Learn more about usage, cautions, and possible side effects of Avandaryl.
Chemical Name: ROSIGLITAZONE (ROE-zi-GLI-ta-zone) and GLIMEPIRIDE (glye-MEP-ir-ide)
Avandaryl 4-4mg is a thiazolidinedione and sulfonylurea antidiabetic combination used to treat 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.
WARNING: Thiazolidinedione antidiabetics such as rosiglitazone, one of the components of Avandaryl 4-4mg, may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Avandaryl 4-4mg should not be used to treat patients that have heart failure with symptoms, or moderate to severe heart failure. You will be monitored for signs of heart failure when you start Avandaryl 4-4mg and when 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 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. Some medicines or medical conditions may interact with Avandaryl 4-4mg. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE AVANDARYL 4-4mg IF you are also taking bosentan or are using insulin. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking beta-blockers; angiotensin-converting enzyme (ACE) inhibitors; anticoagulants; azole antifungals; chloramphenicol; clofibrate; disopyramide; fenfluramine; fluoxetine; monoamine oxidase inhibitors (MAOIs); nonsteroidal anti-inflammatory drugs (NSAIDs); phenylbutazone; probenecid; quinolone antibiotics; salicylates; sulfonamides; calcium channel blockers; corticosteroids; decongestants; diazoxide; diuretics; estrogens; hormonal contraceptives; isoniazid; niacin; phenothiazines; phenytoin; rifamycins; sympathomimetics; thyroid supplements; gemfibrozil; or medicines for high blood pressure, high cholesterol, heart failure, or prevention of heart disease or stroke. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of kidney, thyroid, or blood vessel problems; heart problems (eg, heart failure, heart attack); diabetic ketoacidosis; liver problems or abnormal liver function tests; anemia; stroke; high blood acid levels (acidosis); 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; low levels of an enzyme called glucose 6-phosphate dehydrogenase (G6PD); alcohol abuse; allergies; pregnancy; or breast-feeding. Tell your doctor if you have stomach or bowel problems (eg, blockage, paralysis), fluid retention or swelling problems (edema), vomiting, diarrhea, poor health or nutrition, a fever, an infection, moderate to severe burns, brain or nervous system problems, or if you will be having surgery. Tell your doctor if you have had a severe allergic reaction (eg, severe rash, hives, breathing difficulties, dizziness) to any other sulfonamide medicine (eg, sulfamethoxazole). Tell your doctor if you drink alcohol or have had a recent injury. USE OF AVANDARYL 4-4mg IS NOT RECOMMENDED if you have heart failure with symptoms, or moderate to severe heart failure; severe liver problems (eg, yellowing of the skin or eyes); certain severe problems associated with diabetes (eg, diabetic coma, diabetic ketoacidosis); very high blood acid levels; or type 1 diabetes. USE OF AVANDARYL 4-4mg IS NOT RECOMMENDED if you have a history of liver problems, including jaundice (yellowing of the skin or eyes), during therapy with a similar medicine called troglitazone. Avandaryl 4-4mg should not be used in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
Follow the directions for taking Avandaryl 4-4mg provided by your doctor. Avandaryl 4-4mg comes with an extra patient information sheet called a Medication Guide approved by the U.S. Food and Drug Administration. Read it carefully. Read it again each time you get Avandaryl 4-4mg refilled. TAKE AVANDARYL 4-4mg with breakfast or the first main meal of the day unless instructed otherwise by your doctor. IT MAY TAKE 2 WEEKS FOR AVANDARYL 4-4mg to start to lower your blood sugar. It may take up to 3 months to see the full effect of Avandaryl 4-4mg. Do not take more than the recommended dose or stop taking Avandaryl 4-4mg without checking with 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. WHEN USED FOR LONG PERIODS OF TIME Avandaryl 4-4mg 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. STORE AVANDARYL 4-4mg at 77 degrees F (25 degrees C) away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. KEEP AVANDARYL 4-4mg out of the reach of children and away from pets. Taking Avandaryl 4-4mg at the same time each day will help you remember to take it. CONTINUE TO TAKE AVANDARYL 4-4mg even if you feel well. DO NOT MISS any doses. IF YOU MISS A DOSE OF AVANDARYL 4-4mg, 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. Contact your doctor or pharmacist if you have any questions or concerns about using Avandaryl 4-4mg.
