Avandaryl

Avandaryl is a prescription medication used to treat type 2 diabetes. It is a single tablet containing two different medications, glimepiride and rosiglitazone. Glimepiride belongs to a group of drugs called sulfonylureas. It can help your body release more of its own insulin. Rosiglitazone belongs to a group of drugs called thiazolidinediones. It can help your body respond better to insulin. These medicines can work together to help control your blood sugar.

This medication comes in tablet form and is usually taken once a day, with your first main meal.

Common side effects include new or worse heart failure, headache, and cold symptoms.

Avandaryl is a prescription medication used to treat type 2 diabetes. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

The recommended starting Avandaryl dose is 4 mg/1 mg taken once daily with the first meal of the day.

If necessary, your doctor may decide to slowly increase your dose to a maximum dosage of 8 mg/4 mg once a day.

WARNING: CONGESTIVE HEART FAILURE 

In 2010 the FDA severely restricted the use of Avandaryl, due to the risk of "cardiovascular events" such as heart attacks and strokes. After thorough review and analysis of the research, the FDA announced, in 2013, that there is not an increased risk of cardiovascular events, compared to treatment with standard diabetes medications. Use of this medication is no longer restricted.

Avandaryl may cause serious side effects, including:

• New or worse heart failure. Rosiglitazone, one of the two drugs that make up Avandaryl, can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough.
  • If you have severe heart failure, you cannot start Avandaryl.
  • If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, Avandaryl may not be right for you.

Call your doctor right away if you have any of the following:

• swelling or fluid retention, especially in the ankles or legs
• shortness of breath or trouble breathing, especially when you lie down
• an unusually fast increase in weight
• unusual tiredness
• Myocardial Infarction (“Heart Attack”). Rosiglitazone, one of the medicines in Avandaryl, may raise the risk of heart attack. The risk of having a heart attack may be higher in people who take Avandaryl with insulin. Most people who take insulin should not also take Avandaryl.
  • Symptoms of a heart attack can include the following:
  • chest discomfort in the center of your chest that lasts for more than a few minutes, or that goes away or comes back
  • chest discomfort that feels like uncomfortable pressure, squeezing, fullness or pain
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Call your doctor or go to the nearest hospital emergency room right away if you think you are having a heart attack.

• People with diabetes have a greater risk for heart problems. It is important to work with your doctor to manage other conditions, such as high blood pressure or high cholesterol.

• Low blood sugar (hypoglycemia). Lightheadedness, dizziness, shakiness or hunger may mean that your blood sugar is too low. This can happen if you skip meals, drink alcohol, use another medicine that lowers blood sugar, exercise (particularly hard or long), or if you have certain medical problems. Call your doctor if low blood sugar levels are a problem for you.
• Weight gain. Rosiglitazone, one of the medicines in Avandaryl, can cause weight gain that may be due to fluid retention or extra body fat. Weight gain can be a serious problem for people with certain conditions including heart problems. See “Drug Precautions".
• Liver problems. It is important for your liver to be working normally when you take Avandaryl. Your doctor should do blood tests to check your liver before you start taking Avandaryl and during treatment as needed. Call your doctor right away if you have unexplained symptoms such as:
  • nausea or vomiting
  • stomach pain
  • unusual or unexplained tiredness
  • loss of appetite
  • dark urine
  • yellowing of your skin or the whites of your eyes.
• Macular edema (a diabetic eye disease with swelling in the back of the eye). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly. Very rarely, some people have had vision changes due to swelling in the back of the eye while taking rosiglitazone, one of the medicines in Avandaryl.
• Fractures (broken bones), usually in the hand, upper arm or foot. Talk to your doctor for advice on how to keep your bones healthy.
• Low red blood cell count (anemia).
• Ovulation (release of egg from an ovary in women) leading to pregnancy. Ovulation may happen in premenopausal women who do not have regular monthly periods. This can increase the chance of pregnancy. 

Avandaryl may cause serious side effects. See "Precautions" section.

The most common side effects include:

• cold-like symptoms
• headache

This is not a complete list of Avandaryl side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements. Avandaryl and certain other medicines can affect each other and may lead to serious side effects including high or low blood sugar, or heart problems. Especially tell your doctor if you take:

• insulin.
• any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.

Know the medicines you take. Keep a list of all your medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is alright to take Avandaryl with other medicines.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. No studies have been done in animals, and no well-controlled studies have been done in pregnant women. Avandaryl should be given to a pregnant woman only if clearly needed.

You and your doctor should talk about the best way to control your diabetes during pregnancy. If you are a premenopausal woman (before the “change of life”) who does not have regular monthly periods, Avandaryl may increase your chances of becoming pregnant. Talk to your doctor about birth control choices while taking Avandaryl. Tell your doctor right away if you become pregnant while taking Avandaryl.

Tell your doctor if you are breastfeeding or planning to breastfeed. It is not known if Avandaryl passes into breast milk. You should not use Avandaryl while breastfeeding.