ARX-TELMISARTAN/AMLODIPINE

What it is

ARX-TELMISARTAN/AMLODIPINE is available in four tablet strengths for oral administration, containing 40 mg or 80 mg telmisartan and 5 mg or 10 mg amlodipine (as besilate). The medicine combines two antihypertensive compounds with complementary mechanisms: an angiotensin II receptor blocker, telmisartan, and a dihydropyridinic calcium channel blocker, amlodipine. The combination of these substances has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.

Approved indications

— Treatment of hypertension.

Dosing overview

ARX-TELMISARTAN/AMLODIPINE should be taken once daily. Patients receiving telmisartan and amlodipine from separate tablets can instead receive ARX-TELMISARTAN/AMLODIPINE containing the same component doses in one tablet once daily to enhance convenience or compliance. ARX-TELMISARTAN/AMLODIPINE may be administered in patients whose blood pressure is not adequately controlled with amlodipine or telmisartan alone; individual dose titration with the components is recommended before changing to the fixed-dose combination. Patients treated with 10 mg amlodipine who experience dose limiting adverse reactions such as oedema may be switched to ARX-TELMISARTAN/AMLODIPINE 40/5 once daily, reducing the dose of amlodipine without reducing the overall expected antihypertensive response. No dosage adjustment is required for patients with renal impairment, including those on haemodialysis. For patients with mild to moderate hepatic impairment, the dosage should not exceed 40 mg telmisartan once daily.

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 telmisartan/amlodipine; an effect similar to that observed with ACE inhibitors should be anticipated. Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting; such conditions should be corrected before administration. Changes in renal function (including acute renal failure) have been reported in susceptible individuals when the renin-angiotensin-aldosterone system is inhibited; dual blockade of this system (for example, by adding an ACE inhibitor or direct renin inhibitor to an angiotensin II receptor blocker) is not recommended and should be limited to individually defined cases with close monitoring of renal function. Hyperkalaemia may occur during treatment with ARX-TELMISARTAN/AMLODIPINE, especially in the presence of renal impairment and/or heart failure; monitoring of serum potassium in patients at risk is recommended. Exploratory post-hoc analyses of telmisartan trials suggested an increased risk of fatal myocardial infarction and unexpected cardiovascular death in patients with diabetes mellitus with no documented history of coronary heart disease or myocardial infarction; coronary heart disease may be asymptomatic in diabetic patients and treatment may further reduce coronary perfusion, so patients with diabetes mellitus should undergo specific diagnostics before initiating therapy. In long-term placebo-controlled studies in patients with severe heart failure, the incidence of pulmonary oedema was higher in amlodipine-treated patients; therefore, patients with heart failure should be treated with caution.

Contraindications

ARX-TELMISARTAN/AMLODIPINE is contraindicated in patients with hypersensitivity to the active ingredients or any excipients, hypersensitivity to dihydropyridine derivatives, pregnancy, lactation, biliary obstructive disorders, severe hepatic impairment, severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (such as high grade aortic stenosis), haemodynamically unstable heart failure after acute myocardial infarction, and concomitant use with aliskiren in patients with diabetes mellitus or renal impairment (GFR less than 60 mL/min/1.73 m²).

PBS listing

No information on PBS listing is provided in the source documents.

Regulatory history

ARX-TELMISARTAN/AMLODIPINE was first listed on the ARTG on 1 July 2025 across four strengths: 40/5 mg, 40/10 mg, 80/5 mg, and 80/10 mg tablet formulations, all registered in licence category RE (Registered).