BICARD

What it is

BICARD contains bisoprolol fumarate and is available in tablet strengths of 1.25 mg, 2.5 mg, 3.75 mg, 5 mg and 10 mg. Bisoprolol is a β1-selective-adrenoceptor blocking agent, lacking intrinsic stimulating and relevant membrane stabilising activity. It shows very low affinity to the β2-receptor of the smooth muscles of bronchi and vessels as well as to the β2-receptors concerned with metabolic regulation.

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, starting with 1.25 mg once daily for 1 week, 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. 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 the 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. It is recommended that the dosage be reduced gradually over a period of about 8-14 days during which time the patient's progress should be assessed. Although cardioselective (β1) 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 airway diseases, unless there are compelling clinical reasons for their use. Bisoprolol is contraindicated in patients with severe bronchial asthma or severe chronic obstructive lung disease. Bisoprolol should be used with caution in patients with diabetes mellitus, especially those who are receiving insulin or oral hypoglycaemic agents. Diabetic patients should be warned that β-blockers affect glucose metabolism and may mask some important premonitory signs of acute hypoglycaemia, such as tachycardia.

Contraindications

Bisoprolol is contra-indicated 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; hypersensitivity to bisoprolol or to any of the excipients.

Regulatory history

BICARD was first listed on the ARTG on 13 December 2010, with registrations for the 2.5 mg, 5 mg and 10 mg tablet strengths.