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Avandia®

Brand Name: Avandia®
Active Ingredient:   rosiglitazone
Strength(s): 2 mg, 4 mg, and 8 mg
Dosage Form(s):   Tablets
Company Name:    SmithKline Beecham
Availability:         Prescription only
*Date Approved by the FDA:   May 25, 1999
*Approval by FDA does not mean that the drug is available for consumers at this time.




What is Avandia used for? Avandia, in addition to diet and exercise, improves blood sugar control in adults with type 2 (non-insulin-dependent) diabetes. Avandia can be used alone or in combination with a sulfonylurea or metformin, when diet, exercise, and one of these agents or diet, exercise, plus Avandia alone are not enough to control blood sugar.

Who should not take Avandia?

  • An unpublished Federal Drug Administration study says that the diabetes drug Avandia should be withdrawn: Read more
  • Do not use Avandia for type I diabetes (juvenile diabetes) or diabetic ketoacidosis.
  • If you have heart failure, fluid retention or active liver disease your health care provider will evaluate you to decide if Avandia is right for you.

General Precautions with Avandia:

  • In drug testing, Avandia did not cause liver toxicity or an increase in liver enzymes. However, Avandia is in the same class of drugs as Rezulin, which has been associated with rare but serious liver injury, including liver failure leading to transplant or death.
  • Because Avandia’s liver safety profile is not fully determined yet, your doctor will do blood tests that evaluate your liver before starting you on Avandia. These blood tests should be repeated every two months for the first year, then regularly after that.
  • Call your health care provider right away if you develop nausea, vomiting, stomach pain, a feeling of tiredness, or having no energy, loss of appetite, dark urine, or jaundice (yellow coloring of eyes and skin). These may be symptoms of liver problems.
  • When taking Avandia with other oral diabetes medicines, there is a risk of your blood sugar becoming dangerously low. Ask your health care provider abut symptoms of low blood sugar, conditions that make low blood sugar more likely, and what to do if you get it. Make sure to explain to family members.
  • If you are a woman who has not reached menopause but have not had menstrual periods; you may become pregnant unless you use an effective method of birth control. Avandia, like other drugs in this class, may cause insulin resistant women to start ovulating again.
  • Women should tell their doctor if they notice any changes in their monthly menstrual cycle.
  • During periods of stress on the body, such as fever, trauma, infection, or surgery, your medication requirements may change; contact your health care provider promptly.

Managing your diabetes should include diet control. Caloric restriction, weight loss as needed, and exercise are essential for the proper treatment of diabetes because they help improve insulin sensitivity and the effectiveness of drug therapy.

What are some possible side effects of Avandia? (This list is NOT a complete list of side effects reported with Avandia. Your health care provider can discuss with you a more complete list of side effects.)

  • Cough or cold
  • Headache
  • Inflammation of the sinuses
  • Back pain
  • Swelling or fluid retention
  • For more detailed information about Avandia, ask your health care provider.

    http://www.fda.gov/cder/foi/label/1999/21071LBL.pdf    Avandia's Approved Label

    Posted:  8/3/99
    Updated: 3/28/00
    Revised: 10/31/00

     

    Back to Drug Side Effects


    source: FDA


    last update: December 2004





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