NORVASC

What it is

NORVASC contains amlodipine besilate equivalent to 5 mg or 10 mg of active amlodipine base. NORVASC is available as emerald-shaped, white to off-white tablets. Amlodipine is a calcium ion influx inhibitor that inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle.

Approved indications

— Hypertension: first line treatment of hypertension, used as the sole agent to control blood pressure in the majority of patients. — Chronic stable angina: 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, though titration may proceed more rapidly if clinically warranted, provided the patient is assessed frequently.

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. NORVASC should be used with caution in the presence of a fixed left ventricular outflow obstruction (aortic stenosis). Mild to moderate peripheral oedema was the most common adverse event in the clinical trials, with incidence of peripheral oedema being dose-dependent and 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. There are no adequate studies in patients with liver dysfunction and dosage recommendations have not been established; in a small number of patients with mild to moderate hepatic impairment given single doses of 5 mg, amlodipine half-life has been prolonged and worsening of liver function test values may occur, so NORVASC should be administered with caution in these patients and careful monitoring should be performed.

Contraindications

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

PBS listing

PBS listing information is not available in the provided source documents.

Regulatory history

NORVASC was first approved on 26 February 1993. ARTG registration records show NORVASC amlodipine 5 mg tablet (ARTG 42902) and NORVASC amlodipine 10 mg tablet (ARTG 42903) were first listed on 26 February 1993 with licence category RE.