Schedule H

Oral, Intravenous (IV)

• Tablets: 10 mg, 20 mg, 40 mg, 80 mg

• Sustained-release tablets/capsules (SR/LA): 40 mg, 80 mg, 160 mg

• Injection: 1 mg/mL (1 mL ampoule)

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. HYPERTENSION

Parameter Recommendation

Starting dose 40 mg orally twice daily

Titration Increase every 1–2 weeks based on BP response

Usual maintenance dose 80–160 mg/day in 2–3 divided doses

Maximum dose 320 mg/day

Clinical Notes: Preferred in younger patients with hyperkinetic circulation or anxiety-associated hypertension. Not first-line in elderly or metabolic syndrome.

1. ANGINA PECTORIS (Chronic Stable Angina)

Parameter Recommendation

Starting dose 40 mg orally twice daily

Titration Increase based on exercise tolerance and symptom control

Usual maintenance dose 80–160 mg/day in divided doses

Maximum dose 240 mg/day

Clinical Notes: Avoid abrupt withdrawal — risk of rebound angina. Taper over 1–2 weeks if discontinuing.

1. CARDIAC ARRHYTHMIAS (SVT, Atrial Fibrillation/Flutter, Ventricular Arrhythmias)

Oral Administration:

Parameter Recommendation

Starting dose 10–20 mg orally 3–4 times daily

Titration Adjust based on heart rate and rhythm control

Usual maintenance dose 30–160 mg/day in divided doses

Maximum dose 160 mg/day

Intravenous Administration (Acute Settings Only):

Parameter Recommendation

Dose 1 mg IV over 1 minute

Repeat May repeat every 2 minutes if required

Maximum dose 5 mg total (10 mg under anaesthesia)

Clinical Notes: IV use requires continuous ECG monitoring and specialist supervision. Avoid IV propranolol with IV verapamil or diltiazem.

1. MIGRAINE PROPHYLAXIS

Parameter Recommendation

Starting dose 40 mg/day orally (in 2 divided doses or once daily)

Titration Increase every 1–2 weeks based on response

Usual maintenance dose 80–160 mg/day

Maximum dose 240 mg/day

Clinical Notes: Onset of benefit may take 2–4 weeks. Not for acute migraine treatment. Consider sustained-release formulation for once-daily dosing.

1. THYROTOXICOSIS (Including Thyroid Storm)

Oral Administration:

Parameter Recommendation

Starting dose 10–40 mg orally every 6–8 hours

Titration Adjust based on heart rate response

Usual maintenance dose 30–160 mg/day in divided doses

Maximum dose 160 mg/day (higher in thyroid storm under specialist care)

Intravenous Administration (Thyroid Storm — Specialist Only):

Parameter Recommendation

Dose 1 mg slow IV, may repeat every 6 hours

Maximum dose 10 mg total over 24 hours

Clinical Notes: Provides rapid symptomatic relief of tremor, tachycardia, and anxiety. Does not treat underlying hyperthyroidism. Continue alongside definitive antithyroid therapy.

1. ESSENTIAL TREMOR

Parameter Recommendation

Starting dose 40 mg orally twice daily

Titration Increase weekly based on tremor control and tolerability

Usual maintenance dose 120–240 mg/day in divided doses

Maximum dose 320 mg/day

Clinical Notes: Response often seen at lower doses. Sustained-release formulations improve compliance.

