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Looking for an Advair Diskus Coupon?

Save Up To 75% With This Advair Diskus Discount Card!

Looking for an Advair Diskus Coupon?

Save Up To 75% With This Advair Diskus Discount Card!

Estimated Savings Of Over $1,004,620
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Always pay a fair price for your medication!

Our FREE Advair Diskus discount card helps you save money on the exact same Advair Diskus prescription you're already paying for. Print the card in seconds, then take it to your pharmacy the next time you get your Advair Diskus prescription filled. Hand it to them and save between 10% - 75% off this prescription!

Advair Diskus is a fluticasone and salmeterol inhalation medication used to prevent asthma attacks. Fluticasone is a steroid that prevents inflammation in the body, while salmeterol works to dilate the airway to help improve breathing. In addition to treatment of asthma, it can be used to treat COPD and other conditions deemed appropriate by a physician. Did you know that you might be able to save on your prescription with an Advair Diskus coupon or an Advair Diskus discount card?

Interactions and Side Effects
Inform your doctor of your allergy before taking this medication if you are allergic to milk proteins. If you are currently having an asthma attack or COPD symptoms, do not use this medication. Tell your doctor about any other prescription medications you take before taking Advair.

Side effects of Advair include:
  • Restless feeling
  • Blurred vision
  • Eye pain
  • Headache
  • Dizziness
  • Sores on the mouth or lips
  • Fever
  • Chest pain
  • Fast heartbeat
Consult your doctor or pharmacist if you experience any of these side effects.

Advair Diskus Cost
The cost of Advair Diskus can be different depending on which pharmacy you use, the prescribed dosage, and if you use a discount card. Don’t let the cost of Advair Diskus prevent you from filling your prescription, because using an Advair Diskus discount card has saved millions of patients a significant amount on their Advair prescription. Check with your pharmacist to see how much you can save by using a discount card. To get your own Advair Diskus discount card, just click the "Print Card Now" button and start saving today!

References:
"Advair Diskus." Information from Advair.com. GlaxoSmithKline. 2013. Web. April 20, 2013.
"Advair Diskus." Information from Drugs.com. Cerner Multum, Inc., Jan. 09, 2012. Web. April 20, 2013.
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  • ABC
  • NBC
  • FOX
  • CBS
  • San Francisco Chronicle
  • About.com
  • CIO
  • Boston.com
Estimated Savings Of Over $1,004,620

Always pay a fair price for your medication!

Our FREE Advair Diskus discount card helps you save money on the exact same Advair Diskus prescription you're already paying for. Print the card in seconds, then take it to your pharmacy the next time you get your Advair Diskus prescription filled. Hand it to them and save between 10% - 75% off this prescription!

Advair Diskus is a fluticasone and salmeterol inhalation medication used to prevent asthma attacks. Fluticasone is a steroid that prevents inflammation in the body, while salmeterol works to dilate the airway to help improve breathing. In addition to treatment of asthma, it can be used to treat COPD and other conditions deemed appropriate by a physician. Did you know that you might be able to save on your prescription with an Advair Diskus coupon or an Advair Diskus discount card?

Interactions and Side Effects
Inform your doctor of your allergy before taking this medication if you are allergic to milk proteins. If you are currently having an asthma attack or COPD symptoms, do not use this medication. Tell your doctor about any other prescription medications you take before taking Advair.

Side effects of Advair include:
  • Restless feeling
  • Blurred vision
  • Eye pain
  • Headache
  • Dizziness
  • Sores on the mouth or lips
  • Fever
  • Chest pain
  • Fast heartbeat
Consult your doctor or pharmacist if you experience any of these side effects.

Advair Diskus Cost
The cost of Advair Diskus can be different depending on which pharmacy you use, the prescribed dosage, and if you use a discount card. Don’t let the cost of Advair Diskus prevent you from filling your prescription, because using an Advair Diskus discount card has saved millions of patients a significant amount on their Advair prescription. Check with your pharmacist to see how much you can save by using a discount card. To get your own Advair Diskus discount card, just click the "Print Card Now" button and start saving today!

