TELMISARTAN-WGR

What it is

TELMISARTAN-WGR is available as 40 mg or 80 mg tablets. The 40 mg tablets are white to off-white, oval, biconvex, uncoated tablets debossed with L203 on one side, while the 80 mg tablets are white to off-white, oval, biconvex, uncoated tablets debossed with L204 on one side. TELMISARTAN-WGR is administered as tablets for oral use and may be taken with or without food.

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

Reduction in blood pressure is achieved after the first dose, but maximum antihypertensive effect is generally attained four to eight weeks after the start of treatment. TELMISARTAN-WGR may be used in combination with thiazide-type diuretics such as hydrochlorothiazide or calcium-channel blockers such as amlodipine.

Key safety warnings

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 medicines that affect the renin-angiotensin-aldosterone system. Changes in renal function, including acute renal failure, have been reported in susceptible individuals when medicinal products that affect the renin-angiotensin-aldosterone system are combined; dual blockade is not recommended and should be limited to individually defined cases with close monitoring of renal function. Post-hoc analyses of 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 coronary heart disease or myocardial infarction, as coronary heart disease may be asymptomatic and undiagnosed, and blood pressure lowering may further reduce coronary perfusion; patients with diabetes should undergo specific diagnostics and be treated accordingly before starting therapy. Hyperkalaemia may occur during treatment with medicines that affect the renin-angiotensin-aldosterone system, especially in the presence of renal impairment and/or heart failure, and monitoring of serum potassium levels in patients at risk is recommended. Concurrent use of an ACE inhibitor or angiotensin receptor antagonist with an anti-inflammatory drug and a thiazide diuretic increases the risk of renal impairment and should be accompanied by increased monitoring of serum creatinine, particularly in elderly patients or those with pre-existing renal impairment.

Contraindications

TELMISARTAN-WGR is contraindicated in patients with hypersensitivity to any component, pregnancy, lactation, biliary obstructive disorders, or severe hepatic impairment, and in the concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR less than 60 ml/min/1.73m²).

Regulatory history

TELMISARTAN-WGR 40 mg and 80 mg tablets were first listed on the ARTG on 30 September 2014.