Enalapril 10mg Tablets

Manufacturer TARO Active Ingredient Enalapril Tablets(e NAL a pril) Pronunciation e NAL a 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 in certain patients with heart failure to lower the chance of having to go to the hospital for heart failure that gets worse.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
D
FDA Approved
Dec 1985
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Enalapril 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 help improve symptoms in people with heart failure.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your medication at the same time every day. Continue taking it as directed by your doctor or healthcare provider, even if you start feeling better.

It's essential to stay hydrated by drinking plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake. If you have trouble swallowing pills, you can discuss the option of a liquid suspension with your doctor or pharmacist.

If a liquid suspension is prepared, make sure to shake it well before each use. When measuring liquid doses, use the device that comes with the medication. If one is not provided, ask your pharmacist for a suitable measuring device.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from heat sources. Keep it in a dry place, avoiding storage in a bathroom. 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 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 or twice daily.
  • Do not stop taking enalapril 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 to support blood pressure control.
  • Report any swelling of the face, lips, tongue, or throat immediately to your doctor or seek emergency medical attention.

Dosing & Administration

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Adult Dosing

Standard Dose: Hypertension: Initial 5 mg once daily. Heart Failure: Initial 2.5 mg once daily.
Dose Range: 2.5 - 40 mg

Condition-Specific Dosing:

hypertension: Initial 5 mg once daily; usual maintenance 10-40 mg/day in 1-2 divided doses.
heartFailure: Initial 2.5 mg once daily; target maintenance 10-20 mg/day in 1-2 divided doses.
asymptomaticLeftVentricularDysfunction: Initial 2.5 mg twice daily; target maintenance 10 mg twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Hypertension (≥1 month): Initial 0.08 mg/kg once daily (max 5 mg); adjust based on response, max 0.6 mg/kg/day (max 40 mg/day).
Adolescent: Hypertension: Initial 0.08 mg/kg once daily (max 5 mg); adjust based on response, max 0.6 mg/kg/day (max 40 mg/day).
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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 30-80 mL/min: Hypertension: Initial 2.5 mg once daily. Heart Failure: Initial 2.5 mg once daily.
Severe: CrCl <30 mL/min: Hypertension: Initial 2.5 mg once daily. Heart Failure: Initial 2.5 mg once daily. Titrate cautiously.
Dialysis: Enalaprilat is dialyzable. On dialysis days, administer dose after dialysis. Initial 2.5 mg on dialysis days.

Hepatic Impairment:

Mild: No specific adjustment recommended.
Moderate: No specific adjustment recommended, but use with caution due to potential for impaired conversion to enalaprilat.
Severe: No specific adjustment recommended, but use with caution due to potential for impaired conversion to enalaprilat.

Pharmacology

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Mechanism of Action

Enalapril is a prodrug that is hydrolyzed to enalaprilat, its active metabolite. Enalaprilat is an angiotensin-converting enzyme (ACE) inhibitor. It prevents 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 decreased sympathetic activity. It also inhibits the degradation of bradykinin, a vasodilator, which may contribute to its antihypertensive effect and some side effects like cough and angioedema.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 60% (as enalaprilat)
Tmax: Enalapril: 0.5-1.5 hours; Enalaprilat: 3-4 hours
FoodEffect: Food does not affect the absorption of enalapril.

Distribution:

Vd: Not available (Enalaprilat: 10-15 L/kg)
ProteinBinding: Enalaprilat: Approximately 50-60%
CnssPenetration: Limited

Elimination:

HalfLife: Enalapril: Approximately 1.3 hours; Enalaprilat: Effective accumulation half-life 11 hours
Clearance: Enalaprilat: Approximately 18 L/hr (renal clearance)
ExcretionRoute: Renal (primarily as enalaprilat and unchanged enalapril)
Unchanged: Approximately 6% (as enalapril); 94% (as enalaprilat)
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour
PeakEffect: 4-6 hours
DurationOfAction: 24 hours (for blood pressure lowering)

Safety & Warnings

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BLACK BOX WARNING

When pregnancy is detected, discontinue enalapril 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

Serious Side Effects: Seek Medical Attention Immediately

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 medical help right away:

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
Chest pain or pressure
Liver problems, which can be indicated by:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Upset stomach or stomach pain
+ 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 symptoms that bother you or do not go away, contact your doctor or seek medical help:

Dizziness
* Cough

Reporting Side Effects

This list is not exhaustive, and you may experience other 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
  • Persistent dry cough
  • Yellowing of the skin or eyes (jaundice)
  • Signs of high potassium (e.g., muscle weakness, slow or irregular heartbeat)
  • Signs of infection (e.g., fever, sore throat) - rare
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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 before starting this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Describe the allergic reaction you experienced, including any symptoms that occurred.
Kidney disease, as this may affect how your body processes the medication.
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.
If you are taking a medication containing aliskiren, particularly 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 this medication is not recommended for nursing mothers.

Special Considerations for Children:

If the patient is under 1 month of age, do not administer this medication, as it is not suitable for infants at this age.
If the child was born prematurely and has not yet reached the corrected age of 44 weeks, consult with your doctor before giving this medication.

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 may have. This will help ensure your safety while taking this medication. Never start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

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

When starting this medication, avoid driving and other activities that require alertness until you understand how it affects you. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying position, and be cautious when climbing stairs.

Follow your doctor's instructions for monitoring your blood pressure and having regular blood tests. If you are using 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.

This medication can cause a decrease in white blood cell count, which may increase your risk of infection. This is more likely to occur in individuals 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.

If you have high blood pressure and are taking this medication, consult your doctor before using over-the-counter products that may increase blood pressure, including cough and cold medications, diet pills, stimulants, non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen, and certain natural products or aids.

