Accupril 40mg 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
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Pharmacologic Class
Angiotensin-Converting Enzyme (ACE) Inhibitor
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Pregnancy Category
Not available
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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 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, 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. You can also ask your pharmacist about 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

  • Follow a low-sodium diet as advised by your doctor.
  • Engage in regular physical activity.
  • Limit alcohol intake.
  • Avoid potassium-rich salt substitutes unless approved by your doctor.
  • Do not stop taking the medication suddenly without consulting your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 20-40 mg once daily. Heart Failure: 20-40 mg/day in 1-2 divided doses.
Dose Range: 5 - 80 mg

Condition-Specific Dosing:

Hypertension (initial): 10-20 mg once daily
Heart Failure (initial): 5 mg twice daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for routine use; limited data for hypertension (0.1-0.4 mg/kg/day)
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 10 mg once daily.
Severe: CrCl < 30 mL/min: Initial 5 mg once daily.
Dialysis: Quinaprilat is dialyzable. Administer after dialysis on dialysis days. Initial 5 mg once daily.

Hepatic Impairment:

Mild: No specific adjustment needed, but use with caution.
Moderate: No specific adjustment needed, but use with caution.
Severe: No specific adjustment needed, but 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 inhibits the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor and stimulator of aldosterone secretion. This leads to decreased systemic vascular resistance, reduced aldosterone secretion (resulting in decreased sodium and water retention), and increased bradykinin levels (a vasodilator). The overall effect is vasodilation, reduced blood pressure, and decreased cardiac preload and afterload.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 60% (of quinaprilat)
Tmax: Quinapril: 1 hour; Quinaprilat: 2 hours
FoodEffect: Food decreases absorption slightly but not clinically significant.

Distribution:

Vd: Approximately 100 L (quinaprilat)
ProteinBinding: Approximately 97% (quinaprilat)
CnssPenetration: Limited

Elimination:

HalfLife: Quinapril: ~1 hour; Quinaprilat: ~2-3 hours (effective accumulation half-life ~9 hours)
Clearance: Not available
ExcretionRoute: Renal (primarily quinaprilat) and fecal/biliary
Unchanged: Less than 5% (quinapril)
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour
PeakEffect: 2-6 hours
DurationOfAction: 24 hours (for once-daily dosing)
Confidence: Medium

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

Serious Side Effects: Seek Medical Attention Immediately

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 help right away:

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 symptoms that bother you or do not go away, contact your doctor or seek medical help:

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) - seek immediate medical attention.
  • Difficulty breathing or swallowing - seek immediate medical attention.
  • Persistent dry cough that does not go away.
  • Dizziness or lightheadedness, especially when standing up.
  • Signs of high potassium (muscle weakness, slow or irregular heartbeat).
  • Signs of kidney problems (decreased urination, swelling in ankles/feet, unusual tiredness).
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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 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 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, 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 first consulting your doctor.
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Precautions & Cautions

Important Information to Share with Your Healthcare Providers

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 getting 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

Follow your doctor's instructions for checking your blood pressure regularly. Additionally, have your blood work checked as directed 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.

Caution with Over-the-Counter (OTC) Products

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.

Staying Hydrated

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 prescribed in combination with this one. 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 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
  • Bradycardia
  • Renal failure

What to Do:

Call 911 or your local emergency number immediately. For poison control, call 1-800-222-1222. Treatment is supportive, including intravenous fluid administration to correct hypotension.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment)
  • Sacubitril/valsartan (Entresto) - concurrent use or within 36 hours of switching
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Major Interactions

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

  • Diuretics (e.g., thiazides, loop diuretics) - risk of excessive hypotension
  • Antidiabetic agents (insulin, oral hypoglycemics) - risk of hypoglycemia
  • mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema
  • Neprilysin inhibitors (e.g., sacubitril) - increased risk of angioedema
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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 assess efficacy.

Timing: Prior to initiation

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

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

Timing: Prior to initiation

Serum Potassium (K+)

Rationale: To assess baseline electrolyte status, 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: Individualized, typically <130/80 mmHg for most adults

Action Threshold: Persistent hypotension or uncontrolled hypertension

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

Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months)

Target: Within normal limits or stable from baseline

Action Threshold: Significant increase (e.g., >30% above baseline or >0.5 mg/dL increase) or signs of acute kidney injury

Serum Potassium (K+)

Frequency: Periodically (e.g., 1-2 weeks after initiation/dose change, then every 3-6 months)

Target: 3.5-5.0 mEq/L

Action Threshold: K+ > 5.5 mEq/L

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Symptom Monitoring

  • Signs of angioedema (swelling of face, lips, tongue, throat, difficulty breathing/swallowing)
  • Persistent dry cough
  • Symptoms of hypotension (dizziness, lightheadedness, fainting)
  • Signs of hyperkalemia (muscle weakness, fatigue, irregular heartbeat)
  • Symptoms of renal dysfunction (decreased urine output, swelling)

Special Patient Groups

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Pregnancy

Contraindicated in the second and third trimesters of pregnancy due to risk of fetal injury and death. Use in the first trimester is generally avoided due to potential risks.

Trimester-Specific Risks:

First Trimester: Potential risk, generally avoided. Category C.
Second Trimester: High risk of fetal injury and death (renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death). Category D.
Third Trimester: High risk of fetal injury and death (renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death). Category D.
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Lactation

Low levels of quinaprilat are excreted in human milk. Generally considered compatible with caution, especially in full-term, healthy infants. Monitor infant for adverse effects.

Infant Risk: Low risk (L3 - Moderately Safe)
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Pediatric Use

Safety and efficacy for hypertension 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 and titrate carefully due to potential for decreased renal function.

Clinical Information

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Clinical Pearls

  • First-dose hypotension can occur, especially in patients who are volume-depleted or on diuretics. Consider discontinuing diuretics 2-3 days prior to initiation if possible.
  • A persistent dry cough is a common side effect of ACE inhibitors, occurring in up to 20% of patients. It typically resolves within 1-4 weeks after discontinuation.
  • Angioedema is a rare but potentially life-threatening side effect. Patients should be educated on the signs and symptoms and advised 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.
  • Quinapril is a prodrug that requires hepatic activation; however, dose adjustment for hepatic impairment is generally not required for mild-to-moderate impairment.
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Alternative Therapies

  • Other ACE inhibitors (e.g., Lisinopril, Ramipril, Enalapril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Valsartan, Losartan)
  • 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 $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'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 details. If you have any questions or concerns about this 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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.