Zestril 10mg Tablets

Manufacturer UPSHER-SMITH Active Ingredient Lisinopril Tablets(lyse IN oh pril) Pronunciation lyse IN oh 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 is used to help heart function after a heart attack.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihypertensive, Heart Failure Agent, Post-MI Agent
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Pharmacologic Class
Angiotensin-Converting Enzyme (ACE) Inhibitor
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Pregnancy Category
Contraindicated in 2nd and 3rd trimesters (formerly D); C in 1st trimester
FDA Approved
Dec 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lisinopril is a medicine that helps relax your blood vessels, making it easier for your heart to pump blood. This lowers high blood pressure and can help your heart work better if you have heart failure. It's also used after a heart attack to protect your heart.
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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.
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 feeling well.
Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.

Special Instructions for Liquid (Suspension) Formulation

If you have difficulty swallowing pills, a liquid suspension can be prepared. Consult with your doctor or pharmacist to discuss this option.
If a liquid suspension is prepared:
Shake the suspension well before each use.
Measure the liquid dose carefully using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring device.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication:
Store it at room temperature in a dry place, away from the bathroom.
Keep the lid tightly closed.
Do not freeze your medication.

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 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 the missed dose.
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Lifestyle & Tips

  • Take exactly as prescribed, usually once a day, with or without food.
  • Do not stop taking this medication without talking to your doctor, even if you feel well.
  • Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor, as this medication can increase potassium levels.
  • Limit alcohol intake, as it can further lower blood pressure.
  • Stand up slowly from a sitting or lying position to avoid dizziness or lightheadedness.
  • Report any swelling of the face, lips, tongue, or throat immediately to your doctor or seek emergency medical attention, as this could be a sign of a serious allergic reaction (angioedema).
  • A dry, persistent cough is a common side effect; discuss with your doctor if bothersome.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 10 mg once daily; maintenance 20-40 mg once daily. Heart Failure: 5 mg once daily; maintenance 5-20 mg once daily. Acute MI: 5 mg within 24 hours of symptom onset, then 5 mg after 24 hours, then 10 mg once daily for 6 weeks.
Dose Range: 2.5 - 40 mg

Condition-Specific Dosing:

hypertension: Initial 10 mg once daily; maintenance 20-40 mg once daily. Max 80 mg/day.
heartFailure: Initial 2.5-5 mg once daily; maintenance 5-20 mg once daily.
acuteMI: Initial 5 mg within 24 hours, then 5 mg after 24 hours, then 10 mg once daily for 6 weeks.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Hypertension (>=6 years): Initial 0.07 mg/kg (max 5 mg) once daily. Adjust dose based on response, max 0.6 mg/kg or 40 mg/day. Not recommended for GFR <30 mL/min/1.73m².
Adolescent: Hypertension (>=6 years): Initial 0.07 mg/kg (max 5 mg) once daily. Adjust dose based on response, max 0.6 mg/kg or 40 mg/day. Not recommended for GFR <30 mL/min/1.73m².
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Dose Adjustments

Renal Impairment:

Mild: CrCl >30 mL/min: No initial dose adjustment for hypertension (start 10 mg). For heart failure, consider 2.5 mg initial dose.
Moderate: CrCl 10-30 mL/min: Hypertension initial 5 mg once daily. Heart failure initial 2.5 mg once daily.
Severe: CrCl <10 mL/min: Hypertension initial 2.5 mg once daily. Heart failure initial 2.5 mg once daily.
Dialysis: Initial 2.5 mg once daily. Administer after dialysis. Dosage on non-dialysis days should be adjusted according to blood pressure response.

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Lisinopril is an angiotensin-converting enzyme (ACE) inhibitor. It inhibits the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. This leads to decreased angiotensin II levels, resulting in decreased vasoconstriction, reduced aldosterone secretion (leading to decreased sodium and water reabsorption), and increased bradykinin levels (a vasodilator). These actions collectively lead to vasodilation, reduced peripheral vascular resistance, and decreased blood pressure.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 25-30% (variable, 6-60%)
Tmax: 6-8 hours
FoodEffect: Food does not affect the extent of absorption.

Distribution:

Vd: Approximately 120 L
ProteinBinding: Negligible (<1%)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 12 hours (effective accumulation half-life)
Clearance: Renal clearance is approximately 50 mL/min
ExcretionRoute: Renal (unchanged)
Unchanged: Approximately 100%
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour
PeakEffect: 6-8 hours
DurationOfAction: Approximately 24 hours

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue ZESTRIL 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
Chest pain or pressure
Liver problems, which can be life-threatening. Monitor for signs such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

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 for advice:

Dizziness or headache
* Cough

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to 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)
  • Difficulty breathing or swallowing
  • Severe dizziness or fainting
  • Yellowing of the skin or eyes (jaundice)
  • Dark urine
  • Unusual tiredness or weakness
  • Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat)
  • Signs of infection (e.g., fever, sore throat, chills)
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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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reactions you have experienced, including any symptoms.
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.
Kidney problems, as they may affect the medication's dosage or your ability to take it.
If you are taking a medication containing aliskiren, especially if you have diabetes or kidney problems.
If you have taken a medication containing sacubitril within the last 36 hours.
If you are breast-feeding, as you should not take this medication while nursing.

Special Considerations for Children:
If your child is under 6 years of age, do not administer this medication, as it is not recommended for children younger than 6 years old.

Additional Important Information:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without 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.

Special Considerations

If you have diabetes (high blood sugar), closely monitor your blood sugar levels.
Regularly undergo blood work, blood pressure checks, and other laboratory tests as advised by your doctor.
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor.
If you are on a low-salt or salt-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 (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
Discuss alcohol consumption with your doctor before drinking.

