Aceon

Name: Aceon

What should I avoid while taking perindopril?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Do not use salt substitutes or potassium supplements while taking perindopril, unless your doctor has told you to.

Introduction

Nonsulfhydryl ACE inhibitor.1

Aceon Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Body aches or pain
  • chills
  • cough
  • difficulty breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Less common
  • Abdominal or stomach pain
  • bladder pain
  • bloody or cloudy urine
  • change in hearing
  • chest pain
  • cold or flu-like symptoms
  • congestion
  • difficult, burning, or painful urination
  • dryness of the throat
  • earache or pain in the ear
  • ear drainage
  • frequent urge to urinate
  • hoarseness
  • lower back or side pain
  • swelling
  • tender, swollen glands in the neck
  • trouble with swallowing
  • voice changes
  • vomiting
Rare
  • Blurred vision
  • confusion
  • decreased urination
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry mouth
  • irregular heartbeat
  • muscle cramps or pain
  • numbness, tingling, pain, or weakness in the hands or feet
  • rapid breathing
  • seizures
  • sunken eyes
  • sweating
  • thirst
  • trembling
  • weakness and heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Back pain
  • lack or loss of strength
  • pain or tenderness around the eyes and cheekbones
  • tightness of the chest
Less common
  • Belching
  • bloated
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • diarrhea
  • difficulty moving
  • discouragement
  • excess air or gas in the stomach or intestines
  • feeling sad or empty
  • full feeling
  • hearing loss
  • injury
  • irritability
  • lack of appetite
  • leg pain
  • loss of interest or pleasure
  • muscle aching, stiffness, tension, or tightness
  • nausea
  • neck pain
  • nervousness
  • pain, swelling, or redness in the joints
  • passing gas
  • rash
  • sleepiness or unusual drowsiness
  • stomach discomfort or upset
  • swollen joints
  • trouble concentrating
  • trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

How do I store and/or throw out Aceon?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Indications and Usage for Aceon

Hypertension

Aceon is indicated for 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

Aceon is indicated for 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.

Adverse Reactions

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

The following adverse reactions are discussed elsewhere in labeling:

  • Anaphylactoid reactions, including angioedema [see Warnings and Precautions (5.1)]
  • Hypotension [see Warnings and Precautions (5.2)]
  • Neutropenia and agranulocytosis [see Warnings and Precautions (5.3)]
  • Impaired renal function [see Warnings and Precautions (5.5)]
  • Hyperkalemia [see Warnings and Precautions (5.6)]
  • Cough [see Warnings and Precautions (5.7)]

Hypertension

Aceon has been evaluated for safety in approximately 3,400 patients with hypertension in U.S. and foreign clinical trials. The data presented here are based on results from the 1,417 Aceon-treated patients who participated in the U.S. clinical trials. Over 220 of these patients were treated with Aceon® (perindopril erbumine) for at least one year.

In placebo-controlled U.S. clinical trials, the incidence of premature discontinuation of therapy due to adverse events was 6.5% in patients treated with Aceon and 6.7% in patients treated with placebo. The most common causes were cough, headache, asthenia and dizziness.

Among 1,012 patients in placebo-controlled U.S. trials, the overall frequency of reported adverse events was similar in patients treated with Aceon and in those treated with placebo (approximately 75% in each group). The only adverse events whose incidence on Aceon was at least 2% greater than on placebo were cough (12% vs. 4.5%) and back pain (5.8% vs. 3.1%).

Dizziness was not reported more frequently in the perindopril group (8.2%) than in the placebo group (8.5%), but its likelihood increased with dose, suggesting a causal relationship with perindopril.

Stable Coronary Artery Disease

Perindopril has been evaluated for safety in EUROPA, a double-blind, placebo-controlled study in 12,218 patients with stable coronary artery disease. The overall rate of discontinuation was about 22% on drug and placebo. The most common medical reasons for discontinuation that were more frequent on perindopril than placebo were cough, drug intolerance and hypotension.

Postmarketing Experience

Voluntary reports of adverse events in patients taking Aceon that have been received since market introduction and are of unknown causal relationship to Aceon include: cardiac arrest, eosinophilic pneumonitis, neutropenia/agranulocytosis, pancytopenia, anemia (including hemolytic and aplastic), thrombocytopenia, acute renal failure, nephritis, hepatic failure, jaundice (hepatocellular or cholestatic), symptomatic hyponatremia, bullous pemphigoid, pemphigus, acute pancreatitis, falls, psoriasis, exfoliative dermatitis and a syndrome which may include: arthralgia/arthritis, vasculitis, serositis, myalgia, fever, rash or other dermatologic manifestations, a positive antinuclear antibody (ANA), leukocytosis, eosinophilia or an elevated erythrocyte sedimentation rate (ESR).

