APX-ATENOLOL

What it is

APX-ATENOLOL contains 50 mg atenolol . APX-ATENOLOL tablets are white to off-white, circular biconvex film coated tablets with "50" embossed on one side and break line on other side .

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

In patients with severe renal impairment, dosage should be adjusted; no significant accumulation occurs at creatinine clearance greater than 35 mL/min/1.73m², for creatinine clearance 15–35 mL/min/1.73m² use 50 mg daily or 100 mg on alternate days, and for creatinine clearance less than 15 mL/min/1.73m² use 50 mg on alternate days or 100 mg every fourth day . Patients on haemodialysis should be given 50 mg orally after each dialysis under hospital supervision as marked falls in blood pressure can occur .

Key safety warnings

Beta-adrenergic blockade of smooth muscle of bronchi and bronchioles may result in increased airways resistance and reduced effectiveness of asthma treatment, which may be dangerous in susceptible patients; beta-blockers are contraindicated in any patient with a history of airways obstruction or tendency to bronchospasm . Care should be taken if beta-blockers are discontinued abruptly in patients with coronary artery disease, as severe exacerbation of angina and precipitation of myocardial infarction and ventricular arrhythmias have occurred; dosage should be reduced gradually over about 8 to 14 days . Patients with a history of anaphylactic reaction to allergens may have a more severe reaction on repeated challenge whilst taking beta-blockers and may be unresponsive to usual doses of adrenaline used to treat allergic reactions . Beta-blockers affect glucose metabolism and may mask premonitory signs of acute hypoglycaemia such as tachycardia; in patients with insulin or non-insulin dependent diabetes, especially labile diabetes, beta-blockade may result in loss of diabetic control and delayed recovery from hypoglycaemia, and the dose of insulin or oral hypoglycaemic agent may need adjustment . Beta-adrenergic blocking agents may cause bradycardia in the foetus and newborn infant, and during the final part of pregnancy and parturition should only be given after weighing the needs of the mother against the risk to the foetus .

Contraindications

Bronchospasm; beta-blockers are contraindicated in any patient with a history of airways obstruction or tendency to bronchospasm . Congestive heart failure . Allergic disorders (including allergic rhinitis) which may suggest a predisposition to bronchospasm . 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 A-V block . Shock (including cardiogenic and hypovolaemic shock) . Hypersensitivity to the drug . Hypotension . Metabolic acidosis . Severe peripheral arterial circulatory disturbances . Untreated phaeochromocytoma . Pregnancy and lactation .

Regulatory history

APX-ATENOLOL atenolol 50 mg tablets were first listed on the ARTG on 21 April 2020 .