Zestril 30mg Tablets

Manufacturer ALMATICA 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
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Pharmacologic Class
Angiotensin-Converting Enzyme (ACE) Inhibitor
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Pregnancy Category
D (2nd and 3rd trimesters), X (1st trimester - though FDA has moved away from letter categories, this reflects the severe risk)
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FDA Approved
Dec 1987
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lisinopril is a medication used to treat high blood pressure (hypertension) and heart failure. It works by relaxing blood vessels, which helps blood flow more easily and lowers blood pressure. It can also be used after a heart attack to improve survival.
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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 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.

Special Instructions for Liquid Formulation

If you have trouble swallowing pills, your doctor or pharmacist can help you prepare a liquid suspension. If a liquid formulation is prepared, make sure to shake it well before use. When measuring your dose, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.

Storing and Disposing of Your Medication

To keep your medication effective, store it at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and avoid freezing the medication.

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 dose.
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Lifestyle & Tips

  • Take medication exactly as prescribed, usually once daily.
  • Do not stop taking lisinopril without consulting your doctor, even if you feel well.
  • Avoid potassium supplements or salt substitutes containing potassium unless advised by your doctor.
  • Limit alcohol intake, as it can further lower blood pressure.
  • Maintain a healthy diet (low sodium, rich in fruits/vegetables), regular exercise, and manage stress as advised by your doctor.
  • Stand up slowly from a sitting or lying position to avoid dizziness or lightheadedness.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 10 mg orally once daily; maintenance 20-40 mg once daily. Heart Failure: 2.5-5 mg orally once daily; titrate up to 20-40 mg once daily. Acute Myocardial Infarction: 5 mg orally within 24 hours of symptom onset, then 5 mg after 24 hours, 10 mg after 48 hours, then 10 mg once daily for 6 weeks.
Dose Range: 2.5 - 80 mg

Condition-Specific Dosing:

hypertension: Initial 10 mg QD, usual maintenance 20-40 mg QD, max 80 mg QD.
heart_failure: Initial 2.5-5 mg QD, usual maintenance 5-20 mg QD, max 40 mg QD.
acute_myocardial_infarction: Initial 5 mg QD, then 5 mg after 24h, 10 mg after 48h, then 10 mg QD for 6 weeks.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Hypertension (6-16 years): Initial 0.07 mg/kg (up to 5 mg) orally once daily. Adjust dose based on blood pressure response, max 0.6 mg/kg or 40 mg daily.
Adolescent: Hypertension: Initial 0.07 mg/kg (up to 5 mg) orally once daily. Adjust dose based on blood pressure response, max 0.6 mg/kg or 40 mg daily.
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Dose Adjustments

Renal Impairment:

Mild: CrCl > 30 mL/min: No initial dose adjustment needed for hypertension (start 10 mg). For heart failure, consider starting at 2.5 mg.
Moderate: CrCl 10-30 mL/min: Initial 2.5-5 mg orally once daily. Titrate cautiously based on response.
Severe: CrCl < 10 mL/min: Initial 2.5 mg orally once daily. Titrate cautiously.
Dialysis: Initial 2.5 mg orally once daily. Administer after dialysis. Adjust dose based on blood pressure response.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, but use with caution.
Moderate: No specific dose adjustment recommended, but use with caution.
Severe: No specific dose adjustment recommended, but use with caution. Lisinopril is not metabolized by the liver, but impaired liver function could affect its elimination indirectly.

Pharmacology

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Mechanism of Action

Lisinopril is an ACE (Angiotensin-Converting Enzyme) inhibitor. It prevents the conversion of angiotensin I to angiotensin II, a potent vasoconstrictor. This leads to decreased angiotensin II levels, resulting in vasodilation, reduced aldosterone secretion (leading to decreased sodium and water reabsorption), and increased bradykinin levels (a vasodilator). These actions collectively reduce peripheral vascular resistance, blood pressure, and cardiac preload/afterload.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 25-30% (variable, 6-60%)
Tmax: 6-8 hours
FoodEffect: Absorption is not affected by food.

Distribution:

Vd: Not extensively distributed to tissues; primarily in plasma and extracellular fluid.
ProteinBinding: <1%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 12 hours (effective accumulation half-life)
Clearance: Renal clearance is approximately 50 mL/min
ExcretionRoute: Renal (unchanged)
Unchanged: >99%
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour
PeakEffect: 6 hours
DurationOfAction: 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 indicated by:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)

Note that liver problems have been reported with similar medications, and in some cases, have been fatal. If you experience any of these symptoms, contact your doctor immediately.

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

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 (signs of low blood pressure).
  • Persistent dry cough.
  • Yellowing of the skin or eyes (jaundice), dark urine, or severe stomach pain (signs of liver problems).
  • Signs of high potassium (muscle weakness, slow or irregular heartbeat).
  • Signs of infection (fever, sore throat) - rare, but report to 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 conditions to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction you 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 how your body processes this medication.
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 breastfeeding, as you should not breastfeed while taking this medication.

