BISOPROLOL

Adults:

The usual dose is 10 mg once daily with a maximum recommended dose of 20 mg per day. In some patients 5 mg per day may be adequate. In patients with final stage impairment of renal function (creatinine clearance < 20 ml/min) or liver function, the dose should not exceed 10 mg bisoprolol once daily.

Elderly:

No dosage adjustment is normally required, but 5 mg per day may be adequate in some patients; as for other adults, dosage may have to be reduced in cases of severe renal or hepatic dysfunction.

Children and adolescents under 18:

There is no paediatric experience with bisoprolol, therefore its use cannot be recommended for children.

Route of administration:

Oral

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) Immune system disorders: Unknown: Hypersensitivity reactions (such as itching, flush, rash and angioedema).

Cardiac disorders:

Very common: bradycardia. Common: worsening of heart failure.

Uncommon:

AV-conduction disturbances.

Investigations:

Rare: increased triglycerides, increased liver enzymes (ALAT, ASAT).

Nervous system disorders:

Common: dizziness, headache.

Rare: syncope Eye disorders:

Rare: reduced tear flow (to be considered if the patient uses lenses). Very rare: conjunctivitis.

Ear and labyrinth disorders:

Rare: hearing disorders.

Respiratory, thoracic and mediastinal disorders:

Uncommon: bronchospasm in patients with bronchial asthma or a history of obstructive airways disease. Rare: allergic rhinitis.

Gastrointestinal disorders:

Common: gastrointestinal complaints such as nausea, vomiting, diarrhoea, constipation.

Skin and subcutaneous tissue disorders:

The treatment of stable chronic heart failure with bisoprolol has to be initiated with a special titration phase. 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.

The initiation and cessation of treatment with bisoprolol necessitates regular monitoring. There is no therapeutic experience of bisoprolol treatment of heart failure in patients with the following diseases and conditions: There is no therapeutic experience of bisoprolol treatment in heart failure in patients with the following diseases and conditions: • insulin dependent diabetes mellitus (type I) • severely impaired renal function impaired liver hepatic function • restrictive cardiomyopathy • congenital heart disease • haemodynamically significant organic valvular disease • myocardial infarction within 3 months Bisoprolol must be used with caution in: • bronchospasm (bronchial asthma, obstructive airways diseases) • diabetes mellitus with large fluctuations in blood glucose values; symptoms of hypoglycaemia 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 does not always yield the expected therapeutic effect. • first degree AV block • 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 ischemia during induction and intubation, and the postoperative period.

It is currently recommended that maintenance beta-blockade be continued peri-operatively. The anaesthesist 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.

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