Lisinopril 20mg Tablets

Manufacturer SOLCO 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
Category D
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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 and heart failure. It works by relaxing blood vessels, which helps blood flow more easily and lowers blood pressure. It can also help protect your heart and kidneys.
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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 well. 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 suspension 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 device.

Storing and Disposing of Your Medication

To maintain the effectiveness and safety 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 a missed dose.
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Lifestyle & Tips

  • Take medication at the same time each day, with or without food.
  • Do not stop taking lisinopril without consulting your doctor, even if you feel well.
  • Avoid sudden changes in position (e.g., standing up quickly) to prevent dizziness.
  • Limit alcohol intake as it can further lower blood pressure.
  • Follow a low-sodium diet as recommended by your doctor.
  • Engage in regular physical activity as advised by your doctor.
  • Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 10-40 mg once daily; Heart Failure: 5-20 mg once daily
Dose Range: 2.5 - 40 mg

Condition-Specific Dosing:

hypertensionInitial: 10 mg once daily (5 mg for patients on diuretics or with renal impairment)
heartFailureInitial: 2.5-5 mg once daily
acuteMyocardialInfarction: 5 mg initially, then 5 mg after 24 hours, then 10 mg after 48 hours, then 10 mg once daily 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) once daily; Max 0.6 mg/kg or 40 mg/day
Adolescent: Hypertension: Initial 0.07 mg/kg (up to 5 mg) once daily; Max 0.6 mg/kg or 40 mg/day
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Dose Adjustments

Renal Impairment:

Mild: CrCl > 30 mL/min: No adjustment needed for hypertension; for heart failure, start with 2.5 mg.
Moderate: CrCl 10-30 mL/min: Initial 2.5-5 mg once daily; titrate cautiously.
Severe: CrCl < 10 mL/min: Initial 2.5 mg once daily; titrate cautiously.
Dialysis: Lisinopril is dialyzable. Administer after dialysis. Initial 2.5 mg once daily.

Hepatic Impairment:

Mild: No specific adjustment needed, but caution advised.
Moderate: No specific adjustment needed, but caution advised.
Severe: No specific adjustment needed, but caution advised. Lisinopril is not metabolized by the liver.

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 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: Food does not affect the absorption of lisinopril.

Distribution:

Vd: Not available (low protein binding suggests wide distribution)
ProteinBinding: Approximately 0%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 12 hours (effective accumulation half-life)
Clearance: Renal clearance is proportional to creatinine clearance.
ExcretionRoute: Renal (urine)
Unchanged: >99%
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Pharmacodynamics

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

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue Lisinopril 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
+ Stomach pain or upset
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Possible Side Effects

Most people experience few or no side effects while taking this medication. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

Dizziness or headache
* Cough

This is not an exhaustive list of potential side effects. If you have concerns or questions, 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 - lie down and contact your doctor.
  • Yellowing of the skin or eyes (jaundice), dark urine, or persistent nausea/vomiting (signs of liver problems).
  • Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat).
  • Signs of kidney problems (e.g., decreased urination, swelling in feet/ankles).
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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 difficulties, or unusual hoarseness.
Kidney problems, as they may affect how your body processes this medication.
If you are taking a medication containing aliskiren, particularly if you have diabetes or kidney problems, as this combination may increase the risk of adverse effects.
If you have taken a medication containing sacubitril within the last 36 hours, as this may interact with the current medication.
If you are breastfeeding, as it is recommended not to breastfeed while taking this medication.

Special Considerations for Children:
If your child is under 6 years of age, do not administer this medication, as its safety and efficacy in this age group have not been established.

Additional Guidance:
This list is not exhaustive, and it is essential to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust the dose of any medication without consulting your doctor first.
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Precautions & Cautions

Important Information About Your Medication

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, get up slowly from a sitting or lying down position, and be cautious when climbing stairs.

Managing Diabetes
If you have diabetes, closely monitor your blood sugar levels, as this medication may affect them.

Regular Health Checks
Follow your doctor's instructions for regular blood tests, blood pressure checks, and other laboratory tests to ensure your health is monitored properly.

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 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. Also, consult your doctor before consuming alcohol.

