Schedule H

Intravenous (IV)

• Injection: 100 mg/10 mL vial (10 mg/mL)

• Concentrate for infusion: 250 mg/25 mL (10 mg/mL ready-to-use)

• Concentrate for dilution: 2500 mg/10 mL (250 mg/mL — requires dilution before use)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Supraventricular Tachycardia (SVT) — including perioperative tachyarrhythmias

Parameter Details

Starting dose 500 mcg/kg IV bolus over 1 minute

Titration Follow bolus immediately with infusion at 50 mcg/kg/min; if response inadequate after 4 minutes, may repeat bolus and increase infusion by 50 mcg/kg/min increments

Usual maintenance dose 50–200 mcg/kg/min continuous IV infusion

Maximum dose 300 mcg/kg/min

Key clinical notes Onset of action: 1–2 minutes; effect dissipates within 10–20 minutes of stopping infusion. Continuous ECG and blood pressure monitoring mandatory throughout administration.

1. Perioperative Hypertension and/or Tachycardia (Intraoperative / Postoperative)

Parameter Details

Starting dose Optional loading: 500–1000 mcg/kg IV over 1 minute; then initiate infusion at 50 mcg/kg/min

Titration Adjust by 25–50 mcg/kg/min every 5–10 minutes based on heart rate and blood pressure targets

Usual maintenance dose 50–200 mcg/kg/min IV infusion

Maximum dose 300 mcg/kg/min

Key clinical notes Particularly useful for transient perioperative haemodynamic control. Titrate to predefined target HR (<80–90 bpm) or MAP. Gradually taper before discontinuation to prevent rebound.

Secondary Indications — Adults (Off-label)

Thyroid Storm (OFF-LABEL)

• Dose: 250–500 mcg/kg IV bolus followed by 50–100 mcg/kg/min infusion

• Duration: Short-term until definitive antithyroid therapy effective

• Specialist only: Endocrinology/ICU supervision required

• Evidence basis: Indian ICU protocols, AIIMS endocrine emergencies management; supportive international literature

Acute Aortic Dissection — Initial Heart Rate Control (OFF-LABEL)

• Dose: 500 mcg/kg IV bolus, then 50–200 mcg/kg/min infusion titrated to HR <60 bpm and SBP 100–120 mmHg

• Duration: Until definitive surgical or endovascular management

• Specialist only: ICU/cardiothoracic surgery setting only

• Evidence basis: Indian cardiac surgical practice protocols; emergency cardiovascular care guidelines

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. SVT or Postoperative Tachyarrhythmias

Parameter Details

Starting dose 100–500 mcg/kg IV bolus over 1 minute (maximum single bolus: 1 mg/kg)

Titration Begin infusion at 25–50 mcg/kg/min; increase by 25–50 mcg/kg/min every 5–10 minutes as needed

Usual maintenance dose 50–200 mcg/kg/min IV infusion

Maximum dose 300 mcg/kg/min

Monitoring Continuous ECG and arterial BP monitoring essential

Minimum age Use in neonates (<1 month) only under paediatric cardiology or PICU supervision

Secondary Indications — Paediatrics (Off-label)

Thyroid Storm / Adrenergic Crisis (OFF-LABEL)

• Dose: Individualised; typically 50–100 mcg/kg/min after specialist-directed bolus

• Duration: Until oral beta-blocker transition feasible

• Specialist only: PICU or paediatric endocrinology initiation mandatory

• Evidence basis: Case series from Indian tertiary PICUs

• Minimum age: Not recommended under 1 month except under specialist supervision

Age restriction statement: Not recommended in neonates or infants under 3 months of age outside PICU or paediatric cardiology units.

No dose adjustment required.

Esmolol undergoes rapid hydrolysis by red blood cell esterases and is not dependent on renal elimination. Safe for use in patients with any degree of renal impairment, including those on haemodialysis.

• Sinus bradycardia (HR <50 bpm)

• Second-degree or third-degree AV block (without functional pacemaker)

• Sick sinus syndrome (unless pacemaker in situ)

• Cardiogenic shock

• Decompensated heart failure

• Severe hypotension (systolic BP <90 mmHg)

• Pulmonary hypertension with right ventricular failure

• Known hypersensitivity to esmolol or any beta-blocker

• Untreated phaeochromocytoma (without prior alpha-blockade)

• Bronchial asthma or chronic obstructive pulmonary disease — beta-1 selectivity is dose-dependent and may be lost at higher infusion rates

• Diabetes mellitus — beta-blockade may mask tachycardia and other hypoglycaemia warning signs

• Hypovolaemia or states of reduced cardiac output — correct volume status before initiation

• Concurrent use of calcium channel blockers (verapamil, diltiazem) — risk of profound bradycardia or heart block

• Prinzmetal's (vasospastic) angina

• Peripheral vascular disease

• Elderly or frail patients — initiate at lower doses

• Abrupt discontinuation — taper infusion to avoid rebound tachycardia or hypertension

• High-concentration infusions — use central venous access to reduce extravasation risk

Parameter Details

Risk category Limited human data; animal studies show no teratogenicity at clinical doses. Use only when clearly indicated and benefit outweighs risk.

