APO-Propranolol

What it is

APO-Propranolol contains propranolol hydrochloride , which is a non-selective beta-blocker. Propranolol is characterised by the absence of cardioselective beta-1 beta-blocking activity, an antiarrhythmic effect, and lack of partial agonist activity .

Approved indications

APO-Propranolol is indicated for treatment of proliferating infantile haemangioma requiring systemic therapy, including: — Life- or function-threatening haemangioma — Ulcerated haemangioma with pain and/or lack of response to simple wound care measures — Haemangiomas with a risk of permanent scars or disfigurement

Contraindications

Use in infants less than 5 weeks of age or less than 2.5 kg is contraindicated . APO-Propranolol is also contraindicated in hypersensitivity to propranolol or its excipients, and in asthma or history of bronchospasm . Additional contraindications include second- or third-degree atrioventricular blocks, sinus node disease, bradycardia or hypotension below age-specific limits, cardiogenic shock, uncontrolled heart failure, Prinzmetal's angina, severe peripheral arterial circulatory disturbances, hypoglycaemia proneness, and phaeochromocytoma .

Key safety warnings

Propranolol prevents the response of endogenous catecholamines to correct hypoglycaemia and masks adrenergic warning signs including tachycardia, shakiness, anxiety and hunger. It can aggravate hypoglycaemia in children, especially with fasting, vomiting or overdose, and hypoglycaemic episodes may present as seizures and/or coma . Propranolol may cause or worsen bradycardia or blood pressure abnormalities . After first intake and each dose increase, clinical monitoring including blood pressure and heart rate must be performed at least hourly for at least 2 hours; specialist advice must be sought for symptomatic bradycardia or severe bradycardia or hypotension occurring at any time . Propranolol can cause bronchospasm, and in lower respiratory tract infections with dyspnoea and wheezing, treatment should be temporarily discontinued .

Dosing overview

APO-Propranolol should be initiated in infants aged 5 weeks post-term to 5 months with a starting dose of 0.15 mL/kg (0.5 mg/kg) twice daily taken at least 9 hours apart. After 1 week, increase to 0.3 mL/kg (1.0 mg/kg) twice daily. After 2 weeks, increase to 0.4 mL/kg (1.5 mg/kg) twice daily and maintain for 6 months . Readjust the dose periodically as the child's weight increases .

PBS listing

Tablets containing propranolol hydrochloride 10 mg and 40 mg are listed on the PBS with an ex-manufacturer price of A$3.06 and A$3.31 respectively .

Regulatory history

APO-Propranolol was first included in the Australian Register of Therapeutic Goods on 25 June 2015 .