Aceon 8mg Tablets

Manufacturer XOMA Active Ingredient Perindopril(per IN doe pril) Pronunciation per-IN-doe-pril
WARNING: Do not take if you are pregnant. Use during pregnancy may cause birth defects or loss of the unborn baby. If you get pregnant or plan on getting pregnant while taking this drug, call your doctor right away. @ COMMON USES: It is used to treat high blood pressure.It is used to lower the risk of heart attack and death from heart disease in certain people.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive; Agent for Heart Failure
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Pharmacologic Class
Angiotensin-Converting Enzyme (ACE) Inhibitor
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Pregnancy Category
Category D (2nd and 3rd trimesters); Category C (1st trimester) - Note: FDA has moved to a new labeling system (PLLR) for pregnancy and lactation, but the risk remains high for ACE inhibitors.
FDA Approved
Dec 1993
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Perindopril is a medication that helps relax your blood vessels, making it easier for your heart to pump blood. This lowers your blood pressure and can help your heart work better if you have heart failure. It's often used to treat high blood pressure and certain heart conditions.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day to establish a routine. Continue taking your medication as directed by your doctor or healthcare provider, even if you start feeling better.

It's also important to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Storing and Disposing of Your Medication

To keep your medication effective and safe, store it at room temperature in a dry place, away from the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When your medication is no longer needed or has expired, dispose of it properly. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your doctor or pharmacist. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to check if there are any drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
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Lifestyle & Tips

  • Take medication exactly as prescribed, preferably before a meal.
  • Do not stop taking the medication without consulting your doctor.
  • Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
  • Limit alcohol intake, as it can further lower blood pressure.
  • Maintain a healthy diet (low in sodium), regular exercise, and manage stress as part of a comprehensive treatment plan.
  • Report any swelling of the face, lips, tongue, or throat immediately to your doctor (signs of angioedema).
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: Initial 4 mg once daily; Maintenance 4-8 mg once daily. Heart Failure: Initial 2 mg once daily; Maintenance 4 mg once daily.
Dose Range: 2 - 16 mg

Condition-Specific Dosing:

Hypertension: Initial 4 mg once daily, may be increased to 8 mg once daily. Max 16 mg/day.
Stable Coronary Artery Disease: Initial 4 mg once daily for 2 weeks, then increase to 8 mg once daily.
Heart Failure: Initial 2 mg once daily, may be increased to 4 mg once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (Safety and efficacy not established in pediatric patients. Use generally not recommended.)
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: CrCl > 60 mL/min: No adjustment.
Moderate: CrCl 30-60 mL/min: Initial 2 mg once daily.
Severe: CrCl < 30 mL/min: Initial 2 mg every other day.
Dialysis: Perindoprilat is dialyzable. Administer 2 mg on dialysis days. Monitor blood pressure and renal function closely.

Hepatic Impairment:

Mild: No dose adjustment needed, but monitor closely.
Moderate: No dose adjustment needed, but monitor closely.
Severe: Not well studied; use with caution and monitor closely.

Pharmacology

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Mechanism of Action

Perindopril is a prodrug that is hydrolyzed to its active metabolite, perindoprilat. Perindoprilat inhibits the angiotensin-converting enzyme (ACE), which catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasoconstriction, decreased aldosterone secretion (resulting in increased sodium and water excretion and decreased potassium excretion), and increased plasma renin activity. ACE also degrades bradykinin, a vasodilator peptide; thus, ACE inhibition leads to increased levels of bradykinin, which may contribute to the hypotensive effect and the common side effect of cough.
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Pharmacokinetics

Absorption:

Bioavailability: 65-70% (of perindoprilat from perindopril)
Tmax: Perindopril: 1 hour; Perindoprilat: 3-7 hours
FoodEffect: Food decreases the rate and extent of conversion of perindopril to perindoprilat. It is recommended to take perindopril before meals.

Distribution:

Vd: Not available (Perindoprilat: ~0.2 L/kg)
ProteinBinding: < 30% (Perindoprilat)
CnssPenetration: Limited

Elimination:

HalfLife: Perindopril: 1 hour; Perindoprilat: ~25-30 hours (terminal elimination half-life)
Clearance: Not available
ExcretionRoute: Renal (primarily as perindoprilat)
Unchanged: Not available (Perindoprilat is primarily excreted unchanged in urine)
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour
PeakEffect: 3-7 hours
DurationOfAction: 24 hours

Safety & Warnings

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BLACK BOX WARNING

FETAL TOXICITY: 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.
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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of high potassium levels, such as:
+ Abnormal heartbeat
+ Confusion
+ Weakness, lightheadedness, or dizziness
+ Feeling like passing out
+ Numbness or tingling
+ Shortness of breath
Severe dizziness or fainting
Persistent cough
Severe stomach pain
Severe nausea or vomiting
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Stomach pain or upset
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)
Signs of infection, such as:
+ Fever
+ Chills
+ Sore throat

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects or any other symptoms that concern you, contact your doctor:

Cough
Dizziness
Back pain

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Swelling of the face, lips, tongue, or throat (angioedema) - seek emergency medical attention.
  • Severe dizziness or fainting (signs of low blood pressure).
  • Persistent dry cough.
  • Yellowing of the skin or eyes (jaundice), dark urine, or severe stomach pain (signs of liver problems).
  • Signs of high potassium (muscle weakness, slow or irregular heartbeat).
  • Signs of infection (fever, sore throat) - rare, but report immediately.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a history of angioedema, a severe and potentially life-threatening reaction characterized by symptoms such as swelling of the hands, face, lips, eyes, tongue, or throat, difficulty breathing, swallowing problems, or unusual hoarseness.
If you have kidney disease, as this may affect how your body processes the medication.
If you are currently taking a medication that contains aliskiren and you also have diabetes or kidney problems, as this combination may increase your risk of adverse effects.
* If you have taken a medication containing sacubitril within the last 36 hours, as this may interact with the new medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and be cautious when climbing stairs.

Monitoring Your Condition
Regularly check your blood pressure as directed by your healthcare provider. Additionally, have your blood work and other laboratory tests done as scheduled by your doctor.

Interactions with Other Substances
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult with your doctor. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor.

Over-the-Counter (OTC) Products and Interactions
If you have high blood pressure and are taking this medication, talk to your doctor before using OTC products that may increase blood pressure, such as cough or cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Alcohol Consumption
Discuss your alcohol consumption with your doctor before drinking.

Hot Weather and Physical Activity
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions may lead to low blood pressure.

Effectiveness in Black Patients
This medication may be less effective in lowering blood pressure in Black patients. In some cases, another medication may be necessary in combination with this drug. If you have questions, consult with your doctor.

Risk of Angioedema
A severe and potentially life-threatening reaction called angioedema has been reported. The risk of angioedema may be higher in Black patients.

Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (low blood pressure)
  • Shock
  • Stupor
  • Bradycardia (slow heart rate)
  • Electrolyte disturbances (e.g., hyperkalemia)
  • Renal failure

What to Do:

Call 1-800-222-1222 (Poison Control Center) or seek immediate medical attention. Treatment is symptomatic and supportive. If ingestion is recent, gastric lavage may be considered. Intravenous fluids and vasopressors may be used for hypotension. Atropine for bradycardia. Hemodialysis can remove perindoprilat from circulation.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment (GFR < 60 mL/min/1.73 m²))
  • Sacubitril/Valsartan (Entresto) - concomitant use or within 36 hours of switching due to increased risk of angioedema.
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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) and potassium supplements: Increased risk of hyperkalemia.
  • Lithium: Increased serum lithium levels and symptoms of lithium toxicity.
  • NSAIDs (including selective COX-2 inhibitors): May reduce the antihypertensive effect of ACE inhibitors and increase the risk of renal impairment, including acute renal failure, and hyperkalemia.
  • mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus): Increased risk of angioedema.
  • Racecadotril: Increased risk of angioedema.
  • Gold (sodium aurothiomalate): Nitritoid reactions (flushing, nausea, vomiting, hypotension) have been reported rarely in patients receiving concomitant gold by injection and ACE inhibitor therapy.
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Moderate Interactions

  • Diuretics (thiazide or loop): Enhanced hypotensive effect, especially with initial doses of perindopril. May require dose reduction of diuretic or perindopril.
  • Other antihypertensives: Additive hypotensive effects.
  • Antidiabetic agents (insulin, oral hypoglycemics): Increased risk of hypoglycemia, especially at the start of ACE inhibitor therapy or in patients with renal impairment.
  • Allopurinol: Increased risk of hypersensitivity reactions.
  • Immunosuppressants, corticosteroids, procainamide, cytostatics: Increased risk of leukopenia/agranulocytosis.
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Minor Interactions

  • Alcohol: May enhance hypotensive effect.

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess the need for therapy.

Timing: Prior to initiation of therapy.

Serum Creatinine (Cr) and Blood Urea Nitrogen (BUN)

Rationale: To assess baseline renal function, as perindopril is renally eliminated and can affect renal function.

Timing: Prior to initiation of therapy.

Serum Potassium (K+)

Rationale: To establish baseline and monitor for hyperkalemia, a potential side effect of ACE inhibitors.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially after dose adjustments, then periodically (e.g., monthly for first few months, then every 3-6 months).

Target: <130/80 mmHg (or individualized target)

Action Threshold: Persistent hypotension (<90/60 mmHg) or uncontrolled hypertension (above target).

Serum Creatinine (Cr) and Blood Urea Nitrogen (BUN)

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months) or as clinically indicated.

Target: Stable or within acceptable limits (e.g., <30% increase from baseline).

Action Threshold: Significant increase in Cr (>30% from baseline or rapid rise), indicating potential renal impairment; consider dose adjustment or discontinuation.

Serum Potassium (K+)

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months) or as clinically indicated, especially in patients with renal impairment, diabetes, or those on potassium-sparing diuretics.

Target: 3.5-5.0 mEq/L

Action Threshold: Hyperkalemia (>5.5 mEq/L); consider dose adjustment, discontinuation, or management of hyperkalemia.

Complete Blood Count (CBC)

Frequency: Periodically, especially in patients with renal impairment or collagen vascular disease, or those on other medications that may affect blood counts.

Target: Within normal limits

Action Threshold: Significant decrease in white blood cell count (leukopenia/neutropenia); consider discontinuation.

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Symptom Monitoring

  • Signs of angioedema (swelling of face, lips, tongue, glottis, larynx, extremities)
  • Persistent dry cough
  • Symptoms of hypotension (dizziness, lightheadedness, fainting)
  • Symptoms of hyperkalemia (muscle weakness, fatigue, irregular heartbeat)
  • Signs of infection (fever, sore throat) due to potential neutropenia
  • Symptoms of liver dysfunction (jaundice, dark urine, abdominal pain)

Special Patient Groups

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Pregnancy

Contraindicated during the second and third trimesters of pregnancy due to significant risk of fetal injury and death. Use in the first trimester is generally avoided due to potential risks.

Trimester-Specific Risks:

First Trimester: Limited human data, but potential for teratogenicity cannot be excluded. Generally avoided.
Second Trimester: Significant risk of fetal injury (e.g., oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, renal failure) and death.
Third Trimester: Significant risk of fetal injury (e.g., oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, renal failure) and death. Neonatal hypotension, hyperkalemia, and renal failure may occur.
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Lactation

Not recommended. Perindopril and its active metabolite are excreted in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Potential for hypotension, hyperkalemia, and renal dysfunction in the infant.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients. Use is generally not recommended.

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Geriatric Use

No overall differences in effectiveness or safety have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses (e.g., 2 mg once daily) and titrate slowly, monitoring renal function and potassium closely, due to increased likelihood of decreased renal function.

Clinical Information

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Clinical Pearls

  • Perindopril is a prodrug; its active metabolite is perindoprilat.
  • Take perindopril before meals, as food can decrease its absorption.
  • A common side effect is a persistent dry cough, which is a class effect of ACE inhibitors and usually resolves upon discontinuation.
  • Monitor for angioedema, a rare but potentially life-threatening side effect, especially in the first few weeks of therapy.
  • Avoid concomitant use with potassium supplements or potassium-sparing diuretics due to the risk of hyperkalemia.
  • Caution with NSAIDs due to potential for reduced antihypertensive effect and increased risk of renal impairment.
  • Contraindicated with aliskiren in diabetic patients or those with renal impairment.
  • Contraindicated with sacubitril/valsartan due to increased angioedema risk.
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Alternative Therapies

  • Other ACE inhibitors (e.g., Lisinopril, Enalapril, Ramipril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan, Candesartan)
  • Calcium Channel Blockers (CCBs) (e.g., Amlodipine, Nifedipine)
  • Thiazide Diuretics (e.g., Hydrochlorothiazide)
  • Beta-blockers (e.g., Metoprolol, Carvedilol)
  • Direct Renin Inhibitors (e.g., Aliskiren - limited use)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.