Brand Name: Avandia
Active Ingredient: rosiglitazone
Strength(s): 2 mg, 4 mg, and 8 mg
Dosage Form(s): Tablets
Company Name: GlaxoSmithKline
Availability: Prescription only
*Date Approved by the FDA: May 25, 1999
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, metformin, or insulin
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?
Do not use Avandia for type I diabetes (juvenile diabetes) or diabetic
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
Reports of Patients?Experiences Since Avandia Became Available:
There have been reports of inflammation of the liver (hepatitis) and
elevated liver enzymes. It has not been determined whether these
events are directly related to Avandia. It is recommended that patients
taking Avandia have their liver enzymes monitored periodically.
General Precautions with Avandia:
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' 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.
Patients who experience an unusually rapid increase in weight or retain
fluid (edema) or who develop shortness of breath or other symptoms of
heart failure while on Avandia should immediately report these symptoms
to their health care provider.
When taking Avandia with other oral diabetes medicines, there is a risk
of your blood sugar becoming dangerously low. Ask your health care
provider about 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.
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 should I tell my doctor or health care provider?
Tell you health care provider if you are trying to become pregnant, are
already pregnant, or are breast-feeding.
Because certain other medication may interact with Avandia, review all
medications that you are taking with your health care provider, including
those that you take without a prescription.
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
inflammation of the sinuses
swelling or fluid retention
For more detailed information about Avandia, ask your health care