Preferred alternatives Labetalol (IV or oral) is preferred for sustained BP/HR control in pregnancy; metoprolol if oral route feasible

When esmolol may be used Emergency perioperative settings or ICU where rapid, short-acting beta-blockade is essential

Monitoring required Fetal heart rate monitoring; assess uteroplacental perfusion if infusion >30 minutes

Parameter Details

Compatibility Likely compatible — ultra-short half-life (approximately 9 minutes) results in minimal excretion into breast milk

Expected levels in milk Very low to negligible

Preferred alternatives Oral beta-blockers (metoprolol, labetalol) preferred for longer-term therapy

Infant monitoring Generally not required given rapid drug clearance

• Recommended starting dose: Initiate infusion at 25–50 mcg/kg/min (lower end of dosing range)

• Titration: Slower dose escalation advised; increase by 25 mcg/kg/min increments with longer observation intervals (every 10 minutes)

• Additional risks: Increased susceptibility to bradycardia, hypotension, and syncope. Reduced physiological reserve may lead to exaggerated haemodynamic effects.

• Monitoring: Continuous ECG and invasive or non-invasive BP monitoring essential

Interacting Drug Effect / Mechanism Recommendation

Verapamil / Diltiazem (IV) Additive negative chronotropic and dromotropic effects; severe bradycardia, AV block, or asystole Avoid concurrent IV administration

Digoxin Enhanced risk of bradyarrhythmias Monitor HR closely; adjust doses as needed

Class I antiarrhythmics (procainamide, disopyramide) Additive negative inotropic effect; increased risk of heart failure Use with extreme caution; specialist supervision

Clonidine withdrawal Exaggerated rebound hypertension if clonidine stopped while on beta-blocker Discontinue esmolol before stopping clonidine, or taper clonidine gradually

Interacting Drug Effect / Mechanism Recommendation

Anaesthetic agents (propofol, fentanyl, sevoflurane) Additive hypotension and bradycardia Anticipate haemodynamic effects; have vasopressors and atropine available

Insulin / Oral hypoglycaemics Masking of hypoglycaemia symptoms (tremor, tachycardia) Monitor blood glucose closely in diabetic patients

Diuretics Potentiation of hypotensive effect Monitor BP; adjust doses accordingly

Other antihypertensives Cumulative blood pressure reduction Observe for symptomatic hypotension

NSAIDs May attenuate antihypertensive effect Monitor BP response

• Hypotension (dose-related, most common)

• Bradycardia

• Dizziness or lightheadedness

• Nausea

• Diaphoresis

• Infusion site reactions (pain, erythema, swelling — especially via peripheral IV)

• Fatigue or somnolence during infusion

• Severe hypotension requiring infusion cessation and vasopressor support

• Symptomatic bradycardia or high-grade AV block

• Asystole or cardiac arrest (rare)

• Bronchospasm (particularly in patients with reactive airways)

• Acute decompensated heart failure

• Extravasation injury — local tissue necrosis (rare; risk higher with concentrated solutions via peripheral line)

• Severe injection site reactions progressing to skin necrosis

Action required: Discontinue infusion immediately for severe bradycardia, hypotension unresponsive to dose reduction, bronchospasm, or suspected extravasation.

During infusion Continuous cardiac monitoring (ECG), continuous or frequent BP measurement (every 5 minutes during titration)

After dose changes Reassess HR and BP every 5–10 minutes until stable

Long-term Not applicable — esmolol is intended only for short-term use

• Brevibloc® (Sun Pharma)

• Esocard® (Neon Laboratories)

• Myotop® (Samarth Pharma)

• Esmocard® (Troikaa Pharmaceuticals)

• Esmalol® (various)

Note: Most formulations available as 100 mg/10 mL vials and 250 mg/25 mL ready-to-use bags or concentrate ampules.

• Subject to institutional procurement discounts

• Not currently listed under NLEM (National List of Essential Medicines)

1. Ideal for titrable, short-acting rate control — the ultra-short half-life (~9 minutes) allows precise haemodynamic management in the OT and ICU.

1. Transition strategy — once the patient is haemodynamically stable, plan transition to oral beta-blockers (metoprolol, atenolol, or propranolol as appropriate).

1. Central venous access preferred — for prolonged infusions or when using concentrated solutions (>10 mg/mL), a central line minimises extravasation risk.

1. Avoid abrupt cessation — gradual tapering prevents rebound tachycardia and hypertension.

1. Not for bronchospastic disease — although beta-1 selective, selectivity diminishes at higher doses; avoid or use extreme caution in asthma/COPD.

1. Keep rescue drugs ready — atropine, isoprenaline, and vasopressors should be immediately available during infusion.

short-acting beta-blocker; IV rate control; SVT; perioperative tachycardia; ICU drug; cardioselective; esmolol India; aortic dissection; thyroid storm; specialist use

RxIndia v1.0 — 11 Jun 2025

• CDSCO approved prescribing information — Esmolol Hydrochloride Injection

• Indian Pharmacopoeia / National Formulary of India 2021

• AIIMS ICU Drug Protocols

• API Textbook of Medicine, 11th Edition (2022)

• ICMR Critical Care Medicine Guidance Notes

• Indian Association of Cardiovascular-Thoracic Anaesthesiologists (IACTA) perioperative guidelines

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (supportive reference)