Schedule H

Oral, Intravenous (IV)

• Tablets: 25 mg, 50 mg, 100 mg

• Injection: 5 mg/10 mL ampoule

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Hypertension

Parameter Recommendation

Starting dose 25–50 mg once daily orally

Titration Increase after 2–4 weeks based on BP response

Usual maintenance dose 50–100 mg once daily

Maximum dose 100 mg/day

Clinical Notes:

• Can be combined with diuretics or other antihypertensives

• Cardioselectivity diminishes at higher doses

• Second-line agent; less effective for stroke prevention compared to other antihypertensives

1. Angina Pectoris (Chronic Stable Angina)

Parameter Recommendation

Starting dose 50 mg once daily orally

Titration Increase after 1–2 weeks based on symptom control

Usual maintenance dose 50–100 mg once daily

Maximum dose 100 mg/day

Clinical Notes:

• IV formulation is NOT routinely indicated for stable angina

• Aim for resting heart rate of 55–60 bpm for optimal anti-anginal effect

1. Acute Myocardial Infarction (including post-MI prophylaxis)

Acute Phase (Specialist Use Only):

Step Action

IV Loading 5 mg IV over 5 minutes

Repeat if needed Second 5 mg IV after 10 minutes (if hemodynamically stable)

Transition to oral 50 mg orally 10–15 minutes after last IV dose

Maintenance Phase:

Parameter Recommendation

Starting dose 50 mg once daily (post IV loading)

Titration Increase to 100 mg based on tolerance

Usual maintenance dose 100 mg once daily

Maximum dose 100 mg/day

Prerequisites for IV administration:

• Heart rate >60 bpm

• Systolic BP >100 mmHg

• No clinical signs of heart failure

1. Supraventricular Tachyarrhythmias (Rate Control) — Specialist Only

Parameter Recommendation

Starting dose 25–50 mg once daily orally

Titration Adjust every 1–2 weeks guided by heart rate and BP

Usual maintenance dose 50–100 mg once daily

Maximum dose 100 mg/day

Clinical Notes:

• Oral route preferred for long-term rate control

• IV use rarely employed for this indication in India

Secondary Indications — Adults (Off-label)

Indication Dose Duration Notes

Migraine Prophylaxis (OFF-LABEL) 50–100 mg/day orally Long-term Specialist-guided; supported by international RCT evidence; used in Indian neurology practice

Essential Tremor (OFF-LABEL) 25–100 mg/day orally in divided doses Symptom-guided Specialist only; extrapolated from propranolol data; limited direct evidence

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

Supraventricular Tachycardia (SVT) — Specialist Only

Parameter Recommendation

Starting dose 0.8–1 mg/kg/day orally in 1–2 divided doses

Titration Gradual increase under ECG and BP monitoring

Maximum dose 2 mg/kg/day OR 100 mg/day (whichever is lower)

Minimum age Safety not established below 1 month

Monitoring Required:

• Continuous ECG during initiation

• Regular BP monitoring

• Watch for bradycardia, hypotension, signs of cardiac decompensation

Secondary Indications — Paediatrics (Off-label)

Indication Dose Duration Notes

Hypertension (OFF-LABEL) 0.5–1 mg/kg/day orally in single or divided doses; Max: 2 mg/kg/day (not exceeding 100 mg/day) Long-term Specialist only; monitor BP, growth parameters, fatigue

Age Restriction: Not recommended below 1 month of age except under specialist supervision.

Required — Atenolol is predominantly renally excreted (>85% unchanged)

30 No adjustment; usual dosing

15–30 Maximum 50 mg/day

<15 or on Dialysis Maximum 25 mg/day; administer after haemodialysis session

Note: Atenolol undergoes negligible hepatic metabolism; therefore, hepatic impairment rarely affects drug clearance.

• Sinus bradycardia (<50 bpm)

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

• Cardiogenic shock

• Decompensated heart failure

• Severe peripheral arterial disease (symptomatic)

• Sick sinus syndrome

• Phaeochromocytoma (unless adequately alpha-blocked)

• Hypersensitivity to atenolol or any component

• Diabetes mellitus — may mask tachycardia and tremor associated with hypoglycaemia

• Asthma/COPD — cardioselective but bronchospasm risk persists; avoid if possible

• First-degree AV block — monitor for progression

• Prinzmetal angina — may worsen vasospastic episodes

• Psoriasis — may exacerbate or trigger new lesions

• Myasthenia gravis — may worsen muscle weakness

• Renal impairment — mandatory dose adjustment

• Peripheral vascular disease — may worsen claudication

• Depression history — use cautiously

• Abrupt withdrawal — avoid in ischaemic heart disease; taper over 1–2 weeks

Aspect Details

Safety Category Category D (international classification); NOT preferred in pregnancy

