Type of medicine: antihyperglycemic; antidiabetic
Generic and brand names: rosiglitazone maleate and glimepiride oral; Avandaryl
This medicine combines 2 medicines taken by mouth to treat type 2 diabetes. It should not be used to treat type 1 diabetes or diabetic ketoacidosis. It is taken when diet and exercise have not controlled blood sugar levels.
Because this medicine has been associated with serious side effects, it is restricted to people who:
Talk with your healthcare provider about this.
You must be enrolled in a special program before you can receive this medicine. Only a few healthcare providers are allowed to prescribe this medicine. Also, only a few pharmacies are allowed to sell it. For more information call 1-800-AVANDIA.
Tell your healthcare provider if you have ever had:
Tell your healthcare provider if you are taking any medicines to treat heart failure, high blood pressure, high cholesterol, or to prevent heart disease or stroke.
Tell your provider if you take nitrate medicines or insulin. This medicine is not recommended for people who are taking insulin or nitrates. Also tell your healthcare provider if you get sick, injured, or are scheduled to have surgery.
Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Talk to your healthcare provider about whether you will need to use insulin to control your blood sugar during pregnancy. Do not breast-feed while you are taking this medicine without your healthcare provider's approval.
Read the Medication Guide that comes in the medicine package when you start taking this medicine and each time you get a refill.
Check the label on the medicine for directions about your specific dose. Take this medicine every day exactly as your healthcare provider prescribes. Do not stop taking this medicine without your healthcare provider's approval. Take it with the first meal of the day. Follow carefully the diet and exercise plan your healthcare provider gives you. Diet and exercise affect your dosage. This medicine may start working in 1 to 2 weeks, but it may take 2 to 3 months to have full effect.
If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.
If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.
Symptoms of an acute overdose may include: strong hunger, headache, confusion, irritability, drowsiness, weakness, dizziness, tremors, sweating, fast heartbeat, seizures, fainting, coma.
This medicine may cause or worsen heart failure. It may also increase your risk for a heart attack, stroke, or other heart problems, especially if you also take insulin or nitrate medicines. You will be required to review and sign a statement that you understand the risks. Talk with your healthcare provider about this.
Get medical care right away if you start having chest pain or pressure; shortness of breath; any unexplained swelling; or if you are gaining weight very fast. These may be symptoms of a serious heart problem.
Follow the diet and exercise program prescribed for you. Your healthcare provider will need to check your blood sugar control regularly. Be sure to keep all of your appointments. You will probably be set up with a schedule for testing your blood sugars at home. Keep records of your blood sugar readings and bring this with you to your appointments with your provider.
You may need blood tests at the start of treatment and regularly while you take this medicine to check your liver, kidneys, and blood cells. Keep all appointments for visits with your provider. Low blood sugar (hypoglycemia) can occur if you miss or delay meals, drink too much alcohol, take too much medicine, or exercise more than usual. Symptoms of low blood sugar include confusion, shaking, weakness, strong hunger, cold sweats, headache, nausea, vision problems, and feeling faint. Treat the condition quickly by eating or drinking something with sugar in it such as candy, juice, or nondiet soda. You could also take glucose tablets or gels (available in drug stores) is another quick way to treat hypoglycemia. Be sure to talk about this with your healthcare provider.
This medicine may make birth control pills less effective. Some women who have gone through menopause and no longer have periods may be able to get pregnant while taking this medicine. Ask your healthcare provider if this applies to you. Talk with your healthcare provider if you need birth control.
If you need emergency care, surgery, or dental work, tell the healthcare provider or dentist you are taking this medicine. Wear some form of identification stating that you are a diabetic (such as a Medic Alert bracelet). If you become unconscious, the ID tells emergency healthcare providers that you are a diabetic and need special care.
Rarely, this medicine may cause vision problems. You need to have regular eye exams while taking this medicine.
Some people, particularly women, are at higher risk of having bone fractures while taking this medicine. You may also need bone scans or X-rays to see if this medicine is affecting your bones. Talk to your healthcare provider about how to keep your bones healthy.
This medicine may make your skin more sensitive to the sun and may make you sunburn more easily. Wear protective clothing and sunscreen lotion when you are exposed to the sun. Do not use a sunlamp. If you get a severe sunburn, contact your healthcare provider right away.
Alcohol may affect the way your body responds to this medicine and to food. Do not drink alcohol unless your healthcare provider approves.
Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.
Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help): Allergic reaction (hives; itching; rash; trouble breathing; tightness in your chest; swelling of your lips, tongue, and throat).
Serious (report these to your healthcare provider right away): Chest pain or pressure; severe nausea or vomiting; severe abdominal pain; irregular heartbeat; severe dizziness; increasing tiredness; loss of appetite; dark urine; light-colored bowel movements; yellowing of your eyes or skin; swelling of legs or ankles or any unexplained swelling; shortness of breath; unusual bruising or bleeding; vision problems; unusually fast weight gain.
Other: Runny or stuffy nose, nausea, vomiting, headache, diarrhea.
When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:
Do not drink large amounts of alcohol while you are taking this medicine. Talk to your healthcare provider about this.
If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.
Store this medicine at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.
This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.
Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicines in the trash.
Keep all medicines out of the reach of children.
Do not share medicines with other people.
