NOTEN

What it is

NOTEN contains atenolol 50 mg . NOTEN 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

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 . Where patients are controlled on daily doses of 50 to 100 mg, this may be given once daily . Doses above 100 mg daily should be given on a divided basis . For angina pectoris, therapy should be initiated with 50 mg of atenolol 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 of atenolol is recommended for 1 to 3 years following myocardial infarction . For patients with severe renal impairment (creatinine clearance 15 to 35 mL/min/1.73m²), the oral dose should be 50 mg daily or 100 mg on alternate days . For patients with creatinine clearance 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

Beta-adrenergic blockade may result in increased airways resistance and reduce the effectiveness of asthma treatment, which may be dangerous in susceptible patients; therefore, beta-blockers are contraindicated in any patient with a history of airways obstruction or tendency to bronchospasm . 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; it is recommended that the dosage be reduced gradually over a period of about 8 to 14 days . Patients with a history of anaphylactic reaction may have a more severe reaction on repeated challenge while taking beta-blockers, and may be unresponsive to the usual doses of adrenaline used to treat 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, beta-blockade may result in loss of diabetic control and delayed recovery from hypoglycaemia . Beta-adrenergic blocking agents may cause bradycardia in the foetus and newborn infant, and during the final part of pregnancy and parturition, these drugs should only be given after weighing the needs of the mother against the risk to the foetus .

Contraindications

Bronchospasm or history of airways obstruction; use of cardioselective beta-blockers can also result in severe 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 .

Regulatory history

NOTEN was first registered on the ARTG on 5 October 1993 as a 50 mg tablet blister pack .