Lisinopril 30mg 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
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Pharmacologic Class
Angiotensin-Converting Enzyme (ACE) Inhibitor
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Pregnancy Category
Contraindicated in 2nd and 3rd trimesters; avoid in 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 survival.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow these steps:

Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
You can take your medication with or without food.
Take your medication at the same time every day to establish a routine.
Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Drink plenty of non-caffeinated fluids, unless your doctor advises you to limit your fluid intake.

Special Instructions for Liquid (Suspension) Formulation

If you have trouble swallowing pills, your doctor or pharmacist can help you prepare a liquid (suspension) form of your medication. If a liquid formulation is prepared:

Shake the bottle well before each use.
Measure your dose carefully using the measuring device provided with your medication. If you don't have a measuring device, ask your pharmacist for one.

Storing and Disposing of Your Medication

To keep your medication effective and safe:

Store your medication at room temperature in a dry place, away from the bathroom.
Keep the lid tightly closed.
Do not freeze your 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 dose, skip the missed dose and take your next dose at the regular time.
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 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 further lower blood pressure.
  • Maintain a healthy diet (low in sodium), regular exercise, and manage stress.
  • Report any swelling of the face, lips, tongue, or throat immediately (signs of angioedema).

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: Initial 10 mg once daily; maintenance 20-40 mg once daily. Heart Failure: Initial 2.5-5 mg once daily; maintenance 5-40 mg once daily. Acute Myocardial Infarction: Initial 5 mg, then 5 mg after 24 hours, 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 once daily, usual maintenance 20-40 mg once daily. Max 80 mg/day.
Heart Failure: Initial 2.5-5 mg once daily, usual 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); titrate up to 0.6 mg/kg once daily (max 40 mg).
Adolescent: Hypertension: Initial 0.07 mg/kg once daily (max 5 mg); titrate up to 0.6 mg/kg once daily (max 40 mg).
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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. Administer after dialysis. Dosage should be adjusted according to blood pressure response.

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 may reduce its elimination.

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 inhibition leads to decreased angiotensin II levels, resulting in vasodilation, reduced aldosterone secretion (leading to decreased sodium and water reabsorption), and decreased sympathetic nervous system activity. It also inhibits the degradation of bradykinin, a potent vasodilator, which may contribute to its antihypertensive effect and some side effects like cough and angioedema.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 25-30% (variable)
Tmax: 6-8 hours
FoodEffect: No clinically significant effect on absorption

Distribution:

Vd: Not extensively distributed to tissues
ProteinBinding: <1%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 12 hours (effective accumulation half-life)
Clearance: Renal clearance is proportional to creatinine clearance
ExcretionRoute: Renal
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 indicated by:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Stomach pain or upset
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)

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 unusual symptoms, contact your doctor for guidance:

Dizziness or headache
* Cough

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. 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) - seek emergency medical attention immediately.
  • Severe dizziness or fainting (signs of low blood pressure).
  • Persistent dry cough.
  • Yellowing of the skin or eyes (jaundice), dark urine, or severe stomach pain (signs of liver problems).
  • Signs of high potassium (muscle weakness, slow or irregular heartbeat).
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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 that occurred.
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 and 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 to avoid breastfeeding 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 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 medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor.
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Precautions & Cautions

Important Information to Share with Your Healthcare Providers

Inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Precautions to Ensure Your Safety

To avoid accidents, do not drive or perform tasks that require alertness until you know how this medication affects you. When standing up from a sitting or lying down position, rise slowly to minimize the risk of dizziness or fainting. Be cautious when climbing stairs.

Managing Your Condition

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.

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
* Certain natural products or aids

Lifestyle Precautions

Before consuming alcohol, consult your doctor. In hot weather or during physical activity, 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 Potential Risks

This medication may be less effective in lowering blood pressure in Black patients. In some cases, another medication may be prescribed in combination with this one. If you have questions or concerns, discuss them with your doctor.

Rare but Serious Side Effects

A severe and potentially life-threatening reaction called angioedema has been reported. The risk of angioedema may be higher in Black patients. Additionally, low white blood cell counts have occurred with captopril, a similar medication, which may increase the risk of infection. This is more likely to happen in people with kidney problems, especially those with 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 years 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
  • Syncope (fainting)
  • Tachycardia (rapid heart rate)
  • Palpitations
  • Renal failure
  • Hyperkalemia

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is symptomatic and supportive. If ingestion is recent, gastric lavage may be considered. Intravenous saline infusion may be used to correct hypotension. Hemodialysis can remove lisinopril from circulation.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment [CrCl <60 mL/min])
  • 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

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

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

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

Serum Creatinine (Cr) 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 normal limits or stable from baseline

Action Threshold: Increase in Cr >30% from baseline or significant decline in GFR; consider dose reduction or discontinuation

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), more frequently with concomitant potassium-elevating drugs or renal impairment

Target: 3.5-5.0 mEq/L

Action Threshold: Hyperkalemia (>5.5 mEq/L); consider dose reduction, discontinuation, or management of hyperkalemia

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Symptom Monitoring

  • Signs of angioedema (swelling of face, lips, tongue, glottis, larynx, extremities)
  • Persistent dry cough
  • Symptoms of hypotension (dizziness, lightheadedness, syncope)
  • Symptoms of hyperkalemia (muscle weakness, fatigue, paresthesias, cardiac arrhythmias)
  • Signs of liver dysfunction (jaundice, dark urine, abdominal pain)

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. It should be avoided in the first trimester as well. If pregnancy is detected, discontinue as soon as possible.

Trimester-Specific Risks:

First Trimester: Limited human data, but potential for fetal harm cannot be excluded. Avoid use.
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 compatible with breastfeeding, but monitor the infant for hypotension, hyperkalemia, and renal effects, especially in preterm infants or those with renal impairment.

Infant Risk: Low risk; monitor for adverse effects.
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Pediatric Use

Approved for hypertension in children 6 years and older. Dosing must be carefully titrated based on weight and blood pressure response. Not recommended for children under 6 years or for other indications due to lack of established safety and efficacy.

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Geriatric Use

Start with lower doses (e.g., 2.5-5 mg) due to potential for increased sensitivity, age-related decline in renal function, and increased risk of adverse effects like hypotension and hyperkalemia. Titrate slowly based on response and tolerability.

Clinical Information

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Clinical Pearls

  • 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.
  • A persistent dry cough is a common side effect of ACE inhibitors, occurring in up to 20% of patients. It typically resolves within 1-4 weeks after discontinuation.
  • Angioedema is a rare but potentially life-threatening side effect. Patients should be educated on the signs and symptoms and advised to seek immediate medical attention if it occurs.
  • Monitor potassium levels closely, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or potassium supplements.
  • Lisinopril is a prodrug that 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

  • 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)
  • Direct Renin Inhibitors (e.g., aliskiren - limited use)
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Cost & Coverage

Average Cost: Varies widely, typically low per 30 tablets
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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.