Generic Name: glimepiride/rosiglitazone (glye-MEP-ir-ide/ROE-si-GLI-ta-zone)
Brand Name: Avandaryl
Thiazolidinedione antidiabetics such as rosiglitazone, one of the components of glimepiride/rosiglitazone, may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Glimepiride/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 glimepiride/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.
Glimepiride/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 or another medicine that contains pioglitazone. It is used along with diet and exercise.
Glimepiride/rosiglitazone is a thiazolidinedione and sulfonylurea antidiabetic combination. The thiazolidinedione works by making the cells of the body more sensitive to the insulin that you naturally produce. The sulfonylurea works by causing the pancreas to release insulin, which helps to lower blood sugar.
Do NOT use glimepiride/rosiglitazone if:
- you are allergic to any ingredient in glimepiride/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), certain severe problems associated with diabetes (eg, a diabetic coma, diabetic ketoacidosis), or very high blood acid levels (acidosis)
- you have a history of liver problems, including jaundice (yellowing of the skin or eyes), during therapy with a similar medicine called troglitazone
- you have type 1 diabetes
- you are taking bosentan
- you are using insulin
Contact your doctor or health care provider right away if any of these apply to you.
Before using glimepiride/rosiglitazone:
Some medical conditions may interact with glimepiride/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 had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glipizide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide
- if you have a history of kidney, thyroid, or blood vessel problems; heart problems (eg, heart failure, a heart attack); diabetic ketoacidosis; liver problems or abnormal liver function tests; anemia; a stroke; high blood acid levels; certain hormonal problems (eg, adrenal or pituitary problems, syndrome of inappropriate secretion of antidiuretic hormone [SIADH]); low blood sodium levels; a certain type of diabetic eye disease (macular edema) or other eye or vision problems; or low levels of an enzyme called glucose 6-phosphate dehydrogenase (G6PD)
- if you have stomach or bowel problems (eg, blockage, paralysis)
- if you have fluid retention or swelling problems (edema), vomiting, diarrhea, poor health or nutrition, a fever, an infection, moderate to severe burns, or brain or nervous system problems, or if you have had a recent injury
- if you drink alcohol or have a history of alcohol abuse
- if you will be having surgery
- 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 glimepiride/rosiglitazone. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Bosentan because liver problems may occur and the effectiveness of both medicines may be decreased
- Insulin because the risk of certain heart problems (eg, a heart attack, heart failure) may be increased
- Beta-blockers (eg, propranolol) because the risk of low blood sugar may be increased. They may also hide certain signs of low blood sugar and make it more difficult to notice
- Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), azole antifungals (eg, ketoconazole, miconazole), chloramphenicol, clofibrate, disopyramide, fenfluramine, fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), phenylbutazone, probenecid, quinolone antibiotics (eg, ciprofloxacin), salicylates (eg, aspirin), and sulfonamides (eg, sulfamethoxazole) because the risk of low blood sugar may be increased
- Calcium channel blockers (eg, diltiazem), corticosteroids (eg, prednisone), decongestants (eg, pseudoephedrine), diazoxide, diuretics (eg, furosemide, hydrochlorothiazide), estrogens, hormonal contraceptives (eg, birth control pills), isoniazid, niacin, phenothiazines (eg, promethazine), phenytoin, rifamycins (eg, rifampin), sympathomimetics (eg, albuterol, epinephrine), or thyroid supplements (eg, levothyroxine) because they may decrease glimepiride/rosiglitazone's effectiveness, resulting in high blood sugar
- Gemfibrozil because it may increase the risk of glimepiride/rosiglitazone's side effects
This may not be a complete list of all interactions that may occur. Ask your health care provider if glimepiride/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 glimepiride/rosiglitazone:
Use glimepiride/rosiglitazone as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Glimepiride/rosiglitazone comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get glimepiride/rosiglitazone refilled.
- Take glimepiride/rosiglitazone by mouth with breakfast or the first main meal of the day unless instructed otherwise by your doctor.