PAEDIATRIC DOSING (Specialist Only)

Primary Indications (Approved / Standard in India)

INFANTILE HEMANGIOMA

Parameter Recommendation

Minimum age 5 weeks postnatal (corrected for gestational age)

Starting dose 1 mg/kg/day in 2 divided doses

Titration Increase to 2–3 mg/kg/day over 1–2 weeks

Usual maintenance dose 2 mg/kg/day in 2 divided doses

Maximum dose 3 mg/kg/day

Duration 6 months or longer; reassess for rebound after stopping

Safety Monitoring:

• Heart rate, blood pressure, blood glucose before each dose increase

• Withhold during intercurrent illness with poor oral intake (risk of hypoglycaemia)

• Extra caution in low birth weight infants and those at risk of neonatal hypoglycaemia

Secondary Indications — Paediatric (Off-label)

Indication Age Dosing Notes Evidence Basis

Tachyarrhythmias — OFF-LABEL Any age under cardiac specialist 0.5–1 mg/kg/day divided every 6–8 hours; Max: 4 mg/kg/day ECG monitoring mandatory; Specialist only Paediatric cardiology practice; IAP supportive

Migraine Prophylaxis — OFF-LABEL >12 years only Starting: 10 mg twice daily; Titrate to max 2–4 mg/kg/day (not exceeding 160 mg/day) Not recommended <12 years except under specialist Limited paediatric data; extrapolated from adult practice

Thyrotoxicosis — OFF-LABEL Any age under endocrinologist 0.5–1 mg/kg/day divided 3 times daily For symptomatic control only Standard paediatric endocrine practice

⚠️ Not recommended in children below 5 weeks of age except under specialist supervision with intensive monitoring.

Mild to moderate impairment No dose adjustment required

Note: Propranolol undergoes extensive first-pass hepatic metabolism. Bioavailability increases markedly in cirrhosis.

• Sinus bradycardia (<50 bpm symptomatic)

• Heart block greater than first degree (without pacemaker)

• Cardiogenic shock

• Acute decompensated heart failure

• Bronchial asthma or history of severe bronchospasm

• Severe hypotension

• Sick sinus syndrome (without pacemaker)

• Untreated phaeochromocytoma

• Known hypersensitivity to propranolol or any component

• Chronic obstructive pulmonary disease (COPD) — increased risk of bronchospasm

• Diabetes mellitus — masks hypoglycaemia symptoms (tachycardia, tremor); does not mask sweating

• Phaeochromocytoma — use only after adequate alpha-blockade established

• Severe peripheral vascular disease — may worsen claudication or Raynaud's phenomenon

• Myasthenia gravis — may worsen muscle weakness

• Psoriasis — may exacerbate skin lesions

• First-degree heart block — monitor closely

• History of anaphylaxis — may reduce response to adrenaline

• Metabolic acidosis

• Abrupt withdrawal — risk of rebound angina, arrhythmia, or MI; always taper

Parameter Information

Overall safety Generally not preferred; use only if benefit clearly outweighs risk

Known risks Fetal bradycardia, intrauterine growth restriction, neonatal hypoglycaemia

Preferred alternatives Labetalol (hypertension), Nifedipine (hypertension)

When may be used Maternal cardiac arrhythmias, thyrotoxicosis where no safer alternative exists

Monitoring Fetal growth scans, fetal heart rate monitoring, neonatal glucose and heart rate at delivery

Parameter Information

Compatibility Compatible with breastfeeding

Drug levels in breast milk Low; infant receives <1% of maternal dose

Preferred alternatives Metoprolol or labetalol (if concern exists)

Infant monitoring Observe for bradycardia, sedation, poor feeding

Parameter Recommendation

Starting dose 10–20 mg once or twice daily

Titration Slower titration (every 2–4 weeks)

Special risks Orthostatic hypotension, falls, bradycardia, depression, fatigue

Additional considerations Reduced hepatic clearance; increased CNS effects; regular review of continued need

Interacting Drug Effect Management

Verapamil, Diltiazem Increased risk of bradycardia, AV block, asystole Avoid IV combination; use oral combination with extreme caution and monitoring

Clonidine Rebound hypertension if clonidine stopped while on beta-blocker Stop beta-blocker several days before tapering clonidine

Monoamine oxidase inhibitors (MAOIs) Hypertensive crisis risk Avoid combination

Fingolimod Additive bradycardia Avoid if possible; if essential, overnight cardiac monitoring at initiation

