APO-CANDESARTAN

What it is

APO-CANDESARTAN is candesartan cilexetil, available in four strengths containing 4 mg, 8 mg, 16 mg or 32 mg of the active ingredient. Candesartan is an angiotensin II receptor antagonist, selective for AT1 receptors, with tight binding to and slow dissociation from the receptor. APO-CANDESARTAN should be taken once daily with or without food.

Approved indications

— Hypertension. — Heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.

Dosing overview

In elderly patients, an initial dose of 8 mg is recommended. The maximal antihypertensive effect is attained within 4 weeks following initiation of treatment.

Key safety warnings

In patients whose vascular tone and renal function depend predominantly on the renin-angiotensin-aldosterone system (such as those with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with drugs affecting this system has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure. As with any antihypertensive agent, excessive blood pressure decrease in patients with ischaemic heart disease or atherosclerotic cerebrovascular disease could result in myocardial infarction or stroke. There is evidence that concomitant use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalaemia and decreased renal function (including acute renal failure). Dual blockade of RAAS through combined use of APO-CANDESARTAN with an ACE inhibitor or aliskiren is therefore not recommended. In heart failure patients treated with APO-CANDESARTAN, hyperkalaemia may occur. During treatment with APO-CANDESARTAN in patients with heart failure, periodic monitoring of serum potassium is recommended, especially when taken concomitantly with ACE inhibitors and potassium-sparing diuretics such as spironolactone.

Contraindications

APO-CANDESARTAN is contraindicated in patients with known hypersensitivity to candesartan cilexetil or any excipients, pregnancy and lactation, severe hepatic impairment and/or cholestasis, and in combination with aliskiren-containing medicines in patients with diabetes mellitus (type I or II) or with moderate to severe renal impairment (GFR<60 mL/min/1.73m²).

Regulatory history

APO-CANDESARTAN 4 mg and 8 mg tablets were first registered on the ARTG on 15 March 2012. The 16 mg and 32 mg strengths were registered on 26 July 2012.