Lisinopril 5mg Tablets

Manufacturer LUPIN PHARMACEUTICALS 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 (2nd and 3rd trimesters), Category C (1st trimester)
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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 heart function.
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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. 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 a missed dose.
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Lifestyle & Tips

  • Take Lisinopril exactly as prescribed, usually once a day, with or without food.
  • Do not stop taking Lisinopril without talking to your doctor, even if you feel well.
  • Limit alcohol intake as it can further lower blood pressure.
  • Avoid potassium supplements or salt substitutes containing potassium unless advised by your doctor.
  • Maintain a healthy diet (low sodium), regular exercise, and manage stress to help control blood pressure.
  • Inform your doctor or dentist that you are taking Lisinopril before any surgery or dental procedures.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: Initial 10 mg once daily. Usual maintenance 20-40 mg once daily. Heart Failure: Initial 2.5-5 mg once daily. Myocardial Infarction: Initial 5 mg (within 24 hours), then 5 mg after 24 hours, 10 mg after 48 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. For patients on diuretics, initial 5 mg.
Heart Failure: Initial 2.5-5 mg once daily; maintenance 5-40 mg once daily.
Acute Myocardial Infarction: 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.
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Pediatric Dosing

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

Renal Impairment:

Mild: CrCl > 30 mL/min: Initial 5 mg once daily for hypertension; 2.5 mg once daily for heart failure.
Moderate: CrCl 10-30 mL/min: Initial 2.5 mg once daily.
Severe: CrCl < 10 mL/min: Initial 2.5 mg once daily.
Dialysis: Initial 2.5 mg once daily. Dose should be adjusted according to blood pressure response. Lisinopril is dialyzable.

Hepatic Impairment:

Mild: No specific dose adjustment recommended, but caution advised.
Moderate: No specific dose adjustment recommended, but caution advised.
Severe: No specific dose adjustment recommended, but caution advised. Monitor closely.

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 and afterload.
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Pharmacokinetics

Absorption:

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

Distribution:

Vd: Approximately 120 L
ProteinBinding: Minimal (<10%)
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: 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. Watch for signs such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ 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 help if they bother you or do not go away:

Dizziness or headache
* Cough

Reporting Side Effects

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Swelling of the face, lips, tongue, or throat (angioedema) - seek immediate medical attention.
  • Difficulty breathing or swallowing - seek immediate medical attention.
  • Severe dizziness or fainting.
  • Persistent dry cough.
  • Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat).
  • Signs of kidney problems (e.g., decreased urination, swelling in ankles or feet).
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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 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.
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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.

Monitoring and Precautions

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, 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.

Heat and Fluid Loss Precautions
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 and Racial Considerations
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.

Severe Reactions
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 similar medication. This may increase the risk of infection, particularly in individuals with kidney problems or other underlying health conditions. If you experience symptoms of infection, such as fever, chills, or sore throat, contact your doctor immediately.

Age-Related Precautions
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 (rapid heart rate)
  • Palpitations
  • Renal failure

What to Do:

If overdose is suspected, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive, including intravenous fluids to restore blood pressure. Lisinopril can be removed by hemodialysis.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or 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 (Nonsteroidal Anti-inflammatory Drugs) - 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

  • Diuretics (thiazide, loop) - increased risk of symptomatic hypotension (especially first-dose)
  • Gold (sodium aurothiomalate) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension)
  • Antidiabetic agents (insulin, oral hypoglycemics) - increased risk of hypoglycemia
  • Other antihypertensives - additive hypotensive 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 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

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 changes, then periodically (e.g., monthly, quarterly)

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

Action Threshold: Persistent hypotension (<90/60 mmHg) or uncontrolled hypertension (>140/90 mmHg)

Serum Creatinine and BUN

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months or annually)

Target: Within normal limits or stable from baseline

Action Threshold: Increase in creatinine >30% from baseline or significant increase in BUN, especially if symptomatic

Serum Potassium

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-6 months or annually), more frequently in patients at risk for hyperkalemia

Target: 3.5-5.0 mEq/L

Action Threshold: Potassium >5.5 mEq/L

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Symptom Monitoring

  • Angioedema (swelling of face, lips, tongue, throat, extremities)
  • Persistent dry cough
  • Dizziness or lightheadedness (especially with first dose or dose increases)
  • Signs of hyperkalemia (e.g., muscle weakness, fatigue, irregular heartbeat)
  • Signs of renal dysfunction (e.g., decreased urine output, swelling)

Special Patient Groups

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Pregnancy

Lisinopril is contraindicated in the second and third trimesters of pregnancy due to significant risk of fetal injury and death (e.g., fetal hypotension, anuria, renal failure, skull hypoplasia, death). Use in the first trimester is generally avoided due to potential risks, though less severe than later trimesters.

Trimester-Specific Risks:

First Trimester: Potential risk, but less severe than later trimesters. Generally avoided if possible.
Second Trimester: High risk of fetal injury and death (e.g., renal failure, oligohydramnios, skull hypoplasia, death).
Third Trimester: High risk of fetal injury and death (e.g., renal failure, oligohydramnios, skull hypoplasia, death).
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Lactation

Lisinopril is excreted in human milk in very low concentrations. It is generally considered compatible with breastfeeding, especially for full-term, healthy infants, but monitoring for adverse effects (e.g., hypotension) is prudent.

Infant Risk: Low risk
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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 have not been established.

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Geriatric Use

Start with lower doses (e.g., 2.5 mg or 5 mg) and titrate slowly due to increased sensitivity to hypotensive effects and potential for age-related decline in renal function. Monitor renal function and potassium closely.

Clinical Information

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Clinical Pearls

  • Lisinopril is a once-daily medication, which can improve patient adherence.
  • A common side effect is a persistent, dry, non-productive cough, which occurs in 5-20% of patients and often leads to discontinuation. If cough develops, consider switching to an Angiotensin Receptor Blocker (ARB).
  • First-dose hypotension can occur, especially in patients who are volume-depleted (e.g., on diuretics, heart failure patients). Consider discontinuing diuretics 2-3 days prior to initiation or starting with a very low dose (2.5 mg).
  • Risk of angioedema, a potentially life-threatening swelling of the face, lips, tongue, and throat, is a serious but rare side effect. It can occur at any time during therapy.
  • Monitor renal function and serum potassium regularly, especially in patients with pre-existing renal impairment, heart failure, or those taking potassium-sparing diuretics or supplements.
  • Lisinopril is not metabolized by the liver, making it a good choice for patients with hepatic impairment, though caution is still advised.
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Alternative Therapies

  • Angiotensin Receptor Blockers (ARBs) e.g., Valsartan, Losartan (often used if ACEI cough occurs)
  • Calcium Channel Blockers (CCBs) e.g., Amlodipine, Nifedipine
  • Thiazide Diuretics e.g., Hydrochlorothiazide, Chlorthalidone
  • Beta-blockers e.g., Metoprolol, Carvedilol
  • Other ACE inhibitors e.g., Enalapril, Ramipril
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (5mg 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'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 reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.