Zestril 2.5mg Tablets

Manufacturer ALMATICA 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
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 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 (Suspension) Formulation

If you have trouble swallowing pills, your doctor or pharmacist can help you prepare a liquid (suspension) form of this medication. If a liquid formulation is prepared, be sure to shake it well before use. Measure your dose carefully using the measuring device provided with the 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, 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 exactly as prescribed, usually once daily.
  • Do not stop taking the medication without consulting your doctor.
  • Limit alcohol intake as it can increase the blood pressure-lowering effect.
  • Avoid potassium supplements or salt substitutes containing potassium unless directed by your doctor.
  • Maintain a healthy diet (low sodium), regular exercise, and manage stress.
  • 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: 10 mg once daily; Heart Failure: 5 mg once daily; Acute MI: 5 mg initial dose
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: 2.5-5 mg once daily. Titrate up to 20-40 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 (up to 5 mg) once daily. Max: 0.61 mg/kg or 40 mg/day.
Adolescent: Hypertension (6-16 years): Initial 0.07 mg/kg (up to 5 mg) once daily. Max: 0.61 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, consider lower initial dose.
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 after dialysis. Initial 2.5 mg once daily. Dosage should be adjusted according to blood pressure response.

Hepatic Impairment:

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

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 potassium retention), and reduced sympathetic activity. These actions collectively lower blood pressure and reduce 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: Not available (does not bind to plasma proteins)
ProteinBinding: <1%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 12 hours (effective accumulation half-life)
Clearance: Renal clearance is approximately 50 mL/min
ExcretionRoute: Renal (unchanged)
Unchanged: >99%
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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 Zestril 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

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor for advice:

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 fainting, especially when standing up quickly.
  • Persistent dry cough.
  • Swelling of the face, lips, tongue, or throat (angioedema) - seek immediate medical attention.
  • Difficulty breathing or swallowing - seek immediate medical attention.
  • Yellowing of the skin or eyes (jaundice).
  • 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 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 the medication's efficacy and safety.
Concurrent use of aliskiren-containing medications, particularly if you have diabetes or kidney problems.
Recent use (within the last 36 hours) of sacubitril-containing medications.
If you are breast-feeding, as this medication is not recommended during this time.

Special Considerations for Children:

* If your child is under 6 years of age, do not administer this medication, as it is not approved for use in this age group.

Additional Important Information:

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. This will help ensure the safe use of this medication in combination with your other treatments. Never start, stop, or modify the dosage of any medication without consulting your doctor.
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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.

Precautions and Warnings

Avoid driving and engaging in activities that require alertness until you understand how this medication affects you.
To minimize the risk of dizziness or fainting, stand up slowly after sitting or lying down, and exercise caution when climbing stairs.
If you have diabetes, closely monitor your blood sugar levels.
Follow your doctor's instructions for regular blood tests, blood pressure checks, and other laboratory tests.

Interactions with Other Substances

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, 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
+ Certain natural products or aids
Consult your doctor before consuming alcohol.

Special Considerations

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.

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, discuss them with your doctor.
The risk of angioedema, a severe and potentially life-threatening reaction, may be higher in Black patients.

Rare but Serious Side Effects

Low white blood cell counts have been reported with captopril, a similar medication. This may increase the risk of infection, particularly in individuals with kidney problems or other underlying health conditions. Seek medical attention immediately if you experience symptoms of infection, such as fever, chills, or sore throat.

Age-Related Considerations

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

What to Do:

Call 911 or Poison Control (1-800-222-1222) immediately. Treatment is supportive, including intravenous fluid administration to restore blood pressure. Hemodialysis can remove Lisinopril from circulation.

Drug Interactions

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Contraindicated Interactions

  • Aliskiren (in patients with diabetes or renal impairment)
  • Sacubitril/valsartan (Entresto) - concurrent use or within 36 hours of each other
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Major Interactions

  • Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride)
  • Potassium supplements
  • NSAIDs (including COX-2 inhibitors)
  • Lithium
  • mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus)
  • Neprilysin inhibitors (e.g., sacubitril)
  • Racecadotril
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Moderate Interactions

  • Diuretics (thiazide, loop) - may cause excessive hypotension
  • Antidiabetic agents (insulin, oral hypoglycemics) - increased risk of hypoglycemia
  • Gold (injectable) - nitritoid reactions
  • Trimethoprim
  • Immunosuppressants (e.g., cyclosporine)
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Minor Interactions

  • Alcohol (may enhance hypotensive effect)
  • Sympathomimetics (may reduce antihypertensive effect)

Monitoring

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Baseline Monitoring

Blood Pressure (BP)

Rationale: To establish baseline and guide initial dosing.

Timing: Before 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: Before initiation

Serum Potassium (K+)

Rationale: To assess baseline potassium levels, as ACE inhibitors can cause 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 (or individualized target)

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

Serum Creatinine (SCr) and 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 normal limits or stable from baseline

Action Threshold: Increase in SCr >30% from baseline or significant increase in BUN, especially if accompanied by hyperkalemia.

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 in patients with renal impairment or on potassium-sparing diuretics.

Target: 3.5-5.0 mEq/L

Action Threshold: K+ >5.5 mEq/L

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Symptom Monitoring

  • Dizziness or lightheadedness (especially upon standing)
  • 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 in ankles/feet)

Special Patient Groups

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Pregnancy

Contraindicated in the second and third trimesters of pregnancy due to 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 only if potential benefit justifies potential risk to fetus.
Second Trimester: High risk of fetal injury (e.g., hypotension, anuria, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death).
Third Trimester: High risk of fetal injury (e.g., hypotension, anuria, oligohydramnios, skull hypoplasia, lung hypoplasia, skeletal deformations, death).
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Lactation

Lisinopril is excreted in human milk in very small amounts. Use with caution, especially in preterm infants or during the first few weeks postpartum. Monitor breastfed infant for hypotension.

Infant Risk: Low risk of adverse effects in healthy, full-term infants, but theoretical risk of hypotension or renal effects. Monitor for signs of hypotension.
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Pediatric Use

Approved for hypertension in children 6 years and older. Dosing is weight-based. Safety and efficacy not established in children younger than 6 years or for indications other than hypertension.

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Geriatric Use

No overall differences in effectiveness or safety have been observed between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Start with lower doses (e.g., 2.5-5 mg) and titrate carefully, especially if renal function is impaired.

Clinical Information

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Clinical Pearls

  • Lisinopril is one of the most commonly prescribed ACE inhibitors due to its once-daily dosing and lack of hepatic metabolism.
  • The most common side effect is a persistent dry cough, which occurs in 5-20% of patients and often leads to discontinuation. If cough is bothersome, an ARB may be considered.
  • Angioedema is a rare but potentially life-threatening side effect. Patients should be educated on symptoms and to seek immediate medical attention if it occurs.
  • Monitor renal function and potassium levels, especially in patients with pre-existing renal impairment, heart failure, or those taking potassium-sparing diuretics or NSAIDs.
  • First-dose hypotension can occur, particularly in patients who are volume-depleted (e.g., on high-dose diuretics, heart failure). Consider discontinuing diuretics 2-3 days prior to initiation if possible, or start with a very low dose (2.5 mg) and monitor closely.
  • Lisinopril is not a prodrug, unlike some other ACE inhibitors (e.g., enalapril, ramipril), meaning it 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, chlorthalidone)
  • Beta-blockers (e.g., metoprolol, carvedilol)
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Cost & Coverage

Average Cost: $10 - $30 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'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 your 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.