Quinapril 40mg Tablets

Manufacturer SOLCO 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
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Pharmacologic Class
Angiotensin-Converting Enzyme (ACE) Inhibitor
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Pregnancy Category
Contraindicated in 2nd and 3rd trimesters; avoid 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?

Quinapril is a medicine used to treat high blood pressure (hypertension) and heart failure. It works by relaxing your blood vessels, which helps your heart pump blood more easily and lowers your blood pressure. This can reduce your risk of heart attack, stroke, and kidney problems.
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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, away from light and moisture. Avoid storing it in a bathroom, and keep it out of 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, ask your pharmacist for guidance. 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 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 one.
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Lifestyle & Tips

  • Take Quinapril exactly as prescribed, usually once or twice a day.
  • Do not stop taking this medication without talking to your doctor, even if you feel well.
  • Follow a low-sodium diet as recommended by your doctor or dietitian.
  • Engage in regular physical activity as advised by your healthcare provider.
  • Limit alcohol intake.
  • Avoid smoking.
  • Check your blood pressure regularly at home if advised by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: For Hypertension: 40 mg once daily. For Heart Failure: 20 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 up to 20-40 mg/day in 2 divided doses.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (limited data for hypertension in children, 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 5 mg once daily.
Severe: CrCl 10-30 mL/min: Initial 2.5 mg once daily.
Dialysis: Quinaprilat is dialyzable; administer after dialysis on dialysis days. Use with caution, consider lower initial dose (2.5 mg).

Hepatic Impairment:

Mild: No specific adjustment, monitor closely.
Moderate: No specific adjustment, monitor closely.
Severe: No specific adjustment, monitor closely.

Pharmacology

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Mechanism of Action

Quinapril is a prodrug that is hydrolyzed to quinaprilat, its active metabolite. Quinaprilat inhibits angiotensin-converting enzyme (ACE), which prevents the conversion of angiotensin I to angiotensin II. This inhibition leads to decreased levels of angiotensin II, resulting in vasodilation, reduced aldosterone secretion (leading to decreased sodium and water retention), and reduced sympathetic nervous system activity. ACE inhibition also increases levels of bradykinin, a potent vasodilator, which contributes to the antihypertensive effect and may be responsible for the common side effect of cough.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Quinaprilat: Approximately 120 L
ProteinBinding: Quinaprilat: Approximately 97%
CnssPenetration: Limited

Elimination:

HalfLife: Quinapril: Approximately 1 hour; Quinaprilat: Approximately 2-3 hours (effective accumulation half-life is approximately 25 hours due to tissue binding)
Clearance: Not available (primarily renal and hepatic)
ExcretionRoute: Renal (approximately 60-65% as quinaprilat and other metabolites), Hepatic/Biliary (approximately 30-40%)
Unchanged: <5% (quinapril)
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Pharmacodynamics

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

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue Quinapril 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 list is not exhaustive, and you may experience other 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) - this is a serious allergic reaction and requires immediate medical attention (call 911 or go to the nearest emergency room).
  • Severe dizziness or fainting, especially when standing up.
  • Persistent dry cough (common, but report to your doctor if bothersome).
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems).
  • Signs of high potassium (hyperkalemia) such as muscle weakness, slow or irregular heartbeat.
  • Signs of infection like fever or 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. 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 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 medical 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 (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Do not initiate, discontinue, or modify the dosage 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, rise slowly from a sitting or lying position, 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 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 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 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
- Certain natural products or aids

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

Precautions in Hot Weather
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, an additional medication may be necessary. If you have questions or concerns, discuss them 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.

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

Overdose Symptoms:

  • Severe hypotension (low blood pressure) leading to dizziness, lightheadedness, or fainting.
  • Tachycardia (rapid heart rate) or bradycardia (slow heart rate).
  • Electrolyte disturbances (e.g., hyperkalemia).
  • Renal failure.

What to Do:

In case of suspected overdose, seek immediate medical attention. Call your local poison control center (e.g., 1-800-222-1222 in the US) or go to the nearest emergency room. Treatment is supportive and symptomatic, including intravenous fluid administration for hypotension.

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 increases risk of angioedema; must not be co-administered within 36 hours of switching to or from quinapril.
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Major Interactions

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

  • Diuretics (thiazide or loop) - increased risk of symptomatic hypotension, especially with initial doses.
  • Antidiabetic agents (insulin, oral hypoglycemics) - increased risk of hypoglycemia.
  • Other antihypertensive agents - additive hypotensive effects.
  • Tricyclic antidepressants, antipsychotics, anesthetics - increased hypotensive effect.
  • Corticosteroids - may reduce antihypertensive effect.
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Minor Interactions

  • Alcohol - additive hypotensive effect.

