(ay'' zil sar' tan)

Brand Name(s): Edarbi^®, Edarbyclor^® (as a combination product containing Azilsartan, Chlorthalidone)

IMPORTANT WARNING:

Tell your doctor if you are pregnant or plan to become pregnant. Do not take azilsartan if you are pregnant. If you become pregnant while you are taking azilsartan, stop taking azilsartan and call your doctor immediately. Azilsartan may cause death or serious injury to the fetus when taken in the last 6 months of pregnancy.

WHY is this medicine prescribed?

Azilsartan is used alone or in combination with other medications to treat high blood pressure. Azilsartan is in a class of medications called angiotensin II receptor antagonists. It works by blocking the action of certain natural substances that tighten the blood vessels, allowing the blood to flow more smoothly and the heart to pump more efficiently.

High blood pressure is a common condition, and when not treated it can cause damage to the brain, heart, blood vessels, kidneys, and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Azilsartan comes as a tablet to take by mouth. It is usually taken once a day with or without food. To help you remember to take azilsartan, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take azilsartan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Azilsartan controls high blood pressure but does not cure it. It may take about 2 weeks for you to notice the full benefit of azilsartan. Continue to take azilsartan even if you feel well. Do not stop taking azilsartan without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before taking azilsartan,

• tell your doctor and pharmacist if you are allergic to azilsartan, any other medications, or any of the ingredients in azilsartan tablets. Ask your pharmacist for a list of the ingredients.

• Some medications should not be taken with azilsartan. Other medications may cause dosing changes or extra monitoring when taken with azilsartan. Make sure you have discussed any medications you are currently taking or plan to take before starting azilsartan with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking azilsartan, please get the advice of your doctor or pharmacist.

• The following nonprescription products may interact with azilsartan: aspirin, other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), and potassium supplements. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking azilsartan. Do not start any of these medications while taking azilsartan without discussing with your healthcare provider.

• tell your doctor if you have or have ever had heart failure, or kidney or liver disease.

• tell your doctor if you are breastfeeding.

• you should know that azilsartan may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking azilsartan. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

• you should know that diarrhea, vomiting, not drinking enough fluids, and sweating a lot can cause a drop in blood pressure, which may cause lightheadedness and fainting. Tell your doctor if you have any of these problems or develop them during your treatment.

What SPECIAL DIETARY instructions should I follow?

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.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Azilsartan may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea

Some side effects can be serious. If you experience any of these symptoms below, call your doctor immediately.

• dizziness
• fainting

Azilsartan may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

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.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2023.