PRITOR/AMLODIPINE

What it is

PRITOR/AMLODIPINE is a fixed-dose combination containing telmisartan and amlodipine (as besilate), available in four tablet strengths: 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg, and 80 mg/10 mg. The medicine combines an angiotensin II receptor blocker, telmisartan, and a dihydropyridinic calcium channel blocker, amlodipine, with complementary mechanisms to control blood pressure. The combination has an additive antihypertensive effect, reducing blood pressure to a greater degree than either component alone.

Approved indications

— Treatment of hypertension.

Dosing overview

PRITOR/AMLODIPINE should be taken once daily. The medicine may be taken with or without food. Patients receiving telmisartan and amlodipine from separate tablets can instead receive PRITOR/AMLODIPINE containing the same component doses in one tablet once daily to enhance convenience or compliance. PRITOR/AMLODIPINE may be administered in patients whose blood pressure is not adequately controlled with amlodipine or telmisartan alone.

Key safety warnings

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, and such conditions should be corrected before administration of PRITOR/AMLODIPINE. Changes in renal function, including acute renal failure, have been reported as a consequence of inhibiting the renin-angiotensin-aldosterone system, especially if combining medicines that affect this system. Dual blockade of the renin-angiotensin-aldosterone system should be limited to individually defined cases with close monitoring of renal function. In the ONTARGET trial, patients receiving telmisartan and ramipril did not obtain additional benefit compared to monotherapy, but experienced increased incidence of hyperkalaemia, renal failure, hypotension and syncope. Concomitant use of PRITOR/AMLODIPINE and ramipril is therefore not recommended in patients with already controlled blood pressure. Exploratory post-hoc analyses of placebo-controlled telmisartan trials suggested increased risk of fatal myocardial infarction and unexpected cardiovascular death in patients with diabetes mellitus. Treatment with PRITOR/AMLODIPINE may further reduce coronary perfusion in these patients. Patients with diabetes mellitus should undergo specific diagnostics and be treated accordingly before initiating therapy with PRITOR/AMLODIPINE. In an amlodipine long-term placebo-controlled study in patients with severe heart failure (NYHA class III and IV), the incidence of pulmonary oedema was higher in the amlodipine treated group than in the placebo group. Therefore, patients with heart failure should be treated with caution.

Contraindications

PRITOR/AMLODIPINE is contraindicated in hypersensitivity to the active ingredients or to 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), and haemodynamically unstable heart failure after acute myocardial infarction. The concomitant use of PRITOR/AMLODIPINE with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 mL/min/1.73 m²).

PBS listing

No information regarding PBS listing, restriction type, or ex-manufacturer price is available in the provided source documents.

Regulatory history

PRITOR/AMLODIPINE was first listed on the ARTG on 2013-06-05 across four strengths: 40 mg/5 mg, 40 mg/10 mg, 80 mg/5 mg, and 80 mg/10 mg tablets.