ACEON® was safe and well tolerated for the treatment of hypertension in a 1-year, open-label study of 47,351
patients 5
Among 1,012 patients in placebo-controlled US trials, cough was the reason for withdrawal in 1.3% of perindopril and 0.4% of placebo patients 2
In stable CAD patients...
The overall rate of discontinuation in the EUROPA trial was about 22% on drug and placebo 1,2
The most common medical reasons for discontinuation that were more frequent on perindopril than placebo in the EUROPA trial were cough, drug intolerance, and hypotension 1,2
WARNINGS AND PRECAUTIONS2 Anaphylactoid and Possibly Related Reactions:Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including ACEON® Tablets) may be subject to a variety of adverse reactions, some of them serious, including:
Head and Neck Angioedema
Intestinal Angioedema
Anaphylactoid Reactions During Desensitization
Anaphylactoid Reactions During Membrane Exposure
Patients with a history of angioedema unrelated to ACE inhibitor therapy may be at increased risk of angioedema while receiving an ACE inhibitor (please see full Prescribing Information).
Hypotension: Like other ACE inhibitors, ACEON® Tablets can cause symptomatic hypotension. ACEON® Tablets has been associated with hypotension in 0.3% of uncomplicated hypertensive patients in US placebo-controlled trials. Symptoms related to orthostatic hypotension were reported in another 0.8% of patients.This is most likely to occur in patients who have been volume and/or salt-depleted. This should be corrected before initiating therapy with ACEON® . (See DOSAGE AND ADMINISTRATION.) In patients with congestive heart failure, with or without associated renal insufficiency, ACE inhibitors may cause excessive hypotension, and may be associated with oliguria or azotemia, and rarely with acute renal failure and death. In patients with ischemic heart disease or cerebrovascular disease such an excessive fall in BP could result in a myocardial infarction or a cerebrovascular accident.
Hepatic Failure: Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is not understood. Patients receiving ACE inhibitors who develop jaundice or marked elevations of hepatic enzymes should discontinue the ACE inhibitor and receive appropriate medical follow-up.
Impaired Renal Function:As a consequence of inhibiting the renin-angiotensin-aldosterone system, changes in renal function may be anticipated in susceptible individuals.
Hypertensive Patients With Renal Artery Stenosis: In hypertensive patients with unilateral or bilateral renal artery stenosis, increases in blood urea nitrogen and serum creatinine may occur. Experience with ACE inhibitors suggests that these increases are usually reversible upon discontinuation of the drug. In such patients, renal function should be monitored during the first few weeks of therapy.
Hyperkalemia: Elevations of serum potassium have been observed in some patients treated with ACE inhibitors, including ACEON® Tablets. Risk factors for the development of hyperkalemia include renal insufficiency, diabetes mellitus and the concomitant use of agents such as potassium-sparing diuretics, potassium supplements and/or potassium-containing salt substitutes. Drugs associated with increases in serum potassium should be used cautiously, if at all, with ACEON® Tablets.
Drug Interactions: Because potential drug interactions exist between ACEON® and other therapeutic agents (including diuretics, potassium supplements, potassium-sparing diuretics, and lithium), careful consideration must be given to the total medication profile of patients receiving ACEON® .
