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Treatment of Hypertension or Angina Pectoris: Bisoprolol must be used with caution in patients with hypertension or angina pectoris and accompanying heart failure.
Treatment of Stable Chronic Heart Failure: There is no therapeutic experience of bisoprolol treatment in heart failure in patients with the following diseases and conditions: New York Heart Association (NYHA) class II heart failure; insulin dependent diabetes mellitus (type I); impaired renal function (serum creatinine ≥300 micromol/L); impaired liver function; patients >80 years; restrictive cardiomyopathy; congenital heart disease; haemodynamically significant organic valvular disease; myocardial infarction within 3 months.
Treatment of All Indications: Bisoprolol must be used with caution in bronchospasm (brochial asthma, obstructive airways diseases); diabetes mellitus with large fluctuations in blood glucose values (symptoms of hypoglycaemia can be masked); strict fasting; ongoing desensitization therapy; atrioventricular block of 1st degree; prinzmetal's angina; peripheral arterial occlusive disease (intensification of complaints might happen especially during the start of therapy).
In patients undergoing general anaesthesia, the anaesthetist must be aware of β-blockade. If it is thought necessary to withdraw β-blocker therapy before surgery. This should be done gradually and completed about 48 hrs before anaesthesia.
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 β2-stimulants may have to be increased.
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 (eg, bisoprolol) after carefully balancing the benefits against the risks.
In patients with phaeochromocytoma, bisoprolol must not be administered until after α-receptor blockade.
Under treatment with bisoprolol, symptoms of thyrotoxicosis may be masked.
The initiation of treatment with bisoprolol necessitates regular monitoring.
The cessation of therapy with bisoprolol should not be done abruptly unless clearly indicated.
Effects on the Ability to Drive or Operate Machinery: In study with coronary heart disease patients, bisoprolol did not impair driving performance. However, due to individual variations in reactions to bisoprolol, 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.
Use in pregnancy & lactation: Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and/or the fetus/newborn. In general, β-adrenoceptor blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion or early labor. Adverse effects (eg, hypoglycaemia and bradycardia) may occur in the fetus and newborn infant. If treatment with β-adrenoceptor 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 bisoprolol is excreted in human milk. Therefore, breastfeeding is not recommended during administration of bisoprolol.
