Zestril 40mg Tablets
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.
Drug Class
Antihypertensive, Heart Failure Agent
Pharmacologic Class
Angiotensin-Converting Enzyme (ACE) Inhibitor
Pregnancy Category
Category D (2nd and 3rd trimesters), Category C (1st trimester)
FDA Approved
Dec 1987
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lisinopril is a medication used to treat high blood pressure, heart failure, and to improve survival after a heart attack. It works by relaxing blood vessels, which helps blood flow more easily and lowers blood pressure. This reduces the workload on your heart.
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. To ensure accurate dosing, measure the liquid carefully using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring tool.
Storing and Disposing of Your Medication
To maintain the quality and effectiveness of your medication, 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 the missed one.
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. To ensure accurate dosing, measure the liquid carefully using the measuring device provided with the medication. If no device is included, ask your pharmacist for a suitable measuring tool.
Storing and Disposing of Your Medication
To maintain the quality and effectiveness of your medication, 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 the missed one.
Lifestyle & Tips
- Take medication exactly as prescribed, usually once daily.
- Do not stop taking the medication without consulting your doctor, even if you feel well.
- Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
- Limit alcohol intake as it can increase the blood pressure-lowering effect.
- Maintain a healthy diet (low sodium), regular exercise, and manage stress to support blood pressure control.
- Inform your doctor or dentist that you are taking lisinopril before any surgery or dental procedures.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Hypertension: 10 mg once daily. Heart Failure: 5 mg once daily. Acute MI: 5 mg (initial dose), then 5 mg after 24 hours, 10 mg after 48 hours, then 10 mg once daily.
Dose Range:
2.5 - 40 mg
Condition-Specific Dosing:
hypertension:
Initial: 10 mg once daily; Maintenance: 20-40 mg once daily.
heartFailure:
Initial: 2.5-5 mg once daily; Maintenance: 5-40 mg once daily.
acuteMyocardialInfarction:
Initial: 5 mg 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.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Hypertension (6-16 years): Initial 0.07 mg/kg (up to 5 mg) once daily; Max 0.6 mg/kg or 40 mg/day.
Adolescent:
Hypertension (6-16 years): Initial 0.07 mg/kg (up to 5 mg) once daily; Max 0.6 mg/kg or 40 mg/day.
Dose Adjustments
Renal Impairment:
Mild:
CrCl > 30 mL/min: No initial dose adjustment needed for hypertension. For heart failure, consider lower initial dose.
Moderate:
CrCl 10-30 mL/min: Hypertension initial dose 5 mg once daily. Heart failure initial dose 2.5 mg once daily.
Severe:
CrCl < 10 mL/min (not on dialysis): Hypertension initial dose 2.5 mg once daily. Heart failure initial dose 2.5 mg once daily.
Dialysis:
Initial dose 2.5 mg once daily. Dose should be adjusted based on blood pressure response. Administer after dialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended, but caution advised due to potential for increased lisinopril levels.
Severe:
No specific adjustment recommended, but caution advised due to potential for increased lisinopril levels.
Pharmacology
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 inhibition leads to decreased angiotensin II levels, resulting in decreased vasoconstriction, reduced aldosterone secretion (leading to decreased sodium and water reabsorption and increased potassium retention), and increased bradykinin levels (a vasodilator). These effects collectively lead to reduced peripheral vascular resistance, decreased blood pressure, and reduced cardiac preload and afterload.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 25-30% (variable, 6-60%)
Tmax:
6-8 hours
FoodEffect:
Food does not affect the extent of absorption.
Distribution:
Vd:
0.64 L/kg
ProteinBinding:
Not significantly protein bound (approximately 0%)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 12 hours (effective accumulation half-life)
Clearance:
Renal clearance is approximately 50 mL/min
ExcretionRoute:
Renal (unchanged)
Unchanged:
100%
Pharmacodynamics
OnsetOfAction:
1 hour
PeakEffect:
6 hours
DurationOfAction:
24 hours
Safety & Warnings
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.
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 significant 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
+ Stomach pain or upset
+ 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.
Other Possible Side Effects
As with any medication, you may experience side effects. While many people do not have any side effects or only have mild ones, it is 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:
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.
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 significant 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
+ Stomach pain or upset
+ 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.
Other Possible Side Effects
As with any medication, you may experience side effects. While many people do not have any side effects or only have mild ones, it is 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:
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.
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 - lie down and contact your doctor.
- Persistent dry cough that does not go away.
- Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat).
- Signs of kidney problems (e.g., little or no urination, swelling in your feet or ankles, feeling tired or short of breath).
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is crucial that you 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 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 essential to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. This will help ensure that it is safe to take this medication with your other treatments. Never start, stop, or change the dose of any medication without consulting your doctor first.
It is crucial that you 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 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 essential to inform your doctor and pharmacist about all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions. This will help ensure that it is safe to take this medication with your other treatments. Never start, stop, or change the dose of any medication without consulting your doctor first.
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 down position. Be cautious when climbing stairs.
Managing Diabetes
If you have high blood sugar (diabetes), closely monitor your blood sugar levels as directed by your doctor.
Regular Health Check-Ups
Follow your doctor's instructions for regular blood work, blood pressure checks, and other laboratory tests.
Interactions with Other Medications and Substances
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor. Additionally, if you are on a low-salt or salt-free diet, discuss this with your doctor. When taking this medication for high blood pressure, 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, and certain natural products or aids.
Alcohol Consumption
Discuss alcohol consumption with your doctor before drinking.
Precautions in Hot Weather and Physical Activity
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these 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.
