Generic Name: rosiglitazone/metformin (ROE-si-GLI-ta-zone/met-FOR-min)
Brand Name: Avandamet
Rosiglitazone/metformin may rarely cause a serious and sometimes fatal condition called lactic acidosis. Most of these cases have occurred in diabetic patients who also have certain kidney problems. The risk of lactic acidosis may be greater if you have liver problems, kidney problems, or heart failure. The risk may also be greater in patients who are elderly or who drink alcohol. Lab tests, including kidney function, may be performed while you take rosiglitazone/metformin.
Do not begin to take rosiglitazone/metformin if you are older than 80 years old unless lab tests show that you do not have decreased kidney function. Do not take it if you have a severe infection or low blood oxygen levels, or you are dehydrated. Tell your doctor you take rosiglitazone/metformin before you have any surgery or lab procedures.
Contact your doctor right away if you notice symptoms such as muscle pain or tenderness; unusual drowsiness, dizziness, or light-headedness; slow or irregular heartbeat; fast or difficult breathing; unusual stomach discomfort; or unusual weakness or tiredness. Contact your doctor right away if you start to feel unusually cold or if you have a general feeling of being unwell.
Thiazolidinedione antidiabetics, such as rosiglitazone (one of the components of rosiglitazone/metformin), may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Rosiglitazone/metformin 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/metformin 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/ metformin is used for:
Treating type 2 diabetes in patients. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.
Rosiglitazone/metformin is a thiazolidinedione and biguanide antidiabetic combination. The biguanide works by decreasing the amount of sugar that the liver produces and the intestines absorb. The thiazolidinedione works by making your body more sensitive to the insulin that you naturally produce. This helps to lower blood sugar.
Do NOT use rosiglitazone/ metformin if:
- you are allergic to any ingredient in rosiglitazone/metformin
- you have type 1 diabetes
- you have heart failure with symptoms, or moderate to severe heart failure
- you have a severe infection, low blood oxygen levels, kidney or liver problems, high blood ketone or acid levels (eg, diabetic ketoacidosis), or dehydration
- you have had a stroke or a recent heart attack, or you are in shock
- you are 80 years old or older and have not had a kidney function test
- you will be having surgery or certain lab procedures
- you are using insulin
Contact your doctor or health care provider right away if any of these apply to you.
Before using rosiglitazone/ metformin:
Some medical conditions may interact with rosiglitazone/metformin. 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 heart problems (eg, heart failure, a heart attack), liver problems or abnormal liver function tests, diabetic ketoacidosis, a stroke, lung or breathing problems, thyroid problems, stomach or bowel problems (eg, paralysis, blockage), adrenal or pituitary problems, a certain type of diabetic eye disease (macular edema) or other eye or vision problems, or lactic acidosis
- if you have fluid retention or swelling problems (edema), vomiting, diarrhea, poor health or nutrition, low blood calcium or vitamin B12 levels, or anemia
- if you have an infection, a fever, a recent injury, or moderate to severe burns
- if you drink alcohol or have a history of alcohol abuse
- if you will be having surgery or certain lab procedures
- if you are taking a beta-blocker (eg, propranolol)
- if you take medicines for high blood pressure, high cholesterol, heart failure, or for prevention of heart disease or a stroke
- if you have taken a medicine called troglitazone and have had liver problems, including jaundice (yellowing of the skin or eyes)
Some MEDICINES MAY INTERACT with rosiglitazone/metformin. 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 antidiabetics (eg, glipizide), calcium channel blockers (eg, nifedipine), corticosteroids (eg, prednisone), diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, nicotinic acid, phenothiazines (eg, chlorpromazine), phenytoin, sympathomimetics (eg, albuterol, pseudoephedrine), or thyroid hormones (eg, levothyroxine) because the risk of high or low blood sugar may be increased
- Amiloride, cimetidine, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, vancomycin, or medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, tacrolimus) because they may increase the risk of rosiglitazone/metformin's side effects. Ask you doctor if you are unsure if any of your medicines might harm the kidney
- Gemfibrozil because it may increase the risk of rosiglitazone/metformin's side effects
- Rifamycins (eg, rifampin) because they may decrease rosiglitazone/metformin's effectiveness, resulting in high blood sugar
- Anticoagulants (eg, warfarin) because their effectiveness may be decreased or the risk of their side effects may be increased by rosiglitazone/metformin
This may not be a complete list of all interactions that may occur. Ask your health care provider if rosiglitazone/metformin 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/ metformin:
Use rosiglitazone/metformin as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Rosiglitazone/metformin comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get rosiglitazone/metformin refilled.