References:
"Advair Diskus." Information from Advair.com. GlaxoSmithKline. 2013. Web. April 20, 2013.
"Advair Diskus." Information from Drugs.com. Cerner Multum, Inc., Jan. 09, 2012. Web. April 20, 2013.
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ADVAIR DISKUS prescribing information
This information is not for clinical use. These highlights do not include all the information needed to use Advair Diskus safely and effectively.
Before taking Advair Diskus please consult with your doctor.
WARNING: ASTHMA-RELATED DEATH Long-acting beta2-adrenergic agonists (LABAs), such as salmeterol, one of the active ingredients in ADVAIR DISKUS®, increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT ® Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 out of 13,179 patients on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABAs. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue ADVAIR DISKUS) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use ADVAIR DISKUS for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids [see Warnings and Precautions (5.1)]. WARNING: ASTHMA-RELATED DEATH See full prescribing information for complete boxed warning Long-acting beta2-adrenergic agonists (LABAs), such as salmeterol, one of the active ingredients in ADVAIR DISKUS, increase the risk of asthma-related death. A US study showed an increase in asthma-related deaths in patients receiving salmeterol (13 deaths out of 13,176 patients treated for 28 weeks on salmeterol versus 3 out of 13,179 patients on placebo). Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABAs. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients. (5.1) When treating patients with asthma, only prescribe ADVAIR DISKUS for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue ADVAIR DISKUS) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use ADVAIR DISKUS for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids. (1.1, 5.1)
Boxed Warning June 2010
Indications and Usage (1.1) June 2010
Dosage and Administration (2.1) June 2010
Warnings and Precautions, Asthma-Related Death (5.1) June 2010
1 INDICATIONS AND USAGE ADVAIR DISKUS is a combination product containing a corticosteroid and a LABA indicated for: Treatment of asthma in patients aged 4 years and older. (1.1) Maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD). (1.2) Important limitation: Not indicated for the relief of acute bronchospasm. (1.1, 1.2) 1.1 Treatment of Asthma ADVAIR DISKUS is indicated for the treatment of asthma in patients aged 4 years and older. Long-acting beta2-adrenergic agonists (LABAs), such as salmeterol, one of the active ingredients in ADVAIR DISKUS, increase the risk of asthma-related death. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients [see Warnings and Precautions (5.1)]. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on a long-term asthma control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue ADVAIR DISKUS) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use ADVAIR DISKUS for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids. Important Limitation of Use: ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm. 1.2 Maintenance Treatment of Chronic Obstructive Pulmonary Disease ADVAIR DISKUS 250/50 is indicated for the twice-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. ADVAIR DISKUS 250/50 is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. ADVAIR DISKUS 250/50 twice daily is the only approved dosage for the treatment of COPD because an efficacy advantage of the higher strength ADVAIR DISKUS 500/50 over ADVAIR DISKUS 250/50 has not been demonstrated. Important Limitation of Use: ADVAIR DISKUS is NOT indicated for the relief of acute bronchospasm.
3 DOSAGE FORMS AND STRENGTHS Disposable purple device with 60 blisters containing a combination of fluticasone propionate (100, 250, or 500 mcg) and salmeterol (50 mcg) as an oral inhalation powder formulation. An institutional pack containing 14 blisters is also available. DISKUS device containing a combination of fluticasone propionate (100, 250, or 500 mcg) and salmeterol (50 mcg) as an oral inhalation powder. (3)
4 CONTRAINDICATIONS The use of ADVAIR DISKUS is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma or COPD where intensive measures are required Severe hypersensitivity to milk proteins [see Warnings and Precautions (5.11), Description (11)] Primary treatment of status asthmaticus or acute episodes of asthma or COPD requiring intensive measures. (4) Severe hypersensitivity to milk proteins. (4)
