Lisinopril 10mg 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; Agent for heart failure; Agent for myocardial infarction
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Pharmacologic Class
Angiotensin-converting enzyme (ACE) inhibitor
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Pregnancy Category
Not applicable (Contraindicated in 2nd/3rd trimester, risk in 1st)
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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, 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.
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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 one.
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Lifestyle & Tips

  • Take medication exactly as prescribed, usually once daily.
  • Do not stop taking the medication without consulting your doctor.
  • Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
  • Limit alcohol consumption, 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.
  • Report any swelling of the face, lips, tongue, or throat immediately.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 10 mg orally once daily initially, maintenance 20-40 mg once daily. Heart Failure: 5 mg orally once daily initially, maintenance 5-40 mg once daily. Acute Myocardial Infarction: 5 mg orally within 24 hours of symptom onset, then 5 mg after 24 hours, then 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 PO QD; maintenance 20-40 mg PO QD (max 80 mg/day).
Heart Failure: Initial 2.5-5 mg PO QD; maintenance 5-40 mg PO QD.
Acute Myocardial Infarction: Initial 5 mg PO within 24 hours, then 5 mg PO after 24 hours, then 10 mg PO after 48 hours, then 10 mg PO 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) PO QD; titrate up to 0.6 mg/kg (max 40 mg) PO QD.
Adolescent: Hypertension (6-16 years): Initial 0.07 mg/kg (up to 5 mg) PO QD; titrate up to 0.6 mg/kg (max 40 mg) PO QD.
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Dose Adjustments

Renal Impairment:

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

Hepatic Impairment:

Mild: No specific dose adjustment recommended, but monitor closely.
Moderate: No specific dose adjustment recommended, but monitor closely.
Severe: No specific dose adjustment recommended, but monitor closely. Lisinopril is not metabolized by the liver, but impaired liver function could theoretically affect its elimination if renal function is also compromised.
Confidence: Medium

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

Distribution:

Vd: Approximately 1.24 L/kg
ProteinBinding: Minimal (<10%)
CnssPenetration: Limited

Elimination:

HalfLife: Effective half-life: 12 hours; Terminal half-life: ~30 hours (due to prolonged binding to ACE)
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. Monitor for signs such as:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other 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, 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:

  • Dizziness or lightheadedness, especially when standing up (orthostatic hypotension)
  • Persistent dry cough
  • Swelling of the face, lips, tongue, or throat (angioedema) - seek immediate medical attention
  • Difficulty breathing or swallowing
  • Yellowing of the skin or eyes (jaundice)
  • Signs of high potassium (e.g., muscle weakness, fatigue, irregular heartbeat)
  • Signs of kidney problems (e.g., decreased urination, swelling in ankles/feet)
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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 is not an exhaustive list of all potential interactions or health problems related to this medication. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe treatment. Never start, stop, or change the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Caution with Daily Activities
Until you understand how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution 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 with 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, and certain natural products or aids.

Lifestyle Precautions

Consult with your doctor before consuming alcohol.
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 symptoms 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. If you have questions, discuss them with your doctor.
A severe and potentially life-threatening reaction called angioedema has been reported. The risk of angioedema may be higher 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. If you experience symptoms of infection, such as fever, chills, or sore throat, contact your doctor immediately.

Special Population Warnings

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
  • Tachycardia (rapid heart rate)
  • Palpitations
  • Renal failure
  • Shock

What to Do:

Call 911 or your local emergency number immediately. For non-emergencies, call Poison Control at 1-800-222-1222. Treatment is supportive, including intravenous fluid administration to restore blood pressure. Hemodialysis may be considered if severe renal impairment occurs.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment (GFR < 60 mL/min/1.73 m2))
  • Sacubitril/valsartan (Entresto) - concomitant use or within 36 hours of switching due to increased risk of angioedema.
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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of hyperkalemia.
  • Potassium supplements - increased risk of hyperkalemia.
  • NSAIDs (e.g., ibuprofen, naproxen, celecoxib) - 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.
  • Racecadotril - increased risk of angioedema.
  • Gold (parenteral) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension) have been reported rarely.
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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 hypoglycemics - increased risk of hypoglycemia.
  • Trimethoprim - increased risk of hyperkalemia.
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Minor Interactions

  • Alcohol - may enhance hypotensive effect.
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Confidence Interactions

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation

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

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

Timing: Prior to initiation

Serum Potassium (K+)

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

Timing: Prior to initiation

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially after dose changes and during maintenance therapy (e.g., weekly for first few weeks, then monthly/quarterly)

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

Action Threshold: Symptomatic hypotension, or BP consistently outside target range requiring dose adjustment.

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

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

Target: Within patient's baseline range, or stable with minor increases.

Action Threshold: Significant increase in SCr (>30% above baseline or >0.5 mg/dL increase) or signs of acute kidney injury.

Serum Potassium (K+)

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

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Symptom Monitoring

  • Dizziness or lightheadedness (especially with first dose or dose increase)
  • Persistent dry cough
  • Swelling of face, lips, tongue, or throat (angioedema)
  • Difficulty breathing or swallowing
  • 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. Use in the first trimester is also associated with potential risks. If pregnancy is detected, discontinue as soon as possible.

Trimester-Specific Risks:

First Trimester: Limited data, but some studies suggest a potential increased risk of major congenital malformations. Generally, ACE inhibitors should be avoided if possible.
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 caution is advised, especially for preterm or neonates. Monitor infant for hypotension.

Infant Risk: Low risk of adverse effects in healthy, full-term 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 have not been established. Risk of hypotension and renal dysfunction, especially in neonates or infants.

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Geriatric Use

Elderly patients may be more sensitive to the hypotensive effects and may have age-related decline in renal function. Initiate with lower doses (e.g., 2.5-5 mg) and titrate slowly with careful monitoring of blood pressure and renal function.

Clinical Information

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Clinical Pearls

  • Lisinopril is a commonly prescribed ACE inhibitor, known for its once-daily dosing.
  • The most common side effect is a persistent, dry, non-productive cough, which occurs in 5-20% of patients and often leads to discontinuation. This cough is a class effect of ACE inhibitors.
  • Angioedema, though rare, is a serious and potentially life-threatening adverse effect. Patients should be educated on its symptoms and instructed to seek immediate medical attention if it occurs.
  • 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 if possible, or starting with a very low dose.
  • Hyperkalemia is a risk, particularly in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or potassium supplements.
  • Lisinopril does not require hepatic metabolism, making it a good choice for patients with liver dysfunction.
  • It is renally eliminated, so dose adjustments are crucial in patients with impaired kidney function.
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Alternative Therapies

  • Other ACE inhibitors (e.g., Enalapril, Ramipril, Captopril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., Losartan, Valsartan, Candesartan) - often used if ACE inhibitor-induced cough occurs.
  • Calcium Channel Blockers (CCBs) (e.g., Amlodipine, Nifedipine)
  • Thiazide Diuretics (e.g., Hydrochlorothiazide, Chlorthalidone)
  • Beta-blockers (e.g., Metoprolol, Carvedilol)
  • Direct Renin Inhibitors (e.g., Aliskiren - limited use)
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (10mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 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.