Clinical Laboratory Test Findings

Hematology:  Small decreases in hemoglobin and hematocrit occur frequently in hypertensive patients treated with Aceon, but are rarely of clinical importance. In controlled clinical trials, no patient was discontinued from therapy due to the development of anemia. Leukopenia (including neutropenia) was observed in 0.1% of patients in U.S. clinical trials [see Warnings and Precautions (5.3)].

Liver Function Tests:  Elevations in ALT (1.6% Aceon versus 0.9% placebo) and AST (0.5% Aceon versus 0.4% placebo) have been observed in placebo-controlled clinical trials. The elevations were generally mild and transient and resolved after discontinuation of therapy.

Drug Interactions

Diuretics

Patients on diuretics, and especially those started recently, may occasionally experience an excessive reduction of blood pressure after initiation of Aceon therapy. The possibility of hypotensive effects can be minimized by either decreasing the dose of or discontinuing the diuretic or increasing the salt intake prior to initiation of treatment with perindopril. If diuretic therapy cannot be altered, provide close medical supervision with the first dose of Aceon, for at least two hours and until blood pressure has stabilized for another hour [see Warnings and Precautions (5.2)].

The rate and extent of perindopril absorption and elimination are not affected by concomitant diuretics. The bioavailability of perindoprilat was reduced by diuretics, however, and this was associated with a decrease in plasma ACE inhibition.

Potassium Supplements and Potassium-Sparing Diuretics

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.

Lithium

Increased serum lithium and symptoms of lithium toxicity have been reported in patients receiving concomitant lithium and ACE inhibitor therapy. Frequent monitoring of serum lithium concentration is recommended. Use of a diuretic may further increase the risk of lithium toxicity.

Gold

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.

Digoxin

A controlled pharmacokinetic study has shown no effect on plasma digoxin concentrations when coadministered with Aceon, but an effect of digoxin on the plasma concentration of perindopril/perindoprilat has not been excluded.

Gentamicin

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

Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)

In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors, including perindopril, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving perindopril and NSAID therapy.

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

Dual Blockade of the Renin-Angiotensin System (RAS)

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. Closely monitor blood pressure, renal function and electrolytes in patients on Aceon and other agents that affect the RAS.

Do not co-administer aliskiren with Aceon in patients with diabetes. Avoid use of aliskiren with Aceon in patients with renal impairment (GFR <60 ml/min).

Aceon Drug Class

Aceon is part of the drug class:

  • ACE INHIBITORS, PLAIN

Aceon Interactions

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

  • potassium-sparing diuretics such as:
    • spironolactone (Aldactone)
    • triamterene (Dyrenium)
    • amiloride (Midamor)
  • other diuretics such as:
    • furosemide (Lasix)
    • hydrochlorothiazide
    • torsemide (Demadex)
  • aliskiren (Tekturna)
  • angiotensin receptor blockers such as candesartan (Atacand), losartan (Cozaar), and telmisartan (Micardis, Twynsta)
  • aspirin and other NSAIDs (non-steroidal anti-inflammatory drugs) such as:
    • celecoxib (Celebrex)
    • diclofenac (Cambia, Cataflam, Flector, Voltaren, Zipsor and others)
    • etodolac (Lodine)
    • ibuprofen (Advil, Motrin, Nuprin)
    • indomethacin (Indocin, Indocin SR)
    • ketoprofen (Orudis, Actron, Oruvail)
    • ketorolac (Toradol)
    • meloxicam (Mobic)
    • nabumetone (Relafen)
    • naproxen (Naprosyn)
    • naproxen sodium (Aleve, Anaprox, Naprelan)
    • oxaprozin (Daypro)
    • piroxicam (Feldene)
  • gentamicin (Garamycin)
  • lithium (Eskalith, Lithobid)
  • potassium supplements
  • injectable gold (sodium aurothiomalate)

This is not a complete list of Aceon drug interactions. Ask your doctor or pharmacist for more information.

Aceon Food Interactions

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Aceon, salt substitutes containing potassium should be avoided.

 

 

Aceon and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant. perindopril is usually not recommended for use during pregnancy. See "FDA Warning" section.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Aceon falls into category D. It has been shown that use of Aceon in pregnant women caused some babies to be born with problems. More specifically, it has been shown that use of drugs like Aceon during the second and third trimesters of pregnancy harms the unborn baby’s kidneys and even increases the risk of death to the unborn baby. A more recent study showed that there may, in fact, also be an increased risk to the fetus if it is exposed to Aceon during the first trimester.

However, in some situations the benefit of using this medication may be greater than the risk of harm to the baby.

