Enalapril 5mg 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. This leads to decreased angiotensin II levels, resulting in vasodilation, reduced aldosterone secretion (leading to decreased sodium and water reabsorption), 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.

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:

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
Signs of liver problems, including:
+ Dark urine
+ Fatigue
+ Decreased appetite
+ Nausea or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes (jaundice)

Note: Liver problems have been reported with similar medications, and in some cases, have been fatal.

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 experience any of the following side effects, or if they bother you or do not go away, contact your doctor or seek medical attention:

Dizziness
* Cough

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 symptoms you experienced during the allergic reaction.
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 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 know how this medication affects you, avoid driving and other activities that require you to be alert. To minimize the risk of dizziness or fainting, get up slowly from a sitting or lying down 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. Seek immediate medical attention if you experience symptoms of infection, such as fever, chills, or sore throat.

Over-the-Counter Products 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, and certain natural products or aids.

Alcohol Consumption
Discuss your 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. If you experience excessive sweating, fluid loss, vomiting, or diarrhea, inform your doctor, as this 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)
• Sacubitril/valsartan (Entresto) - concurrent use or within 36 hours of last dose of sacubitril/valsartan
• History of angioedema related to previous ACE inhibitor treatment
• Hereditary or idiopathic angioedema

• Potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride) - increased risk of hyperkalemia
• Potassium supplements - increased risk of hyperkalemia
• Lithium - increased lithium levels and toxicity
• NSAIDs (e.g., ibuprofen, naproxen) - may reduce antihypertensive effect and increase risk of renal impairment
• mTOR inhibitors (e.g., sirolimus, everolimus, temsirolimus) - increased risk of angioedema
• Neprilysin inhibitors (e.g., sacubitril) - increased risk of angioedema
• Gold (parenteral) - nitritoid reactions (facial flushing, nausea, vomiting, hypotension)

• Diuretics (thiazide, loop) - increased risk of symptomatic hypotension (especially with initial dose)
• Other antihypertensives - additive hypotensive effects
• Insulin and oral hypoglycemics - increased risk of hypoglycemia
• Allopurinol - increased risk of hypersensitivity reactions
• Immunosuppressants - increased risk of hypersensitivity reactions
• Tricyclic antidepressants, antipsychotics - enhanced hypotensive effect

• Alcohol - additive hypotensive effect

• Dizziness or lightheadedness (especially upon standing)
• Persistent dry cough
• Swelling of face, lips, tongue, throat (angioedema) - seek immediate medical attention
• Difficulty breathing or swallowing
• Signs of infection (fever, sore throat) due to rare neutropenia
• Yellowing of skin or eyes (jaundice) due to rare hepatic dysfunction

Contraindicated in the 2nd and 3rd trimesters due to risk of fetal injury and death. Use in the 1st trimester is generally discouraged due to potential risks, and alternative antihypertensive therapies are preferred.

Enalapril and enalaprilat are excreted in breast milk in small amounts. Generally considered low risk for healthy, full-term infants, but caution is advised, especially for preterm or neonates. Monitor infant for hypotension.

Approved for hypertension in children ≥1 month. Dosing is weight-based. Close monitoring of blood pressure and renal function is essential. Not recommended for heart failure in pediatric patients due to limited data.

Start with lower doses (e.g., 2.5 mg once daily) due to potential for decreased renal function and increased sensitivity to hypotensive effects. Monitor renal function and potassium closely.

• First-dose hypotension can occur, especially in patients who are volume-depleted (e.g., on diuretics). Consider discontinuing diuretics 2-3 days before starting enalapril if possible.
• A persistent dry cough is a common side effect of ACE inhibitors and may necessitate switching to an ARB.
• 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.
• Monitor potassium levels regularly, especially in patients with renal impairment, diabetes, or those taking potassium-sparing diuretics or supplements.
• Enalapril is a prodrug; its active form, enalaprilat, is responsible for the therapeutic effects.

• Other ACE inhibitors (e.g., lisinopril, ramipril, captopril)
• Angiotensin Receptor Blockers (ARBs) (e.g., losartan, valsartan, 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 emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.