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All about: Avandaryl

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Generic Name: Glimepiride/Rosiglitazone (glye-MEP-i-ride/ROE-zi-GLI-ta-zone)
Brand Name: Avandaryl

Thiazolidinedione antidiabetics such as Avandaryl may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Avandaryl should not be used to treat patients with moderate to severe heart failure. You will be monitored for signs of heart failure when you start Avandaryl and when your dose increases. Contact your doctor at once if you develop swelling of the hands, ankles, or feet; shortness of breath; or sudden unexplained weight gain. Your doctor may need to stop your medicine or change your dose.


Avandaryl is used for:

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

Avandaryl is a thiazolidinedione and sulfonylurea antidiabetic combination. It lowers blood sugar by making the cells of the body more sensitive to the action of insulin. It also causes the pancreas to release insulin, which helps to lower blood sugar.

Do NOT use Avandaryl if:

  • you are allergic to any ingredient in Avandaryl
  • you have moderate to severe heart failure, liver problems or abnormal liver function tests, certain severe problems associated with diabetes (eg, diabetic ketoacidosis, diabetic coma), moderate to severe burns, or very high blood acid levels (acidosis)
  • you have a history of yellowing of the skin or eyes after taking troglitazone
  • you have type 1 diabetes
  • you are taking bosentan or using insulin

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

Before using Avandaryl :

Some medical conditions may interact with Avandaryl . 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, heart, or blood vessel problems; stroke; certain hormonal problems (eg, adrenal or pituitary problems, syndrome of inappropriate secretion of antidiuretic hormone [SIADH]); or low blood sodium levels
  • if you have stomach or bowel problems (eg, stomach or bowel blockage, stomach paralysis), drink alcohol, or have had poor nutrition
  • if you have very poor health, a high fever, a severe infection, severe diarrhea, or high blood acid levels, or if you have had a severe injury
  • if you have swelling problems (edema)
  • if you will be having surgery

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

  • Bosentan because liver problems may occur; the effectiveness of both medicines may be decreased
  • Insulin because the risk of swelling problems and heart problems 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, miconazole, ketoconazole), chloramphenicol, clofibrate, fenfluramine, 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 Avandaryl 's effectiveness, resulting in high blood sugar
  • Gemfibrozil because blood sugar may be increased or decreased

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

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

  • Take Avandaryl by mouth with breakfast or the first main meal of the day unless instructed otherwise by your doctor.
  • Continue to take Avandaryl even if you feel well. Do not miss any doses.
  • Taking Avandaryl at the same time each day will help you remember to take it.
  • If you miss a dose of Avandaryl , 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 Avandaryl .

Important safety information:

  • Avandaryl may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Avandaryl 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 Avandaryl . It may increase the risk of low blood sugar. Rarely, alcohol may interact with Avandaryl and cause a serious reaction with symptoms such as flushing, nausea, vomiting, dizziness, or stomach pain. Discuss any questions or concerns with your doctor.
  • Carry an ID card at all times that says you have diabetes.
  • Follow the diet and exercise program given to you by your health care provider. Proper diet, regular exercise, and regular blood sugar testing are important for best results with Avandaryl .
  • Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Avandaryl exactly as prescribed, tell your doctor.
  • 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.
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Avandaryl may cause low blood sugar levels. 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.
  • Avandaryl may begin to work within a few days. However, it may take up to 3 months for its full effect to occur. Do not take more than the recommended dose or stop taking Avandaryl without checking with your doctor.
  • Avandaryl 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.
  • Avandaryl 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 Avandaryl .
  • Avandaryl may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Avandaryl . 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 Avandaryl before you receive any medical or dental care, emergency care, or surgery.
  • Lab tests, including fasting blood sugar, hemoglobin A1c, liver function, kidney function, and eye exams, may be performed while you use Avandaryl . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Avandaryl with caution in the ELDERLY; they may be more sensitive to its effects, especially the risk of heart problems or low blood sugar.
  • Avandaryl should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Avandaryl may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Avandaryl while you are pregnant. It is not known if Avandaryl is found in breast milk. Do not breast-feed while taking Avandaryl .

When used for long periods of time Avandaryl 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 Avandaryl :

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:

Dizziness; headache; upper respiratory tract infection; weight gain.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest pain; confusion; fainting; fever, chills, or sore throat; increased or painful urination; menstrual changes; symptoms of heart failure (eg, shortness of breath; sudden unexplained weight gain; swelling of the hands, ankles, 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 bruising or bleeding; unusual tiredness or weakness; vision changes or persistent blurred vision.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), 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 Avandaryl :

Store Avandaryl 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 light, heat, and moisture. Do not store Avandaryl in the bathroom. Keep Avandaryl out of the reach of children and away from pets.

General information:

  • If you have any questions about Avandaryl , please talk with your doctor, pharmacist, or other health care provider.
  • Avandaryl 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.

This information is a summary only. It does not contain all information about Avandaryl . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: September 5, 2007
Database Edition 07.3.1.003
Copyright © 2007 Wolters Kluwer Health, Inc.

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