ZANIDIP

What it is

ZANIDIP contains lercanidipine hydrochloride as the active ingredient, available in 10 mg and 20 mg film-coated tablets.

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 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. 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, 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. Inducers of CYP3A4 like anticonvulsants (e.g. phenytoin, carbamazepine) and rifampicin may reduce lercanidipine plasma levels and therefore the efficacy of lercanidipine may be less than expected.

Contraindications

ZANIDIP 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; or severe renal impairment (GFR < 30 mL/min), including patients undergoing dialysis. ZANIDIP coadministration is contraindicated with strong inhibitors of CYP3A4, ciclosporin, grapefruit or grapefruit juice.

PBS listing

PBS listing information is not provided in the available source documents.

Regulatory history

ZANIDIP 10 mg film-coated tablets were first listed on the Australian Register of Therapeutic Goods on 29 May 2001. ZANIDIP 20 mg film-coated tablets were first listed on 2 April 2003. The product was first approved on 6 December 2017 under the current ZIRCOL® brand name (AUST R 295935 for 10 mg and AUST R 295936 for 20 mg).