National Geographic : 2001 Feb
Patient Information About AVANDIA® (rosiglitazone maleate) Tablets 2mg,4mg,and8mg What is Avandia? Avandia is one product in a new class of prescription drugs called thiazolidinediones (thigh-a-zoe-lid-een-die owns). It is used to treat type 2 diabetes by helping the body use the insulin thatit is already making. Avandia comes as pills that can be taken either once a day or twice a day to help improve blood sugar levels. How does Avandia treat type 2 diabetes? If you have type 2 diabetes, your body still produces insulin but it is not able to fully use the insulin. Insulin is needed to allow sugar to be carried from the blood stream into many cells of the body for energy. If insulin is not being used correctly, sugar does not enter the cells very well and builds up in the blood. If not con trolled, the high blood sugar level can lead to serious medical problems, including kidney damage, blindness and amputation. Avandia helps your body use insulin by making the cells more sensitive to insulin so that the sugar can enter the cell. How quickly will Avandia begin to work? Avandia begins to reduce blood sugar levels within 2 weeks. However, since Avandia works to address an important underlying cause of type 2 diabetes, insulin resistance, it may take up to 12 weeks to see the full effect. If you do not respond adequately to your starting dose of Avandia, your physician may increase your daily dose to improve your blood sugar control. How should I take Avandia? Your doctor may tell you to take Avandia once a day in the morning or twice a day in the morning and evening. It can be taken with or without meals. Food does not affect how Avandia works. To help you remember to take Avandia, you may want to take it at the same time every day. What if I miss a dose? If your doctor has prescribed Avandia for use once a day: * As soon as you remember your missed dose, take one tablet anytime during the day. * If you forget and go a whole day without taking a dose, don't try to make it up by adding another dose on the following day. Forget about the missed dose and simply follow your normal schedule. If your doctor has prescribed Avandia for use twice a day: * As soon as you remember the missed dose, take one tablet. * Take the next dose at the normal time on the same day. * Don't try to make up a missed dose from the day before. * You should never take three doses on any single day in order to make up for a missed dose the day before. Do I need to test my blood for sugar while using Avandia? Yes, you should follow your doctor's instructions about your at-home testing schedule. Does Avandia cure type 2 diabetes? Currently there is no cure for diabetes. The only way to avoid the effects of the disease is to maintain good blood sugar control by following your doctor's advice for diet, exercise, weight control, and medication. Avandia, alone or in combination with other prescription drugs, may improve these other efforts by helping your body make better use of the insulin it already produces. Can I take Avandia with other medications? Avandia has been taken safely by people using other medications, including other antidiabetic medications, birth control pills, warfarin (a blood thinner), Zantac® (ranitidine, an antiulcer product manufactured by Glaxo Wellcome Inc.), certain heart medications, and some cholesterol-lowering products. You should discuss with your doctor the most appropriate plan for you. If you are taking prescription or over-the-counter products for your diabetes or for conditions other than diabetes, be sure to tell your doctor. Sometimes a patient who is tak ing two antidiabetic medications each day can become irritable, lightheaded or excessively tired. Tell your doctor if this occurs; your blood sugar levels may be dropping too low, and the dose of your medication may need to be reduced. What should I discuss with my doctor before taking Avandia? You should talk to your doctor if you have a history of edema, liver problems or congestive heart failure, or if you are nursing, pregnant or thinking of becoming preg nant. If you are a premenopausal woman who is not ovulating, you should know that Avandia therapy may result in the resumption of ovulation, which may in crease your chances of becoming pregnant. Therefore, you may need to consider birth control options. What are the possible side effects of Avandia? Avandia was generally well tolerated in clinical trials. The most common side effects reported by people taking Avandia were upper respiratory infection and headache. As with most other diabetes medications, you may expe rience an increase in weight (3 to 8 pounds). This often occurs with improved blood sugar control. Avandia may also cause edema and/or anemia. If you experience any swelling of your extremities (e.g ., legs, ankles) or tired ness, notify your doctor. Talk to your doctor if you expe rience shortness of breath or unusually rapid increase in weight. Who should not use Avandia? The following people should not take Avandia: People with type 1 diabetes, people who experience yellowing of the skin with Rezulin® (troglitazone, Parke-Davis), peo ple who are allergic to Avandia or any of its components and people with diabetic ketoacidosis. Why are laboratory tests recommended? Your doctor may conduct blood tests to measure your blood sugar control. In addition, your doctor may con duct liver enzyme tests. Avandia did not show signs of liver problems in studies. However, because a related drug (Rezulin) has been associated with such problems, and because Avandia has not been widely used, your doctor may recommend a blood test to monitor your liver before you start taking Avandia, every 2 months during the first year and periodically thereafter. It is important that you call your doctor immediately if you experience nausea, vomiting, stomach pain, tired ness, anorexia, dark urine, or yellowing of the skin. How should I store Avandia? Avandia should be stored at room temperature in a childproof container out of the reach of children. Store Avandia in its original container. DATE OF ISSUANCE MAY 2000 ©SmithKline Beecham, 2000 SmithKline Beecham Pharmaceuticals Philadelphia, PA 19101 AV:L4PI Printed in U.S .A .