ATENOLOL

Posology Oral administration As food impairs the bioavailability of atenolol, it should not be taken with the food. The dose must always be adjusted to individual requirements of the patients, with the lowest possible starting dosage.

The following are guidelines:

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. , a diuretic. Angina 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 Initially controlled intravenously. A suitable oral maintenance dosage is 50-100 mg daily, given as a single dose.

Myocardial infarction Initially controlled intravenously, followed by 50 mg orally about 10 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 100 mg daily in 1-2 dosages for 6 days or until discharge from hospital”.

Elderly Dosage requirements may be reduced, especially in patients with impaired renal function. Children There is no paediatric experience with Atenolol and for this reason it is not recommended for use in children. 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 (two 5ml spoonfuls) 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 (one 5ml spoonfuls) daily or 50 mg (two 5ml spoonfuls) on alternate days and the intravenous dose should be 10 mg once every four days.

Patients on haemodialysis should be given 50 mg (two 5ml spoonfuls) orally after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.

Atenolol is well tolerated. In clinical studies, the undesired events reported are usually attributable to the pharmacological actions of atenolol. 01%) including isolated reports, not known (cannot be estimated from the available data).

Organ Systems Frequency Adverse events Blood and lymphatic system disorders Rare Purpura, thrombocytopenia Uncommon Sleep disturbances of the type noted with other beta-blockers Psychiatric disorders Rare Mood changes, nightmares, confusion, psychoses and hallucinations Nervous system disorders Rare Dizziness, headache, paraesthesia Eye disorders Rare Dry eyes, visual disturbances Common Bradycardia Cardiac disorders Rare Heart failure deterioration, precipitation of heart block Common Cold extremities Vascular disorders 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 Common Gastrointestinal disturbancesGastrointestinal disorders Rare Dry mouth Uncommon Elevations of transaminase levels Hepato-biliary disorders Rare Hepatic toxicity including intrahepatic cholestasis Rare Alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes Skin and subcutaneous tissue disorders Not known Hypersensitivity reactions, including angioedema and urticaria 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 Musculoskeletal and connective tissue disorders Not known Lupus-like syndrome 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.

Reporting of suspected adverse reactions:

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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 β1-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. Beta-blockers could further increase the risk of severe hypoglycaemia when used concurrently with sulfonylureas. Diabetic patients should be advised to carefully monitor blood glucose levels.

5). • 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.

• May cause a hypersensitivity reaction including angioedema and urticaria. 2). 73 m2. Although cardioselective (beta1) beta-blockers may have less effect on lung function than non-selective beta-blockers, as with all beta-blockers, these should be avoided in patients with reversible obstructive airways disease, unless there are compelling clinical reasons for their use.

Where such reasons exist, Atenolol may be used with caution. Occasionally, some increase in airways resistance may occur in asthmatic patients however, and this may usually be reversed by commonly used dosage of bronchodilators such as salbutamol or isoprenaline.

The label and patient information leaflet for this product state the following warning: “If you have ever had asthma or wheezing, you should not take this medicine unless you have discussed these symptoms with the prescribing doctor”.

As with other beta-blockers, in patients with a phaeochromocytoma, an alpha- blocker should be given concomitantly.

Excipient warning:

Methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216): May cause allergic reactions (possibly delayed).

Sorbitol (E420):

This medicinal product contains 280mg sorbitol in each ml. Patients with hereditary fructose intolerance (HFI) should not take/be given this medicinal product. 14% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

03mg propylene glycol in each ml.

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