ZIRCOL

What it is

ZIRCOL contains lercanidipine hydrochloride as the active ingredient, supplied as 10 mg or 20 mg film coated tablets. 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.

Approved indications

— Treatment of hypertension.

Dosing overview

The recommended dose is 10 mg once daily, taken 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 2 weeks for the maximal antihypertensive effect to be apparent. Doses above 20 mg are not recommended.

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. Some dihydropyridines may rarely lead to precordial pain or angina pectoris. Very rarely patients with preexisting angina pectoris may experience increased frequency, duration or severity of these attacks. 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. In patients with severe renal dysfunction or dialysis-dependent patients, plasma levels were increased by about 70%. As a consequence, lercanidipine is contraindicated in patients with severe renal impairment (GFR < 30 mL/min), including patients undergoing dialysis.

Contraindications

ZIRCOL is contraindicated in patients with hypersensitivity to any dihydropyridine or any ingredient, left ventricular outflow tract obstruction, untreated congestive cardiac failure, unstable angina pectoris or recent (within 1 month) myocardial infarction, severe hepatic impairment, and severe renal impairment (GFR < 30 mL/min), including patients undergoing dialysis. ZIRCOL is also contraindicated with coadministration of strong inhibitors of CYP3A4, ciclosporin, and grapefruit or grapefruit juice.

PBS listing

The 10 mg tablet is listed on the PBS with an ex-manufacturer price of A$2.50, and the 20 mg tablet is listed with an ex-manufacturer price of A$3.50. Both strengths have 2 PBS items each, with restriction status noted as restricted and unrestricted.

Regulatory history

ZIRCOL 10 and ZIRCOL 20 were first registered on the Australian Register of Therapeutic Goods on 6 December 2017.