Accupril 10mg 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
D
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FDA Approved
Oct 1991
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Quinapril is a medication used to treat high blood pressure (hypertension) and heart failure. It belongs to a class of drugs called ACE inhibitors, which work by relaxing blood vessels, making it easier for blood to flow and lowering blood pressure.
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How to Use This Medicine

Taking Your Medication

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

Take your medication exactly as directed by your doctor.
Read all the information provided with your medication and follow the instructions carefully.
You can take your medication with or without food.
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 to feel 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, away from light and moisture.
Keep your medication in a dry place, such as a closet or drawer, and avoid storing it in the bathroom.
Keep all medications out of the reach of children and pets to prevent accidental ingestion.
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. Instead, check with your pharmacist for guidance on the best way to dispose of your medication. You may also want to explore local 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.
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 dose.
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Lifestyle & Tips

  • Follow a low-sodium diet as recommended by your doctor.
  • Engage in regular physical activity.
  • Maintain a healthy weight.
  • Limit alcohol consumption.
  • Quit smoking.
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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: 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; maintenance 20-40 mg/day in 1-2 divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established (Safety and efficacy not established in pediatric patients <16 years for hypertension.)
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Dose Adjustments

Renal Impairment:

Mild: No adjustment (CrCl >60 mL/min)
Moderate: Initial 5 mg once daily (CrCl 30-60 mL/min)
Severe: Initial 2.5 mg once daily (CrCl <30 mL/min)
Dialysis: Initial 2.5 mg once daily; administer after dialysis (quinaprilat is dialyzable).

Hepatic Impairment:

Mild: No specific adjustment recommended, use with caution.
Moderate: No specific adjustment recommended, use with caution.
Severe: No specific adjustment recommended, use with caution.

Pharmacology

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Mechanism of Action

Quinapril is a prodrug that is hydrolyzed to quinaprilat, an angiotensin-converting enzyme (ACE) inhibitor. It blocks the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor and aldosterone secretor. This leads to vasodilation, decreased aldosterone secretion (reducing sodium and water retention), and reduced bradykinin degradation (contributing to vasodilation and cough).
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Pharmacokinetics

Absorption:

Bioavailability: ~60% (of quinaprilat from quinapril)
Tmax: Quinapril: ~1 hour; Quinaprilat: ~2 hours
FoodEffect: Food may delay absorption but does not significantly affect the extent of absorption.

Distribution:

Vd: Not available
ProteinBinding: Quinapril: ~97%; Quinaprilat: ~97%
CnssPenetration: Limited

Elimination:

HalfLife: Quinapril: ~1 hour; Quinaprilat: ~2-3 hours (effective half-life ~10 hours due to tight ACE binding)
Clearance: Primarily renal
ExcretionRoute: Urine (60% as quinaprilat), Feces (37% as quinaprilat)
Unchanged: <5% (quinapril)
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Pharmacodynamics

OnsetOfAction: ~1 hour
PeakEffect: 2-4 hours
DurationOfAction: 24 hours

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

Most people experience 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 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:

  • Sudden swelling of the face, lips, tongue, or throat (angioedema) - seek immediate medical attention.
  • Severe dizziness or fainting, especially when standing up.
  • Persistent dry cough.
  • Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat).
  • Signs of kidney problems (e.g., decreased urination, swelling in ankles/feet).
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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 swelling of the hands, face, lips, eyes, tongue, or throat, difficulty breathing, swallowing problems, or unusual hoarseness.
If you are undergoing any of the following treatments: apheresis, dialysis, or hemofiltration.
If you are currently taking any of the following medications: aliskiren, azilsartan, candesartan, eprosartan, irbesartan, losartan, olmesartan, telmisartan, or 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. This will help ensure your safety while taking this medication. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
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Precautions & Cautions

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

When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.

Follow your doctor's instructions for monitoring your blood pressure and undergo blood tests as recommended. Discuss your test results with your doctor.

If you are using a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium supplement, consult your doctor. Similarly, if you are on a low-sodium or sodium-free diet, discuss this with your doctor.

If you have high blood pressure and are taking this medication, consult your doctor before using over-the-counter 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.

