Enalapril 20mg Tablets

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 and stimulator of aldosterone secretion. This leads to decreased systemic vascular resistance, reduced blood pressure, and decreased aldosterone-mediated sodium and water retention. It also inhibits the degradation of bradykinin, a vasodilator, contributing to its antihypertensive effect and potentially to side effects like cough and angioedema.

Urgent 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
+ Nausea 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 unusual symptoms, 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, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

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 you should not breastfeed while taking this medication.

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

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 understand 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.

Monitoring Your Condition
Regularly check your blood pressure as directed by your healthcare provider. Additionally, have your blood work checked as instructed by your doctor, and discuss the results with them.

Interactions with Other Substances
If you are taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor. Similarly, if you are on a low-salt or salt-free diet, discuss this with your doctor to ensure safe use of this medication.

Infection Risk
Low white blood cell counts have been associated with captopril, a similar medication. This may increase your risk of infection, particularly if you have kidney problems or other underlying health conditions. Immediately contact your doctor if you experience symptoms of infection, such as fever, chills, or sore throat.

Over-the-Counter Medications and Interactions
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 or cold medications
- Diet pills
- Stimulants
- Non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen or naproxen
- Certain natural products or aids

Alcohol Consumption
Discuss alcohol consumption with your doctor before drinking while taking this medication.

Heat and Fluid Loss
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.

Effectiveness in Black Patients
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 or concerns, discuss them with your doctor.

Risk of Angioedema
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.

• 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 each other due to increased risk of angioedema
• History of angioedema related to previous ACE inhibitor or ARB therapy

• 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 (especially in elderly, volume-depleted, or those with pre-existing renal dysfunction)
• 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)

• Diuretics (thiazide, loop) - enhanced hypotensive effect, especially initial dose; risk of acute renal failure
• Other antihypertensives - additive hypotensive effects
• Insulin and oral hypoglycemics - enhanced glucose-lowering effect, risk of hypoglycemia
• Tricyclic antidepressants, antipsychotics, anesthetics - enhanced hypotensive effect
• Corticosteroids - may reduce antihypertensive effect
• Sympathomimetics - may reduce antihypertensive effect

• Alcohol - additive hypotensive effect

• 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 renal dysfunction (decreased urine output, edema)

Contraindicated in pregnancy, especially during the second and third trimesters, due to significant risk of fetal injury and death. Discontinue as soon as pregnancy is detected.

Enalapril and enalaprilat are excreted in breast milk in small amounts. Generally considered compatible with breastfeeding, especially in older infants, but monitor infant for adverse effects (e.g., hypotension). Use with caution, particularly in preterm or neonates.

Use in children (especially infants and neonates) is limited and generally not recommended as first-line due to potential for adverse effects (e.g., hypotension, renal dysfunction) and lack of extensive safety data. Dosing for hypertension in children ≥1 month exists but requires careful titration and monitoring. Not recommended for heart failure in children due to limited data.

Increased sensitivity to hypotensive effects and higher risk of renal impairment and hyperkalemia due to age-related decline in renal function. Start with lower doses and titrate slowly. Monitor renal function and potassium more frequently.

• Enalapril is a prodrug; its active form, enalaprilat, is responsible for its therapeutic effects.
• First-dose hypotension can occur, especially in volume-depleted patients or those on diuretics. Consider discontinuing diuretics 2-3 days prior to initiation if possible.
• A persistent dry cough is a common side effect of ACE inhibitors, occurring in up to 20% of patients, and often leads to discontinuation. It typically resolves within days to weeks after stopping the medication.
• Angioedema is a rare but life-threatening side effect. Patients should be educated on symptoms and to seek immediate medical attention if it occurs.
• Monitor renal function and serum potassium closely, especially in patients with pre-existing renal impairment, heart failure, or those taking potassium-sparing diuretics or supplements.
• Enalapril is contraindicated in pregnancy due to severe fetal toxicity.

• 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 (CCBs) (e.g., amlodipine, nifedipine)
• Diuretics (e.g., hydrochlorothiazide, furosemide)
• Direct Renin Inhibitors (e.g., aliskiren - limited use)

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. Be prepared to provide information about the medication taken, the amount, and the time it happened, as this will help healthcare professionals provide the best possible care.