COVERSYL

What it is

COVERSYL contains perindopril arginine and is available in three strengths. COVERSYL 2.5 contains 2.5 mg of perindopril arginine, COVERSYL 5 contains 5 mg of perindopril arginine, and COVERSYL 10 contains 10 mg of perindopril arginine.

Approved indications

— Treatment of hypertension . — Treatment of heart failure, recommended to be given with a diuretic and/or digoxin under close medical supervision . — Patients with established coronary artery disease who are stable on concomitant therapy and have no heart failure to reduce the risk of non-fatal myocardial infarction or cardiac arrest .

Dosing overview

Patients with severe hepatic or renal impairment and/or severe salt/volume depletion require careful dose titration as no pharmacokinetic and dose titration studies have been conducted. In patients with renal failure, treatment should be initiated with one COVERSYL 2.5 tablet once daily, with doses adjusted according to creatinine clearance.

Key safety warnings

Administration of COVERSYL to patients under current treatment with a diuretic may induce hypotension and sometimes acute renal failure at the beginning of treatment, with monitoring of plasma creatinine recommended during the first month of treatment. Patients with renovascular hypertension, salt and/or volume depletion, or cardiac decompensation may have a strongly activated renin-angiotensin-aldosterone system and may experience an excessive drop in blood pressure following the first dose of an ACE inhibitor. Renal insufficiency is commonly observed in elderly people, and care should be taken when prescribing COVERSYL to elderly patients, with an initial dose of one COVERSYL 2.5 tablet once daily and close monitoring during the initial stages of treatment.

Regulatory history

COVERSYL 2.5, COVERSYL 5, and COVERSYL 10 tablets were first listed on the ARTG on 8 June 2005.