Discuss alcohol consumption with your doctor before drinking. In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration. Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these conditions may lead to low blood pressure.

It is crucial 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. If you have questions or concerns, discuss them with your doctor.

A severe and potentially life-threatening reaction called angioedema has been reported, with a higher risk observed in Black patients. If you are breastfeeding, consult your doctor to discuss potential risks to your baby.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (low blood pressure)
  • Shock
  • Stupor
  • Bradycardia (slow heart rate)
  • Electrolyte disturbances
  • Renal failure

What to Do:

Call 1-800-222-1222 (Poison Control) or seek emergency medical attention immediately.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment)
  • Sacubitril/Valsartan (Entresto) - within 36 hours of last dose of ACE inhibitor
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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
  • Potassium supplements
  • Lithium
  • NSAIDs (Nonsteroidal Anti-inflammatory Drugs)
  • Gold injections (e.g., sodium aurothiomalate)
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Moderate Interactions

  • Diuretics (initial hypotension)
  • Other antihypertensives
  • Antacids (magnesium/aluminum hydroxide)
  • Tetracyclines

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation.

Serum creatinine

Rationale: To assess baseline renal function.

Timing: Prior to initiation.

Serum potassium

Rationale: To assess baseline electrolyte status.

Timing: Prior to initiation.

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Routine Monitoring

Blood pressure

Frequency: Regularly, especially after dose changes and during titration.

Target: <130/80 mmHg or individualized target.

Action Threshold: Persistent hypertension or symptomatic hypotension.

Serum creatinine

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., <1.5 mg/dL or <30% increase from baseline).

Action Threshold: Significant increase (>30% from baseline or above upper limit of normal), indicating potential renal impairment.

Serum potassium

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: Hyperkalemia (>5.5 mEq/L).

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Symptom Monitoring

  • Persistent dry cough
  • Swelling of face, lips, tongue, or throat (angioedema)
  • Dizziness or lightheadedness (especially upon standing)
  • Fatigue
  • Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
  • Signs of kidney problems (e.g., decreased urination, swelling in ankles/feet)

Special Patient Groups

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Pregnancy

Contraindicated in the 2nd and 3rd trimesters due to significant risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the 1st trimester is generally avoided due to potential, though less clear, risks.

Trimester-Specific Risks:

First Trimester: Potential risk, generally avoided. Limited human data, but animal data suggest risk.
Second Trimester: High risk of fetal injury including renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, and death.
Third Trimester: High risk of fetal injury including renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, and death.
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Lactation

Quinapril and its active metabolite quinaprilat are excreted in breast milk. Use with caution. Monitor infant for adverse effects (e.g., hypotension, bradycardia, hyperkalemia).

Infant Risk: Low to moderate risk. Monitor for signs of hypotension, bradycardia, or hyperkalemia in the infant.
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Pediatric Use

Safety and efficacy have not been established in pediatric patients <16 years for hypertension. Limited data exist for heart failure. Use is generally not recommended.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between older and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses and titrate carefully due to potential for greater sensitivity to hypotensive effects and age-related decline in renal function.

Clinical Information

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Clinical Pearls

  • ACE inhibitors are a common cause of a persistent, dry cough, which usually resolves upon discontinuation.
  • Angioedema is a rare but potentially life-threatening side effect; educate patients to seek immediate medical attention if they experience swelling of the face, lips, tongue, or throat.
  • Monitor potassium levels closely, especially in patients also taking potassium-sparing diuretics, potassium supplements, or those with renal impairment, due to the risk of hyperkalemia.
  • First-dose hypotension can occur, particularly in volume-depleted patients or those on high-dose diuretics. Consider administering the first dose at bedtime or under medical supervision.
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Alternative Therapies

  • Other Angiotensin-Converting Enzyme (ACE) Inhibitors (e.g., Lisinopril, Enalapril, Ramipril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan, Candesartan)
  • Beta-blockers
  • Calcium Channel Blockers
  • Diuretics (e.g., Thiazide diuretics, Loop diuretics)
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Cost & Coverage

Average Cost: $10-$50 (generic) per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2/3 (Brand, if available)
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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's a good idea to check with your pharmacist. 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.