NEPITEN

What it is

NEPITEN is a tablet formulation containing nebivolol hydrochloride in three strengths: 1.25 mg, 5 mg and 10 mg. Nebivolol is a selective β1-receptor antagonist at doses less than or equal to 10 mg.

Approved indications

— Essential hypertension. — Stable chronic heart failure as an adjunct to standard therapies in patients 70 years or older.

Dosing overview

The blood pressure lowering effect becomes evident after 2 weeks of treatment, with optimal effect occasionally reached only after 4 weeks. For chronic heart failure, initiation of therapy and every dose increase should be done under the supervision of an experienced physician over a period of at least 2 hours to ensure that the clinical status remains stable.

Key safety warnings

The cessation of therapy with NEPITEN should not be done abruptly unless clearly indicated. 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 1-2 weeks during which time the patient's progress should be assessed. β-adrenergic antagonists may induce bradycardia: if the pulse rate drops below 50-55 bpm at rest and/or the patient experiences symptoms suggestive of bradycardia, the dosage should be reduced or treatment gradually withdrawn.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 NEPITEN may mask certain symptoms of hypoglycaemia such as tachycardia and palpitations. β-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. This medicinal product contains lactose. Patients with rare hereditary problems of galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Contraindications

Hypersensitivity to nebivolol hydrochloride or to any of the 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, or second and third degree heart block without a pacemaker. History of bronchospasm including that in chronic obstructive pulmonary disease, and/or asthma. Untreated phaeochromocytoma. Metabolic acidosis. Bradycardia with heart rate less than 60 bpm prior to starting therapy. Hypotension with systolic blood pressure less than 100 mmHg. Severe peripheral circulatory disturbances.

Regulatory history

NEPITEN nebivolol was first listed on the Australian Register of Therapeutic Goods on 3 April 2020 in all three strengths: 1.25 mg, 5 mg and 10 mg.