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 and Safety in Certain Populations
This medication may be less effective in lowering blood pressure in Black patients, and in some cases, additional medication may be necessary. Discuss any concerns with your doctor.

Rare but Serious Side Effects
A severe and potentially life-threatening reaction called angioedema has been reported, with a higher risk in Black patients. Additionally, low white blood cell counts have occurred with similar medications, particularly in individuals with kidney problems and other underlying health conditions. If you experience signs 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.
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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). Treatment is supportive. If ingestion is recent, gastric lavage may be considered. Intravenous saline infusion may be used to restore blood pressure. Lisinopril is dialyzable.

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
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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
  • 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
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Moderate Interactions

  • Other antihypertensives - additive hypotensive effect
  • Diuretics (thiazide, loop) - increased risk of first-dose hypotension
  • Gold (sodium aurothiomalate) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension)
  • Allopurinol - increased risk of hypersensitivity reactions
  • Insulin and oral hypoglycemics - increased risk of hypoglycemia
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Minor Interactions

  • Antacids - may decrease bioavailability (separate administration times)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Before initiation

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

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

Timing: Before initiation

Serum Potassium (K+)

Rationale: To assess baseline potassium levels due to risk of hyperkalemia.

Timing: Before initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially after dose changes, then periodically (e.g., monthly to every 3-6 months) once stable.

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

Action Threshold: Persistent BP above target, or symptomatic hypotension.

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

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-12 months) or as clinically indicated.

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

Action Threshold: Significant increase in Cr (>30% from baseline or >2.5 mg/dL), or signs of acute kidney injury.

Serum Potassium (K+)

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-12 months) or as clinically indicated, especially with concomitant diuretics or renal impairment.

Target: 3.5-5.0 mEq/L

Action Threshold: >5.5 mEq/L (consider dose reduction or discontinuation), or symptomatic hyperkalemia.

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Symptom Monitoring

  • Persistent dry cough
  • Swelling of face, lips, tongue, throat (angioedema)
  • Difficulty breathing or swallowing
  • Dizziness or lightheadedness (especially upon standing)
  • Fatigue or weakness
  • Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
  • Signs of kidney problems (e.g., decreased urine output, swelling in ankles/feet)

Special Patient Groups

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Pregnancy

Contraindicated during the second and third trimesters of pregnancy due to significant risk of fetal injury and death. Discontinue as soon as pregnancy is detected.

Trimester-Specific Risks:

First Trimester: Limited data, but potential risk cannot be excluded. Use generally not recommended.
Second Trimester: Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
Third Trimester: Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death.
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Lactation

Lisinopril is excreted in human milk in very low concentrations. Generally considered compatible with breastfeeding, but monitor infant for hypotension.

Infant Risk: Low risk of adverse effects in breastfed infants. Monitor for signs of hypotension (e.g., lethargy, poor feeding).
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Pediatric Use

Approved for hypertension in children 6 years and older. Dosing is weight-based. Safety and efficacy in children younger than 6 years or in pediatric patients with heart failure or acute myocardial infarction have not been established.

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Geriatric Use

Start with lower doses (e.g., 2.5-5 mg) and titrate cautiously due to increased sensitivity to hypotensive effects and higher likelihood of impaired renal function. Monitor renal function and potassium closely.

Clinical Information

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Clinical Pearls

  • Common side effect is a persistent, dry, non-productive cough, which typically resolves upon discontinuation of the drug.
  • Risk of first-dose hypotension, especially in patients who are volume-depleted (e.g., on diuretics, with heart failure, or on dialysis). Consider starting with a lower dose and monitoring closely.
  • Angioedema is a rare but potentially life-threatening adverse effect. Patients should be educated on symptoms and advised to seek immediate medical attention if it occurs.
  • Hyperkalemia risk is increased with concomitant use of potassium-sparing diuretics, potassium supplements, NSAIDs, or in patients with renal impairment or diabetes.
  • Lisinopril does not require hepatic metabolism, making it a suitable choice for patients with liver dysfunction.
  • Unlike some other ACE inhibitors, lisinopril is not a prodrug and is active as administered.
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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)
  • Beta-blockers (e.g., metoprolol, carvedilol)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (20mg generic)
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 is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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 overdose, including the medication taken, the amount, and the time it occurred.