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: To establish baseline and assess efficacy.

Timing: Before initiation

Serum Creatinine and BUN

Rationale: To assess baseline renal function, as ACE inhibitors can affect kidney function.

Timing: Before initiation

Serum Potassium

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

Timing: Before initiation

Complete Blood Count (CBC)

Rationale: Rarely, ACE inhibitors can cause neutropenia/agranulocytosis, especially in patients with renal impairment or collagen vascular disease.

Timing: Before initiation (consider in high-risk patients)

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Routine Monitoring

Blood Pressure

Frequency: Regularly, especially after dose changes and during maintenance therapy.

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

Action Threshold: If consistently above target, consider dose adjustment; if symptomatic hypotension, reduce dose or discontinue.

Serum Creatinine and BUN

Frequency: Periodically (e.g., every 1-3 months initially, then every 6-12 months), more frequently in patients with renal impairment, heart failure, or on diuretics.

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

Action Threshold: If creatinine increases significantly (>30% from baseline or progressive increase), investigate for renal artery stenosis or consider dose reduction/discontinuation.

Serum Potassium

Frequency: Periodically (e.g., every 1-3 months initially, then every 6-12 months), more frequently in patients with renal impairment, diabetes, or on potassium-sparing diuretics/supplements.

Target: 3.5-5.0 mEq/L

Action Threshold: If potassium >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, throat, difficulty breathing or swallowing) - seek immediate medical attention.
  • Persistent dry cough (common side effect, usually benign but can be bothersome).
  • Dizziness or lightheadedness (especially upon standing, indicative of hypotension).
  • Signs of hyperkalemia (muscle weakness, fatigue, irregular heartbeat).
  • Signs of infection (fever, sore throat) - rare, but may indicate neutropenia.
  • Signs of liver dysfunction (yellowing of skin/eyes, dark urine, persistent nausea/vomiting).

Special Patient Groups

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Pregnancy

Quinapril is contraindicated in the second and third trimesters of pregnancy due to significant risks of fetal injury and death. Exposure during these trimesters can cause oligohydramnios, fetal lung hypoplasia, skeletal deformations, anuria, and renal failure in the newborn. While risks in the first trimester are less clear, it should be avoided if possible, and alternative antihypertensive therapies should be considered.

Trimester-Specific Risks:

First Trimester: Potential risk, but less established than later trimesters. Generally, avoid if possible.
Second Trimester: High risk of fetal injury and death (oligohydramnios, fetal renal failure, lung hypoplasia, skeletal deformities).
Third Trimester: High risk of fetal injury and death (oligohydramnios, fetal renal failure, lung hypoplasia, skeletal deformities).
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Lactation

Quinapril and its active metabolite, quinaprilat, are excreted in human milk in small amounts. While generally considered to be of low risk to a breastfed infant, caution is advised, especially when nursing a preterm or newborn infant. Monitor the infant for signs of hypotension (e.g., lethargy, poor feeding).

Infant Risk: Low risk, but monitor for hypotension.
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Pediatric Use

Safety and effectiveness of quinapril in pediatric patients have not been established for routine use. Limited data exist for hypertension in children, but it is generally not recommended.

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Geriatric Use

Elderly patients may be more sensitive to the effects of ACE inhibitors and may have age-related decline in renal function. A lower initial dose (e.g., 5 mg) is recommended, and close monitoring for hypotension and renal function is necessary.

Clinical Information

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Clinical Pearls

  • Quinapril is a prodrug that requires hepatic conversion to its active metabolite, quinaprilat.
  • A common side effect is a persistent, dry, non-productive cough, which typically resolves upon discontinuation of the drug.
  • Angioedema is a rare but potentially life-threatening adverse effect that can occur at any time during treatment. Patients should be educated on its symptoms and to seek immediate medical attention.
  • First-dose hypotension can occur, especially in volume-depleted patients (e.g., those on diuretics, with heart failure, or on dialysis). Consider discontinuing diuretics 2-3 days prior to initiation if possible.
  • Monitor serum potassium levels regularly, as ACE inhibitors can cause hyperkalemia, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or supplements.
  • Avoid concomitant use with aliskiren in diabetic patients or those with renal impairment due to increased risk of adverse events.
  • Do not use with sacubitril/valsartan (Entresto) due to increased risk of angioedema; a 36-hour washout period is required between these medications.
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Alternative Therapies

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

Average Cost: Varies widely, typically $10-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 occurred.