Precautions in Hot Weather and Physical Activity
Be cautious in hot weather and during physical activity, as this medication can increase the risk of fluid loss. Drink plenty of fluids to stay hydrated. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these symptoms can lead to low blood pressure.

Effectiveness and Safety in Specific Populations
This medication may be less effective in lowering blood pressure in Black patients. In some cases, additional medication may be necessary. If you have questions or concerns, discuss them with your doctor.

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

Infection Risk
Low white blood cell counts have been associated with captopril, a medication similar to this one. This can increase the risk of infection, particularly in individuals with kidney problems and other underlying health conditions. If you experience symptoms of infection, such as fever, chills, or sore throat, contact your doctor immediately.

Use in Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Call 1-800-222-1222 (Poison Control) immediately or seek emergency medical attention. Treatment is supportive, including intravenous fluid administration to restore blood pressure.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or moderate-to-severe renal impairment)
  • 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
  • NSAIDs (e.g., ibuprofen, naproxen) - may reduce antihypertensive effect and increase risk of renal impairment (especially in elderly, volume-depleted, or those with pre-existing renal dysfunction)
  • Lithium - increased serum lithium levels and toxicity
  • mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema
  • Racecadotril - increased risk of angioedema
  • Gold (sodium aurothiomalate) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension) have been reported rarely in patients receiving concomitant injectable gold and ACE inhibitors
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Moderate Interactions

  • Diuretics (thiazide or loop) - increased risk of symptomatic hypotension, especially with initial doses
  • Other antihypertensives - additive hypotensive effects
  • Insulin and oral hypoglycemic agents - increased risk of hypoglycemia (rare, monitor blood glucose)
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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

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

Rationale: To assess baseline renal function, as lisinopril is renally eliminated and can affect renal function.

Timing: Prior to initiation

Serum Potassium (K+)

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

Timing: Prior to initiation

Complete Blood Count (CBC) with differential

Rationale: To assess for baseline neutropenia/agranulocytosis (rare but serious adverse effect of ACEIs).

Timing: Prior to initiation (especially in patients with renal impairment or collagen vascular disease)

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly (e.g., daily at home, at each clinic visit)

Target: <130/80 mmHg (individualized based on guidelines and patient comorbidities)

Action Threshold: Symptomatic hypotension or persistently high readings requiring dose adjustment.

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

Action Threshold: Significant increase (>30% from baseline or rapid rise), indicating potential acute kidney injury, requires dose reduction or discontinuation.

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: >5.5 mEq/L (hyperkalemia) requires intervention (e.g., dose reduction, discontinuation, dietary changes).

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Symptom Monitoring

  • Angioedema (swelling of face, lips, tongue, glottis, larynx, extremities)
  • Persistent dry cough
  • Dizziness or lightheadedness (especially with standing)
  • Fatigue
  • Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
  • Signs of infection (e.g., fever, sore throat) - rare, but indicates neutropenia

Special Patient Groups

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Pregnancy

Contraindicated in 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, though less severe than later trimesters.

Trimester-Specific Risks:

First Trimester: Limited human data, but some studies suggest a potential increased risk of major congenital malformations. Generally avoided if possible.
Second Trimester: Significant risk of fetal renal dysfunction, oligohydramnios (low amniotic fluid), fetal lung hypoplasia, skeletal deformations, and fetal death.
Third Trimester: Continued risk of fetal renal dysfunction, oligohydramnios, anuria, hypotension, and death in the neonate. Neonatal anuria may require dialysis.
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Lactation

Lisinopril is excreted in human milk in very low concentrations. Generally considered compatible with breastfeeding, but monitor the infant for potential adverse effects (e.g., hypotension, poor feeding).

Infant Risk: Low risk. Monitor for signs of hypotension (lethargy, poor feeding) or other adverse effects.
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Pediatric Use

Approved for hypertension in children 6 years and older. Not recommended for children under 6 years or those with a glomerular filtration rate (GFR) less than 30 mL/min/1.73m². Safety and efficacy for heart failure or post-MI indications have not been established in pediatric patients.

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Geriatric Use

Start with lower doses (e.g., 2.5-5 mg) and titrate slowly due to increased likelihood of impaired renal function and greater sensitivity to hypotensive effects. More susceptible to adverse effects like hypotension, hyperkalemia, and renal dysfunction.

Clinical Information

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Clinical Pearls

  • Lisinopril is a common cause of persistent dry cough, which typically resolves upon discontinuation.
  • First-dose hypotension can occur, especially in volume-depleted patients (e.g., those on diuretics). Consider discontinuing diuretics 2-3 days prior to initiation if possible, or starting with a very low dose.
  • Angioedema is a rare but potentially life-threatening side effect. Patients should be educated on symptoms and instructed to seek immediate medical attention if it occurs.
  • Monitor renal function and potassium levels closely, especially in patients with pre-existing renal impairment, heart failure, or those on potassium-sparing diuretics/supplements.
  • Unlike some other ACE inhibitors, lisinopril is not a prodrug and is excreted unchanged by the kidneys, making it a good choice for patients with hepatic impairment.
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Alternative Therapies

  • Other ACE inhibitors (e.g., enalapril, ramipril, captopril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan, candesartan)
  • Calcium Channel Blockers (CCBs) (e.g., amlodipine, nifedipine)
  • Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone)
  • Beta-blockers (e.g., metoprolol, carvedilol)
  • Direct Renin Inhibitors (e.g., aliskiren - limited use)
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Cost & Coverage

Average Cost: Highly variable, typically low for generic per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2 (Preferred Brand)
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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. It's also important to note that some medications may come with additional patient information leaflets, so be sure to check with your pharmacist for more details. 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 for clarification. 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 was taken, as this will aid in providing you with the most effective care.