Schedule H

Oral

• Tablet: 100 mg

• Tablet: 200 mg

• Tablet: 400 mg

Note: Limited availability in India; regional variation in stock. Confirm availability before prescribing.

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Hypertension

Parameter Recommendation

Starting dose 200 mg once daily OR 100 mg twice daily

Titration Increase at intervals of 2–4 weeks based on blood pressure response

Usual maintenance dose 400–800 mg/day in 1–2 divided doses

Maximum dose 1200 mg/day

Key Clinical Notes:

• Can be used as monotherapy or combined with other antihypertensives (thiazides, CCBs)

• Due to ISA property, causes less resting bradycardia compared to non-ISA beta-blockers

• Once-daily dosing possible due to long duration of action

• May be taken with or without food

1. Chronic Stable Angina Pectoris

Parameter Recommendation

Starting dose 200 mg twice daily

Titration Adjust based on symptom control and exercise tolerance at 1–2 week intervals

Usual maintenance dose 400–800 mg/day in divided doses

Maximum dose 1200 mg/day

Key Clinical Notes:

• Avoid abrupt withdrawal — risk of rebound angina and myocardial ischaemia

• Taper over 1–2 weeks if discontinuation required

• May be less effective than non-ISA beta-blockers for angina control in some patients

1. Ventricular Arrhythmias (Premature Ventricular Contractions, Non-sustained VT)

Parameter Recommendation

Starting dose 200 mg twice daily

Titration Increase every 3–5 days based on arrhythmia control and tolerance

Usual maintenance dose 400–800 mg/day in divided doses

Maximum dose 1200 mg/day

Key Clinical Notes:

• Use under cardiologist supervision, especially in structural heart disease

• Baseline and periodic ECG monitoring mandatory

• Not first-line for sustained ventricular tachycardia

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes Evidence Basis

Supraventricular Tachycardia (Rate Control) Starting: 200 mg twice daily; Titrate based on ventricular rate As needed for rate control Specialist only; OFF-LABEL Pharmacological rationale and clinical experience; not first-line in Indian practice — metoprolol or bisoprolol preferred

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

Not approved for routine paediatric use in India. Limited data available.

Secondary Indications — Paediatric (Off-label)

Supraventricular Arrhythmias (Specialist Use Only; OFF-LABEL)

Parameter Recommendation

Starting dose 5 mg/kg/day in 2 divided doses

Titration Increase gradually based on response and tolerance

Usual maintenance dose 5–10 mg/kg/day in 2 divided doses

Maximum dose 15 mg/kg/day OR 800 mg/day (whichever is lower)

Safety Monitoring:

• ECG monitoring at baseline and during dose adjustments

• Heart rate and blood pressure monitoring

• Blood glucose monitoring (especially in neonates and infants — risk of hypoglycaemia)

• Observe for signs of bradycardia, fatigue, bronchospasm

Age Restrictions:

• Children <1 year: NOT recommended except in specialist PICU/paediatric cardiology setting with documented justification

• Limited Indian paediatric data available

CrCl (mL/min) Recommendation

≥50 No dose adjustment required

25–49 Reduce dose by 50%; start at 200 mg/day; titrate cautiously

<25 Reduce dose by 75%; start at 100 mg/day; close monitoring

Haemodialysis Not significantly dialyzed; no supplemental dose required post-dialysis; use lowest effective dose

Additional Notes:

• Active metabolite (diacetolol) accumulates in renal impairment

• Monitor heart rate and blood pressure closely during titration

• Mild Impairment (Child-Pugh A): No dose adjustment required

• Moderate Impairment (Child-Pugh B): Start at lower dose (200 mg/day); titrate cautiously with close monitoring

• Severe Impairment (Child-Pugh C): Avoid use or use only under specialist supervision; significant accumulation risk

• Second or third degree atrioventricular block (without functioning pacemaker)

• Sick sinus syndrome (without pacemaker)

• Sinus bradycardia (resting heart rate <50 bpm)

• Decompensated or uncontrolled heart failure

• Cardiogenic shock

• Severe hypotension (systolic BP <90 mmHg)

• Severe peripheral arterial disease with critical limb ischaemia

• Untreated pheochromocytoma

• Known hypersensitivity to acebutolol or other beta-blockers

• Concurrent intravenous use of verapamil or diltiazem

• Compensated heart failure — initiate only when stable; monitor for decompensation

• Bronchospastic disease (asthma, COPD) — although cardioselective, β1-selectivity is not absolute; monitor closely

• Diabetes mellitus — may mask tachycardia and tremor of hypoglycaemia; sweating preserved

• Thyrotoxicosis — may mask clinical signs (tachycardia); do not withdraw abruptly

• First-degree heart block — monitor for progression

• Peripheral vascular disease — may worsen claudication symptoms

• Psoriasis — beta-blockers may exacerbate

• Depression — monitor for worsening; may have lower CNS effects due to hydrophilicity

• Myasthenia gravis — may worsen symptoms

• History of anaphylaxis — reduced response to adrenaline

• Chronic renal impairment — accumulation of active metabolite

• Abrupt withdrawal — avoid in all cardiac patients; taper over 1–2 weeks

• General anaesthesia — inform anaesthetist; discuss perioperative management

Parameter Details

Overall Safety Limited human data; use only if essential and benefit outweighs risk

Fetal Risks Beta-blockers may cause fetal bradycardia, hypoglycaemia, intrauterine growth restriction

Preferred Alternatives Labetalol, methyldopa (standard Indian obstetric practice)

When May Be Used If labetalol or methyldopa contraindicated or ineffective; requires specialist input

