Prescribing Information, including Boxed WARNING                          For Healthcare Professionals
IMPORTANT SAFETY INFORMATION for AVANDIA® (rosiglitazone maleate)
AVANDIA can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart), you cannot be started on AVANDIA (see Boxed WARNING).
SAFETY INFORMATION CONTINUED BELOW 
AVANDIA rosiglitazone maleate | Diabetes Medication
High Blood Sugar
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High Blood Sugar

Having high blood sugar (hyperglycemia) increases your risk of diabetes-related problems. Some serious problems that high blood sugar can lead to include:

  • Eye problems and blindness
  • Heart disease
  • Kidney disease
  • Amputation of limbs
  • Stroke

What Your Doctor May Tell You About High Blood Sugar

High blood sugar can lead to two life-threatening conditions:

Condition What It Means Warning Signs What to Do
Hyperosmolar Hyperglycemic Nonketotic Syndrome (HHNS)
  • Blood sugar levels rise, and the body tries to pass the excess sugar into your urine
  • Most common in elderly people
  • Caused by illness, infection, or missed doses of medicine
  • May take days or weeks to develop
  • If HHNS persists, the severe dehydration will lead to seizures, coma, and eventually death
 Very high blood sugar (hyperglycemia) level (over 600 mg/dL
  • Dry mouth
  • Extreme thirst
  • Hallucinations
  • High fever
  • Loss of vision
  • Sleepiness or confusion
  • Warm, dry skin that does not sweat
  • Weakness on one side of the body
Ketoacidosis
  • Dangerously high levels of ketones, or acids that build up in your blood
  • Ketones appear in the urine when your body doesn’t have enough insulin
  • Ketones are a warning that your diabetes is out of control or that you are getting sick
  • Serious condition that can lead to diabetic coma or even death
  • Constantly feeling tired
  • Dry or flushed skin
  • Frequent urination
  • Fruity odor on breath
  • Hard time breathing (short, deep breaths)
  • Hard time paying attention, or confusion
  • High blood glucose (sugar) levels
  • Nausea, vomiting, or abdominal pain
  • Thirst or a very dry mouth
  • Test your blood sugar at home
  • Check for ketones:
    • When your blood glucose is more than 240 mg/dL, check every 4-6 hours
    • When you are ill, check every 4-6 hours
    • When you have symptoms of ketoacidosis
  • Call your doctor immediately if:
    • Your urine tests show high ketones
    • Your urine tests show high ketones and your blood glucose level is high
    • You have vomited more than twice in four hours and your urine tests show high ketones

 

*Only your doctor can decide if AVANDIA is right for you. AVANDIA is not right for everyone.
Taking AVANDIA with insulin or nitrates is not recommended.

IMPORTANT SAFETY INFORMATION for AVANDIA® (rosiglitazone maleate)

AVANDIA can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart) you cannot be started on AVANDIA. AVANDIA is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe.

AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.

If you have chest pain or a feeling of chest pressure, you should seek immediate medical attention, regardless of what diabetes medicines you are taking. If you take AVANDIA, tell your doctor right away if you have swollen legs or ankles, a rapid increase in weight or difficulty breathing, or unusual tiredness; experience changes in vision; become pregnant.

Before taking AVANDIA, review your medical history and tell your doctor if you:

Women taking AVANDIA should know that AVANDIA may increase the risk of pregnancy. More fractures have been observed in women taking AVANDIA. Other possible side effects of AVANDIA include anemia and hypoglycemia. Your doctor should do blood tests to check your liver before you start AVANDIA and during treatment as needed.

Prescription AVANDIA, along with diet and exercise, helps improve blood sugar control in adults with type 2 diabetes.

For more information about AVANDIA, please see Medication Guide and full Prescribing Information, including Boxed WARNING.