Source: Υπουργείο Υγείας (CY) Revision Year: 2014 Publisher: HEXAL AG, Industriestraße 25, D-83607 Holzkirchen Telephone: +49 (0) 80 24/908-0 Telefax: +49 (0) 80 24/908-1290 e-mail: service@hexal.de Distributor in Cyprus: P.T.Hadjigeorgiou Co Ltd, P.O.Box 53158-3301, ...
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Should not be withdrawn abruptly. The dosage should be withdrawn gradually over a period of 7-14 days, to facilitate a reduction in beta-blocker dosage.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.
Although contraindicated in uncontrolled heart failure (see section 4.3), 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.
Although contraindicated in severe peripheral arterial circulatory disturbances (see section 4.3), 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.
May cause a hypersensitivity reaction including angioedema and urticaria.
May cause an increase in airways resistance in asthmatic patients. Atenolol is a beta1-selective beta-blocker; consequently its use may be considered although utmost caution must be exercised. If increased airways resistance does occur, atenolol should be discontinued and bronchodilator therapy (e.g. salbutamol) administered if necessary.
Should only be given to patients with psoriasis after careful consideration, as psoriasis may be aggravated.
Since atenolol is excreted via the kidneys, dosage should be reduced in patients with a creatinine clearance of below 35 ml/min/1.73 m².
As with other beta-blockers, in patients with a phaeochromocytoma, an alpha-blocker should be given concomitantly.
Should be used with caution in the elderly, starting with a lesser dose (see section 4.2).
Atenolol crosses the placental barrier and appears in the cord blood. No studies have been performed on the use of Atenolol in the first trimester and the possibility of foetal injury cannot be excluded. Atenolol has been used under close supervision for the treatment of hypertension in the third trimester. Administration of Atenolol to pregnant women in the management of mild to moderate hypertension has been associated with intra-uterine growth retardation.
The use of Atenolol in women who are, or may become, pregnant requires that the anticipated benefit be weighed against the possible risks, particularly in the first and second trimesters, since beta-blockers, in general, have been associated with a decrease in placental perfusion which may result in intra-uterine deaths, immature and premature deliveries.
There is significant accumulation of Atenolol in breast milk.
Neonates born to mothers who are receiving atenolol at parturition or breast-feeding may be at risk of hypoglycaemia and bradycardia.
Caution should be exercised when Atenolol is administered during pregnancy or to a woman who is breast-feeding.
Use is unlikely to result in any impairment of the ability of patients to drive or operate machinery. However, it should be taken into account that occasionally dizziness or fatigue may occur.
The frequency of possible side effects listed below are defined as:
Very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1.000, <1/100), rare (≥1/10.000, <1/1.000), very rare (<1/10.000), not known (frequency cannot be estimated from the available data).
Rare: purpura, thrombocytopenia
Uncommon: sleep disturbances
Rare: mood changes, nightmares, confusion, psychoses and hallucinations
Rare: dizziness, headache, paresthesia
Rare: dry eyes, visual disturbances
Common: bradycardia
Rare: heart failure deterioration, precipitation of heart block
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
Rare: bronchospasm may occur in patients with bronchial asthma or a history of asthmatic complaints
Common:gastrointestinal disturbances
Rare: dry mouth
Not known: constipation
Uncommon: elevations of transaminase levels
Rare: hepatic toxicity including intrahepatic cholestasis
Rare: alopecia, psoriasiform skin reactions, exacerbation of psoriasis, skin rashes
Not known: hypersensitivity reactions, including angioedema and urticaria
Rare: impotence
Common: fatigue
Very rare: An increase in ANA (Antinuclear Antibodies) has been observed, however the clinical relevance of this is not clear
None known.
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