Source: Υπουργείο Υγείας (CY) Revision Year: 2014 Publisher: MEDOCHEMIE LTD, 1-10 Constantinoupoleos street, 3011 Limassol, Cyprus
Hypersensitivity to the active substance, or any of the excipients listed in section 6.1.
In patients with: uncontrolled heart failure, second or third degree heart block, bradycardia (<45bpm), cardiogenic shock, severe peripheral arterial circulation disturbances, hypotension, metabolic acidosis, untreated pheochromocytoma or sick sinus syndrome.
Although contraindicated for uncontrolled heart failure, Vascoten may be used with caution in patients whose signs of heart failure have been controlled; especial caution should be used with patients with poor cardiac reserve.
Atenolol is a beta1 selective beta adrenoreceptor blocking drug, it may be used with great caution in patients with Prinzmetal’s angina, due to unopposed alpha receptor mediated coronary artery vasoconstriction it may increase the frequency and duration of angina attacks in such patients.
It can aggravate peripheral arterial circulatory disturbances that are not severe enough to be a contraindication.
In patients with first degree heart block, caution must be exercised as it has a negative effect on conduction time.
Atenolol can mask the symptoms of thyrotoxicosis.
The symptoms of hypoglycemia (especially tachycardia) may be masked by atenolol.
Atenolol reduces heart rate. When a patient develops symptoms of slow heart rate, dose reduction is indicated.
The dosage should be withdrawn gradually, 7-14 days; especially patients with ischemic heart disease should not have Vascoten discontinued suddenly.
Patients with a history of anaphylactic reactions to allergens may suffer more severe anaphylactic reactions to the allergens if on Vascoten.
Unless there are compelling clinical reasons, should not be used in patients with reversible obstructive airways disease, despite having less effect on lung function than non selective beta-adrenoceptor blocking drugs. If used, caution should be exercised. Vascoten in asthmatic patients may occasionally increase airways resistance; this is usually reversible by the commonly used dosages of broncho-dilators.
If using in conjunction with a Class 1 antiarrhythmic agents, i.e. disopyramide, exercise caution.
Concomitant use of beta-adrenoreceptor blockers with negative inotropic effect calcium channel blockers, such as diltiazem or verapamil, can lead to exaggeration of the effects. This happens especially in patients with impaired ventricular function and/or atrio-ventricular or sino-atrial conduction abnormalities. Neither agent should be administered within 48 hours of discontinuing the other.
The risk of hypotension is increased, and in patients with latent cardiac insufficiency cardiac failure may occur, during concomitant therapy with dihydropyridines such as nifedipine.
Following the withdrawal of clonidine, rebound hypertension can occur and this may be exacerbated by beta -adrenoreceptor drugs. If the two are being concomitantly administered, Vascoten should be withdrawn several days prior to clonidine withdrawal. If replacing clonidine with Vascoten, administration should not start until several days post clonidine withdrawal.
Beta-adrenoreceptor drugs in association with digitalis glycosides may increase atrio-ventricular conduction time.
Sympathomimetic agents, i.e. adrenaline, concomitantly administered, may negate the effects of beta-adrenoreceptor blockers.
NSAIDs, that act as prostaglandin synthetase inhibitors, i.e. ibuprofen or indomethacin, concomitantly administered, may decrease the hypotensive effect of the beta-adrenoreceptor blockers.
Beta-adrenoreceptor blocker drugs used with anesthesia can result in attenuation of the reflex tachycardia and increase the risk of hypotension. It is best to withdraw the beta-adrenoreceptor blocker prior to anesthesia, if not caution must be exercised, and the anesthetist should be informed. Anesthetic agents causing myocardial depression should be avoided, and an agent with the least inotropic activity possible should be chosen.
Atenolol may accentuate the blood glucose lowering effect of insulin and oral antidiabetic agents when used concomitantly.
Atenolol crosses the placenta and appears in the cord blood. There are no studies on the use of atenolol in the first trimester and the possibility of foetal injury cannot be excluded. Atenolol has been used for the treatment of mild to moderate hypertension in the third trimester, under close supervision, but has been associated with intra-uterine growth retardation.
Use of atenolol in women who are, or may, become pregnant, especially in the first and second trimester, requires careful assessment of the clinical benefits versus the possible risks.
Atenolol accumulates in breast milk; breast feeding is not recommended, but if done, caution should be exercised.
The ability to drive or operate machines is unlikely to be impaired by atenolol, although dizziness or fatigue may occasionally occur.
Atenolol is usually well tolerated. In clinical studies, the undesired events reported are usually attributable to the pharmacological action 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).
Rare: Thrombocytopenia and purpura.
Uncommon: Sleep disturbances.
Rare: Confusion, mood changes, psychoses and hallucinations.
Rare: Dizziness, headache, paresthesia.
Rare: Visual disturbances, dry eyes.
Common: bradycardia.
Rare: heart failure deterioration, precipitation of heart block.
Common: Cold extremities.
Rare: Postural hypotension which may be associated with syncope, intermittent claudication. Raynaud’s phenomenon have occurred in susceptible patients.
Rare: Patients with bronchial asthma, or a history of asthma, may suffer bronchospasm.
Common: Gastrointestinal disturbances.
Rare: Dry mouth.
Uncommon: Elevations of transaminase levels.
Rare: Hepatic toxicity including intrahepatic cholestatisis
Rare: alopecia, psoriasiform skin reactions or worsening of psoriasis, and skin rashes have been reported.
Common: Fatigue
Very rare: An increase in anti-nuclear antibodies (ANA) has been observed, the clinical relevance is uncertain.
If any of the above are severe, or threatening the patient’s well being, consideration should be given to discontinuing the drug, on the basis of clinical judgement.
Reporting suspected adverse reactions is an important way to gather more information to continuously monitor the benefit/risk balance of the medicinal product. Any suspected adverse reactions should be reported to Pharmaceutical Services, Ministry of Health, CY-1475, www.moh.gov.cy/phs, Fax: +357 22608649.
None.
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