ATENOLOL

Posology The dosage should be determined on an individual basis. It is recommended to start with the lowest possible dosage.

Adults:

Hypertension: A starting dose of 25 mg is recommended. The usual maintenance dosage in hypertension is 50-100 mg daily. The maximum effect will be reached after 1-2 weeks. g. a diuretic. Angina pectoris: 50-100 mg daily, depending on the clinical effect, in order to obtain a heartbeat in rest of 55-60 beats per minute.

Increasing the dose above 100 mg daily does not generally lead to an increased antianginous effect. If desired the dosage of 100 mg daily can be divided in two dosages.

Cardiac arrhythmias:

Having controlled the dysrhythmias with intravenous atenolol a suitable maintenance dosage is 50 mg – 100 mg daily, given as a single dose.

Myocardial infarction:

Initially controlled intravenously, followed by 50 mg orally about 15 minutes after the intravenous dose provided no adverse effects occur. This should be followed by a further 50 mg orally 12 hours later. Maintenance dose is 100 mg daily in 1-2 dosages for 6 days or until discharge from hospital.

If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, atenolol should be discontinued.

Impaired renal function:

Atenolol is excreted via the kidneys, therefore the dosage will need to be adjusted in severe renal conditions. 73 m2 BSA) Recommended daily dose atenolol (mg/day) >35 No dose adjustment necessary 15-35 (equivalent to serum creatinine of 300–600 micromol/litre) 50 <15 (equivalent to serum creatinine of greater than 600 micromol/litre) 25 (or 50 every second day) Patients on haemodialysis should be given 50 mg atenolol orally following each dialysis.

Because of the possibility of marked falls in blood pressure, this should be carried out under hospital supervision.

Elderly:

Dosage requirements may be reduced, especially in patients with impaired renal function. Dosage should be titrated according to clinical effect.

The following undesirable effects have been observed during treatment with atenolol and other beta blockers 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 < 1/1000), very rare (<1/10,000), Not known (cannot be estimated from the available data).

• Blood and Lymphatic System Disorders Rare: Thrombocytopenia, purpura • Endocrine Disorders Beta-blockers may mask the symptoms of thyrotoxicosis. • Metabolic and Nutrition Disorders Beta-blockers may mask the symptoms of hypoglycaemia.

• Psychiatric Disorders Uncommon: Sleep disturbances of the type noted with other beta-blockers Rare: Hallucinations, psychoses, confusion, depression, mood changes and nightmares • Nervous System Disorders Rare: Dizziness, headaches, paraesthesia.

• Eye Disorders Rare: Dry eyes, impaired vision. • Cardiac Disorders Common: Bradycardia, Rare: Precipitation of heart block, heart failure deterioration • Vascular Disorders Common: Cold extremities. Rare: increase of an existing intermittent claudication may be increased if already present in susceptible patients Raynaud’s phenomenon, postural hypotension which may be associated with syncope • Respiratory, Thoracic and Mediastinal Disorders Rare: Bronchospasm in patients with bronchial asthma or a history of asthmatic complaints.

• Gastrointestinal Disorders Common: Gastrointestinal disturbances.

Rare:

Dry mouth. • Hepatobiliary Disorders Rare: Cases of hepatic toxicity, including intrahepatic cholestasis have been reported.

Uncommon:

Elevations of transaminase levels • Skin and Subcutaneous Tissue Disorders Rare: Skin rash, purpura, exacerbation of psoriasis, alopecia, psoriasiform skin reactions.

3), may be used in patients whose signs of heart failure have been controlled. Similarly, care must be taken with patients with poor cardiac reserve. Ischaemic Heart disease: especially in patients with ischaemic heart disease, treatment should not be discontinued suddenly.

e. over 1-2 weeks, if necessary at the same time initiating replacement therapy, to prevent exacerbation of angina pectoris. In addition, hypertension and arrhythmias may develop. Furthermore, there is a risk of myocardial infarction and sudden death.

Patients should be followed during withdrawal, especially those with ischaemic heart disease. Untreated Congestive Heart disease: beta-blockers should not be used in such patients. The condition should be stabilised first. First Degree Heart Block: due to its negative effect on conduction time, beta-blockers should only be given with caution to such patients.

Heart rate disorders: beta-blockers may induce bradycardia. If the pulse rate decreases to less than 50-55 beats per minute at rest and the patient experiences symptoms related to the bradycardia, the dosage should be reduced.

Prinzmetal's angina:

Atenolol may increase the number and duration of anginal 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 Respiratory Disorders: In patients with chronic obstructive pulmonary disorders, airway obstructions may be aggravated. Therefore, atenolol should only be used for these patients with the utmost care.

Patient information leaflets and labels will carry the following warnings:

1. - Second or third-degree heart block. - Cardiogenic shock. - Uncontrolled heart failure. - Sick sinus syndrome (including sino-atrial block). - Untreated phaeochromocytoma. - Metabolic acidosis - Bradycardia (less than 45-50 beats per minute) - Hypotension - Severe peripheral circulatory disturbances - Concomitant intravenous use of verapamil or diltiazem - Severe asthma and severe chronic obstructive pulmonary disease such as airway obstructions.