Accupril 20mg Tablets

Manufacturer PFIZER Active Ingredient Quinapril(KWIN a pril) Pronunciation KWIN-a-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 treat heart failure (weak heart).It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive, Heart Failure Agent
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Pharmacologic Class
Angiotensin-Converting Enzyme (ACE) Inhibitor
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Pregnancy Category
Contraindicated in pregnancy (formerly D in 2nd/3rd trimester, C in 1st trimester)
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FDA Approved
Dec 1991
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Accupril (quinapril) is a medication used to treat high blood pressure (hypertension) and heart failure. It belongs to a class of drugs called ACE inhibitors. It works by relaxing blood vessels, which helps lower blood pressure and makes it easier for your heart to pump blood.
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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. You can take this medication with or without food, and it's best to take it at the same time every day. Continue taking your medication as directed by your doctor or healthcare provider, even if you're feeling well.

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, protected from light, and in a dry place. Avoid storing it in a bathroom. Keep all medications in a secure location, out of the reach of children and pets. When you're finished with your medication or it's 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 how to dispose of your medication, consult with your pharmacist, who may be aware of 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 a missed one.
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Lifestyle & Tips

  • Take medication exactly as prescribed, usually once or twice daily.
  • Do not stop taking the medication without consulting your doctor, even if you feel well.
  • 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 sodium), regular exercise, and manage stress to support blood pressure control.
  • Inform your doctor or dentist that you are taking quinapril before any surgery or dental procedures.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 10-20 mg once daily. Heart Failure: Initial 5 mg twice daily.
Dose Range: 5 - 80 mg

Condition-Specific Dosing:

Hypertension: Initial: 10-20 mg once daily. Maintenance: 20-80 mg/day in 1-2 divided doses.
Heart Failure: Initial: 5 mg twice daily. Titrate to 20-40 mg/day in 1-2 divided doses.
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Pediatric Dosing

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

Renal Impairment:

Mild: CrCl > 60 mL/min: No adjustment needed.
Moderate: CrCl 30-60 mL/min: Initial dose 5 mg once daily. Titrate cautiously.
Severe: CrCl < 30 mL/min: Initial dose 2.5 mg once daily. Titrate cautiously.
Dialysis: Quinaprilat is dialyzable. Administer after dialysis on dialysis days. Initial dose 2.5 mg once daily.

Hepatic Impairment:

Mild: No specific adjustment recommended, but use with caution due to prodrug activation.
Moderate: No specific adjustment recommended, but use with caution due to prodrug activation.
Severe: No specific adjustment recommended, but use with caution due to prodrug activation.

Pharmacology

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Mechanism of Action

Quinapril is a prodrug that is hydrolyzed to quinaprilat, its active metabolite. Quinaprilat competitively inhibits angiotensin-converting enzyme (ACE), which is responsible for the conversion of angiotensin I to angiotensin II. Inhibition of ACE leads to decreased levels of angiotensin II, resulting in vasodilation (reduced peripheral vascular resistance), decreased aldosterone secretion (leading to increased sodium and water excretion and potassium retention), and reduced sympathetic nervous system activity. It also inhibits the degradation of bradykinin, a potent vasodilator, contributing to its antihypertensive effect and potentially to side effects like cough and angioedema.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 60% (as quinaprilat)
Tmax: Quinapril: 1 hour; Quinaprilat: 2 hours
FoodEffect: Food does not significantly affect absorption.

