PERINDOPRIL-WGR

What it is

PERINDOPRIL-WGR is a medicine containing perindopril erbumine as the active ingredient. It is available in tablet strengths of 2 mg, 4 mg, or 8 mg perindopril erbumine.

Approved indications

— Treatment of hypertension. — Treatment of heart failure, with the recommendation that perindopril be given with a diuretic and/or digoxin under close medical supervision. — Reduction of the risk of nonfatal 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 Perindopril should be taken before meals.

In patients with renal failure, treatment should begin with 2 mg daily, with dosage adjusted according to creatinine clearance. Elderly patients with hypertension should start treatment with 2 mg daily, with titration to 4 mg if necessary.

Key safety warnings

ACE inhibitors reduce angiotensin II formation resulting in decreased aldosterone production, which can increase serum potassium levels in some patients. Hyperkalaemia can cause serious, sometimes fatal, arrhythmias. Serum electrolytes (including sodium, potassium and urea) should be measured from time to time when ACE inhibitors are given, especially when diuretics are also prescribed. Life-threatening angioedema has been reported with most ACE inhibitors, with an overall incidence of approximately 0.1 to 0.2%. Angioedema of the face, extremities, lips, tongue, mucous membranes, glottis and/or larynx has been reported in patients treated with ACE inhibitors and has been reported uncommonly with perindopril. If such cases occur, perindopril 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 of perindopril use in patients with salt/volume depletion, for example in patients vigorously treated with diuretics, patients on dialysis, with impaired renal function, or following severe diarrhoea or vomiting. A persistent dry, non-productive, irritating cough has been reported with most ACE inhibitors, with incidence varying between 2% and 15% depending upon the medicine, dosage and duration of use.

Contraindications

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

Regulatory history

PERINDOPRIL-WGR was first registered on the Australian Register of Therapeutic Goods on 28 August 2006, with three registered variants: the 2 mg tablet formulation (ARTG 121615), the 4 mg tablet formulation (ARTG 121618), and the 8 mg tablet formulation (ARTG 121621).