IDAPREX

What it is

IDAPREX contains perindopril erbumine as the active ingredient, available in tablet 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 taken in the morning, with titration to a maximum of 8 mg once daily for optimum blood pressure control. 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 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 to 8 mg once daily depending on tolerance and renal function.

Key safety warnings

Hyperkalaemia may occur because ACE inhibitors reduce aldosterone production. The effect is usually not significant in patients with normal renal function, but serum electrolytes should be measured periodically, 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%. Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported uncommonly with perindopril and may occur at any time during treatment. In such cases perindopril should be promptly discontinued and the patient carefully observed until the swelling disappears. ACE inhibitors should not be reintroduced in patients who have a history of angioedema due to rare reports of recurrence. 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, such as those vigorously treated with diuretics, on dialysis, with impaired renal function, following severe diarrhoea or vomiting, on dietary restrictions, or with severe renin-dependent hypertension. A persistent dry irritating cough has been reported with most ACE inhibitors, with incidence varying between 2–15% depending on the medicine, dose and duration of use.

Contraindications

IDAPREX is contraindicated in patients with a history of previous hypersensitivity to perindopril or any of the 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 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 like AN69) 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 with perindopril not to be initiated earlier than 36 hours after the last dose of sacubitril/valsartan.

PBS listing

Information regarding PBS listing is not provided in the source documents.

Regulatory history

IDAPREX 2 mg and 4 mg tablets were first listed on the ARTG on 30 January 1992. IDAPREX 8 mg tablets were first listed on the ARTG on 11 November 2003.