PIP-AMLODIPINE

What it is

PIP-AMLODIPINE is amlodipine tablets available in 5 mg and 10 mg strengths containing the active ingredient amlodipine besilate. Amlodipine besylate is a dihydropyridine derivative. Amlodipine is a calcium ion influx inhibitor that inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.

Approved indications

— Hypertension: amlodipine is indicated for 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 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. 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 such as aortic stenosis. Mild to moderate peripheral oedema was the most common adverse event in clinical trials, with incidence ranging from 3.0 to 10.8% in the 5 mg to 10 mg dose range. Care should be taken to differentiate this peripheral oedema from the effects of increasing left ventricular dysfunction. In elderly patients aged 65 years or older, clearance of amlodipine is decreased. The incidence of adverse events in elderly patients was approximately 6% higher than that of younger patients, with adverse events including oedema, muscle cramps and dizziness. Amlodipine should be used cautiously in elderly patients. Calcium channel blockers carry the potential to produce fetal hypoxia associated with maternal hypotension and should not be used in pregnant women unless the potential benefit outweighs the risk to the fetus. It is not known whether amlodipine is excreted in human milk. In the absence of this information, breast-feeding should be discontinued during treatment with amlodipine. There is an increased risk of hypotension in patients receiving clarithromycin with amlodipine. Close observation of patients is recommended when amlodipine is co-administered with clarithromycin.

Contraindications

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

Regulatory history

PIP-AMLODIPINE was first listed on the Australian Register of Therapeutic Goods on 13 April 2017, with both the 5 mg and 10 mg tablet formulations registered under licence category RE.