Edarbi (Azilsartan Kamedoxomil)

(ay'' zil sar' tan)

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.

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.

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.

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.
• tell your doctor if you have diabetes (high blood sugar) and you are taking aliskiren (Tekturna, in Amturnide, Tekamlo, Tekturna HCT). Your doctor will probably tell you not to take azilsartan if you have diabetes and you are also taking aliskiren.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec), fosinopril, lisinopril (in Prinzide, in Zestoretic), moexipril (Univasc, in Uniretic), perindopril, (Aceon), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn) and selective COX-2 inhibitors such as celecoxib (Celebrex); diuretics ('water pills'); lithium (Lithobid); and potassium supplements. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• 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.

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.

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.

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.

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.

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.

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.