Risk of Infection
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. If you experience symptoms of infection, such as fever, chills, or sore throat, contact your doctor immediately.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
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 down position. Be cautious when climbing stairs.
Managing Diabetes
If you have high blood sugar (diabetes), closely monitor your blood sugar levels as directed by your doctor.
Regular Health Check-Ups
Follow your doctor's instructions for regular blood work, blood pressure checks, and other laboratory tests.
Interactions with Other Medications and Substances
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor. Additionally, if you are on a low-salt or salt-free diet, discuss this with your doctor. When taking this medication for high blood pressure, 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, and certain natural products or aids.
Alcohol Consumption
Discuss alcohol consumption with your doctor before drinking.
Precautions in Hot Weather and Physical Activity
Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these 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.
Risk of Infection
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. If you experience symptoms of infection, such as fever, chills, or sore throat, contact your doctor immediately.
Special Considerations for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
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
Contraindicated Interactions
- Aliskiren (in patients with diabetes or renal impairment)
- Sacubitril/valsartan (Entresto) - concomitant use or within 36 hours of last dose of sacubitril/valsartan
- Angiotensin Receptor Blockers (ARBs) in combination with Aliskiren in patients with diabetes or renal impairment
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 or volume-depleted patients
- Lithium - increased serum lithium levels and toxicity
- mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema
- Neprilysin inhibitors (e.g., sacubitril) - increased risk of angioedema
- Gold (sodium aurothiomalate) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension)
Moderate Interactions
- Diuretics (thiazide, loop) - enhanced hypotensive effect, especially with initial doses
- Other antihypertensives - additive hypotensive effect
- Insulin and oral hypoglycemics - enhanced glucose-lowering effect, increased risk of hypoglycemia
- Tricyclic antidepressants, antipsychotics, anesthetics - enhanced hypotensive effect
- Sympathomimetics - may reduce antihypertensive effect
Minor Interactions
- Alcohol - additive hypotensive effect
Monitoring
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
Routine Monitoring
Blood Pressure (BP)
Frequency: Regularly, especially after dose changes and then periodically (e.g., monthly, quarterly) once stable.
Target: <130/80 mmHg (or individualized target)
Action Threshold: Sustained readings above target, or symptomatic hypotension.
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, within normal limits or acceptable baseline for patient.
Action Threshold: Increase in SCr >30% from baseline, or significant decline in GFR.
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 with concomitant use of potassium-sparing diuretics or supplements.
Target: 3.5-5.0 mEq/L
Action Threshold: >5.5 mEq/L or symptomatic hyperkalemia.
Symptom Monitoring
- Persistent dry cough
- Swelling of face, lips, tongue, or throat (angioedema)
- Dizziness, lightheadedness, or fainting (hypotension)
- Signs of hyperkalemia (e.g., muscle weakness, fatigue, irregular heartbeat)
- Signs of renal dysfunction (e.g., decreased urine output, swelling in ankles/feet)
- Signs of infection (e.g., fever, sore throat) due to rare neutropenia
Special Patient Groups
Pregnancy
Contraindicated in the second and third trimesters due to risk of fetal injury and death. Use in the first trimester is generally discouraged due to potential risks.
Trimester-Specific Risks:
First Trimester:
Category C. Limited human data, but animal studies show risk. Potential for cardiovascular and CNS malformations. Generally, ACE inhibitors should be avoided if possible.
Second Trimester:
Category D. Significant risk of fetal injury and death, including fetal renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, and death.
Third Trimester:
Category D. Significant risk of fetal injury and death, including fetal renal dysfunction, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, and death.
Lactation
Lisinopril is excreted into breast milk in very small amounts. Generally considered low risk for healthy, full-term infants, but caution is advised, especially for preterm or neonates. Monitor infant for hypotension.
Infant Risk:
Low risk (L3 - Moderately safe)
Pediatric Use
Approved for hypertension in children 6 years and older. Dosing is weight-based. Safety and efficacy in children younger than 6 years have not been established. Close monitoring for adverse effects, especially renal function and hyperkalemia, is crucial.
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 increased likelihood of decreased renal function and concomitant diseases/medications. Monitor renal function and potassium closely.
Clinical Information
Clinical Pearls
- Lisinopril is a once-daily ACE inhibitor, which can improve patient adherence.
- The most common side effect is a persistent dry cough, which occurs in 5-20% of patients and typically resolves upon discontinuation.
- Angioedema is a rare but potentially life-threatening side effect; patients should be educated on symptoms and to seek immediate medical attention.
- Risk of hyperkalemia is increased with concomitant use of potassium-sparing diuretics, potassium supplements, NSAIDs, or in patients with renal impairment or diabetes.
- First-dose hypotension can occur, especially in patients who are volume-depleted (e.g., on diuretics, recent vomiting/diarrhea). Consider discontinuing diuretics 2-3 days prior to initiation if possible, or starting with a very low dose.
- Lisinopril is not metabolized by the liver, making it a good choice for patients with hepatic impairment, though caution is still advised.
Alternative Therapies
- Angiotensin Receptor Blockers (ARBs) e.g., Losartan, Valsartan (for patients intolerant to ACE inhibitor cough)
- 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)
Cost & Coverage
Average Cost:
Not available (varies widely by pharmacy and location) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic), Tier 2-3 (Brand)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may have additional patient information leaflets, so it is a good idea to consult with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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 reporting the overdose, be prepared to provide details about the medication taken, the amount consumed, and the time it occurred, as this information is crucial for proper treatment.