Perindopril 2mg Tablets

Manufacturer AUROBINDO PHARMA 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
Not applicable (new FDA labeling system advises against use in 2nd/3rd trimesters due to fetal toxicity)
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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, heart failure, and to reduce the risk of heart problems in people with stable coronary artery disease. It works by relaxing blood vessels, which helps blood 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.

Staying Hydrated

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

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom.
Keep all medications in a safe and secure location, out of the 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 have questions about disposing 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.
If it's close to the time for your next dose, skip the missed dose and resume your regular 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

  • Continue to follow a low-sodium diet as recommended by your doctor.
  • Engage in regular physical activity.
  • Limit alcohol intake.
  • Quit smoking.
  • Monitor your blood pressure regularly at home as advised by your doctor.
  • Avoid potassium-rich salt substitutes unless approved by 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. Heart Failure: Initial 2 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 8-16 mg once daily.
Heart Failure: Initial 2 mg once daily, target 4 mg once daily.
Stable Coronary Artery Disease: Initial 4 mg once daily for 2 weeks, then 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: No adjustment needed.
Moderate: CrCl 30-60 mL/min: Initial 2 mg once daily.
Severe: CrCl < 30 mL/min: Initial 2 mg every other day.
Dialysis: 2 mg on dialysis days (administer after dialysis).

Hepatic Impairment:

Mild: No initial dose adjustment, but monitor closely.
Moderate: No initial dose adjustment, but monitor closely.
Severe: Not well studied; use with caution and close monitoring, or avoid.

Pharmacology

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Mechanism of Action

Perindopril is a prodrug that is hydrolyzed to perindoprilat, an active metabolite. Perindoprilat inhibits angiotensin-converting enzyme (ACE), which prevents the conversion of angiotensin I to angiotensin II. This leads to decreased vasoconstriction, reduced aldosterone secretion (resulting in decreased sodium and water retention), and potentiation of bradykinin (leading to vasodilation). These actions result in reduced peripheral vascular resistance, decreased blood pressure, and reduced cardiac preload and afterload.
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Pharmacokinetics

Absorption:

Bioavailability: Perindoprilat (from perindopril) approximately 25%
Tmax: Perindopril: 1 hour; Perindoprilat: 3-7 hours
FoodEffect: Food decreases the extent and rate of perindoprilat formation, but the clinical significance is minor. It is recommended to take perindopril before meals.

Distribution:

Vd: Perindoprilat: Approximately 0.2 L/kg
ProteinBinding: Perindopril: 10-20%; Perindoprilat: Approximately 60%
CnssPenetration: Limited

Elimination:

HalfLife: Perindopril: Approximately 1 hour; Perindoprilat: Approximately 17 hours (effective half-life due to tissue binding)
Clearance: Primarily renal clearance for perindoprilat
ExcretionRoute: Renal
Unchanged: Perindoprilat is largely excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour
PeakEffect: 6-12 hours
DurationOfAction: Approximately 24 hours

Safety & Warnings

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BLACK BOX WARNING

FETAL TOXICITY: When pregnancy is detected, discontinue perindopril 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 immediate medical attention:

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
Liver problems, which may be indicated by:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Stomach pain or upset
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)
Signs of low white blood cell count, such as:
+ Fever
+ Chills
+ Sore throat

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Cough
Dizziness
Back pain

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact 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.
  • Difficulty breathing or swallowing.
  • Severe dizziness or fainting.
  • Persistent dry cough that does not go away.
  • Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat).
  • Signs of kidney problems (e.g., decreased urination, swelling in ankles or feet).
  • Yellowing of the skin or eyes (jaundice).
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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 your ability to take this medication.
If you are currently taking a medication that contains aliskiren and you also have diabetes or kidney problems.
* If you have taken a medication containing sacubitril within the last 36 hours.

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 health conditions and medications. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Precautions

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, rise slowly from a sitting or lying position, and exercise caution when climbing stairs.

Monitoring and Maintenance
Regularly check your blood pressure as directed by your healthcare provider. Additionally, have your blood work and other laboratory tests performed 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, consult with 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 while taking this medication.

