Lisinopril 2.5mg 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, Heart Failure Agent
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Pharmacologic Class
Angiotensin-Converting Enzyme (ACE) Inhibitor
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Pregnancy Category
Contraindicated in 2nd and 3rd trimesters (replaces D/X classification)
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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 the heart pump blood more efficiently.
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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, be 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 almost time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take medication exactly as prescribed, usually once daily.
  • Do not stop taking Lisinopril without consulting your doctor, even if you feel well.
  • Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
  • Limit alcohol intake, as it can further lower blood pressure.
  • Maintain a healthy diet (low sodium), regular exercise, and manage stress.
  • Report any swelling of the face, lips, tongue, or throat immediately.
  • Be aware of potential dizziness, especially when standing up quickly; rise slowly.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: 10 mg once daily (initial); Heart Failure: 2.5 mg once daily (initial)
Dose Range: 2.5 - 40 mg

Condition-Specific Dosing:

Hypertension: Initial: 10 mg once daily. Maintenance: 20-40 mg once daily. Max: 80 mg/day.
Heart Failure: Initial: 2.5 mg once daily. Titrate every 2-4 weeks to target dose of 5-40 mg once daily.
Acute 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.
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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 response, max 0.6 mg/kg or 40 mg/day.
Adolescent: Hypertension (6-16 years): Initial 0.07 mg/kg once daily (max 5 mg). Adjust dose based on response, max 0.6 mg/kg or 40 mg/day.
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Dose Adjustments

Renal Impairment:

Mild: CrCl > 30 mL/min: No initial adjustment needed for hypertension. For heart failure, start with 2.5 mg.
Moderate: CrCl 10-30 mL/min: Hypertension: Initial 5 mg once daily. Heart Failure: Initial 2.5 mg once daily.
Severe: CrCl < 10 mL/min: Hypertension: Initial 2.5 mg once daily. Heart Failure: Initial 2.5 mg once daily.
Dialysis: Administer 2.5 mg once daily. On dialysis days, administer after dialysis. Dosage should be adjusted according to blood pressure response.

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 reduced sympathetic activity. It also inhibits the degradation of bradykinin, a potent vasodilator, contributing to its hypotensive effect and potentially to side effects like cough and angioedema.
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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: 0.64 L/kg (approximately 40 L in adults)
ProteinBinding: Not protein bound (or negligibly bound)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 12 hours (effective accumulation half-life)
Clearance: Renal clearance is approximately 50 mL/min
ExcretionRoute: Renal (unchanged)
Unchanged: 100%
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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. Watch 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

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 do not go away:

Dizziness or headache
* Cough

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

  • Swelling of the face, lips, tongue, or throat (angioedema)
  • Difficulty breathing or swallowing
  • Severe dizziness or fainting
  • Yellowing of skin or eyes (jaundice)
  • Signs of high potassium (muscle weakness, slow or irregular heartbeat)
  • Signs of kidney problems (little or no urination, swelling in feet or ankles, unusual tiredness)
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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 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 the medication's dosage or your ability to take it.
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 take this medication while nursing.

Special Considerations for Children:

* Do not administer this medication to children under 6 years of age, as its safety and efficacy in this age group have not been established.

Additional Important Information:

This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. This will help ensure that it is safe to take this medication with your other treatments. Never start, stop, or change the dosage of any medication without consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions

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

Caution with Daily Activities
Until you know how this medication affects you, avoid driving and other tasks that require alertness. To minimize the risk of dizziness or fainting, rise slowly from a sitting or lying position, and be cautious when climbing stairs.

Special Considerations

If you have diabetes (high blood sugar), closely monitor your blood sugar levels.
Regularly undergo blood work, blood pressure checks, and other laboratory tests as directed by your doctor.
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor.
If you follow a low-salt or salt-free diet, discuss this with your doctor.
If you have high blood pressure and are taking this medication, talk to your doctor before using over-the-counter (OTC) products that may increase blood pressure, such as:
+ Cough or cold medications
+ Diet pills
+ Stimulants
+ Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
+ Certain natural products or aids
Consult your doctor before consuming alcohol.
In hot weather or during physical activity, be cautious and drink plenty of fluids to prevent dehydration.
Inform your doctor if you experience excessive sweating, fluid loss, vomiting, or diarrhea, as these may lead to low blood pressure.

