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Avandamet contains a combination of metformin and rosiglitazone, two oral diabetes medicines that help control blood sugar levels. This medicine is for people with type 2 diabetes, and is not for treating type 1 diabetes.

Avandamet may also be used for purposes not listed in this medication guide.

Important information

You should not use Avandamet if you have severe or uncontrolled heart failure, or severe kidney problems. Do not use this medicine if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). Avandamet is not recommended for use with insulin, and is not for treating type 1 diabetes.

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 Avandamet.

Avandamet can cause or worsen congestive heart failure. Call your doctor at once if you have shortness of breath (even with mild exertion), swelling, or rapid weight gain.

Avandamet may cause a serious condition called lactic acidosis. 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, fast or uneven heart rate, dizziness, or feeling very weak or tired.

Before taking this medicine

You should not use Avandamet if you are allergic to metformin and rosiglitazone, or if you have:

  • severe or uncontrolled heart failure;

  • severe kidney problems;

  • metabolic acidosis; 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 Avandamet.

Some people develop a life-threatening condition called lactic acidosis while taking metformin. You may be more likely to develop lactic acidosis if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your individual risk.

To make sure this medication is safe for you, tell your doctor if you have:

  • heart disease, or a history of heart attack or stroke;

  • liver disease; or

  • eye problems caused by diabetes.

Taking this medicine may increase your risk of heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with Avandamet.

Women may be more likely than men to have bone fractures in the upper arm, hand, or foot while taking medicine that contains rosiglitazone. Talk with your doctor if you are concerned about this possibility.

FDA pregnancy category C. It is not known whether Avandamet will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

See also: Pregnancy and breastfeeding warnings (in more detail)

Some women using Avandamet have started having menstrual periods, even after not having a period for a long time due to a medical condition. You may be able to get pregnant if your periods restart. Talk with your doctor about the need for birth control.

It is not known whether metformin and rosiglitazone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Avandamet.

How should I take Avandamet?

Take Avandamet exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take Avandamet with food if it upsets your stomach.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor"s office.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor"s advice.

If you take extra vitamin B12 while you are taking Avandamet, take only the amount of vitamin B12 that your doctor has prescribed.

Avandamet is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor"s instructions very closely.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid?

Avoid drinking alcohol while taking Avandamet.

Avandamet side effects

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

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

Call your doctor at once if you have:

  • chest pain or heavy feeling, pain spreading to the jaw or shoulder, nausea, sweating, general ill feeling;

  • sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

  • shortness of breath (even with mild exertion), swelling, rapid weight gain;

  • pale skin, easy bruising or bleeding, weakness;

  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • changes in your vision.

Common Avandamet side effects may include:

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • headache; or

  • upset stomach, diarrhea.

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.

See also: Side effects (in more detail)

What other drugs will affect Avandamet?

Tell your doctor if you use insulin. Taking Avandamet while you are using insulin may increase your risk of serious heart problems.

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Avandamet, especially:

  • cimetidine;

  • gemfibrozil; or

  • an antibiotic--rifampin, trimethoprim, vancomycin.

You may be more likely to have hyperglycemia (high blood sugar) if you also take other drugs that can raise blood sugar, such as:

  • isoniazid;

  • steroids (prednisone and others);

  • niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);

  • phenothiazines (Compazine and others);

  • thyroid medicine (Synthroid and others);

  • birth control pills and other hormones; and

  • diet pills or medicines to treat asthma, colds or allergies.

These lists are not complete and many other medicines can increase or decrease the effects of Avandamet on lowering your blood sugar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.


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