BESIDEP

What it is

BESIDEP contains the active ingredient amlodipine besilate. Amlodipine besylate is a dihydropyridine derivative. Amlodipine is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist) and inhibits the transmembrane influx of calcium ions into cardiac and vascular smooth muscle. BESIDEP tablets are available in 5 mg and 10 mg strengths.

Approved indications

— Hypertension: BESIDEP 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: BESIDEP 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 BESIDEP 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. BESIDEP 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. BESIDEP (5 mg to 10 mg per day) has been studied in a placebo-controlled trial of 1153 patients with NYHA class III or IV heart failure on stable doses of ACE inhibitor, digoxin and diuretics with follow-up of at least 6 months with a mean of about 14 months, and 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, with incidence ranging from 3.0 to 10.8% in the 5 mg to 10 mg dose range. 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.

Contraindications

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

PBS listing

No information regarding PBS listing is available in the provided source documents.

Regulatory history

BESIDEP was first included in the Australian Register of Therapeutic Goods on 13 April 2017. ARTG 264396 (BESIDEP amlodipine besylate 5 mg tablet blister pack) and ARTG 264397 (BESIDEP amlodipine besylate 10 mg tablet blister pack) were both first listed on 2017-04-13 under licence category RE.