DO NOT USE AVANDARYL 4-4mg IF you are allergic to any ingredient in Avandaryl 4-4mg. AVANDARYL 4-4mg MAY CAUSE DROWSINESS, DIZZINESS, LIGHTHEADEDNESS, OR BLURRED VISION. These effects may be worse if you take it with alcohol or certain medicines. Use Avandaryl 4-4mg 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 4-4mg; it may increase the risk of low blood sugar. Rarely, alcohol may interact with Avandaryl 4-4mg and cause a serious reaction with symptoms such as flushing, nausea, vomiting, dizziness, or stomach pain. LAB TESTS may be performed to monitor your condition or check for side effects. KEEP ALL DOCTOR AND LAB APPOINTMENTS. Tell your doctor or dentist that you take Avandaryl 4-4mg before you receive any medical or dental care, emergency care, or surgery. AVANDARYL 4-4mg MAY CAUSE LOW BLOOD SUGAR LEVELS. Low blood sugar may be more likely to occur if you take Avandaryl 4-4mg along with certain other medicines for diabetes (eg, insulin). Risk of low blood sugar may be increased by severe or prolonged exercise, drinking alcohol, or skipping meals. 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 increase hunger. 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. AVANDARYL 4-4mg 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 4-4mg MAY CAUSE YOU TO BECOME SUNBURNED MORE EASILY. Avoid the sun, sunlamps, or tanning booths until you know how you react to Avandaryl 4-4mg. Use a sunscreen or wear protective clothing if you must be outside for more than a short time. BEFORE YOU BEGIN TAKING ANY NEW MEDICINES, either prescription or over-the-counter, check with your doctor or pharmacist. USE AVANDARYL 4-4mg WITH CAUTION IN THE ELDERLY; they may be more sensitive to its effects. FOR WOMEN: AVANDARYL 4-4mg 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 4-4mg. AN INCREASED INCIDENCE OF BONE FRACTURE has been reported in women who take Avandaryl 4-4mg. 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. AVANDARYL 4-4mg SHOULD NOT BE USED IF YOU ARE PREGNANT. If you think you may be pregnant, contact your doctor. IT IS NOT KNOWN IF AVANDARYL 4-4mg IS FOUND in breast milk. DO NOT BREAST-FEED while taking Avandaryl 4-4mg.
SIDE EFFECTS that may occur while taking Avandaryl 4-4mg include cold-like symptoms or headache. If they continue or are bothersome, check with your doctor. AVANDARYL 4-4mg CONTAINS ROSIGLITAZONE. It may cause or worsen heart failure in some patients. It may also increase the risk of heart attack. Talk with your doctor about the benefits and risks of this or other therapies to treat your condition. CONTACT YOUR DOCTOR IMMEDIATELY if you experience 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; or unusual tiredness or weakness. AN ALLERGIC REACTION to Avandaryl 4-4mg is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; or unusual hoarseness. 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. You may report side effects to FDA at 1-800-FDA-1088.
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. Check drug interactions for Avandaryl
If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include coma, confusion, fainting, fast heartbeat, lethargy, lightheadedness, seizures, severe dizziness or drowsiness, unusual sweating, or tremor.
Proper diet and exercise are important for best results with Avandaryl 4-4mg. FOLLOW THE DIETARY AND EXERCISE PLAN provided by your doctor. Carry an identification card at all times that says you are diabetic. Monitor your blood sugar levels regularly according to your doctor's directions. If your blood sugar level is often higher or lower than it should be and you are taking Avandaryl 4-4mg according to directions, check with your doctor. DO NOT SHARE AVANDARYL 4-4mg with others for whom it was not prescribed. DO NOT USE AVANDARYL 4-4mg for other health conditions. IF USING AVANDARYL 4-4mg FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
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