Irbesartan is an angiotensin II receptor blocker (sometimes called an ARB).

Irbesartan is used to treat high blood pressure (hypertension) in adults and children at least 6 years old. Lowering blood pressure may lower your risk of a stroke or heart attack.

Irbesartan is also used to treat kidney problems caused by type 2 diabetes.

Irbesartan may also be used for purposes not listed in this medication guide.

Do not use if you are pregnant. Stop using and tell your doctor right away if you become pregnant.

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

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Irbesartan 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 irbesartan.

It may take up to 2 weeks before your blood pressure is under control. Keep using this medicine 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 at room temperature away from moisture and heat.

Usual Adult Dose for Hypertension:

Initial dose: 150 mg orally once a day
-Maintenance 150 to 300 mg orally once a day
Maximum dose: 300 mg orally once a day

Comments:
-May be used alone or in combination with other antihypertensive agents.

Use: Treatment of hypertension.

Usual Adult Dose for Diabetic Nephropathy:

300 mg orally once a day

Comments:
-This drug has been shown to reduce the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or ESRD (need for dialysis or renal transplantation).

Use: Treatment of diabetic nephropathy in patients with type 2 diabetes and hypertension with an elevated serum creatinine and proteinuria (greater than 300 mg/day).

You should not use irbesartan if you are allergic to it.

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

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

Tell your doctor if you have ever had:

• a heart condition other than one being treated with irbesartan;

• kidney disease (or if you are on dialysis); 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. Irbesartan 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 using irbesartan.

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.

Overdose symptoms may include fast heartbeats or fainting.

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).

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

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

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

• little or no urination;

• high potassium level--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects of irbesartan may include:

• dizziness;

• feeling light-headed; or

• high potassium.

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:

• heart or blood pressure medication;

• lithium; 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 affect irbesartan, 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 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.

• Avalide® (containing Hydrochlorothiazide, Irbesartan)