Interacting Drug Effect Management

Fluoxetine, Paroxetine (CYP2D6 inhibitors) Increased propranolol levels Monitor for excessive bradycardia; consider dose reduction

Rifampicin Decreased propranolol levels via CYP induction May need increased propranolol dose; monitor response

Digoxin Additive bradycardia risk Monitor heart rate

NSAIDs Reduced antihypertensive effect Monitor BP; use lowest effective NSAID dose

Insulin, Sulfonylureas Prolonged hypoglycaemia; masked symptoms Educate patient; monitor blood glucose closely

Amiodarone Additive bradycardia and hypotension Monitor ECG and BP

Ergot alkaloids Enhanced peripheral vasoconstriction Avoid combination if possible

Anaesthetic agents Enhanced hypotension Inform anaesthetist; may need dose adjustment

• Fatigue and lethargy

• Cold extremities

• Bradycardia

• Dizziness

• Gastrointestinal disturbances (nausea, diarrhoea)

• Sleep disturbances and vivid dreams

• Headache

• Severe bradycardia or complete heart block

• Bronchospasm (especially in susceptible individuals)

• Hypoglycaemia (particularly in infants, children, and fasting diabetics)

• Acute heart failure exacerbation

• Severe hypotension

• Depression and mood disturbances

• Raynaud's phenomenon exacerbation

• Rebound angina, arrhythmia, or myocardial infarction (on abrupt withdrawal)

• Rare: Lupus-like syndrome

Baseline:

• Heart rate and blood pressure

• ECG (if arrhythmia indication or pre-existing conduction abnormality)

• Blood glucose (diabetics, infants)

• Liver function tests (if hepatic impairment suspected)

• Respiratory assessment (if COPD concern)

After Initiation/Dose Change:

• Heart rate and blood pressure within 1–2 weeks

• Symptoms: bradycardia, fatigue, dizziness, bronchospasm, cold extremities

• Blood glucose if diabetic

Long-term:

• Periodic ECG if used for arrhythmia

• Frequency/severity of migraine or angina episodes

• Reassess indication every 6–12 months

• In children with hemangioma: growth, development, blood glucose during illness

• Ciplar (Cipla)

• Ciplar-LA (Cipla) — sustained release

• Inderal (Abbott)

• Provanol (Zydus Cadila)

• Betacard (Torrent)

• Corbis (Micro Labs)

• Multiple generics available

Note: Included in NLEM India; NPPA price-controlled formulations available.

1. Dual benefit: Useful single agent in patients with both migraine and hypertension — reduces pill burden.

1. Asthma is absolute contraindication: Non-selective beta-blocker; use cardioselective alternatives (metoprolol, bisoprolol) if beta-blockade essential in COPD.

1. Never stop abruptly: Taper over 1–2 weeks to prevent rebound angina, arrhythmias, or MI.

1. Masks hypoglycaemia: Counsel diabetic patients that sweating remains as a warning sign; tachycardia and tremor will be blunted.

1. Portal hypertension dosing: Target heart rate reduction of 25% from baseline or resting HR of 55–60 bpm; watch for excessive hypotension in cirrhotics.

1. IV use restricted: Only for acute arrhythmias or thyroid storm under ECG monitoring; never combine IV propranolol with IV calcium channel blockers.

Propranolol; beta-blocker; non-selective; hypertension; migraine prophylaxis; arrhythmia; thyrotoxicosis; infantile hemangioma; portal hypertension; essential tremor; asthma-contraindicated; NLEM India

RxIndia v1.1 — 23 May 2025

• CDSCO approved product information

• Indian Pharmacopoeia

• API Textbook of Medicine

• AIIMS Drug Formulary

• IAP Guidelines for Infantile Hemangioma

• NLEM India 2022

• Harrison's Principles of Internal Medicine

• Goodman & Gilman's The Pharmacological Basis of Therapeutics

• Indian Society of Gastroenterology practice guidance (variceal prophylaxis)