What is the maximum dose of propranolol (beta-blocker)?

Maximum Dose of Propranolol

The maximum dose of propranolol varies by indication: 640 mg/day for hypertension and angina, 480 mg/day for migraine prophylaxis, 320 mg/day for angina in some guidelines, and 3 mg/kg/day for pediatric infantile hemangiomas. 1, 2

Adult Maximum Dosing by Indication

Hypertension

• The FDA-approved maximum dose is 640 mg/day for hypertension, though the usual maintenance dose is 120-160 mg once daily with extended-release formulations 1
• Clinical trials have demonstrated safety and efficacy up to 640 mg/day when added to diuretic therapy, with dose-response curves flattening after 160 mg in most patients 3

Angina Pectoris

• The American College of Cardiology states that doses up to 480 mg/day have been used, though some practitioners claim benefit with massive doses up to 1,000 mg/day—a practice not generally accepted 2
• The FDA label indicates that safety of dosages exceeding 320 mg/day has not been established for angina 1
• Research demonstrates that optimal therapeutic benefit in angina typically occurs at 144 mg/day (average), though individual patients may require up to 480 mg/day for maximal effect 4
• For most patients with angina, the average optimal dosage is 500-800 mg/day, similar to or higher than doses used for hypertension 5

Hypertrophic Cardiomyopathy

• Doses up to 480 mg/day are recommended, with some investigators reporting use of massive doses up to 1,000 mg/day, though this is not standard practice 2

Migraine Prophylaxis

• The maximum dose is 240 mg once daily with extended-release formulations 1
• If adequate response is not achieved within 4-6 weeks at maximum dose, propranolol should be discontinued 1

Ventricular Arrhythmias

• Doses up to 960 mg/day have been studied for suppression of chronic ventricular arrhythmias, with effective plasma levels ranging from 12-1,100 ng/ml 6
• Only one-third of patients respond at doses ≤160 mg/day, but an additional 40% respond with doses of 200-640 mg/day 6

Pediatric Maximum Dosing

Infantile Hemangiomas

• The maximum dose is 3 mg/kg/day divided into 2-3 doses for uncomplicated infantile hemangiomas 2, 7
• For children with comorbidities (hyperinsulinism, preterm birth, low weight), more cautious dosing schedules are required with individualized regimens 2
• For suspected PHACES syndrome, the starting dose is lower (0.5 mg/kg/day) until brain imaging is completed 2

General Pediatric Use

• The standard maximum is 2 mg/kg for children in cardiovascular indications 2

Critical Dosing Principles

Dose Titration Strategy

• Start at low doses (80 mg/day for adults, 1 mg/kg/day for pediatrics) and increase gradually at 3-7 day intervals until optimal response is achieved 1, 2
• Titrate to clinical endpoints (heart rate 55-60 bpm, symptom relief, or side effects) rather than fixed maximum doses 5
• The dose-response relationship shows progressive benefit with logarithmic dose increases, though curves flatten at higher doses 5, 3

Monitoring at Higher Doses

• Monitor for hypotension, bradycardia, and signs of excessive beta-blockade (dizziness, extreme fatigue, syncope) especially during dose escalation 7, 8
• Heart rate and blood pressure should be assessed before each dose increase 7

Safety Considerations at Maximum Doses

• The greatest risk of precipitating heart failure occurs when initiating therapy, not at higher doses, provided increases are gradual 5
• Side effects at very high doses (640 mg propranolol) include fatigue and other beta-blocker effects, though minimal side effects were noted in comparative trials 3
• Never abruptly discontinue propranolol after chronic use at any dose—taper gradually over several weeks to prevent rebound hypertension, tachycardia, or angina 7, 8

Common Pitfalls

• Assuming all patients respond at standard doses—many require higher doses for optimal effect, particularly in angina and arrhythmias 5, 6
• Using fixed low doses when dose titration to clinical endpoints would provide superior outcomes 5
• Failing to recognize that plasma propranolol levels vary widely between patients at the same dose, making dose individualization essential 9