Edarbi is an angiotensin II receptor blocker (sometimes called an ARB). Azilsartan keeps blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Edarbi is used to treat high blood pressure (hypertension). Lowering blood pressure may lower your risk of a stroke or heart attack.

Your doctor may prescribe other medicines for you to take along with Edarbi to treat your high blood pressure.

Do not use Edarbi if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant.

If you have diabetes, do not take Edarbi with any medication that contains aliskiren (a blood pressure medicine).

Before you take this medicine, tell your doctor about all your other medical conditions and allergies. Also make sure your doctor knows if you are pregnant or breast-feeding. In some cases, you may not be able to use Edarbi, or you may need a dose adjustment or special precautions.

Take Edarbi 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.

Edarbi may be taken with or without food.

Your blood pressure will need to be checked often. Your kidney function may also need to be checked.

Call your doctor if you are sick with vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Edarbi.

It may take 2 weeks before your blood pressure is under control. Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms.

You may need to use blood pressure medicine for the rest of your life. Treatment may also include diet, exercise, lowering cholesterol, not smoking, and controlling diabetes.

Store in the original container at room temperature, away from moisture, heat, and light.

Usual Adult Dose for Hypertension:

80 mg orally once a day

Comments: Consider a starting dose of 40 mg orally once a day for patients on high diuretic doses.

If you have diabetes, do not take Edarbi with any medication that contains aliskiren (a blood pressure medicine).

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

To make sure this medicine is safe for you, tell your doctor if you have:

• an electrolyte imbalance (such as low levels of potassium in your blood); or

• if you are on a low-salt diet.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Edarbi can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

If you plan to get pregnant, ask your doctor for a safer medicine to use before and during pregnancy. Having high blood pressure during pregnancy may cause complications in the mother and the baby.

You should not breastfeed while taking azilsartan.

Edarbi is not approved for use by anyone younger than 18 years old.

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.

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

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

Get emergency medical help if you have signs of an allergic reaction to Edarbi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• little or no urination; or

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

Common Edarbi side effects may include:

• diarrhea.

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.

Tell your doctor about all your other medicines, especially:

• a diuretic (water pill) or other medicines that lower blood pressure; or

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

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