- Continue to take glimepiride/rosiglitazone even if you feel well. Do not miss any doses.
- Taking glimepiride/rosiglitazone at the same time each day will help you remember to take it.
- If you miss a dose of glimepiride/rosiglitazone, 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 glimepiride/rosiglitazone.
Important safety information:
- Glimepiride/rosiglitazone may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use glimepiride/rosiglitazone with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not drink alcohol while you are taking glimepiride/rosiglitazone; it may increase the risk of low blood sugar. Rarely, alcohol may interact with glimepiride/rosiglitazone and cause a serious reaction with symptoms such as flushing, nausea, vomiting, dizziness, or stomach pain. Discuss any questions or concerns with your doctor.
- Proper diet and exercise are important in order to lose weight and keep it off. Follow the diet and exercise program given to you by your health care provider.
- 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 or lower than they should be and you take glimepiride/rosiglitazone exactly as prescribed, tell your doctor.
- Glimepiride/rosiglitazone contains rosiglitazone. It may cause or worsen heart failure in some patients. It may also increase the risk of a 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.
- Glimepiride/rosiglitazone may cause low blood sugar levels. Low blood sugar may be more likely to occur if you take glimepiride/rosiglitazone along with certain other medicines for diabetes (eg, 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.
- Risk of low blood sugar may be increased by severe or prolonged exercise, drinking alcohol, or skipping meals.
- It may take 2 weeks for glimepiride/rosiglitazone to start to lower your blood sugar. It may take up to 3 months to see the full effect of glimepiride/rosiglitazone. Do NOT take more than the recommended dose or stop taking glimepiride/rosiglitazone without checking with your doctor.
- Glimepiride/rosiglitazone contains a sulfonylurea. It may increase the risk of death from heart disease. Talk with your doctor about the benefits and risks of this or other therapies to treat your condition.
- Glimepiride/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 glimepiride/rosiglitazone.
- Glimepiride/rosiglitazone may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to glimepiride/rosiglitazone. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Tell your doctor or dentist that you take glimepiride/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 glimepiride/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 A 1c, liver function, kidney function, and eye exams, may be performed while you use glimepiride/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 glimepiride/rosiglitazone 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.
- Glimepiride/rosiglitazone should not be used in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Glimepiride/rosiglitazone should not be used if you are pregnant. If you think you may be pregnant, contact your doctor. It is not known if glimepiride/rosiglitazone is found in breast milk. Do not breast-feed while taking glimepiride/rosiglitazone.
When used for long periods of time glimepiride/rosiglitazone may not work as well. If your blood sugar has been under control and then becomes hard to manage, contact your doctor. Do not change the dose of your medicine without checking with your doctor.
Possible side effects of glimepiride/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; confusion; fainting; fever, chills, or persistent sore throat; increased or painful urination; lightheadedness; menstrual changes; numbness of an arm or a leg; red, swollen, blistered, or peeling skin; sudden, severe headache, vomiting, or dizziness; 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, severe or persistent nausea, stomach pain, unexplained vomiting or loss of appetite, yellowing of the skin or eyes); symptoms of low blood sugar (eg, anxiety, chills, dizziness or drowsiness, fast heartbeat, headache, increased hunger, increased sweating, tremors); unusual bone pain (especially in the hand, foot, or upper arm); unusual bruising or bleeding; 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. Symptoms may include coma; confusion; fainting; fast heartbeat; lethargy; lightheadedness; seizures; severe dizziness or drowsiness; tremor; unusual sweating.Proper storage of glimepiride/rosiglitazone:
Store glimepiride/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. Store away from heat, moisture, and light. Do not store in the bathroom. Keep glimepiride/rosiglitazone out of the reach of children and away from pets.
- If you have any questions about glimepiride/rosiglitazone, please talk with your doctor, pharmacist, or other health care provider.
- Glimepiride/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 glimepiride/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 glimepiride/rosiglitazone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to glimepiride/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 glimepiride/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.