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|Advair Inhalation-Local |
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In Canada—
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DescriptionFluticasone (floo-TIK-a-sone) and salmeterol (sal-ME-te-role) is a combination of two medicines that are used to help control the symptoms of asthma and improve lung function. However, this medicine will not relieve an asthma attack that has already started. Inhaled fluticasone belongs to the family of medicines known as corticosteroids (cortisone-like medicines). It works by preventing certain cells in the lungs and breathing passages from releasing substances that cause asthma symptoms. It will not relieve an asthma attack that has already started. Inhaled salmeterol is a long-acting bronchodilator and it belongs to the family of medicines known as bronchodilators. Bronchodilators are medicines that are breathed in through the mouth to open up the bronchial tubes (air passages) of the lungs. Salmeterol is different than other bronchodilators because it does not act quickly enough to relieve an asthma attack that has already started. This medicine must be used with a short-acting beta2 agonist (e.g. albuterol) for the treatment of an asthma attack or asthma symptoms that need immediate attention. This medicine is available only with your doctor"s prescription, in the following dosage form:
Before Using This MedicineIn deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fluticasone and salmeterol, the following should be considered: Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to fluticasone or salmeterol. Pregnancy—The combination of fluticasone and salmeterol has not been studied in pregnant women. However, studies in animals have shown that the fluticasone and salmeterol causes problems. Before taking this medicine, make sure your doctor knows if you are pregnant or plan to become pregnant. Breast-feeding—It is not known whether the combination of fluticasone and salmeterol passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor. Children—Corticosteroids taken by mouth or injection have been shown to slow or stop growth in children and cause reduced adrenal gland function. If enough fluticasone is absorbed following inhalation, it is possible it also could cause these effects. Your doctor will want you to use the lowest possible dose of fluticasone that controls asthma. This will lessen the chance of an effect on growth or adrenal gland function. It is also important that children taking fluticasone visit their doctors regularly so that their growth rates may be monitored. Children who are taking this medicine may be more susceptible to infections, such as chickenpox or measles. Care should be taken to avoid exposure to chickenpox or measles. If the child is exposed or the disease develops, the doctor should be contacted and his or her directions should be followed carefully. Before this medicine is given to a child, you and your child"s doctor should talk about the good this medicine will do as well as the risks of using it. Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of fluticasone and salmeterol in the elderly with other age groups, this medicine has been used in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults. Elderly people who have cardiovascular disease may have increased chances of side effects from this medicine. Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fluticasone and salmeterol, it is especially important that your doctor and pharmacist know if you are taking any of the following:
Other medical problems—The presence of other medical problems may affect the use of fluticasone and salmeterol combination. Make sure you tell your doctor if you have any other medical problems, especially:
Proper Use of This MedicineInhaled fluticasone and salmeterol is used to prevent asthma attacks. It is not used to relieve an asthma attack that has already started. For relief of an asthma attack that has already started, you should use another medicine. If you do not have another medicine to use for an attack or if you have any questions about this, check with your health care professional. Use this medicine only as directed. Do not use more of it and do not use it more often than your doctor ordered. Also, do not stop taking this medicine without telling your doctor. To do so may increase the chance of side effects. In order for this medicine to help prevent asthma attacks, it must be used every day in regularly spaced doses, as ordered by your doctor. Do not stop using this medicine or other asthma medicines that your doctor has prescribed for you unless you have discussed this with your doctor. Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. However, do not swallow the water after rinsing. Inhaled fluticasone and salmeterol is used with a special inhaler that comes with patient directions. Read the directions carefully before using this medicine. If you do not understand the directions or you are not sure how to use the inhaler, ask your health care professional to show you what to do. Also, ask your health care professional to check regularly how you use the inhaler to make sure you are using it properly. To use the disposable inhaler for inhalation powder:
Dosing—The dose of inhaled fluticasone and salmeterol will be different for different patients. Follow your doctor"s orders or the direction on the label. The following information includes only the average doses of inhaled fluticasone and salmeterol. If your dose is different, do not change it unless your doctor tells you to do so.
Missed dose— If you miss a dose of this medicine skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage—To store this medicine:
Precautions While Using This MedicineCheck with your doctor if your asthma symptoms do not improve or your condition worsens. Check with your doctor if you notice:
Do not use this medicine to treat wheezing that is getting worse. Call your doctor right away if wheezing worsens while using this medicine. Although this medicine decreases the number of asthma episodes, these medicines may increase the chances of a severe asthma episode when they do occur. Be sure to read about these risks in the Medication Guide and talk to your doctor or pharmacist about any questions or concerns that you have. Side Effects of This MedicineAlong with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor as soon as possible if any of the following side effects occur: Black, tarry stools; blindness; blurred vision; burning, tingling, numbness or pain in the hands, arms, feet, or legs; chills; cough; decreased vision; difficulty breathing ; eye pain; fever; headache; nausea or vomiting; noisy breathing; painful or difficult urination; sensation of pins and needles; sore throat; sores, ulcers or white spots on lips or in mouth; stabbing pain in extremities; swollen glands; tearing; unusual bleeding or bruising; wheezing Symptoms of overdose Get emergency help immediately if any of the following symptoms of overdose occur: Darkening of skin ; diarrhea; dizziness; fainting ; loss of appetite ; mental depression; nausea ; skin rash; unusual tiredness or weakness; vomiting; chest pain or tightness ; shortness of breath; dry mouth; fatigue; blurred vision; flushed, dry skin; fruit-like breath odor; headache; increased hunger; increased thirst; high blood pressure; convulsions (seizures); decreased urine output; mood changes; muscle pain or cramps; numbness or tingling in hands, feet, or lips ; confusion ; faintness, or light-headedness when getting up from a lying or sitting position ; sudden sweating; trouble in sleeping; general feeling of discomfort or illness; nervousness; fast, pounding, or irregular heartbeat or pulse ; palpitations; tremors Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: More common Body aches or pain; choking; congestion; dryness of throat; high-pitched noise when breathing; hoarseness; runny nose; sneezing; trouble in swallowing; voice changes Less common Abdominal or stomach pain; cough producing mucus; flu-like symptoms; irritation or inflammation of eye; muscle pain; pain or tenderness around eyes and cheekbones; sleep disorders; stuffy nose; tremors; white patches in the mouth or throat or on the tongue Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor. Additional InformationOnce a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in the product labeling, fluticasone and salmeterol combination is used in certain patients with the following medical conditions:
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