Distribution:

Vd: Not readily available for quinaprilat, but generally low (distributes into most body tissues)
ProteinBinding: Quinapril: Approximately 97%; Quinaprilat: Approximately 97%
CnssPenetration: Limited

Elimination:

HalfLife: Quinapril: Approximately 1 hour; Quinaprilat: Approximately 2-3 hours (effective half-life 10 hours due to slow dissociation from ACE)
Clearance: Primarily renal clearance for quinaprilat.
ExcretionRoute: Urine (approximately 60% as quinaprilat and other metabolites), Feces (approximately 37% as quinaprilat and other metabolites)
Unchanged: Less than 5% of quinapril is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour
PeakEffect: 2-4 hours
DurationOfAction: 24 hours (for once-daily dosing)

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue Accupril 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

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 attention:

Cough
* Dizziness

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 immediate medical attention.
  • Difficulty breathing or swallowing - Seek immediate medical attention.
  • Severe dizziness or fainting - Lie down and contact your doctor.
  • Persistent dry cough - Inform your doctor, as this is a common side effect.
  • Signs of infection like fever, chills, or sore throat - Contact your doctor.
  • Yellowing of the skin or eyes (jaundice), dark urine, or severe stomach pain - Contact your doctor.
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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. Describe the allergic reaction you experienced, including the 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
+ Trouble swallowing
+ Unusual hoarseness
If you are undergoing any of the following medical treatments:
+ Apheresis
+ Dialysis
+ Hemofiltration
If you are currently taking any of the following medications:
+ Aliskiren
+ Azilsartan
+ Candesartan
+ Eprosartan
+ Irbesartan
+ Losartan
+ Olmesartan
+ Telmisartan
+ Valsartan
* If you have taken a medication containing sacubitril within the last 36 hours

Please note that this is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

Important Information to Share with Your Healthcare Team

Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Precautions to Ensure Your Safety

To avoid accidents, do not drive or perform tasks that require alertness until you know how this medication affects you. When standing up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs.

Monitoring Your Condition

Check your blood pressure as directed by your healthcare provider. Additionally, have your blood work checked as instructed by your doctor and discuss the results with them.

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.

Special Considerations

If you have high blood pressure and are taking this medication, talk to your doctor before using over-the-counter (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. Also, consult with your doctor before consuming alcohol.

Staying Safe in Various Situations

In hot weather or during physical activity, be careful to avoid dehydration by drinking plenty of fluids. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions may lead to low blood pressure.

Effectiveness and Potential Risks

It is essential to note that this medication may be less effective in lowering blood pressure in Black patients. In some cases, an additional medication may be necessary. Discuss any concerns with your doctor.

Rare but Serious Reaction

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

Breastfeeding

If you are breastfeeding, consult with your doctor to discuss any potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (low blood pressure)
  • Dizziness
  • Lightheadedness
  • Fainting
  • Tachycardia (rapid heart rate)
  • Bradycardia (slow heart rate)
  • Renal failure

What to Do:

Call 911 or Poison Control (1-800-222-1222) immediately. Treatment is supportive, including intravenous fluid administration to restore blood pressure. Quinaprilat can be removed by hemodialysis.

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) - increased risk of hyperkalemia.
  • Potassium supplements - increased risk of hyperkalemia.
  • Lithium - increased serum lithium levels and toxicity.
  • NSAIDs (Nonsteroidal Anti-inflammatory Drugs) - may reduce antihypertensive effect and increase risk of renal impairment.
  • mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema.
  • Neprilysin inhibitors (e.g., sacubitril) - increased risk of angioedema.
  • Gold (sodium aurothiomalate) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension) reported rarely.
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Moderate Interactions

  • Diuretics (thiazide or loop) - increased risk of symptomatic hypotension, especially with initial doses.
  • Other antihypertensive agents - additive hypotensive effects.
  • Insulin and oral hypoglycemic agents - increased risk of hypoglycemia.
  • Trimethoprim - increased risk of hyperkalemia.
  • Cyclosporine - increased risk of hyperkalemia and renal dysfunction.
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Minor Interactions

  • Antacids (e.g., magnesium hydroxide, aluminum hydroxide) - may decrease quinapril absorption (administer at least 1 hour apart).

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and assess efficacy.

Timing: Prior to initiation.

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

Rationale: To assess renal function, as ACE inhibitors can cause acute renal dysfunction, especially in patients with pre-existing renal impairment or bilateral renal artery stenosis.

