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Information about ADVAIR DISKUS (fliticasone pripieiate 101,250, SGI meg and salaeteroi 51 neg iihalatim pwd«r) What is the most important information I should know about ADVAIR DISKUS? In patients with asthma, long-acting beta,-agonist medicines such as salmeterol (one of the medications in ADVAIR') may increase the chance of death from asthma problems. In a large asthma study, more patients who used salmeterol died from asthma problems compared with patients who did not use salmeterol. So ADVAIR is not for patients whose asthma is well controlled on another asthma controller medicine such as low- to medium-dose inhaled corticosteroids or only need a fast-acting inhaler once in a while. Talk with your doctor about this risk and the benefits of treating your asthma with ADVAIR. ADVAIR should not be used to treat a severe attack of asthma or chronic obstructive pulmonary disease (CQPD) requiring emergency medical treatment ADVAIR should not be used to relieve sudden symptoms or sudden breathing problems. Always have a fast-acting inhaler with you to treat sudden breathing difficulty. If you do not have a fast acting inhaler, contact your doctor to have one prescribed for you. What is ADVAIR DISKUS? There are two medicines in ADVAIR. Fluticasone propionate, an inhaled anti-inflammatory belonging to a group of medicines commonly referred to as corticosteroids, and salmeterol. a long-acting, inhaled bronchodilator belonging to a group of medicines commonly referred to as beta.-agonists. There are 3 strengths of ADVAIR: 100/50,250/50 500/50. For Asthma • ADVAIR is approved tor the maintenance treatment of asthma m patients 4 years of age and older. ADVAIR should only be used if your doctor decides that another asthma controller medicine atone does not control your asthma or that you need 2 asthma controller medications. • The strength of ADVAIR approved for patients ages 4 to 11 years who experience symptoms on an inhaled corticosteroid is ADVAIR DISKUS 100/50 All 3 strengths are approved for patients with asthma ages 12 years and older. For COPD associated with chronic bronchitis ADVAIR 250/50 is the only approved dose for the maintenance treatment of airflow obstruction in patients with COPD associated with chronic bronchitis. The benefit of using ADVAIR for longer than 6 months has not been evaluated. The way anti-inflammatories work in the treatment of COPD is not well defined. Who should not take ADVAIR DISKUS? You should not start ADVAIR if your asthma is becoming significantly or rapidly worse, which can be life threatening. Serious respiratory events, including death, have been reported in patients who started taking salmeterol in this situation, although it is not possible to tell whether salmeterol contributed to these events. This may also occur in patients with less severe asthma. You should not take ADVAIR if you have had an allergic reaction to it or any of its components (salmeterol. fluticasone propionate, or lactose). Tell your doctor if you are allergic to AOVAIR, any other medications, or food products. If you experience an allergic reaction after taking ADVAIR. stop using ADVAIR immediately and contact your doctor. Allergic reactions are when you experience one or more of the following: choking: breathing problems; swelling of the face, mouth and/or tongue; rash, hives; itching, or welts on the skin Tell your doctor about the following: • If you are using your fast-acting inhaler more often or using more doses than you normally do (e g.. 4 or more inhalations of vour fast-acting inhaler for 2 or more days in a row or a whole canister of your fast-acting inhaler in 8 weeks' time), it could be a sign that your asthma is getting worse. If this occurs, tell your doctor immediately. • If you have been using your fast-acting inhaler regularly (e.g.. four times a day). Your doctor may tell you to stop the regular use of these medications. • If your peak flow meter results decrease. Your doctor will tell you the numbers that are right for you. » If you have asthma and your symptoms do not improve after using ADVAIR regularly for 1 week. • If you have been on an oral steroid, like prednisone, and are now using ADVAIR. You should be very careful as you may be less able to heal after surgery, infection, or serious injury. It takes a number of months tor the body to recover its ability to make its own steroid hormones after use of oral steroids Switching from an oral steroid may also unmask a condition previously suppressed by the oral steroid such as allergies, conjunctivitis, eczema, arthritis, and eosinophilic conditions. Symptoms of an eosinophilic condition can include rash, worsening breathing problems, heart complications, and/or feeling of “pins and needles" or numbness in the arms and legs. Talk to your doctor immediately if you experience any of these