Medication Effectiveness and Risks

This medication may be less effective in lowering blood pressure in Black patients. In some cases, an 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, with a higher risk in Black patients.
* Low white blood cell counts have occurred with captopril, a similar medication, which may increase the risk of infection. This is more common in people with kidney problems, especially those with other underlying health conditions. If you experience signs of infection, such as fever, chills, or sore throat, contact your doctor immediately.

Special Precautions for Older Adults
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
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Overdose Information

Overdose Symptoms:

  • Severe hypotension (low blood pressure)
  • Dizziness
  • Lightheadedness
  • Fainting
  • Tachycardia (fast heart rate)
  • Palpitations
  • Renal failure

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 IV fluids for hypotension.

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 last dose of sacubitril/valsartan
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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
  • Gold (parenteral) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension)
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Moderate Interactions

  • Diuretics (thiazide, loop) - increased risk of symptomatic hypotension (especially with initial dose)
  • Other antihypertensives - additive hypotensive effects
  • Insulin and oral hypoglycemics - increased risk of hypoglycemia
  • Trimethoprim - increased risk of hyperkalemia
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Prior to initiation

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

Rationale: To assess 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 to every 3-6 months) once stable.

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

Action Threshold: Persistent elevation 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 3-12 months) or as clinically indicated.

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

Action Threshold: Significant increase (e.g., >30% from baseline or >0.5 mg/dL), especially if accompanied by symptoms or hyperkalemia.

Serum Potassium

Frequency: Within 1-2 weeks of initiation or dose increase, then periodically (e.g., every 3-12 months) or as clinically indicated, especially in patients with renal impairment or on potassium-sparing agents.

Target: 3.5-5.0 mEq/L

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

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Symptom Monitoring

  • Angioedema (swelling of face, lips, tongue, throat, difficulty breathing)
  • Persistent dry cough
  • Dizziness or lightheadedness (especially upon standing)
  • Fatigue
  • Signs of hyperkalemia (muscle weakness, irregular heartbeat)
  • Signs of renal dysfunction (decreased urine output, swelling)

Special Patient Groups

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Pregnancy

Contraindicated during the second and third trimesters of pregnancy due to risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the first trimester is generally avoided due to potential risks, though data are less conclusive than for later trimesters.

Trimester-Specific Risks:

First Trimester: Limited human data, but some studies suggest a potential increased risk of major congenital malformations. Generally avoided.
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 small amounts. Generally considered low risk for healthy, full-term infants, but caution is advised, especially in preterm or neonates. Monitor infant for hypotension.

Infant Risk: Low risk (L3)
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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 for indications other than hypertension have not been established.

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Geriatric Use

No dosage adjustment is generally needed based solely on age, but older patients may be more sensitive to the hypotensive effects and more likely to have age-related decreases in renal function, requiring careful monitoring of blood pressure and renal parameters. Start with lower doses and titrate slowly.

Clinical Information

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Clinical Pearls

  • Lisinopril is a prodrug, but unlike enalapril, it is not metabolized by the liver; it is excreted unchanged by the kidneys. This makes it a good choice for patients with hepatic impairment.
  • The most common side effect is a persistent dry cough, which occurs in 5-20% of patients and often leads to discontinuation. It is a class effect of ACE inhibitors.
  • Angioedema is a rare but potentially life-threatening side effect. Patients should be educated on symptoms and advised 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 start with a very low dose (2.5 mg).
  • Monitor potassium levels, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or supplements.
  • Lisinopril is often preferred for its once-daily dosing and lack of hepatic metabolism.
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Alternative Therapies

  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan)
  • Beta-blockers (e.g., metoprolol, carvedilol)
  • Calcium Channel Blockers (CCBs) (e.g., amlodipine, diltiazem)
  • Thiazide diuretics (e.g., hydrochlorothiazide)
  • Loop diuretics (e.g., furosemide) for heart failure
  • Direct Renin Inhibitors (e.g., aliskiren - less common)
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (2.5mg 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 is 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 it's a good idea to check with your pharmacist. 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 medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.