Brand Name(s):

• Avandia®
• Avandamet®(as a combination product containing Metformin, Rosiglitazone)
• Avandaryl®(as a combination product containing Glimepiride, Rosiglitazone)

IMPORTANT WARNING

Rosiglitazone may cause fluid retention (a condition where the body keeps excess fluid) that may lead to or worsen congestive heart failure (condition in which the heart is unable to pump enough blood to the other parts of the body). Before you start to take rosiglitazone, tell your doctor if you have or have ever had congestive heart failure, especially if your heart failure is so severe that you must limit your activity and are only comfortable when you are at rest or you must remain in a chair or bed. Also tell your doctor if you were born with a heart defect, and if you have or have ever had swelling of the arms, hands, feet, ankles, or lower legs; heart disease, high blood pressure; coronary artery disease (narrowing of the blood vessels that lead to the heart); a heart attack; an irregular heartbeat; or high cholesterol or fats in the blood. Your doctor may tell you not to take rosiglitazone or may monitor you carefully during your treatment.

If you develop congestive heart failure or other heart problems, you may experience certain symptoms. Tell your doctor immediately if you have any of the following symptoms, especially when you first start taking rosiglitazone or after your dose is increased: large weight gain in a short period of time; shortness of breath; swelling of the arms, hands, feet, ankles, or lower legs; swelling or pain in the stomach; waking up short of breath during the night; the need to sleep with extra pillows in order to breathe while lying down; frequent dry cough; or increased tiredness.

Taking rosiglitazone may increase the risk that you will experience a heart attack. This risk may be higher if you take insulin along with rosiglitazone. Your doctor may tell you not to take rosiglitazone if you are taking insulin. Tell your doctor or get emergency medical care immediately if you experience any of the following symptoms: shortness of breath; pain in the jaw, arm, back, neck, or stomach; pain in the center of the chest that lasts for a more than a few minutes or that goes away and comes back; uncomfortable pressure, fullness, or squeezing in the chest; breaking out in a cold sweat; nausea or vomiting; or lightheadedness.

A program has been set up to limit the use of rosiglitazone and to inform people about the increased the risk of heart attack while taking this medication. Only people are already taking rosiglitazone and people whose blood sugar cannot be controlled by other medications should consider taking rosiglitazone. The program also makes sure that everyone who takes rosiglitazone understands the risks and benefits of taking the medication and has talked to his or her doctor about these risks.

You will be able to take rosiglitazone only if you and the doctor who prescribes your medication have enrolled in the program. You will receive your medication by mail from a participating pharmacy; you will not be able to get your medication from a local retail pharmacy. Ask your doctor if you have any questions about participating in the program or receiving your medication.

WHY is this medicine prescribed?

Rosiglitazone is used along with a diet and exercise program and sometimes with one or more other medications to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Because of the risk of serious side effects, rosiglitazone should only be used to treat people who are already taking the medication, or people whose blood sugar cannot be controlled with other medications and who have decided not to take pioglitazone (Actos, a medication that is similar to rosiglitazone but that may not cause the same serious side effects) for medical reasons. Rosiglitazone is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. Rosiglitazone is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may occur if high blood sugar is not treated).

HOW should this medicine be used?

Rosiglitazone comes as a tablet to take by mouth. It is usually taken once or twice daily with or without meals. Take rosiglitazone at about the same time(s) 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 rosiglitazone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may increase your dose of rosiglitazone after 8-12 weeks, based on your body's response to the medication.

Rosiglitazone helps control type 2 diabetes but does not cure it. It may take 2 weeks for your blood sugar to decrease, and 2-3 months or longer for you to feel the full benefit of rosiglitazone. Continue to take rosiglitazone even if you feel well. Do not stop taking rosiglitazone without talking to your doctor.

Are there OTHER USES for this medicine?

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

What SPECIAL PRECAUTIONS should I follow?

Before taking rosiglitazone,

• tell your doctor and pharmacist if you are allergic to rosiglitazone or any other medications.
• tell your doctor and pharmacist what 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: gemfibrozil (Lopid); other medications for diabetes; medications for high blood pressure, high cholesterol, heart failure, or prevention of heart attack or stroke; and rifampin (Rifadin, Rimactane, in Rifamate). 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 any of the conditions mentioned in the IMPORTANT WARNING section or diabetic eye disease such as macular edema (swelling of the back of the eye); or liver disease. Also tell your doctor if you have ever taken troglitazone (Rezulin, no longer available in the United States), especially if you stopped taking it because you experienced side effects.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking rosiglitazone, call your doctor.
• if you have not yet experienced menopause (change of life; end of monthly menstrual periods) you should know that rosiglitazone may increase the chance that you will become pregnant even if you do not have regular monthly periods or you have a condition that prevents you from ovulating (releasing an egg from the ovaries). Talk to your doctor about methods of birth control that will work for you.

What SPECIAL DIETARY instructions should I follow?

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet, exercise regularly, and lose weight if necessary. This will help to control your diabetes and help rosiglitazone work more effectively

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 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?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

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). 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.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor, your eye doctor, and the laboratory. Your doctor will probably order regular eye examinations and certain laboratory tests to check your body's response to rosiglitazone. Your blood sugar and glycosylated hemoglobin should be checked regularly to determine your response to rosiglitazone. Your doctor may also tell you how to check your response to rosiglitazone by measuring your blood sugar levels at home. Follow these directions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

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: August 15, 2011.