Brand Name(s):

    
  • Avapro®
  • IMPORTANT WARNING

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

    WHY is this medicine prescribed?

    Irbesartan is used alone or in combination with other medications to treat high blood pressure. It is also used to treat kidney disease caused by diabetes in patients with type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood) and high blood pressure. Irbesartan 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.

    HOW should this medicine be used?

    Irbesartan 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 irbesartan, take it at 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 irbesartan exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

    Your doctor may start you on a low dose of irbesartan and gradually increase your dose.

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

    Are there OTHER USES for this medicine?

    Irbesartan is also used sometimes to treat congestive heart failure (condition in which the heart is unable to pump enough blood to the rest of the body). Talk to your doctor about the possible risks of using this medication for your condition.

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

    What SPECIAL PRECAUTIONS should I follow?

    Before taking irbesartan,

        
  • tell your doctor and pharmacist if you are allergic to irbesartan,any other medications, or any of the ingredients in irbesartan 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 irbesartan 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: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), and selective COX-2 inhibitors such as celecoxib (Celebrex); diuretics ('water pills'); 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 disease.
  • tell your doctor if you are breast-feeding.
  • you should know that irbesartan 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 irbesartan. 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 your 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?

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

        
  • diarrhea
  • heartburn
  • excessive tiredness
  • Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

        
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • hoarseness
  • difficulty breathing or swallowing
  • Irbesartan 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 [at Web Site] 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 excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    Symptoms of overdose may include:

        
  • dizziness
  • fainting
  • fast or slow heartbeat
  • 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 irbesartan.

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

    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.

    AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

    Selected Revisions: November 15, 2012.