TOTAMOL

Posology The dose must always be adjusted to individual requirements of the patients, with the lowest possible starting dosage.

The following are guidelines:

Adults: Hypertension One tablet daily. Most patients respond to 100 mg daily given orally as a single dose. Some patients, however, will respond to 50 mg given as a single daily dose. The effect will be fully established after one to two weeks.

A further reduction in blood pressure may be achieved by combining atenolol with other antihypertensive agents. For example co-administration of atenolol with a diuretic, as in Tenoretic, provides a highly effective and convenient antihypertensive therapy.

Angina Most patients with angina pectoris will respond to 100 mg given orally once daily or 50 mg given twice daily. It is unlikely that additional benefit will be gained by increasing the dose. Cardiac arrhythmias Having controlled the arrhythmias with intravenous atenolol, a suitable oral maintenance dosage is 50–100 mg daily, given as a single dose.

Myocardial Infarction For patients suitable for treatment with intravenous beta-blockade and presenting within 12 hours of the onset of chest pain, following treatment with intravenous atenolol, 50 mg oral atenolol may be given about 15 minutes later, provided no untoward effects have occurred from the intravenous dose.

This should be followed by a further 50 mg orally 12 hours after the intravenous dose, and then 12 hours later by 100 mg orally, once daily. If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, atenolol should be discontinued.

Older population:

Dosage requirements may be reduced, especially in patients with impaired renal function. Renal failure Since atenolol is excreted via the kidneys, the dosage should be adjusted in cases of severe impairment of renal function. 73 m2).

73 m2 (equivalent to serum creatinine of 300–600 micromol/litre), the oral dose should be 50 mg daily and the intravenous dose should be 10 mg once every two days. 73 m2 (equivalent to serum creatinine of greater than 600 micromol/litre), the oral dose should be 25 mg daily or 50 mg on alternate days and the intravenous dose should be 10 mg once every four days.

Atenolol is well tolerated. In clinical studies, the undesired events reported areusually attributable to the pharmacological actions of atenolol. The following undesired events, listed by body system, have been reported with the following frequencies: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) including isolated reports, not known (cannot be estimated from the available data).

System Organ Class Frequency Undesirable Effect Blood and lymphatic system disorders Rare Purpura, thrombocytopenia Psychiatric disorders Uncommon Sleep disturbances of the type noted with other beta-blockers Rare Mood changes, depression, anxiety, nightmares, confusion, psychoses and hallucinations Nervous system disorders Rare Dizziness, headache, paraesthesia Eye disorders Rare Dry eyes, visual disturbances Cardiac disorders Common Bradycardia Rare Heart failure deterioration, precipitation of heart block Vascular disorders Common Cold extremities Rare Postural hypotension which may be associated with syncope, intermittent claudication may be increased if already present, in susceptible patients Raynaud's phenomenon Respiratory, thoracic and mediastinal disorders Rare Bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints Gastrointestinal disorders Common Gastrointestinal disturbances Rare Dry mouth Hepatobiliary disorders Uncommon Elevations of transaminase levels Rare Hepatic toxicity including intrahepatic cholestasis Skin and subcutaneous tissue disorders Rare Alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes Not known Hypersensitivity reactions, including angioedema and urticaria Musculoskeletal and connective tissue disorders Not known Lupus-like syndrome Reproductive system and breast disorders Rare Impotence General disorders and administration site conditions Common Fatigue Investigations Very rare An increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear Discontinuance of the drug should be considered if, according to clinical judgement, the well-being of the patient is adversely affected by any of the above reactions.

Atenolol as with other beta-blockers: • Should not be withdrawn abruptly. The dosage should be withdrawn gradually over a period of 7–14 days, to facilitate a reduction in beta- blocker dosage. Patients should be followed during withdrawal, especially those with ischaemic heart disease.

• When a patient is scheduled for surgery and a decision is made to discontinue beta-blocker therapy, this should be done at least 24 hours prior to the procedure. The risk-benefit assessment of stopping beta- blockade should be made for each patient.

If treatment is continued, an anaesthetic with little negative inotropic activity should be selected to minimise the risk of myocardial depression. The patient may be protected against vagal reactions by intravenous administration of atropine.

3), may be used in patients whose signs of heart failure have been controlled. Caution must be exercised in patients whose cardiac reserve is poor. • May increase the number and duration of angina attacks in patients with Prinzmetal's angina due to unopposed alpha-receptor mediated coronary artery vasoconstriction.

Atenolol is a beta1-selective beta-blocker; consequently, its use may be considered although utmost caution must be exercised. 3), may also aggravate less severe peripheral arterial circulatory disturbances. • Due to its negative effect on conduction time, caution must be exercised if it is given to patients with first-degree heart block.

• May mask the symptoms of hypoglycaemia, in particular, tachycardia. • May mask the signs of thyrotoxicosis. • Will reduce heart rate as a result of its pharmacological action. In the rare instances when a treated patient develops symptoms which may be attributable to a slow heart rate and the pulse rate drops to less than 50–55 bpm at rest, the dose should be reduced.

• May cause a more severe reaction to a variety of allergens when given to patients with a history of anaphylactic reaction to such allergens. Such patients may be unresponsive to the usual doses of adrenaline (epinephrine) used to treat the allergic reactions.

1 • cardiogenic shock • uncontrolled heart failure • sick sinus syndrome • second-or third-degree heart block • untreated phaeochromocytoma • metabolic acidosis • bradycardia (<45 bpm) • hypotension • severe peripheral arterial circulatory disturbances.