Avandia Diabetes Type 2 Treatment - Avandia Patient Information

Brand name: Avandia
Generic name: Rosiglitazone maleate (oral)

Pronunciation: (row zi GLI ta zone)

Avandia, rosiglitazone maleate, full prescribing information

What is Avandia and why is Avandia prescribed?

Avandia is an oral diabetes medicine that helps control blood sugar levels by making the cells of the body more sensitive to the action of insulin.

Avandia is for people with type 2 (non-insulin-dependent) diabetes. It is sometimes used in combination other medications, but it is not for treating type 1 diabetes. Taking Avandia with insulin or nitrates is not recommended.

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

Important information about Avandia

Do not use Avandia if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

Before taking Avandia, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, liver disease, or eye problems caused by diabetes.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them, including hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma (severe hypoglycemia can be fatal). Always keep a source of sugar available in case you have symptoms of low blood sugar.

Some women using Avandia have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control. Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking Avandia. Talk with your doctor if you are concerned about this possibility.

Taking certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with Avandia.

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Before taking Avandia

Do not use Avandia if you have type 1 diabetes, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you have certain conditions, you may need a dose adjustment or special tests to safely use Avandia. Before taking this medication, tell your doctor if you have:

• congestive heart failure or heart disease;
• a history of heart attack or stroke;
• liver disease; or
• eye problems caused by diabetes.

Taking certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with Avandia.

Some women using Avandia have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control. Women may also be more likely than men to have bone fractures in the upper arm, hand, or foot while taking Avandia. Talk with your doctor if you are concerned about this possibility.

FDA pregnancy category C. Avandia may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether rosiglitazone passes into breast milk or if it could harm a nursing baby. Do not take Avandia without first talking to your doctor if you are breast-feeding a baby.

How should I take Avandia?

Take Avandia exactly as it was prescribed for you. Do not take the medication in larger or smaller amounts, or take it for longer than recommended by your doctor. Your doctor may occasionally change your dose to make sure you get the best results from Avandia.

Avandia is usually taken in the morning and evening. You may take the medicine with or without food.

Avandia is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your doctor may also recommend other medicines to treat your diabetes.

It is important to use this medicine regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To be sure Avandia is helping your condition, your blood will need to be tested on a regular basis. Your liver function may also need to be tested, and you may need regular eye exams. It is important that you not miss any scheduled visits to your doctor.

Your medication needs may change if you become sick or injured, if you have a serious infection, or if you have any type of surgery. Your doctor may want you to stop taking Avandia for a short time if any of these situations affect you.

Take care not to let your blood sugar get too low, causing hypoglycemia. You may have hypoglycemia if you skip a meal, exercise too long, drink alcohol, or are under stress.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them:

• hunger, headache, confusion, irritability;
• drowsiness, weakness, dizziness, tremors;
• sweating, fast heartbeat;
• seizure (convulsions); or
• fainting, coma (severe hypoglycemia can be fatal).

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Store Avandia at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. You may have signs of low blood sugar, such as hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizure (convulsions), fainting, or coma.

What should I avoid while taking Avandia?

Avoid drinking alcohol while taking Avandia. Alcohol lowers blood sugar and may increase the risk of hypoglycemia while you are taking this medicine.

Avandia side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using Avandia and call your doctor at once if you have any of these serious side effects:

• feeling short of breath, even with mild exertion;
• swelling or rapid weight gain;
• chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• blurred vision;
• increased thirst or hunger, urinating more than usual; or
• pale skin, easy bruising or bleeding, weakness.

Less serious Avandia side effects may include:

• sneezing, runny nose, cough or other signs of a cold;
• headache;
• gradual weight gain;
• mild diarrhea; or
• back pain

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.

What other drugs will affect Avandia?

You may be more likely to have hyperglycemia (high blood sugar) if you are taking Avandia with other drugs that raise blood sugar. Drugs that can raise blood sugar include:

• isoniazid;
• diuretics (water pills);
• steroids (prednisone and others);
• phenothiazines (Compazine and others);
• thyroid medicine (Synthroid and others);
• birth control pills and other hormones;
• seizure medicines (Dilantin and others); and
• diet pills or medicines to treat asthma, colds or allergies.

You may be more likely to have hypoglycemia (low blood sugar) if you are taking Avandia with other drugs that lower blood sugar. Drugs that can lower blood sugar include:

• nonsteroidal anti-inflammatory drugs (NSAIDs);
• aspirin or other salicylates (including Pepto-Bismol);
• sulfa drugs (Bactrim and others);
• a monoamine oxidase inhibitor (MAOI);
• beta-blockers (Tenormin and others); or
• probenecid (Benemid).

Some medications may interact with Avandia. Tell your doctor if you are using any of the following drugs:

• gemfibrozil (Gemcor);
• rifampin (Rifater, Rifadin, Rimactane); or
• a nitrate drug for chest pain or heart problems, such as nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), or isosorbide mononitrate (Imdur, ISMO, Monoket).

If you are using any of these drugs, you may not be able to take Avandia, or you may require a dosage adjustment or special monitoring.

There may be other drugs not listed that can affect Avandia. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about Avandia.

What does my medication look like?

Rosiglitazone is available with a prescription under the brand name Avandia. Other brand or generic formulations may also be available. Ask your pharmacist any questions you have about Avandia, especially if it is new to you.

• Avandia 2 mg - pink, five-sided, film-coated tablets
• Avandia 4 mg - orange, five-sided, film-coated tablets
• Avandia 8 mg - red-brown, five-sided, film-coated tablets
• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Avandia, rosiglitazone maleate, full prescribing information

Detailed Info on Signs, Symptoms, Causes, Treatments of Diabetes

last updated: 04/2009

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