Enalapril 2.5mg Tablets

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 possible increased serum potassium), and increased plasma renin activity. ACE also degrades bradykinin, a potent vasodilator; inhibition of ACE leads to increased levels of bradykinin, which may contribute to the antihypertensive effect and the adverse effect of cough and angioedema.

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. 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
* 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 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 the 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 Guidance:

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, stand up slowly after sitting or lying down, and exercise caution 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 supplement, consult your doctor. Additionally, if you are on a low-sodium or sodium-free diet, discuss this with your doctor.

Be aware that this medication, similar to captopril, can cause a decrease in white blood cell count, increasing the 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.

Discuss alcohol consumption with your doctor before drinking. In hot weather or during physical activity, be cautious 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 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 questions or concerns, consult your doctor.

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

• Aliskiren (in patients with diabetes or renal impairment)
• Sacubitril/Valsartan (Entresto) - concurrent 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 toxicity.
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema.
• Neprilysin inhibitors (e.g., sacubitril) - increased risk of angioedema.

• Diuretics (thiazide, loop) - increased risk of symptomatic hypotension, especially with initial doses.
• Other antihypertensive agents - additive hypotensive effects.
• Gold therapy (sodium aurothiomalate) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension) have been reported rarely in patients receiving concomitant ACE inhibitors.
• Insulin and oral hypoglycemic agents - increased risk of hypoglycemia.
• Trimethoprim/sulfamethoxazole - increased risk of hyperkalemia.

• Alcohol - may enhance hypotensive effect.

• Dizziness or lightheadedness (especially upon standing - orthostatic hypotension)
• Persistent dry cough
• Swelling of face, lips, tongue, throat, or extremities (angioedema) - seek immediate medical attention
• Difficulty breathing or swallowing
• Signs of hyperkalemia (e.g., muscle weakness, fatigue, irregular heart beat)
• Signs of liver injury (e.g., jaundice, dark urine, abdominal pain)

Enalapril is contraindicated in the second and third trimesters of pregnancy due to the risk of fetal injury and death. Exposure during the first trimester may also carry risks, though less severe. If pregnancy is detected, discontinue enalapril as soon as possible.

Enalapril and its active metabolite, enalaprilat, are excreted in human milk in small amounts. While generally considered compatible with breastfeeding, caution is advised, especially when nursing a preterm infant or an infant with renal impairment. Monitor the infant for hypotension and adverse effects.

Enalapril is approved for use in pediatric patients (≥1 month of age) for hypertension and heart failure. Dosing is weight-based. Close monitoring of blood pressure, renal function, and electrolytes is crucial. Neonates and infants are more susceptible to adverse effects.

Elderly patients may be more sensitive to the hypotensive effects of enalapril and may have age-related decline in renal function. A lower initial dose (e.g., 2.5 mg once daily) and careful titration are recommended. Close monitoring of blood pressure, renal function, and potassium levels is essential.

• Enalapril is a prodrug; its active form is enalaprilat.
• The most common side effect is a persistent, dry cough, which occurs in 5-20% of patients and often leads to discontinuation. It is thought to be due to bradykinin accumulation.
• Angioedema is a rare but potentially life-threatening side effect. Patients should be educated on symptoms and instructed to seek immediate medical attention if it occurs.
• First-dose hypotension can occur, especially in patients who are volume-depleted (e.g., on diuretics, recent vomiting/diarrhea) or with severe heart failure. Consider discontinuing diuretics 2-3 days prior to initiation if possible, or starting with a very low dose (2.5 mg).
• Monitor renal function and potassium levels closely, especially in patients with pre-existing renal impairment, diabetes, or those taking potassium-sparing diuretics or supplements.
• Enalapril is a good option for patients with hypertension and comorbid conditions like heart failure, left ventricular dysfunction, or diabetic nephropathy.

• Angiotensin Receptor Blockers (ARBs) e.g., Losartan, Valsartan (for patients intolerant to ACE inhibitors due to cough)
• Calcium Channel Blockers (CCBs) e.g., Amlodipine, Nifedipine
• Thiazide Diuretics e.g., Hydrochlorothiazide, Chlorthalidone
• Beta-blockers e.g., Metoprolol, Carvedilol
• 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 safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.