Aceon FDA Warning

WARNING: AVOID USE IN PREGNANCY

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

Adverse Effects

>10%

Headache (23%)

Cough (12%)

1-10%

Dizziness (8%)

Back pain (6%)

Lower extremity pain (5%)

Abnormal ECG (2%)

Palpitation (1%)

Depression (2%)

Somnolence (1%)

Menstrual disorder (1%)

Edema (4%)

ALT increased (2%)

Sexual dysfunction (male 1%)

Sleep disorder (3%)

Chest pain (2%)

Nausea/vomiting (2%)

Flatulence (1%)

Rash (2%)

Hyperkalemia (1%)

Tinnitus (2%)

Frequency Not Defined

Intestinal angioedema

Liver failure (rare)

Leukopenia

Pruritus

Stroke

Syncope

Urinary retention

Vertigo

Amnesia

Angioedema, More frequent in black patients (0.1%), Angioedema of lips, More frequent in black patients (0.1%), Angioedema of throat, More frequent in black patients (0.1%)

Before taking this medicine

You should not use Aceon if you are allergic to perindopril or if:

  • you have hereditary angioedema; or

  • you are allergic to any other ACE inhibitor, such as benazepril, captopril, enalapril, fosinopril, lisinopril, moexipril, quinapril, ramipril, or trandolapril.

You may also need to avoid taking Aceon with aliskiren if you have kidney disease.

You should not use Aceon if you have hereditary angioedema.

To make sure this medicine is safe for you, tell your doctor if you have:

  • kidney disease (or if you are on dialysis);

  • liver disease;

  • heart disease or congestive heart failure;

  • diabetes; or

  • a connective tissue disease such as Marfan syndrome, Sjogren's syndrome, lupus, scleroderma, or rheumatoid arthritis.

Do not use Aceon if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Perindopril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

It is not known whether perindopril passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Aceon dosing information

Usual Adult Dose for Coronary Artery Disease:

Initial dose: 4 mg orally once a day for 2 weeks, then increase to maintenance dose as tolerated.
Maintenance dose: 8 mg orally once a day

Use: Treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction.

Usual Adult Dose for Hypertension:

Initial dose: 4 mg orally once a day
Maintenance dose: 4 to 8 mg orally per day in 1 or 2 divided doses
Maximum dose: 16 mg/day

Comments: In patients treated with a diuretic, consider reducing the diuretic dose prior to starting this drug.

Usual Geriatric Dose for Coronary Artery Disease:

Greater than 70 Years:
Initial dose:
-Week 1: 2 mg orally once a day
-Week 2: 4 mg orally once a day, then increase to maintenance dose as tolerated.
Maintenance dose: 8 mg orally once a day

Use: Treatment of patients with stable coronary artery disease to reduce the risk of cardiovascular mortality or nonfatal myocardial infarction.

Usual Geriatric Dose for Hypertension:

Initial dose: 4 mg orally per day in 1 or 2 divided doses

Comments: Experience with doses above 8 mg is limited; administer with careful blood pressure monitoring and dose titration.

Aceon side effects

Get emergency medical help if you have signs of an allergic reaction to Aceon: hives; severe stomach pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a light-headed feeling, like you might pass out;

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;

  • little or no urination;

  • swelling, rapid weight gain;

  • high potassium--nausea, slow or unusual heart rate, weakness, loss of movement;

  • pale skin, easy bruising or bleeding; or

  • jaundice (yellowing of the skin or eyes).

Common Aceon side effects may include:

  • dizziness;

  • back pain; or

  • cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Aceon?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • gold injections to treat arthritis;

  • lithium;

  • NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;

  • a potassium supplement;

  • salt substitutes that contain potassium; or

  • a diuretic or "water pill."

This list is not complete. Other drugs may interact with perindopril, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Perindopril Levels and Effects while Breastfeeding

Summary of Use during Lactation

Limited information indicates that only low levels of perindopril and its active metabolite are found in breastmilk, which is consistent with other drugs in this class. Amounts ingested by the infant are small and would not be expected to cause any adverse effects in breastfed infants.

Drug Levels

Maternal Levels. A breast feeding mother who was taking perindopril erbumine 10 mg twice daily for 2 weeks donated one breastmilk sample 9 hours after a dose. The sample contained 0.9 mcg/L of perindopril and 22.5 mcg/L of perindoprilat in breastmilk.[1]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Benazepril, Captopril, Enalapril, Quinapril

References

1. Lwin EMP, Gerber C, Song Y et al. A new LC-MS/MS bioanalytical method for perindopril and perindoprilat in human plasma and milk. Anal Bioanal Chem. 2017. PMID: 28842738

Perindopril Identification

Substance Name

Perindopril

CAS Registry Number

82834-16-0

Drug Class

Antihypertensive Agents

Angiotensin-Converting Enzyme Inhibitors

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