Vasotec (enalapril) is used alone or in combination with other medications to treat high blood pressure in adults and children at least 1 month old.

Vasotec can also be used to prevent and treat congestive congestive heart failure in adults.

Vasotec belongs to a class of medications called angiotensin-converting enzyme (ACE) inhibitors. Enalapril works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly and the heart can pump blood more efficiently.

Do not use Vasotec if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

Tell your doctor about all your other medicines. Some drugs should not be used with Vasotec.

If you have diabetes, do not use enalapril together with any medication that contains aliskiren (such as Tekturna or Tekamlo).

You should not use Vasotec if you have ever had angioedema. Do not take Vasotec within 36 hours before or after taking any medicine that contains sacubatril (such as Entresto).

Enalapril can affect your heart or your electrolyte levels. Call your doctor if you have chest pain, pounding heartbeats or fluttering in your chest, a slow heart rate or weak pulse, a tingly feeling, muscle weakness, or muscle tightness or contraction.

Before taking this medicine

You should not use Vasotec if you are allergic to enalapril or to any other ACE (angiotensin converting enzyme) inhibitor such as benazepril, captopril, fosinopril, trandolapril, lisinopril, moexipril, perindopril, quinapril, or ramipril.

Do not use Vasotec within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

Do not use Vasotec if you have a history of angioedema (severe allergic reaction).

To make sure Vasotec is safe for you, tell your doctor if you have ever had:

• heart disease, heart problems such as a recent heart attack;

• low blood pressure;

• stomach pain;

• low white blood cell count;

• if you are on a low-salt diet;

• diabetes;

• kidney disease (or if you are on dialysis); or

• liver disease.

You may also need to avoid taking Vasotec with aliskiren if you have kidney disease.

Stop using this medicine and tell your doctor right away if you become pregnant. Enalapril can cause injury or death to the unborn baby if you use the medicine during your second or third trimester.

Do not breastfeed.

Take Vasotec exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Vasotec tablets are taken by mouth.

You may take Vasotec tablets with or without food.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Vasotec. This can lead to very low blood pressure, an electrolyte imbalance, or kidney failure.

Your blood pressure will need to be checked often and you may need frequent blood tests.

Tell your doctor if you have a planned surgery.

If you have high blood pressure, keep using Vasotec even if you feel well. High blood pressure often has no symptoms.

Store Vasotec tablets tightly closed at room temperature, away from moisture and heat.

Usual Adult Dose for Hypertension:

Initial dose: 5 mg orally once a day
Maintenance dose: 10 to 40 mg orally per day as a single dose or in 2 divided doses
Maximum dose: 40 mg orally daily as a single dose or in 2 divided doses

In combination with diuretics:
Initial dose: 2.5 mg orally once a day
If feasible, the diuretic should be discontinued 2 to 3 days prior to initiation of therapy with enalapril. If required, diuretic therapy may be gradually resumed.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 2.5 mg orally once a day
Maintenance dose: 2.5 to 20 mg daily in 2 divided doses
Maximum dose: 40 mg orally per day in 2 divided doses

Comments:
-Treatment is usually combined with diuretics and digitalis.
-Doses should be titrated upward, as tolerated, over a period of a few days or weeks.

Usual Adult Dose for Left Ventricular Dysfunction:

Initial dose: 2.5 mg orally twice a day
Maintenance dose: 20 mg orally per day in 2 divided doses

Comments:
-After the initial dose, the patient should be observed for at least 2 hours and until blood pressure has stabilized for at least an additional hour.
-If possible, the dose of any concomitant diuretic should be reduced which may diminish the likelihood of hypotension.

Usual Pediatric Dose for Hypertension:

Children 1 month to 17 years:
Initial dose: 0.08 mg/kg/day (up to 5 mg) in 1 to 2 divided doses. Adjust dosage based on patient response.
Maximum dose: Doses greater than 0.58 mg/kg (40 mg) have not been evaluated in pediatric patients.

Comment:
-Not recommended in neonates and in pediatric patients with glomerular filtration rate less than 30 mL/min, as no data are available.

You should not use Vasotec if you are allergic to enalapril or to any other ACE (angiotensin converting enzyme) inhibitor such as benazepril, captopril, fosinopril, trandolapril, lisinopril, moexipril, perindopril, quinapril, or ramipril.

Do not use Vasotec within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

Do not use Vasotec if you have a history of angioedema (severe allergic reaction).

To make sure Vasotec is safe for you, tell your doctor if you have ever had:

• heart disease, heart problems such as a recent heart attack;

• low blood pressure;

• stomach pain;

• low white blood cell count;

• if you are on a low-salt diet;

• diabetes;

• kidney disease (or if you are on dialysis); or

• liver disease.

You may also need to avoid taking Vasotec with aliskiren if you have kidney disease.

Stop using this medicine and tell your doctor right away if you become pregnant. Enalapril can cause injury or death to the unborn baby if you use the medicine during your second or third trimester.

Do not breastfeed.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Do not use potassium supplements or salt substitutes, unless your doctor has told you to.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Get emergency medical help if you have signs of an allergic reaction to Vasotec: hives, severe stomach pain, difficulty breathing, swelling of your face, lips, tongue, or throat.

Enalapril may cause serious side effects. Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• high blood potassium - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement;

• low white blood cell counts - fever, mouth sores, skin sores, sore throat, cough;

• kidney problems - swelling, urinating less, feeling tired or short of breath; or

• liver problems - loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Vasotec side effects may include:

• cough, diarrhea;

• chest pain, dizziness, tiredness;

• headache, nausea; or

• low blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Enalapril can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis.

Tell your doctor about all your other medicines, especially:

• a diuretic or "water pill" that may increase blood potassium such as spironolactone, triamterene, amiloride;

• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others;

• medicine to prevent organ transplant rejection such as temsirolimus, sirolimus, or everolimus; or

• heart or blood pressure medication.

This list is not complete. Other drugs may interact with enalapril, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.