AMLODIPINE-WGR

What it is

AMLODIPINE-WGR contains amlodipine besilate, available in 5 mg and 10 mg tablets. The 5 mg tablets are white to off-white, circular, biconvex, uncoated tablets debossed with 'E 21' on one side and a score line on the other side, while the 10 mg tablets are white to off-white, round, biconvex, uncoated tablets with '10' debossing on one side. Amlodipine is a calcium ion influx inhibitor that inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.

Approved indications

— Hypertension, as first-line treatment and as sole agent or in combination with other antihypertensive drugs. — Chronic stable angina, as first-line treatment.

Dosing overview

For hypertension or angina, the usual initial dose is 2.5 to 5 mg once daily, which may be increased to a maximum dose of 10 mg depending on the individual patient's response. Small, fragile or elderly individuals, or patients with hepatic insufficiency should be started on 2.5 mg once daily, and this dose may be used when adding amlodipine to other antihypertensive therapy. In general, titration should proceed over 7 to 14 days so that the physician can fully assess the patient's response to each dose level.

Key safety warnings

Rarely, patients particularly those with severe obstructive coronary artery disease have developed documented increased frequency, duration and/or severity of angina on starting calcium channel blocker therapy or at the time of dosage increase. Amlodipine should be used with caution in the presence of a fixed left ventricular outflow obstruction (aortic stenosis). In general, calcium channel blockers should be used with caution in patients with heart failure. Amlodipine is not a beta-blocker and therefore provides no protection against the dangers of abrupt beta-blocker withdrawal; any such withdrawal should be by gradual reduction of the dose of beta-blocker. Mild to moderate peripheral oedema was the most common adverse event in clinical trials, with dose-dependent incidence ranging from 3.0 to 10.8% in the 5 to 10 mg dose range. Care should be taken to differentiate this peripheral oedema from the effects of increasing left ventricular dysfunction. In patients with mild to moderate hepatic impairment, amlodipine half-life has been prolonged, worsening of liver function test values may occur, and amlodipine should be administered with caution and careful monitoring should be performed. In elderly patients (≥65 years), clearance of amlodipine is decreased with a resulting increase in area under the curve, and the incidence of adverse events in elderly patients was approximately 6% higher than that of younger population.

Contraindications

Amlodipine is contraindicated in patients with a known hypersensitivity to amlodipine, other dihydropyridines, or any of the inactive ingredients.

Regulatory history

AMLODIPINE-WGR was first registered on the Australian Register of Therapeutic Goods on 13 April 2017, with both the 5 mg and 10 mg tablet presentations listed on the same date.