APO-TELMISARTAN

What it is

APO-TELMISARTAN contains telmisartan, a specific angiotensin II receptor (type AT1) antagonist. It is available in 2 strengths as tablets for oral administration containing 40 mg and 80 mg of telmisartan.

Approved indications

— Treatment of hypertension in adults. — Prevention of cardiovascular morbidity and mortality in adults 55 years or older with coronary artery disease, peripheral artery disease, previous stroke, transient ischaemic attack or high risk diabetes with evidence of end organ damage.

Dosing overview

While reduction in blood pressure is achieved after the first dose, the maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment. APO-TELMISARTAN may be administered with or without food.

Key safety warnings

Exploratory post-hoc analyses of two placebo-controlled telmisartan trials suggested an increased risk of fatal myocardial infarction and unexpected cardiovascular death in patients with diabetes mellitus who have no documented medical history of either coronary heart disease or myocardial infarction. In patients with diabetes mellitus, coronary heart disease may be asymptomatic and can therefore remain undiagnosed. Treatment with telmisartan may further reduce coronary perfusion in these patients. For this reason, patients with diabetes mellitus should undergo specific diagnostics and be treated accordingly before initiating therapy with APO-TELMISARTAN. There is an increased risk of severe hypotension and renal insufficiency when patients with bilateral renal artery stenosis or stenosis of the artery to a single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system. As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function (including acute renal failure) have been reported in susceptible individuals, especially if combining medicinal products that affect this system. Dual blockade of the renin-angiotensin-aldosterone system is not recommended and should therefore be limited to individually defined cases with close monitoring of renal function. During treatment with medicinal products that affect the renin-angiotensin-aldosterone system, hyperkalaemia may occur, especially in the presence of renal impairment and/or heart failure. Monitoring of serum potassium levels in patients at risk is recommended.

Contraindications

APO-TELMISARTAN is contraindicated in patients with hypersensitivity to any of the components of the product, pregnancy, lactation, biliary obstructive disorders, or severe hepatic impairment. The concomitant use of telmisartan with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m²).

Regulatory history

APO-TELMISARTAN monotherapy tablets (40 mg and 80 mg) were first registered on the ARTG on 19 May 2014 with licence category RE. Fixed-dose combination formulations of APO-TELMISARTAN HCTZ were registered earlier, with the 40/12.5 mg and 80/25 mg blister pack variants listed on 8 April 2014.