Epaned (Oral)

Enalapril is used on its own or with other medicines to treat high blood pressure (hypertension). High blood pressure makes the heart and arteries work harder. If it lasts for a long time, it can lead to problems with how the heart and arteries work. This can harm the blood vessels in the brain, heart, and kidneys, which can cause a stroke, heart failure, or kidney failure. Lowering blood pressure can lower the chance of having strokes and heart attacks.

Enalapril is an angiotensin converting enzyme (ACE) inhibitor. It works by blocking a substance in the body that makes blood vessels tighten. Because of this, enalapril relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Enalapril is also used with other medicines to treat congestive heart failure and reduce the number of hospital visits for heart issues.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy. If you think you have become pregnant while using the medicine, tell your doctor right away.

You should not use this medicine with sacubitril. Do not use this medicine and sacubitril/valsartan (Entresto®) within 36 hours of each other.

This medicine may cause serious allergic reactions, including anaphylaxis. This can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

Call your doctor right away if you have severe stomach pain (with or without nausea or vomiting). This could be a symptom of a condition called intestinal angioedema.

Dizziness, lightheadedness, or fainting may also occur, especially when you get up from a lying or sitting position or if you have been taking a diuretic (water pill). Do not drive or do anything else that could be dangerous until you or your child know how this medicine affects you. If you feel dizzy, lie down so you do not faint. Then sit for a few moments before standing to prevent the dizziness from returning.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt and may lead to low blood pressure. You can also lose water by sweating, so drink plenty of water during exercise or in hot weather.

Check with your doctor if you have a fever, chills, or sore throat. These could be symptoms of an infection due to low white blood cells.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Hyperkalemia (high potassium in the blood) may occur while using this medicine. Check with your doctor right away if you have the following symptoms: abdominal or stomach pain, confusion, difficulty breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, shortness of breath, or weakness or heaviness in the legs. Do not use supplements or salt substitutes containing potassium without first checking with your doctor.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine against the benefits it can provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown any specific problems in children aged 1 month to 16 years that would limit the use of enalapril for treating high blood pressure. However, it is not recommended for children younger than 1 month or for those with severe kidney disease.

Geriatric

There is no information on how age affects the effects of enalapril in older patients. Elderly patients are more likely to have kidney problems related to age, which may require caution and an adjustment in the dose for those taking enalapril.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction might happen. In such cases, your doctor may change the dose, or other precautions may be needed. It is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Aliskiren
• Sacubitril

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Allopurinol
• Alteplase, Recombinant
• Amiloride
• Aspirin
• Azathioprine
• Azilsartan
• Azilsartan Medoxomil
• Candesartan
• Canrenoate
• Eplerenone
• Eprosartan
• Everolimus
• Furosemide
• Interferon Alfa-2a
• Irbesartan
• Levoketoconazole
• Lithium
• Losartan
• Melphalan
• Mercaptopurine
• Methotrexate
• Olmesartan
• Oxypurinol
• Potassium Citrate
• Potassium Phosphate
• Sirolimus
• Spironolactone
• Tacrolimus
• Telmisartan
• Tenapanor
• Triamterene
• Trimethoprim
• Valsartan

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aceclofenac
• Acemetacin
• Amtolmetin Guacil
• Bromfenac
• Bufexamac
• Bumetanide
• Bupivacaine
• Bupivacaine Liposome
• Capsaicin
• Celecoxib
• Choline Salicylate
• Clomipramine
• Clonixin
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Diflunisal
• Dipyrone
• Droxicam
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Etozolin
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Floctafenine
• Flufenamic Acid
• Flurbiprofen
• Gold Sodium Thiomalate
• Ibuprofen
• Indomethacin
• Ketoprofen
• Ketorolac
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Meclofenamate
• Mefenamic Acid
• Meloxicam
• Morniflumate
• Nabumetone
• Naproxen
• Nepafenac
• Nesiritide
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Oxaprozin
• Oxyphenbutazone
• Parecoxib
• Phenylbutazone
• Piketoprofen
• Piretanide
• Piroxicam
• Pranoprofen
• Proglumetacin
• Propionic Acid
• Propyphenazone
• Proquazone
• Rifampin
• Rofecoxib
• Salicylic Acid
• Salsalate
• Sodium Salicylate
• Sulindac
• Tenoxicam
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Valdecoxib

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical issues, especially:

• Angioedema (swelling of the face, lips, tongue, throat, arms, or legs), history of—This may increase the risk of this condition happening again.

• Collagen vascular disease (an autoimmune disease) along with kidney disease—Increased risk of blood problems.

• Diabetes or
• Kidney problems—Increased risk of potassium levels in the body becoming too high.

• Diabetic patients who are also taking aliskiren (Tekturna®) or
• Hereditary or idiopathic angioedema—Should not be used in patients with these conditions.

• Electrolyte imbalance (e.g., low sodium in the blood) or
• Fluid imbalances (caused by dehydration, vomiting, or diarrhea) or
• Heart or blood vessel problems (e.g., aortic stenosis, hypertrophic cardiomyopathy) or
• Kidney disease or
• Liver disease—Use with caution. This may worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

More common

• Blurred vision
• Confusion
• Dizziness, faintness, or lightheadedness when standing up quickly from a lying or sitting position
• Sweating
• Unusual tiredness or weakness

Less common

• Chest pain
• Cough producing mucus
• Diarrhea
• Difficulty or labored breathing
• Fainting
• Fever or chills
• Nausea
• Sneezing
• Sore throat
• Tightness in the chest
• Vomiting

Some side effects may happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

More common

• Dizziness

Less common

• Lack or loss of strength
• Rash

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your health care professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Epaned
• Vasotec

Available Dosage Forms:

• Tablet
• Solution

Therapeutic Class: Antihypertensive

Pharmacologic Class: Enalapril

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

If your child cannot swallow the tablets, an oral liquid may be given. Ask your doctor or pharmacist about this.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (oral solution or tablets): For high blood pressure: Adults—At first, 5 milligrams (mg) once a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day. Children 1 month of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is usually 0.08 mg per kilogram (kg) of body weight per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 0.58 mg per kg of body weight or 40 mg per day. Children younger than 1 month of age—Use is not recommended. For heart failure: Adults—At first, 2.5 milligrams (mg) two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 40 mg per day. Children—Use and dose must be determined by your doctor. For abnormal heart ventricle: Adults—At first, 2.5 milligrams (mg) two times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 20 mg per day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the Epaned® mixed oral liquid in the refrigerator or at room temperature for up to 60 days. Keep the Vasotec® mixed oral liquid in the refrigerator and store it for up to 30 days. Do not freeze.

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