IPCA-AMLODIPINE

What it is

IPCA-AMLODIPINE is amlodipine tablets available in 5 mg and 10 mg strengths. The tablets contain the active ingredient amlodipine 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

— Hypertension: amlodipine is indicated for the first line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. — Chronic stable angina: amlodipine is indicated for the first line treatment of chronic stable angina.

Dosing overview

For hypertension or angina, the usual initial dose is 2.5 mg 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. Calcium channel blockers should be used with caution in patients with heart failure. Amlodipine (5 mg to 10 mg per day) has been studied in a placebo-controlled trial of 1153 patients with New York Heart Association (NYHA) class III or IV heart failure on stable doses of ACE inhibitor, digoxin and diuretics. There was 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 the clinical trials. The incidence of peripheral oedema was dose-dependent and ranged in frequency from 3.0 to 10.8% in the 5 mg to 10 mg dose range. IPCA-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.

Contraindications

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

Regulatory history

IPCA-AMLODIPINE was first included in the Australian Register of Therapeutic Goods on 13 April 2017. The 5 mg and 10 mg tablet formulations (ARTG 264398 and 264399) were first listed on 13 April 2017 under licence category RE (established medicines).