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Medications and Drugs

Brand Names: Avandamet

Generic Name: metformin and rosiglitazone (Pronunciation: met FOR min and ROE zi GLI ta zone)

What is metformin and rosiglitazone (Avandamet)?

Metformin and rosiglitazone is a combination of two oral diabetes medicines that help control blood sugar levels.

Metformin and rosiglitazone is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes.

Taking metformin and rosiglitazone may increase your risk of serious heart problems, such as heart attack or stroke. Therefore, metformin and rosiglitazone is available only to certain people with type 2 diabetes that cannot be controlled with other diabetes medications.

Metformin and rosiglitazone is available only under a special program called Avandia-Rosiglitazone Medicines Access Program. You must be registered in the program and sign documents stating that you understand the risks and benefits of taking this medication.

Metformin and rosiglitazone may also be used for purposes not listed in this medication guide.

Avandamet 1000 mg-2 mg

oval, yellow, imprinted with gsk, 2/1000

Avandamet 1000 mg-4 mg

oval, pink, imprinted with gsk, 4/1000

Avandamet 500 mg-2 mg

oval, pink, imprinted with gsk, 2/500

Avandamet 500 mg-4 mg

oval, orange, imprinted with gsk, 4/500

What are the possible side effects of metformin and rosiglitazone (Avandamet)?

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or irregular heart rate, dizziness, or feeling very weak or tired.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any other serious side effects, such as:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;
  • sudden numbness, weakness, headache, confusion, or problems with vision, speech, or balance;
  • swelling or rapid weight gain, feeling short of breath, (even with mild exertion);
  • pale skin, feeling light-headed, rapid heart rate, trouble concentrating, fever, confusion or weakness;
  • severe blistering, peeling, and red skin rash; or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • headache, tired feeling;
  • nausea, vomiting, upset stomach, diarrhea; or
  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about metformin and rosiglitazone (Avandamet)?

Taking metformin and rosiglitazone may increase your risk of serious heart problems, such as heart attack or stroke. Therefore, metformin and rosiglitazone is available only to certain people with type 2 diabetes that cannot be controlled with other diabetes medications.

You should not use this medication if you are allergic to metformin (Glucophage) or rosiglitazone (Avandia), or if you advanced heart failure, kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking metformin and rosiglitazone.

Before taking metformin and rosiglitazone, tell your doctor if you have congestive heart failure or heart disease, a history of heart attack or stroke, liver disease, or eye problems caused by diabetes.

Some people develop lactic acidosis while taking metformin. Early symptoms may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.



Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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