PERISYL

What it is

PERISYL is perindopril erbumine, available as tablets in strengths of 2 mg, 4 mg or 8 mg.

Approved indications

— Treatment of hypertension. — Treatment of heart failure. — Reduction of the risk of non-fatal myocardial infarction or cardiac arrest in patients with established coronary artery disease who are stable on concomitant therapy and have no heart failure.

Dosing overview

For hypertension, the usual starting dose is 4 mg once daily in the morning, with optimum control achieved by titrating the dose against blood pressure to a maximum of 8 mg once daily. Elderly patients with hypertension should start treatment with 2 mg daily, with titration to 4 mg if necessary. For congestive heart failure, the usual starting dose is 2 mg, given with a diuretic and/or digitalis, increased to 4 mg daily for maintenance. For stable coronary artery disease, perindopril should be introduced at a dose of 4 mg once daily for two weeks, then increased to 8 mg once daily, depending on tolerance and renal function. Elderly patients should receive 2 mg once daily for one week, then 4 mg once daily the next week, before increasing the dose up to 8 mg once daily depending on tolerance and renal function.

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 from time to time, especially in combination with diuretics, as 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%, and has been reported uncommonly with perindopril. This may occur at any time during treatment, and perindopril should be promptly discontinued and the patient carefully observed until the swelling disappears. Symptomatic hypotension is rarely seen in uncomplicated hypertension but is a potential consequence of perindopril use in patients with salt or volume depletion, such as those vigorously treated with diuretics, on dialysis, with impaired renal function, following severe diarrhoea or vomiting, or on dietary restrictions. A persistent dry, non-productive, irritating cough has been reported with most ACE inhibitors, with incidence varying between 2–15% depending upon the medicine, dose and duration of use.

Contraindications

PERISYL is contraindicated in patients with a history of previous hypersensitivity to perindopril or any excipient ingredients, during pregnancy and for lactating women, in patients with bilateral or unilateral renal artery stenosis, and in patients with a history of hereditary and/or idiopathic angioedema or angioedema associated with previous ACE inhibitor treatment. It is also contraindicated 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. Combined use with aliskiren-containing products is contraindicated in patients with diabetes or renal impairment (GFR < 60 mL/min/1.73 m²), and combined use with sacubitril/valsartan fixed dose combinations is contraindicated—perindopril must not be initiated earlier than 36 hours after the last dose of sacubitril/valsartan.

Regulatory history

PERISYL perindopril erbumine tablets in strengths of 2 mg, 4 mg and 8 mg were first listed on the ARTG on 12 May 2021.