- Take rosiglitazone/metformin by mouth with meals.
- Taking rosiglitazone/metformin at the same time each day will help you remember to take it.
- Take rosiglitazone/metformin on a regular schedule to get the most benefit from it.
- Continue to take rosiglitazone/metformin even if you feel well. Do not miss any doses.
- If you miss a dose of rosiglitazone/metformin, take it as soon as possible. If it is 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/metformin.
Important safety information:
- Rosiglitazone/metformin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use rosiglitazone/metformin 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/metformin. Follow the diet and exercise program given to you by your health care provider.
- Do not drink large amounts of alcohol while you take rosiglitazone/metformin. Talk to your doctor or health care provider before you drink alcohol while you take rosiglitazone/metformin.
- Tell your doctor or dentist that you take rosiglitazone/metformin before you receive any medical or dental care, emergency care, or surgery.
- Rosiglitazone/metformin may increase the risk of a heart attack. Seek immediate medical attention if you have chest pain or pressure; pain in the arms, back, neck, jaw, or stomach; shortness of breath; cold sweats; severe dizziness or fainting; or severe nausea or vomiting.
- Be careful not to become dehydrated, especially during hot weather, while you are being active, or if you have vomiting or diarrhea. Dehydration may increase your risk of side effects from rosiglitazone/metformin.
- Rosiglitazone/metformin may cause ovulation in women who have not reached menopause but do not ovulate. To avoid pregnancy, be sure to use an effective form of birth control while taking rosiglitazone/metformin.
- Carry an ID card at all times that says you have diabetes. Check your blood sugar levels regularly as directed by your doctor. If they are often higher or lower than they should be and you take rosiglitazone/metformin exactly as prescribed, tell your doctor.
- Rosiglitazone/metformin 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/metformin 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.
- 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/metformin may commonly cause upset stomach, indigestion, nausea, or diarrhea at the beginning of treatment. If you develop unusual or unexpected stomach problems, or if you develop stomach problems later during treatment, contact your doctor at once. This may be a sign of lactic acidosis.
- An increased incidence of bone fracture has been reported in women who take rosiglitazone/metformin. 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.
- Have eye exams as you have been told by your doctor.
- Lab tests may be performed while you use rosiglitazone/metformin. 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/metformin with caution in the ELDERLY; they may be more sensitive to its effects, especially the risk of heart failure or low blood sugar. Low blood sugar levels may also be more difficult to recognize in the elderly.
- Rosiglitazone/metformin should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using rosiglitazone/metformin while you are pregnant. You will also need to talk about the best way to control your diabetes during pregnancy. It is not known if this medicine is found in breast milk. Do not breast-feed while taking rosiglitazone/metformin.
Possible side effects of rosiglitazone/ metformin:
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:
Back or joint pain; cold-like symptoms; diarrhea; dizziness; headache; indigestion; nausea; stomach upset; tiredness.
Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); blurred vision or other vision changes; fainting; fast or difficult breathing; feeling of being unusually cold; fever, chills, or persistent sore throat; general feeling of being unwell; light-headedness; muscle pain or weakness; numbness of an arm or leg; persistent loss of appetite; red, swollen, blistered, or peeling skin; severe or persistent nausea or vomiting; shortness of breath; slow or irregular heartbeat; sudden, severe headache or dizziness; 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 stomach pain or discomfort; 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/metformin:
Store rosiglitazone/metformin at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in bathroom. Keep rosiglitazone/metformin out of the reach of children and away from pets.
- If you have any questions about rosiglitazone/metformin, please talk with your doctor, pharmacist, or other health care provider.
- Rosiglitazone/metformin 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/metformin 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/metformin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to rosiglitazone/metformin. 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/metformin.
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.
More about metformin/rosiglitazone
- Other brands: Avandamet