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6. Do Not Use an Inhaled, Long-Acting Beta2-Agonist in Conjunction With ADVAIR DISKUS: Patients who are receiving ADVAIR DISKUS twice daily should not use additional salmeterol or other inhaled, long-acting beta2-agonists (e.g., formoterol) for prevention of exercise-induced bronchospasm (EIB) or the maintenance treatment of asthma or the maintenance treatment of bronchospasm associated with COPD. Additional benefit would not be gained from using supplemental salmeterol or formoterol for prevention of EIB since ADVAIR DISKUS already contains an inhaled, long-acting beta2-agonist. 7. Do Not Exceed Recommended Dosage: ADVAIR DISKUS should not be used more often or at higher doses than recommended. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Large doses of inhaled or oral salmeterol (12 to 20 times the recommended dose) have been associated with clinically significant prolongation of the QTc interval, which has the potential for producing ventricular arrhythmias. Text Continues Below
8. Paradoxical Bronchospasm: As with other inhaled asthma and COPD medications, ADVAIR DISKUS can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs following dosing with ADVAIR DISKUS, it should be treated immediately with an inhaled, short-acting bronchodilator, ADVAIR DISKUS should be discontinued immediately, and alternative therapy should be instituted. 9. Immediate Hypersensitivity Reactions: Immediate hypersensitivity reactions may occur after administration of ADVAIR DISKUS, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm. 10. Upper Airway Symptoms: Symptoms of laryngeal spasm, irritation, or swelling, such as stridor and choking, have been reported in patients receiving fluticasone propionate and salmeterol, components of ADVAIR DISKUS. 11. Cardiovascular Disorders: ADVAIR DISKUS, like all products containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Salmeterol, a component of ADVAIR DISKUS, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of salmeterol at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce ECG changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. 12. Discontinuation of Systemic Corticosteroids: Transfer of patients from systemic corticosteroid therapy to ADVAIR DISKUS may unmask conditions previously suppressed by the systemic corticosteroid therapy, e.g., rhinitis, conjunctivitis, eczema, arthritis, and eosinophilic conditions. 13. Immunosuppression: Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In such children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered. PRECAUTIONS General: Cardiovascular Effects: Cardiovascular and central nervous system effects seen with all sympathomimetic drugs (e.g., increased blood pressure, heart rate, excitement) can occur after use of salmeterol, a component of ADVAIR DISKUS, and may require discontinuation of ADVAIR DISKUS. ADVAIR DISKUS, like all medications containing sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders or thyrotoxicosis; and in patients who are unusually responsive to sympathomimetic amines. As has been described with other beta-adrenergic agonist bronchodilators, clinically significant changes in ECGs have been seen infrequently in individual patients in controlled clinical studies with ADVAIR DISKUS and salmeterol. Clinically significant changes in systolic and/or diastolic blood pressure and pulse rate have been seen infrequently in individual patients
in controlled clinical studies with salmeterol, a component of ADVAIR DISKUS. Metabolic and Other Effects: Long-term use of orally inhaled corticosteroids may affect normal bone metabolism, resulting in a loss of bone mineral density (BMD). A 2-year study of 160 patients (females 18 to 40 and males 18 to 50 years of age) with asthma receiving chlorofluorocarbon-propelled fluticasone propionate inhalation aerosol 88 or 440 mcg twice daily demonstrated no statistically significant changes in BMD at any time point (24, 52, 76, and 104 weeks of double-blind treatment) as assessed by dual-energy x-ray absorptiometry at lumbar region L1 through L4. Long-term treatment effects of fluticasone propionate on BMD in the COPD population have not been studied. In patients with major risk factors for decreased bone mineral content, such as tobacco use, advanced age, sedentary lifestyle, poor nutrition, family history of osteoporosis, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants and corticosteroids), ADVAIR DISKUS may pose an additional risk. Since patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is recommended, including prior to instituting ADVAIR DISKUS 250/50 and periodically thereafter. If significant reductions in BMD are seen and ADVAIR DISKUS 250/50 is still considered medically important for that patient’s COPD therapy, use of medication to treat or prevent osteoporosis should be strongly considered. ADVAIR DISKUS 250/50 mcg twice daily is the only approved dosage for the treatment of COPD associated with chronic bronchitis, and higher doses, including ADVAIR DISKUS 500/50, are not recommended. Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma and COPD following the long-term administration of inhaled corticosteroids, including fluticasone propionate, a component of ADVAIR DISKUS; therefore, regular eye examinations should be considered. Lower respiratory tract infections, including pneumonia, have been reported following the inhaled administration of corticosteroids, including fluticasone propionate and ADVAIR DISKUS. Doses of the related beta2-adrenoceptor agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease in serum potassium is usually transient, not requiring supplementation. Clinically significant changes in blood glucose and/or serum potassium were seen infrequently during clinical studies with ADVAIR DISKUS at recommended doses. During withdrawal from oral corticosteroids, some patients may experience symptoms of systemically active corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement of respiratory function. Fluticasone propionate, a component of ADVAIR DISKUS, will often help control asthma symptoms with less suppression of HPA function than therapeutically equivalent oral doses of prednisone. Since fluticasone propionate is absorbed into the circulation and can be systemically active at higher doses, the beneficial effects of ADVAIR DISKUS in minimizing HPA dysfunction may be expected only when recommended dosages are not exceeded and individual patients are titrated to the lowest effective dose. A relationship between plasma levels of fluticasone propionate and inhibitory effects on stimulated cortisol production has been shown after 4 weeks of treatment with fluticasone propionate inhalation aerosol. Since individual sensitivity to effects on cortisol production exists, physicians should consider this information when prescribing ADVAIR DISKUS. Because of the possibility of systemic absorption of inhaled corticosteroids, patients treated with ADVAIR DISKUS should be observed carefully for any evidence of systemic corticosteroid effects. Particular care should be taken in observing patients postoperatively or during periods of stress for evidence of inadequate adrenal response. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression (including adrenal crisis) may appear in a small number of patients, particularly when fluticasone propionate is administered at higher than recommended doses over prolonged periods of time. If such effects occur, the dosage of ADVAIR DISKUS should be reduced slowly, consistent with accepted procedures for reducing systemic corticosteroids and for management of asthma symptoms. Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients (see PRECAUTIONS: Pediatric Use). Patients should be maintained on the lowest strength of ADVAIR DISKUS that effectively controls their asthma. The long-term effects of ADVAIR DISKUS in human subjects are not fully known. In particular, the effects resulting from chronic use of fluticasone propionate on developmental or immunologic processes in the mouth, pharynx, trachea, and lung are unknown. Some patients have received inhaled fluticasone propionate on a continuous basis for periods of 3 years or longer. In clinical studies in patients with asthma treated for 2 years with inhaled fluticasone propionate, no apparent differences in the type or severity of adverse reactions were observed after long-versus short-term treatment. In clinical studies with ADVAIR DISKUS, the development of localized infections of the pharynx with Candida albicans has occurred. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral antifungal) therapy while remaining on treatment with ADVAIR DISKUS, but at times therapy with ADVAIR DISKUS may need to be interrupted. Inhaled corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated systemic fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex. Eosinophilic Conditions: In rare cases, patients on inhaled fluticasone propionate, a component of ADVAIR DISKUS, may present with systemic eosinophilic conditions, with some patients presenting with clinical features of vasculitis consistent with Churg-Strauss syndrome, a condition that is often treated with systemic corticosteroid therapy. These events usually, but not always, have been associated with the reduction and/or withdrawal of oral corticosteroid therapy following the introduction of fluticasone propionate. Cases of serious eosinophilic conditions have also been reported with other inhaled corticosteroids in this clinical setting. Physicians should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal relationship between fluticasone propionate and these underlying conditions has not been established (see ADVERSE REACTIONS: Observed During Clinical Practice: Eosinophilic Conditions). Chronic Obstructive Pulmonary Disease: ADVAIR DISKUS 250/50 twice daily is the only dosage recommended for the treatment of airflow obstruction in patients with COPD associated with chronic bronchitis. Higher doses, including ADVAIR DISKUS 500/50, are not recommended, as no additional improvement in lung function (defined by predose and postdose FEV1) was observed in clinical trials and higher doses of corticosteroids increase the risk of systemic effects. The benefit of treatment of patients with COPD associated with chronic bronchitis with ADVAIR DISKUS 250/50 for periods longer than 6 months has not been evaluated. Patients who are treated with ADVAIR DISKUS 250/50 for COPD associated with chronic bronchitis for periods longer than 6 months should be reevaluated periodically to assess the continuing benefits and potential risks of treatment.
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