ARTG Entry

INDERAL

ARTG entry for INDERAL (propranolol hydrochloride), ARTG 474026 — Product Information, dosage form, registration history. Compiled by arcimedes.

What it is

INDERAL contains propranolol hydrochloride. INDERAL tablets are available in 10 mg and 40 mg strengths for oral administration. Propranolol hydrochloride is a β-adrenoreceptor blocking agent which acts non-selectively on β-receptors (β1 and β2). The most important effect of propranolol hydrochloride is to reduce the influence of excessive sympathetic nervous stimulation on the heart, reducing pulse rate, force of cardiac contraction and cardiac output resulting in a significant reduction in myocardial oxygen demand.

Approved indications INDERAL is indicated for:

— Angina pectoris — Hypertension — Prevention of migraine — Cardiac dysrhythmias: certain intrinsic cardiac dysrhythmias; dysrhythmias associated with thyrotoxicosis; anxiety tachycardia; certain drug-induced dysrhythmias (such as tachycardia due to digitalis or adrenaline overdosage) — Essential tremor, including familial and senile tremor — Phaeochromocytoma (only with concurrent α-receptor blockade) — Hypertrophic subaortic stenosis — Suspected or definite myocardial infarction — Fallot's tetralogy

Dosing overview

For hypertension, the standard starting dose is 40 mg twice daily, increasing by the same amount at weekly intervals according to patient response, with an adequate response usually seen in the range 120 to 320 mg/day. For angina pectoris and essential tremor, the dose is 40 mg two or three times daily, increasing at weekly intervals, with an adequate response in essential tremor usually seen in the range 80 to 160 mg/day and in angina 120 to 320 mg/day. For migraine, the standard starting dose is 40 mg twice daily, with a response usually in the range 80 to 160 mg/day evident within three months. For cardiac dysrhythmias, anxiety tachycardia, dysrhythmias associated with thyrotoxicosis and hypertrophic subaortic stenosis, most patients respond within the dosage range of 10 to 40 mg three or four times a day.

Key safety warnings β-adrenergic blockade may result in increased airways resistance and reduced effectiveness of asthma treatment, which may be dangerous in susceptible patients; therefore β-blockers are contraindicated in any patient with a history of bronchial asthma, airways obstruction or a tendency to bronchospasm. β-blockade depresses myocardial contractility and may precipitate cardiac failure in patients with a history of cardiac failure, chronic myocardial insufficiency or unsuspected cardiomyopathy, and in patients without a history of cardiac failure, continuing depression of the myocardium may lead to cardiac failure. Care should be taken if β-blockers have to be discontinued abruptly in patients with coronary artery disease, as severe exacerbation of angina and precipitation of myocardial infarction and ventricular arrhythmias have occurred; therefore it is recommended that the dosage be reduced gradually over a period of about 8 to 14 days. Propranolol may block or modify the signs and symptoms of hypoglycaemia (especially tachycardia) and occasionally causes hypoglycaemia, even in non-diabetic patients.

Contraindications

INDERAL is contraindicated in cardiovascular conditions including congestive heart failure, right ventricular failure secondary to pulmonary hypertension, significant right ventricular hypertrophy, sick sinus syndrome, sinus bradycardia (less than 45 to 50 beats/minute), second and third degree AV block, hypotension, severe peripheral arterial circulatory disturbances, and Prinzmetal's angina. Propranolol must not be used in patients prone to hypoglycaemia, including patients after prolonged fasting or patients with restricted counter regulatory reserves. β-blockers are contraindicated in any patient with a history of bronchial asthma, airways obstruction or a tendency to bronchospasm. INDERAL is contraindicated in allergic disorders (including allergic rhinitis) which may suggest a predisposition to asthma or bronchospasm, shock (including cardiogenic and hypovolaemic shock), hypersensitivity to the drug, anaesthesia with agents that produce myocardial depression (such as ether or chloroform), and untreated phaeochromocytoma.

Regulatory history

INDERAL propranolol hydrochloride 10 mg and 40 mg tablet bottles were first registered on the ARTG on 11 July 1991. INDERAL propranolol hydrochloride 10 mg and 40 mg tablet blister pack presentations were first registered on the ARTG on 29 July 2025.

TGA Public Summary — ARTG 474026