bisoprolol fumarate: clinical use

Prescribing considerations

• Confirm the product-specific licensed indication.
• Patients with chronic heart failure should be clinically stable before initiation, with experienced supervision and close observation during treatment changes.
• Abrupt withdrawal can worsen underlying heart disease, particularly ischaemic heart disease.
• Assess respiratory disease, variable glucose control, peripheral arterial disease, first-degree AV block, psoriasis, thyroid disease, fasting, desensitisation therapy and planned anaesthesia.
• Evidence in children is insufficient in the selected product information.

Contraindications and cautions

• Acute or decompensated heart failure requiring intravenous inotropic treatment
• Cardiogenic shock
• Second- or third-degree atrioventricular block without appropriate pacing, sick sinus syndrome or sinoatrial block
• Symptomatic bradycardia or symptomatic hypotension
• Severe bronchial asthma
• Severe peripheral arterial occlusive disease or severe Raynaud's syndrome
• Untreated phaeochromocytoma
• Metabolic acidosis
• Hypersensitivity to bisoprolol or product excipients

Monitoring

• Heart rate, blood pressure and signs of worsening heart failure, particularly during initiation and treatment changes
• Respiratory symptoms in obstructive airways disease
• Blood glucose when diabetes, fasting or hypoglycaemia risk is relevant
• Renal and hepatic status when clinically relevant
• Fetal growth and newborn heart rate and glucose when treatment continues during pregnancy

Clinical pharmacology

Bisoprolol is highly beta-1 selective without intrinsic sympathomimetic activity. Oral bioavailability is high, protein binding is low, and elimination is divided approximately equally between hepatic metabolism to inactive metabolites and unchanged renal excretion.

Formulation and product differences

• Film-coated tablets are swallowed with liquid and should not be chewed; the selected scored tablet can be divided into equal parts.
• Orodispersible tablets disintegrate on the tongue before swallowing, with or without water; the selected tablet is scored.
• The selected oral solution is measured with its supplied oral syringe. It contains methyl and propyl parahydroxybenzoate, which may cause delayed allergic reactions, and should be discarded 60 days after first opening.

Dispersible tablet

Route: Oral

Strengths: 1.25 mg, 2.5 mg, 5 mg

Oral solution

Route: Oral

Strengths: 0.5 mg/mL, 1 mg/mL