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What is rosiglitazone?

Rosiglitazone is an oral diabetes medicine that helps control blood sugar levels.

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

Rosiglitazone is not recommended for use with insulin.

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

Precautions

Instructions

Side Effects

Interactions

Precautions

Do not use rosiglitazone 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 this medication. Before taking rosiglitazone, 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 rosiglitazone.

Some women using rosiglitazone 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 rosiglitazone. Talk with your doctor if you are concerned about this possibility.

Categoría C del embarazo por la FDA. No se conoce si rosiglitazone le puede hacer daño al bebé nonato. Antes de usar esta medicina, dígale a su médico usted está embarazada o planea tener un embarazo durante su tratamiento.

It is not known whether rosiglitazone passes into breast milk or if it could harm a nursing baby. Do not take rosiglitazone without first talking to your doctor if you are breast-feeding a baby.

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

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Instructions

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.

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.

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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 rosiglitazone 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 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.

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Interactions

You may be more likely to have hyperglycemia (high blood sugar) if you are taking rosiglitazone 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 rosiglitazone 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 rosiglitazone. 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).

This list is not complete and there may be other drugs that can interact with rosiglitazone. 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.

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