PERINDOPRIL

What it is

PERINDOPRIL ARGININE/AMLODIPINE-WGR contains perindopril arginine and amlodipine besilate as active components. The medicine is available in four tablet strengths: 5 mg perindopril arginine with 5 mg amlodipine, 5 mg perindopril arginine with 10 mg amlodipine, 10 mg perindopril arginine with 5 mg amlodipine, and 10 mg perindopril arginine with 10 mg amlodipine.

Approved indications —

Hypertension in patients already controlled with separate doses of perindopril and amlodipine given concurrently at the same dose level — Stable coronary heart disease in patients already controlled with separate doses of perindopril and amlodipine given concurrently at the same dose level Treatment should not be initiated with this combination.

Dosing overview

PERINDOPRIL ARGININE/AMLODIPINE-WGR is available as substitution therapy for patients already controlled with separate doses of perindopril (5 or 10 mg) and amlodipine (5 or 10 mg), given concurrently at the indicated dose level. The recommended treatment is one tablet per day as a single dose, preferably taken in the morning and before a meal. Dose adjustments should be based on clinical judgment and individual patient profile, and can be made by decreasing or increasing the dose of either perindopril and/or amlodipine using separate products within the recommended dose range until clinical stability is re-established.

Key safety warnings

ACE inhibitors reduce angiotensin II formation resulting in decreased production of aldosterone, which may increase serum potassium in some patients, although the effect is usually not significant in patients with normal renal function. Serum electrolytes should be measured periodically when ACE inhibitors are given, especially in combination with diuretics. Hyperkalaemia can cause serious, sometimes fatal arrhythmias. Life-threatening angioedema has been reported with most ACE inhibitors, with an overall incidence of approximately 0.1-0.2 per cent. Angioedema of the face, extremities, lips, tongue, mucous membranes, glottis and/or larynx has been reported uncommonly with perindopril. If angioedema occurs, treatment should be promptly discontinued and the patient carefully observed until the swelling disappears. Hypotension has been reported in patients commencing treatment with ACE inhibitors. Symptomatic hypotension is rarely seen in uncomplicated hypertension but is a potential consequence in patients with salt/volume depletion, for example in patients vigorously treated with diuretics, in patients on dialysis, with impaired renal function, following severe diarrhoea or vomiting, in patients on dietary restrictions or in those with severe renin-dependent hypertension. A persistent dry irritating cough has been reported with most ACE inhibitors, with the incidence varying between 2–15 per cent depending upon the ACE inhibitor, dose and duration of use.

Contraindications

PERINDOPRIL ARGININE/AMLODIPINE-WGR is contraindicated in patients with a history of previous hypersensitivity to either of the active ingredients (perindopril or amlodipine), ACE inhibitors, dihydropyridines or excipient ingredients, and during pregnancy and for lactating women. The medicine is contraindicated in patients with bilateral or unilateral renal artery stenosis, and in patients receiving extracorporeal treatments leading to contact of blood with negatively charged surfaces such as dialysis or haemofiltration with certain high-flux membranes (such as polyacrylonitrile membranes) and low density lipoprotein apheresis with dextran sulfate due to increased risk of severe anaphylactoid reactions. The combination is contraindicated in combination with aliskiren-containing products in patients with diabetes or renal impairment (GFR less than 60 mL/min/1.73 m²), and combined use with sacubitril/valsartan fixed dose combinations is contraindicated, with PERINDOPRIL ARGININE/AMLODIPINE-WGR not to be initiated earlier than 36 hours after the last dose of sacubitril/valsartan. PERINDOPRIL ARGININE/AMLODIPINE-WGR is also contraindicated in severe hypotension, shock (including cardiogenic shock), obstruction of the outflow-tract of the left ventricle (such as high grade aortic stenosis), unstable angina pectoris (excluding Prinzmetal's angina), and heart failure after acute myocardial infarction.

Regulatory history

PERINDOPRIL ARGININE/AMLODIPINE-WGR was first registered on the ARTG on 28 June 2024 in four strengths: 5/5 mg, 5/10 mg, 10/5 mg, and 10/10 mg.