34 However, this patient population may require lower maintenance doses because the bioavailability of both acebutolol hydrochloride and its metabolite are approximately doubled in this age group.
This increased bioavailability is probably due to decreases in first-pass metabolism and renal function in the elderly (see WARNINGS AND PRECAUTIONS, Special Populations).
Pediatrics:
There is no experience with acebutolol in the treatment of pediatric age groups and therefore use in children is not recommended (see WARNINGS AND PRECAUTIONS, Special Populations). CONTRAINDICATIONS APO-ACEBUTOLOL (acebutolol hydrochloride) is contraindicated in: Patients who are hypersensitive to this drug, beta-blockers, or to any ingredient in the formulation or component of the container.
For a complete listing, see DOSAGE FORMS, COMPOSITION AND PACKAGING section of the product monograph. Patients exhibiting sinus bradycardia. Patients with sick sinus syndrome. Patients with second and third degree A-V block. Patients with right ventricular failure secondary to pulmonary hypertension.
Patients with congestive heart failure. Patients with cardiogenic shock. g. ether. Patients with severe peripheral circulatory disorders. Patients with phaeochromocytoma. WARNINGS AND PRECAUTIONS General APO-ACEBUTOLOL dosage should be individually adjusted when used concomitantly with other antihypertensive agents (see DOSAGE AND ADMINISTRATION).
Cessation of therapy with a beta-blocker should be gradual (see WARNINGS AND PRECAUTIONS section, under ‘Cardiovascular’). APO-ACEBUTOLOL Product Monograph Page 5 of 34 Dizziness and/or fatigue may occur with beta-blocker administration and this should be taken into account when driving or operating machinery.
Posology The dose and treatment duration should be based on the individual response and should be adequately monitored by the treating physician. If long-term treatment will be discontinued, withdrawal of treatment by betablockers should be achieved by gradual dosage reduction.
Hypertension:
The usual initial daily dose is 400 mg. Based on pharmacokinetic studies it is recommended to administer the entire dose at once in the morning. In exceptional cases, the daily dose can be divided into two separate doses of 200 mg administered in the morning and evening.
If response is not adequate within two weeks, dosage may be increased up to 400 mg orally twice daily; in some patients 1200 mg orally daily, given as 800 mg at breakfast and 400 mg in the evening may be required. A further reduction in blood pressure may be obtained by the concurrent administration of a thiazide diuretic or other antihypertensive agent .
Angina pectoris:
Initial dosage of 400 mg orally once daily at breakfast or 200 mg twice daily. In severe forms up to 300 mg three times daily may be required. Up to 1200 mg daily has been used.
Cardiac Arrhythmias:
When given orally, an initial dose of 200 mg is recommended. The daily dose requirement for long term anti arrhythmic activity should lie between 400 and 1200 mg daily. The dose can be gauged by response, and better control may be achieved by divided doses rather than single doses.
It may take up to three hours for maximal antiarrhythmic effect to become apparent.
Renal impairment:
Dosage in patients with renal impairment should be based on creatinine clearance. Creatinine clearance 25-50 ml / min, the dose should be reduced in 50%. 4).
Elderly:
There are no specific dosage recommendations for the elderly with normal glomerular filtration rate. 4) Paediatric population Paediatric dose has not been established. The safety and efficacy of Acebutolol in children has not been established.
No data are available Method of administration Oral use For all indications, it is advised that the lowest recommended dosage be used initially. Acebutolol tablets are swallowed with a glass of water and not chewed or crushed.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised March 6, 2026[2]
Summary of safety profile Adverse reactions associated with acebutolol during controlled clinical trials in patients with hypertension, angina pectoris or arrhythmia (1002 patients exposed to acebutolol) are presented by system organ class and by decreasing order of frequency.
The frequency of the events “antinuclear antibody” and “lupus like syndrome” was found from 1440 patients suffering from hypertension, angina pectoris or arrhythmia and exposed to acebutolol in open or double blind studies performed in the United States.
Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), Not known (cannot be estimated from the available data) When the exact frequency of the event was not reported, the frequency category assigned is “not known” (ADRs with *).
Adverse reactions reported from post marketing experience are also listed. These adverse reactions are derived from spontaneous reports and therefore, the frequency of these adverse reactions is “not known” (cannot be estimated from the available data).
The most frequent and serious adverse reactions of acebutolol are related to the beta adrenergic blocking activity. The most frequent reported clinical adverse reactions are fatigue and gastrointestinal disorders. Among the most serious adverse reactions are cardiac failure, atrioventricular block and bronchospasm.
4).
Tabulated list of adverse reactions:
Very common Antinuclear antibody Uncommon Lupus like syndrome Immune system disorders Rare Although antinuclear factor titres have increased in some patients, the incidence of associated clinical syndromes is rare and, if present, an immediate discontinuation of treatment is required.
4) **Stopped after the end of the treatment Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
GBOfficial regulatory label· Warnings and precautions· revised March 6, 2026[2]
Renal impairment:
Renal impairment is not contraindicated to the use of Acebutolol which has both renal and non-renal excretory pathways. Some caution should be exercised when administering high doses to patients with severe renal impairment as accumulation could possibly occur in these circumstances.