Before consuming alcohol, discuss it with your doctor. In hot weather or during physical activity, be cautious and drink plenty of fluids to avoid dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions may lead to low blood pressure.

It is crucial to note that this medication may be less effective in lowering blood pressure in Black patients. In some cases, additional medication may be necessary. If you have any questions or concerns, discuss them with your doctor.

A severe and potentially life-threatening reaction called angioedema has been associated with this medication. The risk of angioedema may be higher in Black patients.
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Overdose Information

Overdose Symptoms:

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

What to Do:

Immediately contact a poison control center (Call 1-800-222-1222) or seek emergency medical attention. Treatment is supportive and symptomatic. Intravenous saline infusion may be used to restore blood pressure. Enalaprilat can be removed by hemodialysis.

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
  • History of angioedema related to previous ACE inhibitor treatment
  • Hereditary or idiopathic 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
  • Lithium - increased serum lithium levels and toxicity
  • NSAIDs (e.g., ibuprofen, naproxen) - may reduce antihypertensive effect and increase risk of renal impairment, especially in elderly or volume-depleted patients
  • Dual blockade of the RAAS (e.g., with ARBs or direct renin inhibitors) - increased risk of hypotension, hyperkalemia, and renal impairment
  • 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 or loop) - increased risk of symptomatic hypotension, especially with initial doses
  • Antidiabetic agents (insulin, oral hypoglycemics) - increased risk of hypoglycemia
  • Gold (sodium aurothiomalate) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension) reported rarely with concomitant injectable gold and ACE inhibitor therapy
  • Tricyclic antidepressants, antipsychotics, anesthetics - may enhance hypotensive effect
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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 of therapy.

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

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

Timing: Prior to initiation of therapy.

Serum Potassium (K+)

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

Blood Pressure (BP)

Frequency: Regularly, especially after dose adjustments and during maintenance therapy.

Target: Individualized, typically <130/80 mmHg for most adults with hypertension.

Action Threshold: Persistent hypotension (e.g., symptomatic or SBP <90 mmHg) or inadequate BP control.

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 acceptable limits.

Action Threshold: Significant increase in SCr (e.g., >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, diabetes, or those on potassium-sparing diuretics/supplements.

Target: 3.5-5.0 mEq/L.

Action Threshold: K+ >5.5 mEq/L.

Complete Blood Count (CBC)

Frequency: Periodically, especially in patients with renal impairment or collagen vascular disease, due to rare risk of neutropenia/agranulocytosis.

Target: Within normal limits.

Action Threshold: Significant decrease in white blood cell count.

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Symptom Monitoring

  • Angioedema (swelling of face, lips, tongue, glottis, larynx)
  • Persistent dry cough
  • Dizziness or lightheadedness (especially upon standing)
  • Fatigue
  • Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
  • Signs of infection (e.g., fever, sore throat) - rare, but indicates neutropenia

Special Patient Groups

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Pregnancy

CONTRAINDICATED in the 2nd and 3rd trimesters of pregnancy due to significant risk of fetal injury and death. Discontinue as soon as pregnancy is detected. Use in the 1st trimester is generally discouraged due to potential risks, though less severe than later trimesters.

Trimester-Specific Risks:

First Trimester: Limited data, but potential for cardiovascular and central nervous system malformations. Generally considered Category C, but discontinuation is recommended upon detection of pregnancy.
Second Trimester: Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death. Category D.
Third Trimester: Significant risk of fetal renal dysfunction, oligohydramnios, fetal lung hypoplasia, skeletal deformations, and death. Category D.
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Lactation

Enalapril and its active metabolite, enalaprilat, are excreted into breast milk in small amounts. Generally considered compatible with breastfeeding, especially for older infants. Monitor breastfed infants for hypotension, hyperkalemia, and renal dysfunction.

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

Approved for hypertension in children ≥1 month of age. Dosing is weight-based. Close monitoring of blood pressure, renal function, and electrolytes is crucial. Not recommended for heart failure in pediatric patients.

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Geriatric Use

Use with caution in elderly patients, who may be more sensitive to the hypotensive effects and more likely to have age-related decreases in renal function. Lower initial doses may be appropriate. Monitor renal function and potassium closely.

Clinical Information

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Clinical Pearls

  • Enalapril is a prodrug; its active form is enalaprilat. This means it needs to be metabolized by the liver to become active.
  • The most common side effect is a persistent dry cough, which occurs in 5-20% of patients and is due to bradykinin accumulation. If bothersome, an ARB may be considered as an alternative.
  • 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.
  • Risk of hyperkalemia is increased with concomitant use of potassium-sparing diuretics, potassium supplements, NSAIDs, or in patients with renal impairment or diabetes.
  • First-dose hypotension can occur, especially in volume-depleted patients (e.g., those on high-dose diuretics). Consider discontinuing diuretics 2-3 days prior to initiation if possible, or starting with a very low dose and monitoring closely.
  • Enalapril is effective in reducing cardiovascular morbidity and mortality in patients with heart failure and left ventricular dysfunction.
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Alternative Therapies

  • Other ACE inhibitors (e.g., lisinopril, ramipril, captopril)
  • Angiotensin Receptor Blockers (ARBs) (e.g., valsartan, losartan, candesartan)
  • Beta-blockers (e.g., metoprolol, carvedilol)
  • Calcium Channel Blockers (e.g., amlodipine, nifedipine)
  • Thiazide diuretics (e.g., hydrochlorothiazide, chlorthalidone)
  • Direct Renin Inhibitors (e.g., aliskiren - limited use)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (10mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (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 emergency medical attention. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.