5 WARNINGS AND PRECAUTIONS Asthma-related death: LABAs increase the risk. Prescribe only for recommended patient populations. (5.1) Deterioration of disease and acute episodes: Do not initiate in acutely deteriorating asthma or to treat acute symptoms. (5.2) Use with additional LABA: Do not use in combination because of risk of overdose. (5.3) Localized infections: Candida albicans infection of the mouth and throat may occur. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse the mouth following inhalation. (5.4) Pneumonia: Increased risk in patients with COPD. Monitor patients for signs and symptoms of pneumonia. (5.5) Immunosuppression: Potential worsening of infections (e.g., existing tuberculosis, fungal, bacterial, viral, or parasitic infection; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients. (5.6) Transferring patients from systemic corticosteroids: Risk of impaired adrenal function when transferring from oral steroids. Taper patients slowly from systemic corticosteroids if transferring to ADVAIR DISKUS. (5.7) Hypercorticism and adrenal suppression: May occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue ADVAIR DISKUS slowly. (5.8) Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Risk of increased systemic corticosteroid and cardiovascular effects. Use not recommended with ADVAIR DISKUS. (5.9) Paradoxical bronchospasm: Discontinue ADVAIR DISKUS and institute alternative therapy if paradoxical bronchospasm occurs. (5.10) Patients with cardiovascular or central nervous system disorders: Use with caution because of beta-adrenergic stimulation. (5.12) Decreases in bone mineral density: Assess bone mineral density initially and periodically thereafter. (5.13) Effects on growth: Monitor growth of pediatric patients. (5.14) Glaucoma and cataracts: Close monitoring is warranted. (5.15) Metabolic effects: Be alert to eosinophilic conditions, hypokalemia, and hyperglycemia. (5.16, 5.18) Coexisting conditions: Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis. (5.17) 5.1 Asthma-Related Death LABAs, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, increase the risk of asthma-related death. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABAs. Available data from controlled clinical trials suggest that LABAs increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Therefore, when treating patients with asthma, physicians should only prescribe ADVAIR DISKUS for patients not adequately controlled on a long-term asthma-control medication, such as an inhaled corticosteroid, or whose disease severity clearly warrants initiation of treatment with both an inhaled corticosteroid and a LABA. Once asthma control is achieved and maintained, assess the patient at regular intervals and step down therapy (e.g., discontinue ADVAIR DISKUS) if possible without loss of asthma control and maintain the patient on a long-term asthma control medication, such as an inhaled corticosteroid. Do not use ADVAIR DISKUS for patients whose asthma is adequately controlled on low- or medium-dose inhaled corticosteroids. A large placebo-controlled US study that compared the safety of salmeterol with placebo, each added to usual asthma therapy, showed an increase in asthma-related deaths in patients receiving salmeterol. The Salmeterol Multi-center Asthma Research Trial (SMART) was a randomized double-blind study that enrolled LABA-naive patients with asthma to assess the safety of salmeterol (SEREVENT® Inhalation Aerosol) 42 mcg twice daily over 28 weeks compared with placebo when added to usual asthma therapy. A planned interim analysis was conducted when approximately half of the intended number of patients had been enrolled (N = 26,355), which led to premature termination of the study. The results of the interim analysis showed that patients receiving salmeterol were at increased risk for fatal asthma events (see Table 1 and Figure 1). In the total population, a higher rate of asthma-related death occurred in patients treated with salmeterol than those treated with placebo (0.10% versus 0.02%, relative risk: 4.37 [95% CI: 1.25, 15.34]). Post-hoc subpopulation analyses were performed. In Caucasians, asthma-related death occurred at a higher rate in patients treated with salmeterol than in patients treated with placebo (0.07% versus 0.01%, relative risk: 5.82 [95% CI: 0.70, 48.37]). In African Americans also, asthma-related death occurred at a higher rate in patients treated with salmeterol than those treated with placebo (0.31% versus 0.04%, relative risk: 7.26 [95% CI: 0.89, 58.94]). Although the relative risks of asthma-related death were similar in Caucasians and African Americans, the estimate of excess deaths in patients treated with salmeterol was greater in African Americans because there was a higher overall rate of asthma-related death in African American patients (see Table 1). Given the similar basic mechanisms of action of beta2-agonists, the findings seen in the SMART study are considered a class effect. Post-hoc analyses in pediatric patients aged 12 to 18 years were also performed. Pediatric patients accounted for approximately 12% of patients in each treatment arm. Respiratory-related death or life-threatening experience occurred at a similar rate in the salmeterol group (0.12% [2/1,653]) and the placebo group (0.12% [2/1,622]; relative risk: 1.0 [95% CI: 0.1, 7.2]). All-cause hospitalization, however, was increased in the salmeterol group (2% [35/1,653]) versus the placebo group (<1% [16/1,622]; relative risk: 2.1 [95% CI: 1.1, 3.7]). The data from the SMART study are not adequate to determine whether concurrent use of inhaled corticosteroids, such as fluticasone propionate, the other active ingredient in ADVAIR DISKUS, or other long-term asthma control therapy mitigates the risk of asthma-related death. Table 1. Asthma-Related Deaths in the 28-Week Salmeterol Multi-center Asthma Research Trial (SMART) Salmeteroln (%a) Placebon (%a) Relative Riskb (95% ConfidenceInterval) Excess Deaths Expressed per 10,000 Patientsc (95% ConfidenceInterval) Total Populationd Salmeterol: N = 13,176 13 (0.10%) 4.37 (1.25, 15.34) 8 (3, 13) Placebo: N = 13,179 3 (0.02%) Caucasian Salmeterol: N = 9,281 6 (0.07%) 5.82 (0.70, 48.37) 6 (1, 10) Placebo: N = 9,361 1 (0.01%) African American Salmeterol: N = 2,366 7 (0.31%) 7.26 (0.89, 58.94) 27 (8, 46) Placebo: N = 2,319 1 (0.04%) aLife-table 28-week estimate, adjusted according to the patients’ actual lengths of exposure to study treatment to account for early withdrawal of patients from the study. bRelative risk is the ratio of the rate of asthma-related death in the salmeterol group and the rate in the placebo group. The relative risk indicates how many more times likely an asthma-related death occurred in the salmeterol group than in the placebo group in a 28-week treatment period. cEstimate of the number of additional asthma-related deaths in patients treated with salmeterol in SMART, assuming 10,000 patients received salmeterol for a 28-week treatment period. Estimate calculated as the difference between the salmeterol and placebo groups in the rates of asthma-related death multiplied by 10,000. dThe Total Population includes the following ethnic origins listed on the case report form: Caucasian, African American, Hispanic, Asian, and “Other.” In addition, the Total Population includes those patients whose ethnic origin was not reported. The results for Caucasian and African American subpopulations are shown above. No asthma-related deaths occurred in the Hispanic (salmeterol n = 996, placebo n = 999), Asian (salmeterol n = 173, placebo n = 149), or “Other” (salmeterol n = 230, placebo n = 224) subpopulations. One asthma-related death occurred in the placebo group in the subpopulation whose ethnic origin was not reported (salmeterol n = 130, placebo n = 127). Figure 1. Cumulative Incidence of Asthma-Related Deaths in the 28-Week Salmeterol Multi-center Asthma Research Trial (SMART), by Duration of Treatment A 16-week clinical study performed in the United Kingdom, the Salmeterol Nationwide Surveillance (SNS) study, showed results similar to the SMART study. In the SNS study, the rate of asthma-related death was numerically, though not statistically significantly, greater in patients with asthma treated with salmeterol (42 mcg twice daily) than those treated with albuterol (180 mcg 4 times daily) added to usual asthma therapy. The SNS and SMART studies enrolled patients with asthma. No studies have been conducted that were primarily designed to determine whether the rate of death in patients with COPD is increased by LABAs. 5.2 Deterioration of Disease and Acute Episodes ADVAIR DISKUS should not be initiated in patients during rapidly deteriorating or potentially life-threatening episodes of asthma or COPD. ADVAIR DISKUS has not been studied in patients with acutely deteriorating asthma or COPD. The initiation of ADVAIR DISKUS in this setting is not appropriate. Serious acute respiratory events, including fatalities, have been reported when salmeterol, a component of ADVAIR DISKUS, has been initiated in patients with significantly worsening or acutely deteriorating asthma. In most cases, these have occurred in patients with severe asthma (e.g., patients with a history of corticosteroid dependence, low pulmonary function, intubation, mechanical ventilation, frequent hospitalizations, previous life-threatening acute asthma exacerbations) and in some patients with acutely deteriorating asthma (e.g., patients with significantly increasing symptoms; increasing need for inhaled, short-acting beta2-agonists; decreasing response to usual medications; increasing need for systemic corticosteroids; recent emergency room visits; deteriorating lung function). However, these events have occurred in a few patients with less severe asthma as well. It was not possible from these reports to determine whether salmeterol contributed to these events. Increasing use of inhaled, short-acting beta2-agonists is a marker of deteriorating asthma. In this situation, the patient requires immediate reevaluation with reassessment of the treatment regimen, giving special consideration to the possible need for replacing the current strength of ADVAIR DISKUS with a higher strength, adding additional inhaled corticosteroid, or initiating systemic corticosteroids. Patients should not use more than 1 inhalation twice daily (morning and evening) of ADVAIR DISKUS. ADVAIR DISKUS should not be used for the relief of acute symptoms, i.e., as rescue therapy for the treatment of acute episodes of bronchospasm. An inhaled, short-acting beta2-agonist, not ADVAIR DISKUS, should be used to relieve acute symptoms such as shortness of breath. When prescribing ADVAIR DISKUS, the physician must also provide the patient with an inhaled, short-acting beta2-agonist (e.g., albuterol) for treatment of acute symptoms, despite regular twice-daily (morning and evening) use of ADVAIR DISKUS. When beginning treatment with ADVAIR DISKUS, patients who have been taking oral or inhaled, short-acting beta2-agonists on a regular basis (e.g., 4 times a day) should be instructed to discontinue the regular use of these drugs. 