Product Dossier

LERCAN

Product Dossier for LERCAN (lercanidipine hydrochloride, Viatris). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.

What it is

LERCAN contains lercanidipine hydrochloride 10 mg or 20 mg as the active ingredient. Lercanidipine is a calcium antagonist of the dihydropyridine group that selectively inhibits the transmembrane influx of calcium into cardiac and vascular smooth muscle, with a greater effect on vascular smooth muscle than on cardiac smooth muscle. The antihypertensive action is due to a direct relaxant effect on vascular smooth muscle which lowers total peripheral resistance and hence blood pressure.

Approved indications

— Treatment of hypertension.

Dosing overview

The recommended dose is 10 mg once daily, at least 15 minutes before a meal. The dose may be increased to 20 mg once daily depending on the individual response. Dose titration should be gradual, as it may take about two weeks for the maximal antihypertensive effect to be apparent. Since it is unlikely that increasing the dose beyond 20 mg will further improve the efficacy, and may be associated with side effects, doses above 20 mg are not recommended. Some individuals not adequately controlled on a single antihypertensive agent may benefit from the addition of lercanidipine at the same doses used in monotherapy to the existing regimen with a beta-blocker, a diuretic or an ACE inhibitor.

Key safety warnings

Some short-acting dihydropyridines may be associated with increased cardiovascular risk in patients with ischaemic heart disease. Although lercanidipine is long-acting, caution should be required in such patients. Safety of lercanidipine in patients with congestive heart failure has not been established. Lercanidipine should be used with caution in patients receiving treatment for heart failure. Lercanidipine has been associated with the development of cloudy peritoneal effluent in patients on peritoneal dialysis. The turbidity is due to an increased triglyceride concentration in the peritoneal effluent. Whilst the mechanism is unknown, the turbidity tends to resolve soon after withdrawal of lercanidipine. This is an important association to recognise as cloudy peritoneal effluent can be mistaken for infective peritonitis with consequential unnecessary hospitalisation and empiric antibiotic administration. Alcohol should be avoided while taking lercanidipine since it may potentiate the effect of vasodilating antihypertensive drugs.

Contraindications

Hypersensitivity to any dihydropyridine or any ingredient in this medicine. Left ventricular outflow tract obstruction. Untreated congestive cardiac failure. Unstable angina pectoris or recent (within 1 month) myocardial infarction. Severe hepatic impairment. Severe renal impairment (GFR < 30 mL/min), including patients undergoing dialysis. Concomitant treatment of lercanidipine with strong inhibitors of CYP3A4, ciclosporin, or grapefruit or grapefruit juice.

PBS listing

No PBS listing information is provided in the source documents.

Regulatory history

LERCAN was first approved on 30 June 2011. The 10 mg and 20 mg tablet formulations were first listed on the ARTG on 26 March 2010.