APO-AMLODIPINE

What it is

APO-AMLODIPINE contains amlodipine besilate as the active ingredient. Each tablet contains 2.5 mg, 5 mg or 10 mg of amlodipine (as besilate). Amlodipine is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist) that inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. Amlodipine is a peripheral arterial vasodilator that acts directly on vascular smooth muscle to cause a reduction in peripheral vascular resistance and reduction in blood pressure.

Approved indications

— First line treatment of hypertension. — First line treatment of chronic stable angina.

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. 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). Calcium channel blockers should be used with caution in patients with heart failure. However, amlodipine (5–10 mg per day) in a placebo-controlled trial showed no overall adverse effect on survival or cardiac morbidity (as defined by life-threatening arrhythmia, acute myocardial infarction, or hospitalisation for worsened heart failure). Mild to moderate peripheral oedema was the most common adverse event in clinical trials, with incidence dose-dependent and ranging from 3.0 to 10.8% in the 5 to 10 mg dose range. Calcium channel blockers carry the potential to produce foetal hypoxia associated with maternal hypotension and should not be used in pregnant women unless the potential benefit outweighs the risk to the foetus. Breast-feeding should be discontinued during treatment with amlodipine.

Contraindications

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

Regulatory history

APO-AMLODIPINE was first registered on the ARTG on 13 December 2007 in three strengths (2.5 mg, 5 mg and 10 mg) across blister pack and bottle formulations.