Is indicated for:

Hypertension:

• The treatment of patients with essential hypertension. ACEON may be used alone or given with other classes of antihypertensives, especially thiazide diuretics.

Stable Coronary Artery Disease:

• The treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction. ACEON can be used with conventional treatment for management of coronary artery disease, such as antiplatelet, antihypertensive or lipid-lowering therapy.

When pregnancy is detected, discontinue ACEON as soon as possible. Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus.

Avoid use of aliskiren with ACEON in patients with renal impairment (GFR <60 ml/min).

Intestinal angioedema has been reported in patients treated with ACE inhibitors. These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal.

ACE inhibitors have been associated with agranulocytosis and bone marrow depression, most frequently in patients with renal impairment, especially patients with a collagen vascular disease such as systemic lupus erythematosus or scleroderma.

Rarely, ACE inhibitors have been associated with a syndrome that starts with cholestatic jaundice and progresses to fulminant hepatic necrosis and sometimes death.

In patients with severe congestive heart failure, where renal function may depend on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors, including ACEON, may be associated with oliguria, progressive azotemia, and, rarely, acute renal failure and death.

Presumably because of the inhibition of the degradation of endogenous bradykinin, persistent nonproductive cough has been reported with all ACE inhibitors, generally resolving after discontinuation of therapy.

ACEON is contraindicated in patients with angioedema related to previous treatment with an ACE inhibitor, or a history of hereditary or idiopathic angioedema.

Do not co-administer aliskiren with ACEON in patients with diabetes.

ACEON is contraindicated in combination with neprilysin inhibitor (e.g., sacubitril). Do not administer ACEON within 36 hours of switching to or from sacubitril/valsartan, a neprilysin inhibitor.

Patients taking concomitant mTOR inhibitor (e.g., temsirolimus) therapy or a neprilysin inhibitor may be at increased risk for angioedema.

In patients undergoing surgery or during anesthesia with agents that produce hypotension, ACEON may block angiotensin II formation that would otherwise occur secondary to compensatory renin release. Hypotension attributable to this mechanism can be corrected by volume expansion.

ACEON may increase serum potassium because of its potential to decrease aldosterone production. Use of potassium-sparing diuretics (spironolactone, amiloride, triamterene and others), potassium supplements or other drugs capable of increasing serum potassium (indomethacin, heparin, cyclosporine and others) can increase the risk of hyperkalemia. Therefore, if concomitant use of such agents is indicated, monitor the patient’s serum potassium frequently.

Increased serum lithium and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy.

Nitritoid reactions (symptoms include facial flushing, nausea, vomiting and hypotension) have been reported rarely in patients on therapy with injectable gold (sodium aurothiomalate) and concomitant ACE Inhibitor therapy including ACEON.

Animal data have suggested the possibility of interaction between perindopril and gentamicin. However, this has not been investigated in human studies.

The antihypertensive effect of ACE inhibitors, including perindopril, may be attenuated by NSAIDs including selective COX-2 inhibitors.

Dual blockade of the RAS with angiotensin receptor blockers, ACE inhibitors, or aliskiren is associated with increased risks of hypotension, hyperkalemia, and changes in renal function (including acute renal failure) compared to monotherapy. Most patients receiving the combination of two RAS inhibitors do not obtain any additional benefit compared to monotherapy. In general, avoid combined use of RAS inhibitors.

Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected discontinue ACEON as soon as possible

Milk of lactating rats contained radioactivity following administration of 14C-perindopril. It is not known whether perindopril is secreted in human milk.

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• In non-elderly patients with normal renal function, dosage greater than 16 mg per day for hypertension and greater than 8 mg per day for stable coronary artery disease. GoToSource

• Use in patients under the age of 18. GoToSource 

• Methamphetamine dependence. GoToSource

• Heart failure. GoToSource

• Diabetic nephropathy. GoToSource

• Stroke prevention. GoToSource

• Parkinson’s disease. GoToSource 

• Early stage dementia. GoToSource

Cough. GoToSource

Fetal injury and death. GoToSource

Pemphigus vulgaris (skin disorder causing blisters on skin or mucous membranes). GoToSource

Psoriasis and pustulosis palmoplantaris (inflammatory skin condition). GoToSource

Increased severity of allergic reactions associated with bee, ant or wasp stings. GoToSource

Hypotension (low blood pressure). GoToSource

Intestinal angioedema (swelling of the wall of the bowel/intestines). GoToSource

Head and neck angioedema (swelling). GoToSource

Hyperkalemia (elevated potassium levels) and neutropenia (low level of neutrophils a type of white blood cell). GoToSource 

Pulmonary eosinophilic syndrome (group of pulmonary disorders with increased blood or lung eosinophils). GoToSource

Lawsuits filed for birth defects.