ATENOLOL

Posology Atenolol oral solution is intended for patients unable to swallow atenolol tablets. The dose must always be adjusted to individual requirements of the patients, with the lowest possible starting dosage. e. 50 mg or 100 mg in patients unable to take 50 mg or 100 mg tablets.

Most patients respond to 100 mg (four 5 ml spoonfuls) once daily. Some patients, however, will respond to 50 mg (two 5 ml spoonfuls) 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.

Angina:

Most patients with angina pectoris will respond to 100 mg (four 5 ml spoonfuls) given orally once a day, or 50 mg (two 5 ml spoonfuls) given twice daily. It is unlikely that additional benefit will be gained by increasing the dose. e.

1 mg/minute). This may be repeated at 5 minute intervals until a response is observed up to a maximum dosage of 10 mg. 15 mg/kg body weight may be administered over a 20 minute period. If required, the injection or infusion may be repeated every 12 hours.

Having controlled the arrhythmias with intravenous atenolol, a suitable oral maintenance dosage is 50-100 mg (two to four 5 ml spoonfuls of Atenolol Oral Solution) daily, given as a single dose.

Myocardial Infarction:

For patients suitable for treatment with intravenous beta-adrenoceptor blockade and presenting within 12 hours of the onset of the chest pain, atenolol injection 5-10 mg should be given by slow intravenous administration (1 mg/minute) followed by Atenolol Oral Solution 50 mg (two 5 ml spoonfuls) orally about 15 minutes later, provided no untoward effects have occurred from the intravenous dose.

This should be followed by a further 50 mg orally (two 5 ml spoonfuls), 12 hours after the intravenous dose and then 12 hours later by 100 mg (four 5 ml spoonfuls) orally, to be given once daily. If bradycardia and/or hypotension requiring treatment, or any other untoward effects occur, atenolol should be discontinued.

Special populations Elderly:

Dosage requirements may be reduced, especially in patients with impaired renal function.

Renal impairment:

Since atenolol is excreted via the kidneys, 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 5 ml spoonfuls) daily and the intravenous dose should be 10 mg once every two days.

73 m2 (equivalent to serum creatinine of >600 micromol/litre) the oral dose should be 25 mg (one 5 ml spoonful) daily or 50 mg (two 5 ml 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 5 ml spoonfuls) orally after each dialysis; this should be done under hospital supervision as marked falls in blood pressure can occur.

Paediatric population There is no paediatric experience with atenolol and for this reason it is not recommended for use in children. Method of administration For oral use.

Atenolol is well tolerated. In clinical studies, the undesired events reported are usually 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); not known (cannot be estimated from the available data).

System Organ Class Frequency Undesirable Effect Blood and lymphatic system disorders Rare Thrombocytopenia Uncommon Sleep disturbances of the type noted with other beta-blockers Rare Mood changes, nightmares, confusion, psychoses and hallucinations Psychiatric disorders Not known Depression Nervous system disorders Rare Dizziness, headache and paraesthesia Eye disorders Rare Dry eyes, visual disturbances Common BradycardiaCardiac disorders Rare Heart failure deterioration, atrioventricular block Common Peripheral coldnessVascular disorders Rare Orthostatic 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 Hepatobiliary disorders Rare Hepatic toxicity including intrahepatic cholestasis Rare Alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes, purpura Skin and subcutaneous tissue disorders 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 Uncommon Transaminases increasedInvestigations Very rare An increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear Discontinuance of the medicinal product 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

4 Special warnings and special precautions for use 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), it 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.

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). 73m2. 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.

” As with other beta-blockers, in patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly. Atenolol Oral Solution contains sodium methyl parahydroxybenzoate (E219) and sodium propyl parahydroxybenzoate (E217).

These may cause allergic reactions (possibly delayed). This product also contains Maltitol Liquid. Patients with rare hereditary problems of fructose intolerance should not take this medicine. 2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

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