The dosage frequency should not exceed once daily in patients with renal impairment. 2). Monitoring for heart rate could further guide on the appropriate dose in clinical practice, and should be reduced if excessive bradycardia appears (< 50-55 beats/min at rest).
Asthma and chronic obstructive pulmonary disease:
Drug-induced bronchospasm is usually at least partially reversible by the use of a suitable agonist. Although cardio-selective beta blockers may have less effect on lung function than nonselective beta blockers as with all beta blockers these should be avoided in patients with obstructive airways disease unless there are compelling clinical reasons for their use.
Where such reasons exist, cardio-selective β-blockers should be used with the utmost care. Acebutolol can only be administered to mild forms of bronchospastic disease or bronchial asthma, but the initial dose is low. Respiratory function tests are recommended before starting treatment.
If bronchospasm occurs during treatment, beta-mimetic bronchodilators may be used.
Bradycardia:
Betablockers may induce bradycardia. In such cases (< 50-55 beats/min at rest), the dosage should be reduced. 3).
Heart failure:
In treatment-compensated heart failure, acebutolol should be given at very low, gradually increasing doses and under strict medical supervision if necessary.
Atrioventricular block first degree:
Given their dromotropic negative effect, beta-blockers should be administered with caution to patients with atrioventricular block first degree.
Prinzmetal angina:
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised March 6, 2026[2]
1 or to beta blockers. Cardiogenic shock is an absolute contraindication. Extreme caution is required in patients with blood pressures of the order of 100/60 mmHg or below. Acebutolol is also contraindicated in patients with - Asthma and chronic obstructive pulmonary disease in their severe forms, - Second and third degree heart block, - Prinzmetal angina - Sick sinus syndrome - Marked bradycardia (< 45 – 50 bpm) - Raynaud's phenomenon and peripheral arterial disease in their severe forms, - Decompensated heart failure - Metabolic acidosis - Severe peripheral circulatory disorders - Untreated phaeochromocytoma.
6).
This is not medical advice. Consult a qualified healthcare professional.
Beta-blockers may increase the number and duration of seizures in patients with variant angina.
Peripheral circulatory disorders:
In patients with peripheral arterial disorders (Raynaud's disease or syndrome, arteritis or chronic occlusive arterial disease of the lower limbs), beta-blockers can cause aggravation of these disorders. g. acebutolol) are preferred, although this should be administered with caution.
Pheochromocytoma:
The use of beta-blockers in the treatment of hypertension due to pheochromocytoma treated requires close monitoring of blood pressure. They should only be used in patients with pheochromocytoma with concomitant alpha- adrenoreceptor therapy.
Elderly In the elderly, the absolute respect of contraindications is imperative. Care should be taken to initiate treatment with a low dose and be closely monitored.
Diabetic patients:
Warn the patient and reinforce glycemic self-monitoring at the start of treatment. The warning signs of hypoglycaemia may be masked, particularly tachycardia, palpitations and sweating.
Thyrotoxicosis:
Acebutolol may mask signs of thyrotoxicosis.
Psoriasis:
Aggravation of the disease has been reported with beta-blockers. Patients with known psoriasis should take betablockers only after careful consideration.
Sensitivity to antigens and anaphylactic reactions:
Beta-blockers may increase the sensitivity to allergens and the severity of anaphylactic reactions. In patients susceptible to severe anaphylactic reactions, whatever its origin, particularly with iodine contrast products or floctafenin or during desensitizing treatments, the beta-blocker treatment may lead to worsening of the reaction and resistance to treatment by adrenaline in usual doses.
e. over 1-2 weeks this is especially important in patients with ischaemic heart disease. If necessary replacement therapy should be initiated at the same time, to prevent exacerbation of angina pectoris. Abrupt withdrawal of beta-blockers is to be avoided.
Abrupt discontinuation of treatment may result in severe cardiac arrhythmias, myocardial infarction or sudden death.
General anesthesia:
Beta blockers will cause an attenuation of the reflex tachycardia and increased risk of hypotension. Continued treatment with beta-blocker reduces the risk of arrhythmia, myocardial ischemia and hypertensive crisis. The anaesthesiologist should be informed when the patient is receiving beta-blockers.
• If discontinuation of treatment is deemed necessary, a suspension of at least 24 hours may be considered sufficient for the reappearance of sensitivity to catecholamines. • In some cases, beta-blocker treatment cannot be interrupted: o in patients with coronary insufficiency, it is desirable to continue treatment until surgery, given the risk associated with abrupt discontinuation of beta blockers, o Emergency stop or failure, the patient should be protected from vagal predominance by adequate atropine premedication renewed as needed.
Anesthesia will make use of products as little as possible myocardial depressant and blood loss must be compensated. • Anaphylactic risk should be taken into account. Myasthenia gravis In patients with myasthenia gravis can lead to aggravation of symptoms.
Depression Caution should be exercised in patients with depression. Information about excipient This medicine contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.