Rosiglitazone

Conditions Treated

Rosiglitazone is used along with a diet and exercise program and sometimes with one or more other medications to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Because of the risk of serious side effects, rosiglitazone should only be used to treat people who are already taking the medication, or people whose blood sugar cannot be controlled with other medications and who have decided not to take pioglitazone (Actos, a medication that is similar to rosiglitazone but that may not cause the same serious side effects) for medical reasons. Rosiglitazone is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. Rosiglitazone is not used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may occur if high blood sugar is not treated).

Possible Side Effects

What Side Effects Can This Cause?

This medication may cause changes in your blood sugar. You should know the symptoms of low and high blood sugar and what to do if you have these symptoms.

Rosiglitazone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• runny nose and other cold symptoms
• sore throat
• back pain

Some side effects can be serious. If you experience any of the following symptoms, or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• loss of appetite
• nausea
• vomiting
• stomach pain
• dark urine
• yellowing of the skin or eyes
• blurred vision
• vision loss
• difficulty seeing colors
• difficulty seeing in the dark
• pale skin
• dizziness
• swelling of the eyes, face, lips, tongue, or throat
• hoarseness
• difficulty swallowing or breathing
• hives
• itching
• fever
• blisters

Rosiglitazone may cause other side effects. Call your doctor if you experience any unusual problems while you are taking this medication.Taking rosiglitazone may increase the risk that you will experience a fracture, usually in the upper arms, hands, or feet. Talk to your doctor about the risk of taking this medication and about ways to keep your bones healthy during your treatment.If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

Usage Instructions

How Should This Medication Be Used

Rosiglitazone comes as a tablet to take by mouth. It is usually taken once or twice daily with or without meals. Take rosiglitazone at about the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take rosiglitazone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Your doctor may increase your dose of rosiglitazone after 8-12 weeks, based on your body's response to the medication. Rosiglitazone helps control type 2 diabetes but does not cure it. It may take 2 weeks for your blood sugar to decrease, and 2-3 months or longer for you to feel the full benefit of rosiglitazone. Continue to take rosiglitazone even if you feel well. Do not stop taking rosiglitazone without talking to your doctor.

What Dietary Instructions Should I Follow

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet, exercise regularly, and lose weight if necessary. This will help to control your diabetes and help rosiglitazone work more effectively

Are There Any Special Instructions

Before taking rosiglitazone, tell your doctor and pharmacist if you are allergic to rosiglitazone or any other medications. tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: gemfibrozil (Lopid); other medications for diabetes; medications for high blood pressure, high cholesterol, heart failure, or prevention of heart attack or stroke; and rifampin (Rifadin, Rimactane, in Rifamate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or diabetic eye disease such as macular edema (swelling of the back of the eye); or liver disease. Also tell your doctor if you have ever taken troglitazone (Rezulin, no longer available in the United States), especially if you stopped taking it because you experienced side effects.