Known Risks Fetal growth restriction, neonatal bradycardia, hypoglycaemia

Preferred Alternative Labetalol (first-line for gestational hypertension in India)

When to Use Only if clearly indicated and benefits outweigh risks (e.g., post-MI, specific arrhythmias)

Monitoring Serial fetal growth ultrasound, fetal heart rate monitoring, maternal BP

Aspect Details

Compatibility Generally compatible with breastfeeding

Drug Levels in Milk Low concentrations detected

Infant Monitoring Watch for bradycardia, lethargy, poor feeding

Preferred Alternatives Propranolol or labetalol if initiating new beta-blocker therapy

Aspect Recommendation

Starting dose 25 mg once daily

Titration Slower than younger adults; increase at 4-week intervals

Special Risks Bradycardia, orthostatic hypotension, falls, cognitive dulling

Renal Consideration Assess eGFR; dose reduction often required due to age-related renal decline

Interacting Drug Effect/Risk Management

Verapamil / Diltiazem (IV) Severe bradycardia, heart block, asystole Avoid concomitant IV use; oral combination requires caution

Clonidine Rebound hypertensive crisis on clonidine withdrawal If stopping both, withdraw beta-blocker first, then taper clonidine

Class I antiarrhythmics (e.g., disopyramide, flecainide) Profound negative inotropy and bradycardia Avoid or use with extreme caution

Digoxin Additive bradycardia and AV nodal blockade Monitor heart rate closely

Interacting Drug Effect/Risk Management

NSAIDs Reduced antihypertensive efficacy Monitor BP; adjust dose if needed

Amiodarone Increased risk of bradycardia and AV block Monitor ECG and heart rate

Insulin / Oral hypoglycaemics Masking of hypoglycaemic symptoms Counsel patients; frequent glucose monitoring

Rifampicin May reduce atenolol levels Monitor clinical response

Alcohol Enhanced hypotensive effect Counsel regarding intake

Antipsychotics Additive hypotension Monitor BP

• Fatigue and tiredness

• Cold extremities

• Dizziness / light-headedness

• Bradycardia (usually asymptomatic)

• Gastrointestinal disturbance (nausea, diarrhoea)

• Sleep disturbances (less common than with propranolol)

• Erectile dysfunction

Adverse Effect Action Required

Severe symptomatic bradycardia Discontinue; consider atropine or temporary pacing

High-grade AV block Discontinue immediately

Acute bronchospasm Discontinue; administer bronchodilator

Acute decompensated heart failure Discontinue; initiate heart failure management

Severe hypotension Supportive care; IV fluids; consider glucagon

Rare: SLE-like syndrome Discontinue

Rare: Thrombocytopenia Monitor counts; discontinue if confirmed

Long-term Annual renal function; periodic assessment of fatigue, exercise tolerance, mood, sexual function

Special Populations Post-MI: monitor for heart failure signs; Diabetics: frequent glucose checks

• Tenormin (AstraZeneca)

• Aten (Intas)

• Atenova (Lupin)

• Betacard (Torrent)

• Lonol (Cipla)

• Atekind (Mankind)

• Multiple generic formulations under DPCO price control

Note: Included in NLEM; price controlled by NPPA. Available through government supply channels at subsidised rates.

1. Renal accumulation: Reserve atenolol for patients with stable renal function; accumulates significantly in renal impairment — prefer metoprolol or carvedilol if eGFR <30.

1. Stroke prevention limitation: Less effective for stroke prevention compared to other antihypertensives (e.g., amlodipine, ARBs) — consider as second-line for essential hypertension.

1. Diabetic caution: Masks hypoglycaemic tachycardia but NOT sweating — counsel diabetic patients accordingly.

1. CNS advantage: Minimal blood-brain barrier penetration — fewer nightmares and sleep disturbances compared to propranolol.

1. Withdrawal protocol: Never stop abruptly in ischaemic heart disease — taper over 1–2 weeks to prevent rebound angina or MI.

1. Pregnancy alternative: Not suitable as first choice in pregnancy — labetalol is preferred for gestational hypertension in India.

Atenolol; hypertension; beta-blocker; angina; post-MI; cardioselective; renal-excreted; pregnancy-caution; NLEM India; cardiology

RxIndia v1.0 — 12 May 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia (IP)

• National List of Essential Medicines (NLEM) 2022

• API Textbook of Medicine

• AIIMS Hospital Drug Formulary

• ICMR Guidelines on Hypertension Management

• Indian Society of Cardiology practice recommendations for post-MI care

• WHO Essential Medicines List (supportive data for paediatric and maternal safety)