Monitoring Fetal heart rate monitoring, serial growth scans; neonatal observation for bradycardia and hypoglycaemia post-delivery

Parameter Details

Compatibility Generally compatible with breastfeeding

Drug Levels in Milk Low; acebutolol and active metabolite excreted in breast milk

Preferred Alternatives Labetalol, metoprolol (more safety data); avoid atenolol (higher milk levels)

Infant Monitoring Observe for bradycardia, hypotension, poor feeding, lethargy, hypoglycaemia

• Recommended starting dose: 100–200 mg once daily

• Titration: Slow titration at 2–4 week intervals; assess tolerance before each increment

• Extra Risks:

• Increased sensitivity to hypotensive effects — orthostatic hypotension and falls risk

• Reduced renal clearance — accumulation of active metabolite; start low

• Higher risk of bradycardia and conduction abnormalities

• CNS effects (fatigue, depression, confusion) — less common than with lipophilic beta-blockers but still possible

• Monitor renal function periodically

Interacting Drug Mechanism / Effect Clinical Advice

Verapamil / Diltiazem (especially IV) Additive negative inotropic and chronotropic effects Avoid combination — risk of severe bradycardia, heart block, or cardiac failure

Class I Antiarrhythmics (disopyramide, quinidine, flecainide) Additive myocardial depression Avoid combination or use with extreme caution under specialist supervision

Clonidine Rebound hypertension if clonidine withdrawn while on beta-blocker Discontinue beta-blocker first (taper over 1 week), then taper clonidine

MAO inhibitors Potentiation of hypotensive effect Avoid concurrent use

Adrenaline (epinephrine) Beta-blockade reduces efficacy of adrenaline in anaphylaxis Higher adrenaline doses may be required; consider glucagon

Fingolimod Additive bradycardia Avoid concomitant initiation

Interacting Drug Effect Recommendation

Insulin / Oral hypoglycaemics Masking of hypoglycaemia symptoms (except sweating); prolonged hypoglycaemia Monitor blood glucose more frequently; counsel patients

Digoxin Additive bradycardia and AV nodal suppression Monitor heart rate and ECG regularly

Amiodarone Additive bradycardia and conduction disturbances Monitor ECG; may need dose reduction

NSAIDs (ibuprofen, diclofenac) Reduced antihypertensive effect; fluid retention Monitor blood pressure; use alternative analgesics if possible

Rifampicin Enhanced hepatic metabolism — reduced acebutolol levels Monitor blood pressure; may need dose increase

Antipsychotics Additive hypotensive effect Monitor blood pressure

Ergotamine Increased peripheral vasoconstriction Avoid combination or monitor closely

• Fatigue, tiredness

• Dizziness

• Headache

• Bradycardia (less pronounced than non-ISA beta-blockers)

• Cold extremities (less common than non-ISA agents)

• Gastrointestinal disturbances (nausea, diarrhoea, constipation)

• Sleep disturbances, vivid dreams

• Mild depression

• Dyspnoea on exertion

Adverse Effect Clinical Notes

Severe bradycardia / Heart block Requires drug discontinuation; may need temporary pacing

Heart failure exacerbation Discontinue; manage with appropriate heart failure therapy

Bronchospasm Especially in patients with reactive airways; discontinue and treat urgently

Drug-induced lupus syndrome Rare but reported with acebutolol (positive ANA); discontinue if symptoms develop

Severe hypotension IV fluids; consider inotropic support if needed

Hypoglycaemia unawareness Particularly in diabetics on insulin or sulfonylureas — educate patients

Long-term Heart rate and blood pressure at each visit; renal function every 6–12 months; periodic ECG in elderly or those on antiarrhythmics; ANA if lupus symptoms suspected

• Sectral® (Sanofi) — limited availability

• Generic acebutolol — limited availability from regional manufacturers

Note: Acebutolol has very limited market availability in India compared to other beta-blockers (metoprolol, atenolol, bisoprolol). Confirm local availability before prescribing. Fixed-dose combinations are not commonly available.

• Not included in NLEM 2022

• Not NPPA price-controlled

• Limited availability in both government and private sector pharmacies

• May require special ordering

1. ISA advantage: Acebutolol causes less resting bradycardia and fatigue than beta-blockers without ISA — consider in patients who experience excessive fatigue or bradycardia with atenolol or metoprolol.

1. Cardioselectivity is relative: Although β1-selective, bronchospasm can still occur in susceptible patients — monitor closely if used in patients with reactive airways.

1. Not ideal for post-MI or HFrEF: Unlike carvedilol, bisoprolol, or metoprolol succinate, acebutolol lacks proven mortality benefit in these conditions — avoid as first-line.

1. Lupus-like syndrome: Unique to acebutolol among beta-blockers — monitor for arthralgias, myalgias, rash, or positive ANA on long-term therapy; discontinue if suspected.

1. Limited availability: Before prescribing, confirm local availability — metoprolol, bisoprolol, and atenolol are more readily accessible alternatives in India.

1. Avoid abrupt withdrawal: Particularly in patients with coronary artery disease — taper over 1–2 weeks to prevent rebound angina, arrhythmias, or hypertensive crisis.

acebutolol; beta-blocker; cardioselective; ISA; hypertension; angina; arrhythmia; limited-availability-India; not-NLEM; lupus-risk; renal-adjustment-needed

RxIndia v1.0 — 10 Jun 2025

• CDSCO approved drug database

• Indian Pharmacopoeia

• National Formulary of India (NFI)

• NLEM 2022 (not listed)

• API Textbook of Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Harrison's Principles of Internal Medicine

• AIIMS Drug Formulary