Enalapril 1mg/ml Oral Soln

Enalapril is a prodrug that is hydrolyzed to enalaprilat, an angiotensin-converting enzyme (ACE) inhibitor. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin II. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex. Inhibition of ACE results in decreased plasma angiotensin II, which leads to decreased vasoconstriction, decreased aldosterone secretion (resulting in increased sodium and water excretion and decreased potassium excretion), and increased plasma renin activity. ACE also degrades bradykinin, a potent vasodilator; inhibition of ACE leads to increased levels of bradykinin, contributing to the hypotensive effect and potentially the cough side effect.

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
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. Many people may not experience any side effects or may only have mild ones. If you are bothered by any of the following side effects or if they persist, 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.

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, such as foods or drugs. 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, 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 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 your 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 that it is safe to take this medication with your other treatments. Never start, stop, or change the dose of any medication without consulting your doctor first.

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.

There is a risk of developing low white blood cell counts with this medication, which can increase the chance 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.

Discuss alcohol consumption with your doctor before drinking. Be cautious in hot weather or during physical activity, and drink plenty of fluids to prevent dehydration. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as these conditions can lead to low blood pressure.

It is essential 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, consult your doctor.

A rare but potentially life-threatening reaction called angioedema can occur with this medication. The risk of angioedema may be higher in Black patients.

• Aliskiren (in patients with diabetes or renal impairment)
• Sacubitril/valsartan (Entresto) - concomitant use or within 36 hours of last dose of sacubitril/valsartan due to increased risk of angioedema.

• 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 or volume-depleted patients.
• Lithium - increased serum lithium levels and lithium toxicity.
• Trimethoprim - increased risk of hyperkalemia.
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema.
• Neprilysin inhibitors (e.g., sacubitril) - increased risk of angioedema.

• Diuretics (thiazide, loop) - may cause excessive hypotension, especially with initial doses.
• Antidiabetic agents (insulin, oral hypoglycemics) - enhanced glucose-lowering effect, increased risk of hypoglycemia.
• Gold (sodium aurothiomalate) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension) reported rarely with concomitant injectable gold and ACE inhibitor therapy.
• Other antihypertensives - additive hypotensive effects.

• Alcohol - may enhance hypotensive effect.

• Persistent dry cough
• Swelling of face, lips, tongue, throat (angioedema)
• Difficulty breathing or swallowing
• Dizziness, lightheadedness, fainting (hypotension)
• Signs of hyperkalemia (e.g., muscle weakness, irregular heartbeat)
• Signs of infection (e.g., fever, sore throat) - rare, but can indicate neutropenia

Contraindicated in the second and third trimesters of pregnancy due to risk of fetal injury and death. Use in the first trimester is generally discouraged due to potential risks.

Enalapril and enalaprilat are present in human milk in low concentrations. Generally considered compatible with breastfeeding, especially for full-term, healthy infants, but monitor infant for hypotension.

Used for hypertension and heart failure in children. Dosing is weight-based and requires careful titration. Renal function should be closely monitored, especially in infants and those with pre-existing renal impairment. Oral solution is particularly useful for accurate dosing in this population.

Start with lower doses and titrate slowly due to increased likelihood of decreased renal function and potential for greater sensitivity to hypotensive effects. Monitor renal function and potassium closely.

• Enalapril is a prodrug; its active form, enalaprilat, is responsible for its therapeutic effects.
• The oral solution (Epaned) is particularly useful for pediatric patients or adults who have difficulty swallowing tablets, allowing for precise dose adjustments.
• 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 instructed to seek immediate medical attention if it occurs.
• Hyperkalemia is a risk, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or potassium supplements.
• First-dose hypotension can occur, particularly in patients who are volume-depleted (e.g., on high-dose diuretics, heart failure patients). Consider administering the first dose at bedtime or under medical supervision.

• Other ACE inhibitors (e.g., lisinopril, ramipril, captopril)
• Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan, candesartan) - often used if ACEI-induced cough occurs.
• Beta-blockers (e.g., metoprolol, carvedilol)
• Calcium Channel Blockers (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 promptly. 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.