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Azilsartan medoxomil

Generic Name: azilsartan (AY-zil-SAR-tan)
Brand Name: Edarbi

Azilsartan medoxomil may cause injury or death to the fetus if taken while you are pregnant. If you think you may be pregnant, contact your doctor right away. If you are planning to become pregnant, talk with your doctor about other treatment options.


Azilsartan medoxomil is used for:

Treating high blood pressure alone or with other medicines. It may also be used for other conditions as determined by your doctor.

Azilsartan medoxomil is an angiotensin II receptor blocker (ARB). It works by relaxing blood vessels. This helps to lower blood pressure.

Do NOT use azilsartan medoxomil if:

  • you are allergic to any ingredient in azilsartan medoxomil
  • you are pregnant
  • you are taking a medicine that contains aliskiren and you also have diabetes or kidney problems. Check with your doctor or pharmacist if you are not sure if a medicine you take contains aliskiren

Contact your doctor or health care provider right away if any of these apply to you.

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Before using azilsartan medoxomil:

Some medical conditions may interact with azilsartan medoxomil. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of angioedema (swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness), including angioedema caused by treatment with an angiotensin-converting enzyme (ACE) inhibitor (eg, lisinopril) or another ARB (eg, valsartan)
  • if you have a history of heart problems (eg, heart failure), blood vessel problems, blood flow problems, liver problems, diabetes, or kidney problems (eg, renal artery stenosis)
  • if you have a history of a stroke or a recent heart attack
  • if you are dehydrated or have low blood volume
  • if you have electrolyte problems (eg, high blood potassium levels, low blood sodium levels), vomiting or diarrhea, or are on a low-salt (sodium) diet
  • if you take other medicines for high blood pressure or heart problems

Some MEDICINES MAY INTERACT with azilsartan medoxomil. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Diuretics (eg, furosemide, hydrochlorothiazide) because the risk of low blood pressure may be increased
  • ACE inhibitors (eg, enalapril) or aliskiren because the risk of certain side effects (eg, kidney problems, high blood potassium levels, low blood pressure) may be increased
  • Potassium-sparing diuretics (eg, spironolactone, triamterene) or potassium supplements because the risk of high blood potassium levels may be increased
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, indomethacin, celecoxib) because they may decrease azilsartan medoxomil's effectiveness and the risk of kidney problems may be increased
  • Lithium because the risk of its side effects may be increased by azilsartan medoxomil

This may not be a complete list of all interactions that may occur. Ask your health care provider if azilsartan medoxomil may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use azilsartan medoxomil:

Use azilsartan medoxomil as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with azilsartan medoxomil. Talk to your pharmacist if you have questions about this information.
  • Take azilsartan medoxomil by mouth with or without food.
  • Taking azilsartan medoxomil at the same time each day will help you remember to take it.
  • Take azilsartan medoxomil on a regular schedule to get the most benefit from it.
  • Continue to take azilsartan medoxomil even if you feel well. Do not miss any doses.
  • If you miss a dose of azilsartan medoxomil, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use azilsartan medoxomil.

Important safety information:

  • Azilsartan medoxomil may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use azilsartan medoxomil with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Azilsartan medoxomil may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
  • Dehydration, excessive sweating, vomiting, or diarrhea may increase the risk of low blood pressure. Contact your health care provider at once if any of these occur.
  • Check with your doctor before you use a salt substitute or a product that has potassium in it.
  • Azilsartan medoxomil may not work as well in black patients. They may also be at greater risk of side effects. Contact your doctor if your symptoms do not improve or if they become worse.
  • Tell your doctor or dentist that you take azilsartan medoxomil before you receive any medical or dental care, emergency care, or surgery.
  • Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
  • If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
  • Lab tests, including blood pressure, blood electrolyte levels, and kidney function, may be performed while you use azilsartan medoxomil. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use azilsartan medoxomil with caution in the ELDERLY; they may be more sensitive to its effects.
  • Azilsartan medoxomil should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Azilsartan medoxomil may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if azilsartan medoxomil is found in breast milk. Do not breast-feed while taking azilsartan medoxomil.

Possible side effects of azilsartan medoxomil:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); change in the amount of urine produced; chest pain; fast, slow, or irregular heartbeat; muscle pain, spasms, or cramps; sudden, severe nausea or vomiting; symptoms of low blood pressure (eg, fainting, severe dizziness, light-headedness); unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of azilsartan medoxomil:

Store azilsartan medoxomil at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store azilsartan medoxomil in its original container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep azilsartan medoxomil out of the reach of children and away from pets.

General information:

  • If you have any questions about azilsartan medoxomil, please talk with your doctor, pharmacist, or other health care provider.
  • Azilsartan medoxomil is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take azilsartan medoxomil or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about azilsartan medoxomil. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to azilsartan medoxomil. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using azilsartan medoxomil.

Issue Date: November 5, 2014
Database Edition 14.4.1.002
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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