symptoms. • Sometimes patients experience unexpected bronchospasm right after taking ADVAIR. This condition can be life threatening and if it occurs, you should immediately stop using ADVAIR and seek immediate medical attention • If you have any type of heart disease such as coronary artery disease, irregular heart beat or high blood pressure. ADVAIR should be used with caution Be sure to talk with your doctor about your condition because salmeterol. one of the components of ADVAIR, may affect the heart by increasing heart rate and biood pressure, it may cause symptoms such as heart fluttering, chest pain, rapid heart rate, tremor, or nervousness. • If you have seizures, overactive thyroid gland, liver problems, or are sensitive to certain medications for breathing. • If your breathing problems get worse over time or if your fast-acting inhaler does not work as well for you while using ADVAIR. if your breathing problems worsen quickly, get emergency medical care • If you have been exposed to or currently have chickenpox or measles or if you have an immune system problem Patients using medications that weaken the immune system are more likely to get infections than healthy individuals. ADVAIR contains a corticosteroid (fluticasone propionate) which may weaken the immune system Infections like chickenpox and measles, for example, can be very serious or even fatal in susceptible patients using corticosteroids. How should I take ADVAIR DISKUS? ADVAIR should be used 1 inhalation, twice a day (morning and evening). ADVAIR should never be taken more than 1 inhalation twice a day. The full benefit of taking ADVAIR may take 1 week or longer. If you miss a dose of ADVAIR. just skip that dose. Take your next dose at your usual time. Do not take two doses at one time. Do not stop using ADVAIR unless told to do so by your doctor because your symptoms might get worse. Do not change or stop any of your medicines used to control or treat your breathing problems. Your doctor will adjust your medicines as needed. When using ADVAIR, remember: • Never breathe into or take the DISKUS* apart. • Always use the DISKUS in a level position. • After each inhalation, rinse your mouth with water without swallowing. • Never wash any part of the DISKUS. Always keep it in a dry place. • Never take an extra dose, even if you feel you did not receive a dose. • Discard 1 month after removal from the foil overwrap. • Do not use ADVAIR with a spacer device. Children should use ADVAIR with an adult's help as instructed by the child’s doctor. Can I take ADVAIR DISKUS with other medications? Tell your doctor about all the medications you take, including prescription and nonpresenption medications, vitamins, and herbal supplements If you are taking ADVAIR, you should not take SEREVENT DISKUS or Foradil Aerolizer for any reason If you take ritonavir (an HIV medication), tell your doctor. Ritonavir may interact with ADVAIR and could cause serious side effects The anti-HIV medicines Norvir Soft Gelatin Capsules, Norvir Oral Solution, and Kaietra contain ritonavir. No formal drug interaction studies have been performed with ADVAIR In clinical studies, there were no differences in effects on the heart when ADVAIR was taken with varying amounts of albuterol The effect of using AOVAIR in patients with asthma while taking more than 9 puffs a day of albuterol has not been studied. ADVAIR should be used with extreme caution during and up to 2 weeks after treatment with monoamine oxidase (MAO) inhibitors or tricyclic antidepressants since these medications can cause ADVAIR to have an even greater effect on the circulatory system. ADVAIR should be used with caution in people who are taking ketoconazole (an antifungus medication) or other drugs broken down by the body m a similar way These medications can cause ADVAIR to have greater steroid side effects. Generally, people with asthma should not take beta-blockers because they counteract the effects of beta.-agonists and may also cause severe bronchospasm. However, in some cases, for instance, following a heart attack, selective beta-blockers may still be used if there is no acceptable alternative. The ECG changes and/or low blood potassium that may occur with some diuretics may be made worse by ADVAIR, especially at higher-than-recommended doses. Caution should be used when these drugs are used together In clinical studies, there was no difference in side effects when ADVAIR was taken with methylxanthines (e g., theophylline) or with FLONASE’ What are other important safety considerations with ADVAIR DISKUS? Osteoporosis: Long-term use of inhaled corticosteroids may result in bone loss (osteoporosis). Patients who are at risk for increased bone loss (tobacco use. advanced age, inactive lifestyle, poor nutrition, family history of osteoporosis, or long-term use of drugs such as corticosteroids) may have a greater risk with ADVAIR. If you