Azilsartan belongs to a group of drugs called angiotensin II receptor blocker (sometimes called an ARB). ARB's stop blood vessels from narrowing, which lowers blood pressure and improves blood flow.

Azilsartan is a prescription medicine 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 azilsartan to treat your high blood pressure.

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

Do not use azilsartan if you are pregnant. Stop using this medication and tell your doctor right away if you become pregnant. You should not use this medicine if you are allergic to azilsartan medoxomil.

Before you take this medicine, tell your doctor if you have kidney or liver disease, an electrolyte imbalance (low levels of potassium or magnesium in your blood), congestive heart failure, or if you are dehydrated.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of azilsartan. Do not use potassium supplements or salt substitutes while you are taking this medicine, unless your doctor has told you to.

Your blood pressure will need to be checked often. Visit your doctor regularly.

Keep using azilsartan as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Before taking this medicine

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

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

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

• 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. Azilsartan 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.

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

Take azilsartan 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.

Azilsartan 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 azilsartan.

It may take 2 weeks before your blood pressure is under control. Keep using azilsartan 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 azilsartan with any medication that contains aliskiren (a blood pressure medicine).

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

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

• 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. Azilsartan 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.

Azilsartan 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from light, excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not use salt substitutes containing potassium without talking to your doctor. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

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 azilsartan: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

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

• little or no urination; or

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

Common azilsartan 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.

Keep all appointments with your doctor and the laboratory. Your blood pressure should be checked regularly to determine your response to azilsartan.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Azilsartan tablets have a noticeable odor. Ask your pharmacist if you have any questions regarding your medication.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Edarbyclor® (containing Azilsartan, Chlorthalidone)