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Patient Information Sheet
Rosiglitazone (marketed as Avandia)
This is a summary of
the most important information about Avandia. For details, talk to
your healthcare professional.
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. Avandia
can also be used in addition to a sulfonylurea plus metformin when
diet, exercise, and both agents are not enough to control blood
sugar.
Who should not take Avandia?
- 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 healthcare provider will evaluate you
to decide if Avandia is right for you.
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’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 healthcare 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 healthcare provider.
-
Call your doctor if you develop visual symptoms, such as decreased
vision or blurry vision, while taking Avandia. Some patients have
developed macular edema (a swelling in the back of the eye) while
taking Avandia. All patients with diabetes should have eye
examinations regularly, no matter what medicine(s) they are taking
for diabetes..
- When taking Avandia with other oral diabetes medicines, there
is a risk of your blood sugar becoming dangerously low. Ask your
healthcare 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.
- During periods of stress on the body, such as fever, trauma,
infection, or surgery, your medication requirements may change;
contact your healthcare 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 should I tell my doctor or healthcare provider?
Tell your healthcare 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 healthcare
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 healthcare 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
Reports of Patients’ Experiences After 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.
For more detailed information about Avandia, ask your healthcare
provider.
Link to Avandia's Approved Labeling and Patient Information 
PDF requires the free Adobe Acrobat Reader
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Date created: August 3, 1999, August 9, 2006
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