have risk factors for bone loss, you should talk to your doctor about ways to reduce your risk and whether you should have your bone density evaluated Glaucoma and cataracts: Glaucoma, increased pressure in the eyes, and cataracts have been reported with the use of inhaied steroids, including fluticasone propionate, a medicine contained in ADVAIR. Regular eye examinations should be considered if you are taking ADVAIR Lower respiratory tract infection: Lower respiratory tract infections, including pneumonia, have been reported with the use of inhaled corticosteroids, including ADVAIR Blood sugar: Salmeterol may affect blood sugar and/or cause low blood potassium in some patients, which could lead to a side effect like an irregular heart rate. Significant changes in blood sugar and blood potassium were seen infrequently in clinical studies with ADVAIR. Growth: inhaled steroids may cause a reduction in growth velocity in children and adolescents Steroids: Taking steroids can affect your body’s ability to make its own steroid hormones, which are needed during infections and times of severe stress to your body, such as an operation. These effects can sometimes be seen with inhaled steroids (but it is more common with oral steroids), especially when taken at higher-than-recommended doses over a long period of time. In some cases, these effects may be severe. Inhaled steroids often help control symptoms with less side effects than oral steroids. Yeast infections: Patients taking ADVAIR may develop yeast infections of the mouth and/or throat ("thrush") that should be treated by their doctor. Tuberculosis or other untreated infections: ADVAIR should be used with caution, if at all, in patients with tuberculosis, herpes infections of the eye, or other untreated infections. What a,e the other possible side effects of ADVAIR DISKUS? ADVAIR may produce side effects in some patients. In clinical studies, the most common side effects with ADVAIR included: • Respiratory infections • Bronchitis • Musculoskeletal pain • Throat irritation • Cough • Dizziness • Hoarseness • Headaches • Fever • Sinus infection • Nausea and vomiting • Ear. nose, and throat infections • Yeast infection of the mouth • Diarrhea • Nosebleed Tell your doctor about any side effect that bothers you or that does not go away These are not all the side effects with ADVAIR. Ask your doctor or pharmacist for more information. What if I am pregnant, planning to become pregnant, or nursing? Talk to your doctor about the benefits and risks of using ADVAIR during pregnancy, labor, or if you are nursing. There have been no studies of ADVAIR used during pregnancy, labor, or in nursing women. Salmeterol is known to interfere with labor contractions. It is not known whether ADVAIR is excreted in breast milk, but other corticosteroids have been detected in human breast milk. Fluticasone propionate, like other corticosteroids, has been associated with birth defects in animals (e g., cleft palate and fetal death). Salmeterol showed no effect on fertility in rats at 180 times the maximum recommended daily dose. What other important tests were conducted with ADVAIR? There is no evidence of enhanced toxicity with ADVAIR compared with the components administered separately. In animal studies with doses much higher than those used in humans, salmeterol was associated with uterine tumors. Ybur healthcare professional can tell you more about how drugs are tested on animals and what the results of these tests may mean to your safety. For more information on ADVAIR DISKUS This page is only a brief summary of important information about ADVAIR DISKUS. For more information, talk to your doctor. You can also visit www.ADVAIR.com or call 1-888-825-5249. Patients receiving ADVAIR DISKUS should read the medication guide provided by the pharmacist with the prescription. ADVAIR DISKUS, FLONASE, SEREVENT, and DISKUS are registered trademarks of GlaxoSmithKline. The following are registered trademarks of their respective manufacturers: Foradil Aerolizer/Novartis Pharmaceuticals Corporation; Norvir and Kaletra/Abbott Laboratones. GlaxoSmithKline GlaxoSmithKline Research Triangle Park, NC 27709 RL-2260 ©2006 The GlaxoSmithKline Group of Companies. Ail rights reserved. Printed in USA. AD33BORO April 2006 Canyon de Chelly recalls two Indian civilizations, the prehistoric-era Anasazi and the Navajo, who have dwelt amid the stun ning sandstone spires and sheer red cliffs for centuries. People who prefer greenery in their visual diet enjoy trekking through Muir Woods National Monument 12 miles north of San Francisco. “This is the best tree-lovers monument that could possibly be found in all the forests of the world," declared conser vationist John Muir of the coastal redwood forest that now bears his name. Ancient redwood trees tower overhead at Muir Woods National Monument in California. 2T Page 6 American Profile