Revision Year: 2020 Publisher: Merck Serono (Ireland) Limited, 4045 Kingswood Road, Citywest Business Campus, Dublin 24, Ireland
Bisoprolol is contra-indicated in patients with:
Bisoprolol must be used with caution in:
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 obstructive airways diseases, unless there are compelling clinical reasons for their use. Where such reasons exist, Emcor may be used with caution. In patients with obstructive airways diseases, the treatment with bisoprolol should be started at the lowest possible dose and patients should be carefully monitored for new symptoms (e.g., dyspnea, exercise intolerance, cough). In bronchial asthma or other chronic obstructive lung diseases, which may cause symptoms, bronchodilating therapy may have to be given concomitantly. Occasionally an increase of the airway resistance may occur in patients with asthma; therefore the dose of β2-stimulants may have to be increased.
In patients undergoing general anaesthesia beta-blockade reduces the incidence of arrhythmias and myocardial ischemia during induction and intubation, and the post-operative period. It is currently recommended that maintenance of beta-blockade be continued peri-operatively. The anaesthetist must be aware of beta-blockade because of the potential for interactions with other drugs, resulting in bradyarrhythmias, attenuation of the reflex tachycardia and the decreased reflex ability to compensate for blood loss. If it is thought necessary to withdraw beta-blocker therapy before surgery, this should be done gradually and completed about 48 hours before anaesthesia.
As with other β-blockers, bisoprolol may increase both the sensitivity towards allergens and the severity of anaphylactic reactions. Adrenaline treatment does not always give the expected therapeutic effect.
Patients with psoriasis or with a history of psoriasis should only be given β-blockers (e.g. bisoprolol) after carefully balancing the benefits against the risks.
In patients with phaeochromocytoma bisoprolol must not be administered until after alpha-receptor blockade.
Under treatment with bisoprolol the symptoms of a thyrotoxicosis may be masked.
The cessation of therapy with bisoprolol should not be done abruptly unless clearly indicated. For further information, see section 4.2.
Calcium antagonists such as verapamil and to a lesser extent diltiazem: Negative influence on contractility and atrio-ventricular conduction. Intravenous administration of verapamil in patients on beta-blocker treatment may lead to profound hypotension and atrioventricular block.
Centrally-acting antihypertensive drugs (e.g. clonidine methyldopa, moxonodine, rilmenidine): Concomitant use of centrally-acting antihypertensive drugs may lead to reduction of heart rate and cardiac output and to vasodilatation. Abrupt withdrawal may increase the risk of ‘rebound hypertension’.
Calcium antagonists of the dihydropyridine type such as nifedipine: Concomitant use may increase the risk of hypotension, and an increase in the risk of a further deterioration of the ventricular pump function in patients with heart failure cannot be excluded.
Class-I antiarrhythmic drugs (e.g. disopyramide, quinidine): Effect on atrio-ventricular conduction time may be potentiated and negative inotropic effect may be increased.
Class-III antiarrhythmic drugs (e.g. amiodarone): Effect on atrio-ventricular conduction time may be potentiated.
Parasympathomimetic drugs: Concomitant use may increase atrio-ventricular conduction time and the risk of bradycardia.
Topical beta-blockers (e.g. eye drops for glaucoma treatment) may add to the systemic effects of bisoprolol.
Insulin and oral antidiabetic drugs: Intensification of blood sugar lowering effect. Blockade of β-adrenoceptors may mask symptoms of hypoglycaemia.
Concomitant use with antihypertensive agents as well as with other medicines with blood pressure lowering potential (e.g. tricyclic antidepressants, barbiturates, phenothiazines) may increase the risk of hypotension.
Anaesthetic agents: Attenuation of the reflex tachycardia and increase of the risk of hypotension. (For further information on general anaesthesia see also section 4.4).
Digitalis glycosides: Reduction of heart rate, increase of atrio-ventricular conduction time.
Non-steroidal anti-inflammatory drugs (NSAIDs): NSAIDs may reduce the hypotensive effect of bisoprolol.
β-sympathomimetics (e.g. isoprenaline, dobutamine): combination with bisoprolol may reduce the effect of both agents.
Sympathomimetics that activate β- and α-adrenoceptors: Combination with bisoprolol may unmask the alpha-adrenoceptor-mediated vasoconstrictor effects of these agents leading to blood pressure increase and exacerbated intermittent claudication. Such interactions are considered to be more likely with non-selective β-blockers.
Sympathomimetic agents: Combination with bisoprolol may reduce the effect of both agents. Higher doses of epinephrine may be necessary for treatment of allergic reactions.
Mefloquine: increased risk of bradycardia.
Monoamineoxidase inhibitors (except MAO-B inhibitors): Enhanced hypotensive effect of ß-blockers but also risk of hypertensive crisis.
Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the foetus/newborn. In general, β- blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion or early labour. Adverse effects (e.g. hypoglycaemia and bradycardia) may occur in the foetus and newborn infant. If treatment with βadrenoceptor blockers is necessary, β1-selective adrenoceptor blockers are preferable.
Bisoprolol should not be used during pregnancy unless clearly necessary. If treatment with bisoprolol is considered necessary, the uteroplacental blood flow and the fetal growth should be monitored. In case of harmful effects on pregnancy or the fetus alternative treatment should be considered. The newborn infant must be closely monitored. Symptoms of hypoglycaemia and bradycardia are generally to be expected within the first 3 days.
It is not known whether this drug is excreted in human milk. Therefore, breastfeeding is not recommended during administration of bisoprolol.
In a study with coronary heart disease patients bisoprolol did not impair driving performance. However, due to individual variations in reactions to the drug, the ability to drive a vehicle or to operate machinery may be impaired. This should be considered particularly at start of treatment and upon change of medication as well as in conjunction with alcohol.
The following definitions apply to the frequency terminology used hereafter: 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), Frequency not known (cannot be estimated from available data).
Uncommon: AV-conduction disturbances, worsening of pre-existing heart failure, bradycardia.
Rare: increased triglycerides, increased liver enzymes (ALAT, ASAT).
Common: dizziness*, headache*.
Rare: Syncope
Rare: reduced tear flow (to be considered if the patient uses lenses).
Very rare: conjunctivitis.
Rare: hearing disorders.
Uncommon: bronchospasm in patients with bronchial asthma or a history of obstructive airways disease.
Rare: allergic rhinitis.
Common: gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation.
Rare: hypersensitivity reactions (pruritus, flush, rash and angioedema).
Very rare: beta-blockers may provoke or worsen psoriasis or induce psoriasis-like rash, alopecia.
Uncommon: muscular weakness and cramps.
Common: feeling of coldness or numbness in the extremities, hypotension.
Uncommon: Orthostatic hypotension.
Common: fatigue*
Uncommon: asthenia.
Rare: hepatitis.
Rare: erectile dysfunction.
Uncommon: sleep disorder, depression.
Rare: nightmares, hallucinations.
* These symptoms especially occur at the beginning of the therapy. They are generally mild and often disappear within 1-2 weeks.
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. Healthcare professionals are asked to report any suspected adverse reactions via: HPRA Pharmacovigilance, Website: www.hpra.ie.
None.
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