This medication may infrequently cause or worsen a certain heart problem (congestive heart failure). Tell your doctor right away if you notice any symptoms of heart failure, including: swelling of the hands/feet, unusual/sudden weight gain, trouble breathing, unusual tiredness.
This medication is not recommended in patients with certain types of heart failure. Before using this medication, tell your doctor if you have heart failure.Who should not take Avandaryl?
This medication is a combination of two drugs, rosiglitazone and glimepiride. It is used along with a proper diet and exercise program to control high blood sugar in patients with type 2 diabetes. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke.
Rosiglitazone belongs to a class of drugs known as thiazolidinediones or "glitazones". It works by helping to restore your body's proper response to insulin, thereby lowering your blood sugar.
Glimepiride belongs to a class of drugs known as sulfonylureas. It works by stimulating the release of your body's natural insulin.
Read the Medication Guide provided by your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist.
Take this medication by mouth, usually once daily with the first meal of the day or as directed by your doctor.
The dosage is based on your medical condition and response to therapy.
Colesevelam can decrease the absorption of glimepiride. If you are taking colesevelam, take this product at least 4 hours before taking colesevelam.
Use this medication regularly in order to get the most benefit from it. Remember to take it at the same time each day. Monitor your blood sugar levels on a regular basis, and share the results with your doctor.
It may take up to 2-3 months before the full benefit of this drug takes effect.
See also Warning section.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: bone fracture, yellowing eyes/skin, stomach/abdominal pain, persistent nausea/vomiting, dark urine, easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), mental/mood changes, vision changes (e.g., color or night vision problems).
This medication can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, rapid heart rate, weakness, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where you don't have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals.
Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking this medication, tell your doctor or pharmacist if you are allergic to rosiglitazone or glimepiride; or to other "glitazones" (e.g., pioglitazone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, heart problems (e.g., congestive heart failure, heart attack, angina), fluid in your lungs, swelling (edema, fluid retention), kidney disease, thyroid problems, certain hormonal conditions (adrenal/pituitary insufficiency, SIADH-syndrome of inappropriate secretion of antidiuretic hormone), mineral imbalance (hyponatremia), anemia, high blood cholesterol, eye (retina) problems, bone problems (e.g., osteoporosis, osteopenia).
You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.
Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar (hypoglycemia).
During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor because a change in your medication may be required.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
This medication may increase the risk of bone fracture (upper arm, hand, foot) in female patients. To lower the chance of getting injured, use caution when doing activities such as contact sports.
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, the elderly may be at greater risk for hypoglycemia while using this drug.
This medication can cause changes in the menstrual cycle (promote ovulation) in women with certain fertility problems. Consult your doctor or pharmacist about the use of reliable birth control while taking this medication.
This medication is not recommended for use during pregnancy. Insulin treatment may be preferred. Use of rosiglitazone/glimepiride close to the expected delivery date may increase the risk of low blood sugar in your newborn. Consult your doctor for more details and follow all instructions carefully.
It is unknown if this medication passes into breast milk, and it may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
See also How to Use section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
A product that may interact with this drug is: insulin.
Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet.
Beta-blocker medications (including metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.
Check the labels on all your medicines (such as cough-and-cold products) because they may contain ingredients that could affect your blood sugar. Ask your pharmacist about the safe use of those products.
If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: shakiness, rapid heartbeat, unexplained sweating, loss of consciousness.
Do not share this medication with others.
It is recommended you attend a diabetes education program to understand diabetes and all the important aspects of its treatment including meals/diet, exercise, weight loss, personal hygiene, medications and getting regular eye, foot, and medical exams. Consult your doctor or pharmacist.
Keep all medical appointments. Laboratory and/or medical tests (e.g., liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) should be performed periodically to monitor your progress or check for side effects. Regularly check your blood or urine for sugar as directed by your doctor or pharmacist.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).
Information last revised May 2014. Copyright(c) 2014 First Databank, Inc.
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