BICOR

What it is

BICOR contains bisoprolol fumarate, available in tablet strengths of 1.25 mg, 2.5 mg, 3.75 mg, 5 mg or 10 mg. Bisoprolol is a β1-selective-adrenoceptor blocking agent, lacking intrinsic stimulating and relevant membrane stabilising activity.

Approved indications

— Treatment of stable chronic moderate to severe heart failure in addition to ACE inhibitors, and diuretics, and optionally cardiac glycosides.

Dosing overview

Treatment of stable chronic heart failure with bisoprolol requires a titration phase, with treatment starting at 1.25 mg once daily for 1 week, then increasing to 2.5 mg once daily for a further week, then 3.75 mg once daily for a further week, then 5 mg once daily for 4 weeks, then 7.5 mg once daily for 4 weeks, and finally 10 mg once daily for maintenance therapy if well tolerated at each step. The maximum recommended dose is 10 mg once daily. Bisoprolol tablets should be taken in the morning and can be taken with food.

Key safety warnings

Close monitoring of vital signs (heart rate, blood pressure), conduction disturbances and symptoms of worsening heart failure is recommended during the titration phase. Symptoms may already occur within the first day after initiating therapy. Transient worsening of heart failure, hypotension, or bradycardia may occur during titration period and thereafter. The cessation of therapy with bisoprolol should not be done abruptly unless clearly indicated. Care should be taken if β-blockers have to be discontinued abruptly in patients, particularly in patients with coronary artery disease. Severe exacerbation of angina and precipitation of myocardial infarction and ventricular arrhythmias have occurred following abrupt discontinuation of β-blockade in patients with ischaemic heart disease. Therefore, the dosage should be reduced gradually over a period of about 8-14 days. Although cardioselective (β1) beta-blockers may have less effect on lung function than non-selective beta-blockers, these should be avoided in patients with obstructive airway diseases, unless there are compelling clinical reasons for their use. Where such reasons exist bisoprolol may be used with caution. In patients with bronchial asthma or other chronic obstructive airway diseases, which may cause symptoms, bronchodilating therapy should be given concomitantly. Bisoprolol is contraindicated in patients with severe bronchial asthma or severe chronic obstructive lung disease.

Contraindications

Bisoprolol is contraindicated in patients with: acute heart failure, episodes of heart failure decompensation requiring intravenous inotropic therapy, cardiogenic shock; AV block of second or third degree (without a pacemaker); sick sinus syndrome or sinoatrial block; bradycardia with less than 60 beats/min before the start of therapy; hypotension (systolic blood pressure less than 100 mm Hg); severe bronchial asthma or severe chronic obstructive pulmonary disease; late stages of peripheral arterial occlusive disease; Raynaud's syndrome; untreated phaeochromocytoma; metabolic acidosis; and hypersensitivity to bisoprolol or to any of the excipients.

Regulatory history

BICOR bisoprolol fumarate tablets in strengths of 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg were first listed on the ARTG on 23 April 2002.