ATENOLOL-AFT

What it is

Atenolol-AFT contains atenolol. The registered formulation is an oral solution of 50 mg in 10 mL.

Approved indications —

All grades of hypertension, including hypertension of renal origin. — Frequent disabling angina without evidence of cardiac failure. — Cardiac arrhythmias (acute treatment of supraventricular and ventricular arrhythmias including those associated with acute myocardial infarction). — Myocardial infarction: Late intervention (beta-blocker class effect greater than 12 hours after onset of chest pain).

Dosing overview

For hypertension, therapy should be initiated with 50 mg of atenolol daily, which may be increased each week in daily doses of 50 mg up to a maximum of 200 mg. Doses of 50 to 100 mg may be given once daily, whilst doses above 100 mg daily should be given on a divided basis. For angina pectoris, therapy should be initiated with 50 mg daily, which may be increased if required to 100 mg daily given as a single or divided dose. For cardiac dysrhythmias, atenolol given orally at a dosage of 50 to 100 mg daily will help maintain control after dysrhythmias have been controlled with other intravenous agents. For myocardial infarction, maintenance oral therapy of 50 mg daily is recommended for 1 to 3 years following myocardial infarction, beginning after early intervention with other agents or immediately in those patients who present more than 12 hours after suffering an acute myocardial infarction. Dosage adjustment is required in severe renal impairment: for patients with a creatinine clearance of 15 to 35 mL/min/1.73m², the oral dose should be 50 mg daily or 100 mg on alternate days; for patients with a creatinine clearance of less than 15 mL/min/1.73m², the oral dose should be 50 mg on alternate days or 100 mg every fourth day.

Key safety warnings

Care should be taken if beta-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 following abrupt discontinuation. The dosage should be reduced gradually over a period of about 8 to 14 days during which time the patient's progress should be reassessed. Patients with a history of anaphylactic reaction may have a more severe reaction on repeated challenge whilst taking beta-adrenoreceptor blocking drugs, and such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions. Beta-blockers affect glucose metabolism and may mask some important premonitory signs of acute hypoglycaemia, such as tachycardia. In patients with insulin or non-insulin dependent diabetes, especially labile diabetes or with a history of spontaneous hypoglycaemia, beta-blockade may result in the loss of diabetic control and delayed recovery from hypoglycaemia, and the dose of insulin or oral hypoglycaemic agent may need adjustment.

Contraindications

Beta-blockers are contraindicated in any patient with a history of airways obstruction or tendency to bronchospasm. Congestive heart failure is a contraindication. Allergic disorders (including allergic rhinitis) which may suggest a predisposition to bronchospasm are contraindicated. Right ventricular failure secondary to pulmonary hypertension and significant right ventricular hypertrophy are contraindications. Sick sinus syndrome, sinus bradycardia (less than 45 to 50 beats/minute), and second and third-degree A-V block are contraindicated. Shock (including cardiogenic and hypovolaemic shock) is contraindicated. Hypersensitivity to the drug, hypotension, metabolic acidosis, severe peripheral arterial circulatory disturbances, and untreated phaeochromocytoma are contraindications. Pregnancy and lactation are contraindications.

PBS listing

Atenolol-AFT oral solution 50 mg in 10 mL is listed on the PBS with 2 items, under restriction, with an ex-manufacturer price of A$34.53.

Regulatory history

Atenolol-AFT was first registered on the ARTG on 3 August 2012 as an oral solution in the RE licence category.