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 inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without consulting your doctor first.
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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.
Follow your doctor's instructions for regular blood work, blood pressure checks, and other laboratory tests.
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, 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
+ Certain natural products or aids
Consult your doctor before consuming alcohol.
In hot weather or during physical activity, be cautious and drink plenty of fluids to avoid dehydration.
Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these may lead to low blood pressure.

Medication Effectiveness and Risks

This medication may be less effective in lowering blood pressure in Black patients. In some cases, additional medication may be necessary. Discuss any concerns with your doctor.
A severe and potentially life-threatening reaction called angioedema has been reported, with a higher risk in Black patients.
* Low white blood cell counts have been associated with captopril, a similar medication. This may increase the risk of infection, particularly in individuals with kidney problems and other underlying health conditions. Seek medical attention immediately if you experience signs of infection, such as fever, chills, or sore throat.

Special Precautions for 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 (very low blood pressure)
  • Dizziness
  • Lightheadedness
  • Fainting
  • Tachycardia (fast heart rate)
  • Palpitations
  • Renal failure

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including intravenous fluids to restore blood pressure.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment)
  • Sacubitril/valsartan (Entresto) - do not co-administer within 36 hours of switching to or from lisinopril 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 (Nonsteroidal Anti-inflammatory Drugs) - may reduce antihypertensive effect and increase risk of renal impairment, especially in dehydrated or elderly patients.
  • Lithium - increased serum lithium levels and toxicity.
  • mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema.
  • Racecadotril - increased risk of angioedema.
  • Gold (parenteral) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension) have been reported rarely in patients receiving concomitant 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.
  • Tricyclic antidepressants, antipsychotics, anesthetics - may enhance hypotensive effect.
  • Sympathomimetics - may reduce antihypertensive effects.
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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 kidney function.

Timing: Prior to initiation

Serum Potassium (K+)

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

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

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

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

Action Threshold: Persistent hypotension (<90/60 mmHg) or uncontrolled hypertension (>140/90 mmHg) warrants dose adjustment or further evaluation.

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: Within patient's baseline range, or acceptable increase (e.g., <30% increase from baseline)

Action Threshold: Significant increase in SCr (>30% from baseline or >2.5 mg/dL) or progressive azotemia warrants 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, especially in patients with renal impairment or on potassium-sparing diuretics.

Target: 3.5-5.0 mEq/L

Action Threshold: K+ > 5.5 mEq/L warrants dose reduction, discontinuation, or intervention.

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Symptom Monitoring

  • Signs of angioedema (swelling of face, lips, tongue, glottis, larynx, extremities)
  • Persistent dry cough
  • Symptoms of hypotension (dizziness, lightheadedness, syncope)
  • Symptoms of hyperkalemia (muscle weakness, fatigue, paresthesias, cardiac arrhythmias)
  • Signs of infection (fever, sore throat) due to rare neutropenia/agranulocytosis

Special Patient Groups

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Pregnancy

Contraindicated during the 2nd and 3rd trimesters of pregnancy due to significant risk of fetal injury and death. Should be avoided in the 1st trimester as well. If pregnancy is detected, discontinue as soon as possible.

Trimester-Specific Risks:

First Trimester: Potential for major congenital malformations, though data are less conclusive than for later trimesters. Generally advised to avoid.
Second Trimester: Significant risk of fetal renal dysfunction, oligohydramnios (low amniotic fluid), fetal lung hypoplasia, skeletal deformations, and fetal death.
Third Trimester: High risk of fetal renal dysfunction, oligohydramnios, anuria, renal failure, hypotension, skull hypoplasia, and fetal death. Neonatal complications include hypotension, hyperkalemia, and renal failure.
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Lactation

Lisinopril is excreted in human milk in very small amounts. Generally considered compatible with breastfeeding, especially for full-term, healthy infants, but monitor the infant for hypotension and kidney function. Use with caution, especially in preterm or medically fragile infants.

Infant Risk: Low risk; monitor for adverse effects like hypotension or renal impairment.
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Pediatric Use

Use in children 6 years and older for hypertension is established. Safety and efficacy in children younger than 6 years or for indications other than hypertension have not been established. Monitor renal function and potassium levels closely, especially in children with pre-existing renal impairment.

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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., 2.5-5 mg) and titrate slowly due to increased likelihood of decreased renal function and potential for exaggerated hypotensive response.

Clinical Information

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Clinical Pearls

  • First-dose hypotension can occur, especially in patients who are volume-depleted (e.g., on diuretics, heart failure). Consider discontinuing diuretics 2-3 days prior to initiation if possible.
  • A persistent dry, non-productive cough is a common side effect of ACE inhibitors, occurring in up to 20% of patients. It typically resolves within days to weeks after discontinuation.
  • Angioedema, though rare, is a serious and potentially life-threatening side effect. Patients should be educated on symptoms and advised to seek immediate medical attention if it occurs.
  • Lisinopril is unique among ACE inhibitors in that it is not metabolized by the liver and is excreted unchanged by the kidneys, making it a good choice for patients with liver impairment.
  • Monitor potassium levels closely, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or potassium supplements, due to the risk of hyperkalemia.
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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, diltiazem)
  • 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)
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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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.