BEPROL

What it is

BEPROL is a film-coated tablet containing bisoprolol fumarate as the active ingredient. BEPROL is available as tablets containing 1.25, 2.5, 3.75, 5, 7.5 and 10 mg of bisoprolol fumarate. 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, starting with 1.25 mg once daily for 1 week, increasing by increments of 1.25 to 2.5 mg at weekly intervals up to 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, and should be swallowed with liquid and not chewed.

Key safety warnings

Bisoprolol has pharmacological effects that may cause harmful effects on pregnancy and the foetus or newborn, as β-adrenoceptor blockers reduce placental perfusion, which has been associated with growth retardation, intrauterine death, abortion or early labour. Bisoprolol should not be used during pregnancy unless clearly necessary. Breastfeeding is not recommended during administration of bisoprolol. The cessation of therapy with bisoprolol should not be done abruptly unless clearly indicated, as 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, and it is recommended that the dosage be reduced gradually over a period of about 8–14 days. There is a risk of exacerbating coronary artery spasm if patients with Prinzmetal or variant angina are treated with a β-blocker, and if this treatment is essential, it should only be undertaken in a Coronary or Intensive Care Unit. Bisoprolol should be used with caution in patients with diabetes mellitus, especially those who are receiving insulin or oral hypoglycaemic agents, as 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, second or third degree atrioventricular block without a pacemaker, sick sinus syndrome or sinoatrial block, bradycardia with less than 60 beats per minute before the start of therapy, hypotension with 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.

PBS listing

No information regarding PBS listing is available in the provided sources.

Regulatory history

BEPROL 1.25, 3.75 and 7.5 mg were first listed on the ARTG on 20 October 2011 under licence category RE.