Product Dossier
LERCANIDIPINE-WGR
Product Dossier for LERCANIDIPINE-WGR (lercanidipine hydrochloride 10 mg, GM Pharma). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: GM Pharma
- Active ingredient: lercanidipine hydrochloride 10 mg
- Therapeutic area: Cardiology
- Same area: ATOZET
- Same area: OPSUMIT
What it is
LERCANIDIPINE-WGR is a medicine containing lercanidipine hydrochloride, available in 10 mg and 20 mg tablet strengths. 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, taken at least 15 minutes before a meal. The dose may be increased to 20 mg once daily depending on individual response, and dose titration should be gradual as it may take about two 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 an existing regimen with a beta-blocker, a diuretic or an ACE inhibitor.
Key safety warnings
Although short-acting dihydropyridines may be associated with increased cardiovascular risk in patients with ischaemic heart disease, lercanidipine is long-acting but caution should be exercised in such patients. Safety of lercanidipine in patients with congestive heart failure has not been established, and lercanidipine should be used with caution in patients receiving treatment for heart failure. Lercanidipine has been associated with cloudy peritoneal effluent in patients on peritoneal dialysis due to increased triglyceride concentration; although the mechanism is unknown and turbidity tends to resolve after withdrawal, this is important to recognise as it can be mistaken for infective peritonitis. This medicine contains lactose, and patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine. 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 with strong inhibitors of CYP3A4, ciclosporin, or grapefruit or grapefruit juice is contraindicated.
Regulatory history
LERCANIDIPINE-WGR was first listed on the Australian Register of Therapeutic Goods on 30 May 2024, with registrations for both 10 mg and 20 mg tablet strengths.