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Rosiglitazone and glimepiride

Generic Name: rosiglitazone and glimepiride (ROE-si-GLI-ta-zone & glye-MEP-ir-ide)
Brand Name: Avandaryl

Thiazolidinedione antidiabetics such as rosiglitazone, one of the components of rosiglitazone and glimepiride, may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Rosiglitazone and glimepiride 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 glimepiride 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 and glimepiride is used for:

Treating type 2 diabetes. It is used along with diet and exercise.

Rosiglitazone and glimepiride 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 rosiglitazone and glimepiride if:

  • you are allergic to any ingredient in rosiglitazone and glimepiride
  • you have heart failure with symptoms, or moderate to severe heart failure
  • you have high blood acid levels associated with diabetes (diabetic ketoacidosis) or type 1 diabetes
  • you are using insulin

Contact your doctor or health care provider right away if any of these apply to you.

Before using rosiglitazone and glimepiride:

Some medical conditions may interact with rosiglitazone and glimepiride. 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 sulfamethoxazole, valdecoxib, or zonisamide
  • if you have a history of heart problems (eg, heart failure, a heart attack); high blood acid levels or diabetic ketoacidosis; liver problems or abnormal liver function tests; stroke; syndrome of inappropriate secretion of antidiuretic hormone [SIADH]); low blood sodium levels; bone fracture, low calcium intake, or weak bones (eg, osteoporosis)
  • if you have kidney problems, anemia, adrenal gland or pituitary gland problems, eye or vision problems (eg, macular edema), stomach or bowel problems (eg, blockage, paralysis), glucose-6-phosphate dehydrogenase (G6PD) deficiency, 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 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
  • if you have a history of liver problems, including jaundice (yellowing of the skin or eyes), during therapy with a similar medicine called troglitazone

Some MEDICINES MAY INTERACT with rosiglitazone and glimepiride. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • 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
  • Anabolic steroids and androgens (eg, testosterone), angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), chloramphenicol, clarithromycin, cyclophosphamide, disopyramide, fibrates (eg, fenofibrate), fluconazole, fluoxetine, guanethidine, H2 receptor antagonists (eg, famotidine), insulin or other medicines for diabetes (eg, metformin, pramlintide), miconazole, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), pentoxifylline, phenyramidol, probenecid, propoxyphene, quinolone antibiotics (eg, ciprofloxacin), salicylates (eg, aspirin), somatostatin analogues (eg, octreotide), sulfinpyrazone, sulfonamides (eg, sulfamethoxazole), or tetracyclines (eg, doxycycline) because the risk of low blood sugar may be increased
  • Barbiturates (eg, phenobarbital), clozapine, corticosteroids (eg, prednisone), danazol, diazoxide, diuretics (eg, furosemide, hydrochlorothiazide), estrogens, glucagon, hormonal contraceptives (eg, birth control pills), isoniazid, laxatives (eg, bisacodyl), nicotinic acid, olanzapine, phenothiazines (eg, promethazine), phenytoin, protease inhibitors (eg, ritonavir), rifampin, somatropin, sympathomimetics (eg, albuterol, epinephrine), or thyroid supplements (eg, levothyroxine) because they may decrease rosiglitazone and glimepiride's effectiveness, resulting in high blood sugar
  • Gemfibrozil because it may increase the risk of rosiglitazone and glimepiride's side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if rosiglitazone and glimepiride 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 and glimepiride:

Use rosiglitazone and glimepiride as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Rosiglitazone and glimepiride comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get rosiglitazone and glimepiride refilled.
  • Take rosiglitazone and glimepiride by mouth with breakfast or the first main meal of the day unless instructed otherwise by your doctor.
  • If you also take colesevelam, do not take it within 4 hours after taking rosiglitazone and glimepiride. Check with your doctor if you have questions.
  • Continue to take rosiglitazone and glimepiride even if you feel well. Do not miss any doses.
  • Taking rosiglitazone and glimepiride at the same time each day will help you remember to take it.
  • If you miss a dose of rosiglitazone and glimepiride, 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 and glimepiride.

Important safety information:

  • Tell your doctor or dentist that you take rosiglitazone and glimepiride before you receive any medical or dental care, emergency care, or surgery.
  • Rosiglitazone and glimepiride may cause drowsiness, dizziness, light-headedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use rosiglitazone and glimepiride with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Check with your doctor before you drink alcohol.
  • 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 rosiglitazone and glimepiride exactly as prescribed, tell your doctor.
  • Rosiglitazone and glimepiride contains rosiglitazone. It 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.
  • 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 and glimepiride may cause low blood sugar levels. Low blood sugar may be more likely to occur if you take rosiglitazone and glimepiride 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 nondiet 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.
  • Rosiglitazone and glimepiride 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.
  • Rosiglitazone and glimepiride 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 and glimepiride.
  • An increased incidence of bone fracture has been reported in women who take rosiglitazone and glimepiride. Tell your doctor right away if you experience any unusual bone pain, especially in the hand, foot, or upper arm.
  • A severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause serious health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
  • Have eye exams as you have been told by your doctor.
  • Lab tests may be performed while you use rosiglitazone and glimepiride. 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 and glimepiride with caution in the ELDERLY; they may be more sensitive to its effects.
  • Rosiglitazone and glimepiride 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 and your doctor will need to talk about the benefits and risks of using rosiglitazone and glimepiride 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 and glimepiride.

Possible side effects of rosiglitazone and glimepiride:

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:

Cold-like symptoms; headache; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

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); confusion; fainting; fast or irregular heartbeat; menstrual changes; one-sided weakness; severe 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 tiredness or weakness; vision or speech changes.

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 and glimepiride:

Store rosiglitazone and glimepiride in the original container 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 the bathroom. Keep rosiglitazone and glimepiride out of the reach of children and away from pets.

General information:

  • If you have any questions about rosiglitazone and glimepiride, please talk with your doctor, pharmacist, or other health care provider.
  • Rosiglitazone and glimepiride 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 and glimepiride 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 and glimepiride. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to rosiglitazone and glimepiride. 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 and glimepiride.

Review Date: August 8, 2016

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.

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