Generic Name: rosiglitazone (ROE-si-GLI-ta-zone)
Brand Name: Avandia
Thiazolidinedione antidiabetics such as rosiglitazone may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Rosiglitazone should not be used to treat patients who have heart failure with symptoms, or moderate to severe heart failure. You will be monitored for signs of heart failure when you start rosiglitazone and if your dose increases. Contact your doctor at once if you develop symptoms of heart failure (eg, swelling of the hands, ankles, legs, or feet; shortness of breath; sudden unexplained weight gain). Your doctor may need to stop your medicine or change your dose.
Rosiglitazone may also increase the risk of a heart attack. Seek immediate medical attention if you experience chest, jaw, or arm pain; numbness of an arm or leg; sudden, severe headache, dizziness, or vomiting; sudden vision changes; or fainting.
Rosiglitazone is used for:
Treating type 2 diabetes in patients who are already taking rosiglitazone. It may also be used in certain patients who are unable to control their blood sugar on other diabetes medicines and, after talking with their doctor, have decided not to take pioglitazone. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.
Rosiglitazone is a thiazolidinedione antidiabetic. It lowers blood sugar by making the cells of the body more sensitive to the insulin that you naturally produce.
Do NOT use rosiglitazone if:
- you are allergic to any ingredient in rosiglitazone
- you have heart failure with symptoms or moderate to severe heart failure
- you have severe liver problems (eg, yellowing of the skin or eyes), type 1 diabetes, or diabetic ketoacidosis (a severe problem associated with diabetes)
- you have a history of liver problems, including jaundice (yellowing of the skin or eyes), during therapy with a similar medicine called troglitazone
- you are using insulin
Contact your doctor or health care provider right away if any of these apply to you.
Before using rosiglitazone:
Some medical conditions may interact with rosiglitazone. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of liver problems or abnormal liver function tests, diabetic ketoacidosis, a stroke, heart problems (eg, congestive heart failure, a heart attack), a certain type of diabetic eye disease (macular edema), or other eye or vision problems
- if you have anemia, or fluid retention or swelling problems (edema)
- if you take medicines for high blood pressure, high cholesterol, or heart failure, or for prevention of heart disease or a stroke
Some MEDICINES MAY INTERACT with rosiglitazone. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Insulin because the risk of certain heart problems (eg, a heart attack, heart failure) may be increased
- Other antidiabetic medicines (eg, glipizide) because the risk of low blood sugar may be increased
- Rifamycins (eg, rifampin) because it may decrease rosiglitazone's effectiveness, resulting in high blood sugar
- Gemfibrozil because it may increase the risk of rosiglitazone's side effects
- Anticoagulants (eg, warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by rosiglitazone
This may not be a complete list of all interactions that may occur. Ask your health care provider if rosiglitazone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use rosiglitazone:
Use rosiglitazone as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Rosiglitazone comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get rosiglitazone refilled.
- Take rosiglitazone by mouth with or without food.
- Continue to take rosiglitazone even if you feel well. Do not miss any doses. Taking rosiglitazone at the same time each day will help you remember to take it.
- If you miss a dose of rosiglitazone, take it as soon as possible. If it almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use rosiglitazone.
Important safety information:
- Rosiglitazone may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Take rosiglitazone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Proper diet and exercise are important for best results with rosiglitazone. Follow the diet and exercise program given to you by your health care provider.
- It may take 2 weeks for rosiglitazone to start to lower your blood sugar. It may take up to 3 months to see the full effect of rosiglitazone. Do NOT take more than the recommended dose or stop taking rosiglitazone without checking with your doctor.
- Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher than they should be and you take rosiglitazone exactly as prescribed, tell your doctor.
- Rosiglitazone may cause or worsen heart failure in some patients. It may also increase the risk of heart attack. Talk with your doctor about the benefits and risks of this or other therapies to treat your condition.
- It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.
- Rosiglitazone does not usually cause low blood sugar. Low blood sugar may be more likely to occur if you skip a meal, exercise heavily, or drink alcohol. It may also be more likely if you take rosiglitazone along with certain other medicines for diabetes (eg, sulfonylureas, insulin). Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
- Rosiglitazone may cause ovulation in women who have not reached menopause but do not ovulate. To avoid pregnancy, be sure to use effective birth control while using rosiglitazone.
- Tell your doctor or dentist that you take rosiglitazone before you receive any medical or dental care, emergency care, or surgery.
- An increased incidence of bone fracture has been reported in women who take rosiglitazone. Tell your doctor if you have a history of bone fracture, low calcium intake, or weak bones (eg, osteoporosis). Tell your doctor right away if you experience any unusual bone pain, especially in the hand, foot, or upper arm.
- Lab tests, including complete blood cell counts, fasting blood sugar, hemoglobin A1c, eye examinations, and liver function, may be performed while you take rosiglitazone. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use rosiglitazone with caution in the ELDERLY; they may be more sensitive to its effects, especially the risk of heart failure.
- Rosiglitazone should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Do not take rosiglitazone if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if rosiglitazone is found in breast milk. Do not breast-feed while taking rosiglitazone.
Possible side effects of rosiglitazone:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Cold-like symptoms; headache.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred vision or other vision changes; chest, jaw, or arm pain or discomfort; fainting; lightheadedness; numbness of an arm or leg; red, swollen, blistered, or peeling skin; severe headache, stomach pain, or vomiting; symptoms of heart failure (eg, shortness of breath; sudden, unexplained weight gain; swelling of the hands, ankles, legs, or feet); symptoms of liver problems (eg, dark urine; yellowing of the skin or eyes; unexplained nausea, vomiting, or loss of appetite; stomach pain); symptoms of low blood sugar (eg, anxiety, increased sweating, dizziness or drowsiness, headache, chills, tremors, increased hunger); unusual bone pain (especially in the hand, foot, or upper arm); unusual tiredness or weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.Proper storage of rosiglitazone:
Store rosiglitazone at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store rosiglitazone in the bathroom. Store away from heat, moisture, and light. Keep rosiglitazone out of the reach of children and away from pets.
- If you have any questions about rosiglitazone, please talk with your doctor, pharmacist, or other health care provider.
- Rosiglitazone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take rosiglitazone or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about rosiglitazone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to rosiglitazone. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using rosiglitazone.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.