Acebutolol Schedule (India)

Schedule H

Acebutolol Routes

Oral

Acebutolol Formulations

Tablet: 100 mg

Tablet: 200 mg

Tablet: 400 mg

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

Acebutolol Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

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

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

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

Acebutolol Paediatric indications

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

Acebutolol Renal Adjustments

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

Acebutolol Hepatic adjustment

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

Acebutolol Contraindications

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

Acebutolol Cautions

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

Acebutolol Pregnancy

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

Acebutolol Lactation

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

Acebutolol Elderly

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

Acebutolol Major drug interactions

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

Acebutolol Moderate drug interactions

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

Acebutolol Common Adverse effects

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

Acebutolol Serious Adverse effects

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

Acebutolol Monitoring requirements

Timing	Parameters
Baseline	Heart rate, blood pressure, ECG, renal function (eGFR/CrCl), fasting blood glucose (diabetics), pulmonary function if history of airway disease
After initiation / dose change	Heart rate and blood pressure weekly during titration; ECG if symptoms of bradycardia or conduction delay

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

Acebutolol Brands in India

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.

Acebutolol Price range (INR)

Formulation	Approximate Price (per tablet)
Acebutolol 100 mg tablet ₹4–₹8 per tablet
Acebutolol 200 mg tablet ₹6–₹12 per tablet
Acebutolol 400 mg tablet ₹10–₹18 per tablet

Not included in NLEM 2022

Not NPPA price-controlled

Limited availability in both government and private sector pharmacies

May require special ordering

Acebutolol Clinical pearls

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.

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

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.

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

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

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

Acebutolol Tags

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

Acebutolol Version

RxIndia v1.0 — 10 Jun 2025

Acebutolol Reference

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

RxIndia

The Drug Registry

Acebutolol