Timing: Prior to initiation.

Serum Potassium (K+)

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

Timing: Prior to initiation.

Complete Blood Count (CBC) with differential

Rationale: To assess for neutropenia/agranulocytosis, a rare but serious adverse effect, especially in patients with renal impairment or collagen vascular disease.

Timing: Prior to initiation (consider, especially in high-risk patients).

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially during dose titration and periodically thereafter.

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

Action Threshold: Symptomatic hypotension, or BP consistently outside target range.

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: Stable, within normal limits or acceptable baseline variation.

Action Threshold: Increase in SCr >30% from baseline, or significant decline in GFR.

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.

Target: 3.5-5.0 mEq/L

Action Threshold: K+ >5.5 mEq/L or symptomatic hyperkalemia.

Liver Function Tests (LFTs)

Frequency: Periodically, if clinically indicated (rare reports of hepatic failure).

Target: Within normal limits.

Action Threshold: Significant elevation of liver enzymes or signs of hepatic dysfunction.

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Symptom Monitoring

  • Persistent dry cough
  • Swelling of face, lips, tongue, or throat (angioedema)
  • Dizziness or lightheadedness (hypotension)
  • Fatigue or weakness
  • Signs of infection (fever, sore throat) - rare, but indicative of neutropenia
  • Yellowing of skin or eyes, dark urine, abdominal pain (signs of liver dysfunction)

Special Patient Groups

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Pregnancy

Contraindicated in pregnancy. ACE inhibitors can cause fetal and neonatal morbidity and death when administered to pregnant women. If pregnancy is detected, discontinue Accupril as soon as possible.

Trimester-Specific Risks:

First Trimester: Limited human data, but potential for major congenital malformations 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. Neonatal effects include hypotension, hyperkalemia, and renal failure.
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Lactation

Quinapril and its active metabolite quinaprilat are present in human milk. While levels are low, caution should be exercised. The American Academy of Pediatrics considers ACE inhibitors compatible with breastfeeding. Monitor breastfed infant for hypotension and adverse effects.

Infant Risk: Low risk, but monitor for signs of hypotension (e.g., lethargy, poor feeding) and hyperkalemia.
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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 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., 5 mg once daily) and titrate cautiously, especially if renal function is impaired.

Clinical Information

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Clinical Pearls

  • First-dose hypotension can occur, especially in patients who are volume-depleted (e.g., on diuretics, salt-restricted diet, or with heart failure). Consider discontinuing diuretics 2-3 days prior to initiation if possible, or starting with a very low dose.
  • Persistent dry cough is a common side effect of ACE inhibitors, occurring in up to 20% of patients. It is usually non-productive and resolves within days to weeks after discontinuation. If bothersome, consider switching to an ARB.
  • Angioedema is a rare but life-threatening side effect. Patients should be educated on the signs (swelling of face, lips, tongue, throat) and instructed to seek immediate medical attention if it occurs.
  • Monitor renal function and serum potassium regularly, especially in patients with pre-existing renal impairment, heart failure, or those on potassium-sparing diuretics or supplements.
  • Quinapril is a prodrug that requires hepatic activation. While severe hepatic impairment is rare, monitor liver function if clinically indicated.
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Alternative Therapies

  • Angiotensin Receptor Blockers (ARBs) e.g., Valsartan, Losartan, Candesartan (often used if ACEI cough occurs)
  • Beta-blockers e.g., Metoprolol, Carvedilol
  • Calcium Channel Blockers (CCBs) e.g., Amlodipine, Diltiazem
  • Thiazide diuretics e.g., Hydrochlorothiazide
  • Loop diuretics e.g., Furosemide (for heart failure with fluid overload)
  • Direct Renin Inhibitors e.g., Aliskiren (less common, contraindicated with ACEI in certain populations)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets
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'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 your medication, don't hesitate to reach out to 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.