ATENOLOL

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

The following are guidelines; Adult Dose:

I. Hypertension 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 anti-hypertensive agents.

For example, co-administration of Atenolol with a diuretic provides a highly effective and convenient anti-hypertensive therapy. II. 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. III. Cardiac Arrhythmias Having controlled the arrhythmia with intravenous atenolol, a suitable oral maintenance dosage of 50 to 100 mg daily may be given as a single dose.

IV. Myocardial Infarction For patients suitable for treatment with intravenous beta-blockade and presenting within 12 hours of the onset of the chest pain, atenolol 5-10 mg should be given by slow intravenous injection (1 mg/minute) followed by Atenolol 50 mg orally about 15 minutes later, provided no untoward effects occur 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.

Elderly patients:

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

Paediatric population:

Atenolol is not recommended for use in children.

Dosage in renal failure:

Since atenolol is excreted via the kidneys, the dosage should be adjusted in cases of severe impairment of renal function. 73m2). 73m2 (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.

73m2 (equivalent to serum creatinine of > 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. Patients on haemodialysis should be given 50 mg orally after each dialysis, this should be done under hospital supervision as marked falls in blood pressure can occur.

Method of Administration:

Oral

In clinical studies, the side effects 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 (≥1/1000 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: purpura, thrombocytopenia Psychiatric disorders: Uncommon: sleep disturbances of the type noted with other beta-blockers Rare: mood changes, nightmares, confusion, psychoses and hallucinations, Not known: depression 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 Not known: conduction disorders 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 Not known: hypotension 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 Hepato-biliary 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 urticarial 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. Cessation of therapy with a beta-adrenoceptor blocking drug should be gradual.

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 should not be taken if there is a history of wheezing or asthma, until a doctor or pharmacist has been consulted. Although cardioselective beta-adrenoceptor blocking drugs may have less effect on lung function than non-selective beta-adrenoceptor blocking drugs, as with all betaadrenoceptor blocking drugs, 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: “Tell your doctor before you take this medicine if you have asthma, wheezing or any other similar breathing problems. 3), Atenolol may be used in patients whose signs of heart failure have been controlled.

Special care should be taken with patients whose cardiac reserve is poor. Due to its negative effect on conduction time, caution must be exercised if it is given to patients with first-degree heart block. One of the pharmacological actions of atenolol is to reduce heart rate.

In rare instances when symptoms may be attributable to the slow heart rate and the pulse rate drops to less than 50–55 bpm at rest, the dose may be reduced. Atenolol 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). As with other beta-blocking drugs, treatment should not be discontinued 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. Atenolol 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), Atenolol may also aggravate less severe peripheral arterial circulatory disorders. Atenolol may cause a hypersensitivity reaction including angioedema and urticaria.

While taking beta-adrenoceptor blocking drugs patients with a history of anaphylactic reaction to a variety of allergens may have a more severe reaction on repeated challenge. Such patients may be unresponsive to the usual doses of adrenaline used to treat the allergic reactions.

Atenolol may mask the signs of thyrotoxicosis. As with other beta-blockers, in patients with a phaeochromocytoma, an alpha- blocker should be given concomitantly. When a patient is scheduled for surgery, and a decision is made to discontinue betablocker therapy, this should be done at least 24 hours prior to the procedure.

The riskbenefit 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. 2). 2). Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

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