BISPRO

What it is

BISPRO contains bisoprolol fumarate. Each tablet contains 1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg or 10 mg of bisoprolol fumarate as the active ingredient. 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

Patients should be stable (without acute failure) when bisoprolol treatment is initiated. The treatment with bisoprolol is to be started with a gradual uptitration according to the following steps: 1.25 mg once daily for 1 week, if well tolerated increase to 2.5 mg once daily for a further week, if well tolerated increase to 3.75 mg once daily for a further week, if well tolerated increase to 5 mg once daily for the 4 following weeks, if well tolerated increase to 7.5 mg once daily for the 4 following weeks, if well tolerated increase to 10 mg once daily for the 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. Transient worsening of heart failure, hypotension, or bradycardia may occur during titration period and thereafter. If discontinuation is considered, gradual dose decrease is recommended, since abrupt withdrawal may lead to acute deterioration of the patient's condition. 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. 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 contraindicated in patients with acute heart failure, episodes of heart failure decompensation requiring intravenous inotropic therapy, cardiogenic shock; second or third degree AV block (without a pacemaker); sick sinus syndrome or sinoatrial block; bradycardia with less than 60 beats per minute before the start of therapy; hypotension (systolic blood pressure less than 100 mmHg); 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

BISPRO bisoprolol fumarate was first listed on the Australian Register of Therapeutic Goods on 2 February 2007 across all strength variants (1.25 mg, 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg).