Aceon 2mg Tablets

Manufacturer SOLVAY 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
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Pharmacologic Class
Angiotensin-Converting Enzyme (ACE) Inhibitor
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Pregnancy Category
Contraindicated in 2nd and 3rd trimesters (formerly Category D/X)
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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 used to treat high blood pressure and to help prevent heart problems in people with stable coronary artery disease. It works by relaxing blood vessels, which allows blood to flow more easily and lowers blood pressure.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow these guidelines:

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start feeling better.

It's also important to:

Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Storing and Disposing of Your Medication

To ensure your medication remains effective and safe:

Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a secure location, out of reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them 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 have access to drug take-back programs in your area.

What to Do If You Miss a Dose

If you miss a dose of your medication:

Take the missed dose as soon as you remember.
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 a missed dose.
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Lifestyle & Tips

  • Follow a low-sodium diet as recommended by your doctor.
  • Engage in regular physical activity.
  • Limit alcohol intake.
  • Avoid potassium-rich salt substitutes unless advised by your doctor.
  • Do not stop taking this medication suddenly without consulting your doctor.
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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. Stable Coronary Artery Disease: Initial 4 mg once daily for 2 weeks, then 8 mg once daily.
Dose Range: 2 - 16 mg

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: CrCl > 60 mL/min: 4 mg once daily
Moderate: CrCl 30-60 mL/min: 2 mg once daily
Severe: CrCl 15-29 mL/min: 2 mg every other day
Dialysis: CrCl < 15 mL/min: 2 mg on dialysis days. Administer after dialysis.

Hepatic Impairment:

Mild: No dosage adjustment generally needed, but monitor closely.
Moderate: No dosage adjustment generally needed, but monitor closely.
Severe: Not available (use with caution, monitor closely)

Pharmacology

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Mechanism of Action

Perindopril is a prodrug that is hydrolyzed to perindoprilat, an active angiotensin-converting enzyme (ACE) inhibitor. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. 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 potent vasodilator; thus, ACE inhibition leads to increased levels of bradykinin, contributing to the hypotensive effect.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 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. Administer before meals.

Distribution:

Vd: Not widely distributed (perindoprilat)
ProteinBinding: Perindoprilat: < 30%
CnssPenetration: Limited

Elimination:

HalfLife: Perindopril: ~1 hour; Perindoprilat: 3-10 hours (effective half-life); Terminal half-life of perindoprilat: ~25-30 hours (due to slow dissociation from ACE)
Clearance: Primarily renal clearance of perindoprilat
ExcretionRoute: Renal (primarily as perindoprilat and its glucuronide)
Unchanged: Not available (minimal unchanged perindopril)
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour
PeakEffect: 6-8 hours
DurationOfAction: 24 hours

Safety & Warnings

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BLACK BOX WARNING

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 Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

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 experience either no side effects or only mild ones. However, if you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Cough
Dizziness
Back pain

This is not an exhaustive list of possible side effects. If you have 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 immediately.
  • Severe dizziness or fainting (signs of low blood pressure).
  • Persistent dry cough that does not go away.
  • Signs of high potassium (muscle weakness, slow or irregular heartbeat).
  • Signs of kidney problems (little or no urination, swelling in your feet or ankles, feeling tired or short of breath).
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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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
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.
Kidney disease, as this condition may affect how your body processes the medication.
If you are taking a medication containing aliskiren, particularly if you have diabetes or kidney problems, as this combination may increase the risk of adverse effects.
* If you have taken a medication containing sacubitril within the last 36 hours, as this may interact with the current 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 if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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 understand 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 instructed by your healthcare provider. Additionally, have your blood work and other laboratory tests done as recommended 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.

Precautions in 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 any questions or concerns, 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 for Older Adults and Breastfeeding Mothers
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 (dizziness, lightheadedness, fainting)
  • Bradycardia (slow heart rate)
  • Electrolyte disturbances (e.g., hyperkalemia)
  • Renal failure

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is symptomatic and supportive. If ingestion is recent, gastric lavage may be considered. Intravenous saline infusion may be used to correct hypotension. Perindoprilat can be removed by hemodialysis.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment)
  • Sacubitril/valsartan (Entresto) - do not co-administer within 36 hours of switching to or from an ACE inhibitor
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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
  • Potassium supplements
  • NSAIDs (Nonsteroidal Anti-inflammatory Drugs) - increased risk of renal impairment and reduced antihypertensive effect
  • Lithium - increased serum lithium levels and toxicity
  • mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema
  • Racecadotril - increased risk of angioedema
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Moderate Interactions

  • Diuretics (thiazide or loop) - risk of excessive hypotension, especially with initial dose
  • Antidiabetic agents (insulin, oral hypoglycemics) - increased risk of hypoglycemia
  • Gold (sodium aurothiomalate) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension) reported rarely
  • Corticosteroids - may reduce antihypertensive effect
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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 guide initial dosing.

Timing: Prior to initiation

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

Serum Potassium (K+)

Rationale: To assess baseline potassium levels, as ACE inhibitors can cause hyperkalemia.

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially after dose adjustments

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

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

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, within normal limits or acceptable baseline variation

Action Threshold: Increase in Cr > 30% from baseline or significant decline in GFR; consider dose reduction 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 with concomitant medications (e.g., diuretics, potassium supplements).

Target: 3.5-5.0 mEq/L

Action Threshold: K+ > 5.5 mEq/L; consider dose reduction, discontinuation, or management of hyperkalemia.

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Symptom Monitoring

  • Signs of angioedema (swelling of face, lips, tongue, glottis, larynx, extremities)
  • Symptoms of hypotension (dizziness, lightheadedness, syncope)
  • Persistent dry cough
  • Signs of hyperkalemia (muscle weakness, fatigue, paresthesias, cardiac arrhythmias)
  • Symptoms of renal dysfunction (decreased urine output, edema)

Special Patient Groups

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Pregnancy

Contraindicated during the second and third trimesters of pregnancy due to risk of fetal injury and death. Discontinue as soon as pregnancy is detected.

Trimester-Specific Risks:

First Trimester: Limited human data, but potential risk cannot be excluded. Generally, avoid if possible.
Second Trimester: Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Third Trimester: Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death. Neonatal hypotension, anuria, and death may occur.
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Lactation

Not recommended during breastfeeding. Perindopril and its active metabolite perindoprilat are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, 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. Risk is considered low for healthy, full-term infants, but caution is advised.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. 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 carefully, monitoring renal function and potassium levels closely due to increased likelihood of impaired renal function.

Clinical Information

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Clinical Pearls

  • Administer perindopril once daily before meals, as food decreases the conversion to the active metabolite perindoprilat.
  • Monitor for first-dose hypotension, especially in patients who are volume-depleted (e.g., on diuretics, dialysis, or with heart failure). Consider discontinuing diuretics 2-3 days prior to initiation if possible.
  • A persistent dry, non-productive cough is a common side effect of ACE inhibitors and typically resolves upon discontinuation.
  • Angioedema (swelling of the face, lips, tongue, glottis, and/or larynx) is a rare but potentially life-threatening side effect. Patients should be educated on symptoms and instructed to seek immediate medical attention if it occurs.
  • Risk of hyperkalemia is increased with concomitant use of potassium-sparing diuretics, potassium supplements, NSAIDs, or in patients with renal impairment or diabetes.
  • Perindopril is a good option for patients with stable coronary artery disease due to its proven cardiovascular benefits beyond blood pressure lowering.
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Alternative Therapies

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

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

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.