Heat and Fluid Loss
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 and Ethnicity
This medication may be less effective in lowering blood pressure in Black patients. In some cases, an additional medication may be necessary. If you have questions or concerns, discuss them with your doctor.

Angioedema Warning
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. Inform your doctor if you are breastfeeding, as you will need to discuss potential risks to your baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

If overdose is suspected, seek emergency medical attention immediately. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic, including intravenous fluids for hypotension and hemodialysis to remove perindoprilat.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment (CrCl <60 mL/min))
  • Sacubitril/valsartan (Entresto) (concomitant use or within 36 hours of last dose of sacubitril/valsartan 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 toxicity)
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (including selective COX-2 inhibitors) (may reduce antihypertensive effect, increase risk of renal impairment and hyperkalemia)
  • mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) (increased risk of angioedema)
  • Racecadotril (increased risk of angioedema)
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Moderate Interactions

  • Diuretics (increased risk of symptomatic hypotension, especially with initial doses)
  • Other antihypertensive agents (additive hypotensive effect)
  • Antidiabetic agents (insulin, oral hypoglycemics) (increased risk of hypoglycemia)
  • Gold (parenteral) (nitritoid reactions including flushing, nausea, vomiting, hypotension)
  • Tricyclic antidepressants, antipsychotics, anesthetics (increased hypotensive effect)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation of therapy.

Serum Creatinine (SCr) 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 assess baseline potassium levels, as ACE inhibitors can cause hyperkalemia.

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, every 3-6 months) once stable.

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

Action Threshold: Persistent high BP (consider dose increase or add-on therapy); symptomatic hypotension (consider dose reduction or discontinuation).

Serum Creatinine (SCr) 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: Within patient's baseline range; monitor for significant increases.

Action Threshold: Increase in SCr >30% from baseline or significant decline in GFR (consider dose reduction, discontinuation, or investigation for renal artery stenosis).

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 or on potassium-sparing diuretics.

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

  • Angioedema (swelling of face, lips, tongue, glottis, larynx, extremities)
  • Persistent dry cough
  • Dizziness or lightheadedness (especially upon standing, indicative of hypotension)
  • Signs of hyperkalemia (e.g., muscle weakness, fatigue, paresthesias, cardiac arrhythmias)
  • Signs of renal dysfunction (e.g., decreased urine output, edema)

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. Discontinue as soon as pregnancy is detected. Use in the first trimester is generally avoided due to potential risks.

Trimester-Specific Risks:

First Trimester: Limited human data, but potential for fetal harm cannot be excluded. Generally avoided.
Second Trimester: Significant risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations) and death.
Third Trimester: Significant risk of fetal injury (e.g., renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations) and death.
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Lactation

Perindopril and its active metabolite perindoprilat are excreted into breast milk in small amounts. Due to potential for serious adverse effects in the infant (e.g., hypotension, hyperkalemia, renal impairment), use is generally not recommended. Consider an alternative drug with a better safety profile during lactation.

Infant Risk: Low to moderate risk; potential for hypotension, hyperkalemia, and renal effects in the infant. Monitor infant for adverse effects.
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Pediatric Use

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

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Geriatric Use

No overall differences in safety or effectiveness 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, especially in those with impaired renal function. Monitor renal function and potassium closely.

Clinical Information

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Clinical Pearls

  • Perindopril is a prodrug; its active metabolite is perindoprilat.
  • First-dose hypotension can occur, especially in patients who are volume-depleted (e.g., on diuretics, salt-restricted diet). Consider discontinuing diuretics 2-3 days prior to initiation if possible, or start with a very low dose (e.g., 2 mg).
  • A persistent dry cough is a common side effect of ACE inhibitors, occurring in up to 20% of patients. It typically resolves within days to weeks after discontinuation.
  • Monitor for angioedema, a rare but potentially life-threatening side effect. It can occur at any time during therapy.
  • Avoid concomitant use with sacubitril/valsartan (Entresto) due to increased risk of angioedema; a 36-hour washout period is required between drugs.
  • Hyperkalemia risk is increased with potassium-sparing diuretics, potassium supplements, NSAIDs, and in patients with renal impairment or diabetes.
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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)
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Cost & Coverage

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

If your symptoms or health issues persist or worsen, it's 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 be sure 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.