NEBALOC

What it is

NEBALOC is a medicine containing nebivolol (as hydrochloride) in tablet form, available in 5 mg and 10 mg strengths.

Approved indications

— Treatment of essential hypertension. — Treatment of stable chronic heart failure as an adjunct to standard therapies in patients 70 years or older.

Dosing overview

In patients with renal insufficiency for hypertension, the recommended starting dose is 2.5 mg daily, which may be increased to 5 mg if needed. In patients over 65 years with hypertension, the recommended starting dose is 2.5 mg daily, which may be increased to 5 mg if needed.

Key safety warnings

Cessation of therapy with NEBALOC should not be done abruptly unless clearly indicated. In patients with coronary artery disease, severe exacerbation of angina, precipitation of myocardial infarction and ventricular arrhythmias have occurred following abrupt discontinuation. The dosage should be reduced gradually over about 1–2 weeks. Prior to surgery, the anaesthetist should be informed that the patient is receiving nebivolol because of potential interactions resulting in severe bradyarrhythmias and hypotension. Continuation of beta-blockade reduces the risk of arrhythmias during induction and intubation. If beta-blockade is interrupted in preparation for surgery, the medication should be discontinued at least 24 hours beforehand. Beta-adrenergic antagonists may induce bradycardia; if the pulse rate drops below 50–55 bpm at rest or the patient experiences symptoms suggestive of bradycardia, the dosage should be reduced or treatment gradually withdrawn. Care should be taken in diabetic patients as nebivolol may mask certain symptoms of hypoglycaemia (tachycardia, palpitations). Beta-blockers could further increase the risk of severe hypoglycaemia when used concurrently with sulfonylureas. Diabetic patients should be advised to carefully monitor blood glucose levels.

Contraindications

NEBALOC is contraindicated in hypersensitivity to nebivolol hydrochloride or to any excipients; liver insufficiency or liver function impairment; acute heart failure, cardiogenic shock or episodes of heart failure decompensation requiring intravenous inotropic therapy; sick sinus syndrome including sino-atrial block; second and third degree heart block without a pacemaker; history of bronchospasm (including in chronic obstructive pulmonary disease) and/or asthma; untreated phaeochromocytoma; metabolic acidosis; bradycardia (heart rate less than 60 bpm prior to starting therapy); hypotension (systolic blood pressure less than 100 mmHg); and severe peripheral circulatory disturbances.

PBS listing

No information about PBS listing is contained in the provided source documents.

Regulatory history

NEBALOC nebivolol 5 mg and 10 mg tablets were first registered on the Australian Register of Therapeutic Goods on 18 February 2025 by Pharmacor.