Applies only to hypertension or angina pectoris
Bisoprolol must be used with caution in patients with hypertension or angina pectoris and accompanying heart failure.
Applies only to chronic heart failure
The treatment of stable chronic heart failure with bisoprolol has to be initiated with a special titration phase.
The initiation and cessation of treatment of stable chronic heart failure with bisoprolol necessitates regular monitoring.
There is no therapeutic experience of bisoprolol treatment of heart failure in patients with the following diseases and conditions:
+ Insulin dependent diabetes mellitus (type I).
+ Severely impaired renal function.
+ Severely impaired liver function.
+ Restrictive cardiomyopathy.
+ Congenital heart disease.
+ Haemodynamically significant organic valvular disease.
+ Myocardial infarction within 3 months.
Applies to all indications
Especially in patients with ischaemic heart disease the cessation of therapy with bisoprolol must not be done abruptly unless clearly indicated, because this may lead to transitional worsening of heart condition.
There is a risk of myocardial infarction and sudden death if the treatment is suddenly discontinued in patients with coronary heart disease.
Bisoprolol must be used with caution in:
– Bronchospasm (bronchial asthma, chronic obstructive pulmonary disease (COPD)): 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, this medicinal product 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. dyspnoea, exercise intolerance, cough). In bronchial asthma or other chronic obstructive lung diseases, which may cause symptoms, bronchodilating therapy should be given concomitantly. Occasionally an increase of the airway resistance may occur in patients with asthma, therefore the dose of beta2-stimulants may have to be increased.
– Diabetes mellitus with large fluctuations in blood glucose values: Symptoms of hypoglycaemia (e.g. tachycardia, palpitations or sweating) can be masked.
– Strict fasting.
– Ongoing desensitisation therapy: As with other beta-blockers, bisoprolol may increase both the sensitivity towards allergens and the severity of anaphylactic reactions. Epinephrine treatment may not always yield the expected therapeutic effect.
– AV block of first degree.
– Prinzmetal’s angina: Cases of coronary vasospasm have been observed. Despite its high beta1-selectivity, angina attacks cannot be completely excluded when bisoprolol is administered to patients with Prinzmetal’s angina.
– Peripheral arterial occlusive disease: Aggravation of symptoms may occur especially when starting therapy.
– General anaesthesia: In patients undergoing general anaesthesia beta-blockade reduces the incidence of arrhythmias and myocardial ischaemia during induction and intubation, and the post-operative period. It is currently recommended that maintenance of beta-blockade should be continued peri-operatively. The anaestheist must be aware of beta-blockade because of the potential for interactions with other medicinal products, 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-blocking agent therapy before surgery, this should be done gradually and completed about 48 hours before anaesthesia.
– Patients with psoriasis or a history of psoriasis should only be given beta-blocking agents (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.
– Combination of bisoprolol with calcium antagonists of the verapamil or diltiazem type, with Class I antiarrhythmic medicinal products and with centrally acting antihypertensive medicinal products is generally not recommended.
Bisoprolol is not recommended during pregnancy unless clearly necessary.
It is not known whether this drug is excreted in human milk. Therefore, breast-feeding is not recommended during administration of bisoprolol.
In a study with coronary heart disease patients bisoprolol did not impair driving performance. Depending on the individual patient’s response the ability to drive a vehicle or to use machines may be impaired. This needs to be considered particularly at start of treatment, upon change of medication, or in conjunction with alcohol.