Avandia is an oral diabetes medicine that helps control blood sugar levels.

Avandia is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Avandia is not for treating type 1 diabetes.

Avandia is not recommended for use with insulin. Taking this medicine while you are using insulin may increase your risk of serious heart problems.

Avandia can cause or worsen congestive heart failure. You should not use this medicine if you have severe or uncontrolled heart failure.

Stop using Avandia and call your doctor at once if you have shortness of breath (especially when lying down), unusual tiredness, swelling, or rapid weight gain.

Take Avandia exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You may take Avandia with or without food.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or close friends know how to give you this injection in an emergency.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

It may take up to 2 weeks before your blood sugar levels start to improve. Keep using the medication as directed and tell your doctor if your levels do not improve within 2 or 3 months.

Avandia 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 this medicine in the original bottle at room temperature away from moisture, heat, and light. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Diabetes Type 2:

Initial dose: 4 mg orally once a day
Maintenance dose: If inadequate response is not achieved after 8 to 12 weeks, increase to 8 mg/day
Maximum dose: 8 mg/day

Comments:
-May take as a single daily dose or in 2 divided doses.
-Monitor closely for fluid related adverse events with initiation and dose titration.

Use: To improve glycemic control in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise.

You should not use Avandia if you are allergic to rosiglitazone, or if you have:

• severe or uncontrolled heart failure; or

• diabetic ketoacidosis (call your doctor for treatment).

To make sure Avandia is safe for you, tell your doctor if you have ever had:

• congestive heart failure or heart disease;

• a heart attack or stroke;

• eye problems caused by diabetes; or

• liver disease.

Avandia may increase your risk of serious heart problems, but not treating your diabetes can also damage your heart and other organs. Talk to your doctor about the risks and benefits of this medicine.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Rosiglitazone may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

Women may be more likely to have a broken bone while using rosiglitazone. Talk with your doctor about ways to keep your bones healthy.

You should not breastfeed while using Avandia.

Avandia is not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. You may have signs of low blood sugar, such as extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction to Avandia (hives, itching, dizziness, rapid heartbeats, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using this medicine and call your doctor at once if you have symptoms of liver damage: nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

Call your doctor at once if you have:

• shortness of breath (especially when lying down), unusual tiredness, swelling, rapid weight gain;

• chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• pale skin, feeling light-headed or short of breath, cold hands and feet;

• changes in your vision; or

• sudden unusual pain in your hand, arm, or foot.

Common Avandia side effects may include:

• headache; or

• cold symptoms such as stuffy nose, sinus pain, sneezing, sore throat.

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.

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

Tell your doctor about all your current medicines. Many drugs can interact with rosiglitazone, especially:

• blood pressure medications

• cholesterol medication; or

• heart medication.

This list is not complete and many other drugs may interact with rosiglitazone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.