5.3 Excessive Use of ADVAIR DISKUS and Use With Other Long-Acting Beta2-Agonists As with other inhaled drugs containing beta2-adrenergic agents, ADVAIR DISKUS should not be used more often than recommended, at higher doses than recommended, or in conjunction with other medications containing LABAs, as an overdose may result. Clinically significant cardiovascular effects and fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. Patients using ADVAIR DISKUS should not use an additional LABA (e.g., salmeterol, formoterol fumarate, arformoterol tartrate) for any reason, including prevention of exercise-induced bronchospasm (EIB) or the treatment of asthma or COPD. 5.4 Local Effects In clinical studies, the development of localized infections of the mouth and pharynx with Candida albicans has occurred in patients treated with ADVAIR DISKUS. When such an infection develops, it should be treated with appropriate local or systemic (i.e., oral antifungal) therapy while treatment with ADVAIR DISKUS continues, but at times therapy with ADVAIR DISKUS may need to be interrupted. Patients should rinse the mouth after inhalation of ADVAIR DISKUS. 5.5 Pneumonia Physicians should remain vigilant for the possible development of pneumonia in patients with COPD as the clinical features of pneumonia and exacerbations frequently overlap. Lower respiratory tract infections, including pneumonia, have been reported in patients with COPD following the inhaled administration of corticosteroids, including fluticasone propionate and ADVAIR DISKUS. In 2 replicate 12-month studies of 1,579 patients with COPD, there was a higher incidence of pneumonia reported in patients receiving ADVAIR DISKUS 250/50 (7%) than in those receiving salmeterol 50 mcg (3%). The incidence of pneumonia in the patients treated with ADVAIR DISKUS was higher in patients over 65 years of age (9%) compared with the incidence in patients less than 65 years of age (4%). [See Adverse Reactions (6.2), Use in Specific Populations (8.5).] In a 3-year study of 6,184 patients with COPD, there was a higher incidence of pneumonia reported in patients receiving ADVAIR DISKUS 500/50 compared with placebo (16% with ADVAIR DISKUS 500/50, 14% with fluticasone propionate 500 mcg, 11% with salmeterol 50 mcg, and 9% with placebo). Similar to what was seen in the 1-year studies with ADVAIR DISKUS 250/50, the incidence of pneumonia was higher in patients over 65 years of age (18% with ADVAIR DISKUS 500/50 versus 10% with placebo) compared with patients less than 65 years of age (14% with ADVAIR DISKUS 500/50 versus 8% with placebo). [See Adverse Reactions (6.2), Use in Specific Populations (8.5).] 5.6 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 a patient is exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient is 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. 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. 5.7 Transferring Patients From Systemic Corticosteroid Therapy Particular care is needed for patients who have been transferred from systemically active corticosteroids to inhaled corticosteroids because deaths due to adrenal insufficiency have occurred in patients with asthma during and after transfer from systemic corticosteroids to less systemically available inhaled corticosteroids. After withdrawal from systemic corticosteroids, a number of months are required for recovery of hypothalamic-pituitary-adrenal (HPA) function. Patients who have been previously maintained on 20 mg or more per day of prednisone (or its equivalent) may be most susceptible, particularly when their systemic corticosteroids have been almost completely withdrawn. During this period of HPA suppression, patients may exhibit signs and symptoms of adrenal insufficiency when exposed to trauma, surgery, or infection (particularly gastroenteritis) or other conditions associated with severe electrolyte loss. Although ADVAIR DISKUS may provide control of asthma symptoms during these episodes, in recommended doses it supplies less than normal physiological amounts of glucocorticoid systemically and does NOT provide the mineralocorticoid activity that is necessary for coping with these emergencies. During periods of stress or a severe asthma attack, patients who have been withdrawn from systemic corticosteroids should be instructed to resume oral corticosteroids (in large doses) immediately and to contact their physicians for further instruction. These patients should also be instructed to carry a warning card indicating that they may need supplementary systemic corticosteroids during periods of stress or a severe asthma attack. Patients requiring oral corticosteroids should be weaned slowly from systemic corticosteroid use after transferring to ADVAIR DISKUS. Prednisone reduction can be accomplished by reducing the daily prednisone dose by 2.5 mg on a weekly basis during therapy with ADVAIR DISKUS. Lung function (mean forced expiratory volume in 1 second [FEV1] or morning peak expiratory flow [PEF]), beta-agonist use, and asthma symptoms should be carefully monitored during withdrawal of oral corticosteroids. In addition to monitoring asthma signs and symptoms, patients should be observed for signs and symptoms of adrenal insufficiency, such as fatigue, lassitude, weakness, nausea and vomiting, and hypotension. Transfer of patients from systemic corticosteroid therapy to inhaled corticosteroids or ADVAIR DISKUS may unmask conditions previously suppressed by the systemic corticosteroid therapy (e.g., rhinitis, conjunctivitis, eczema, arthritis, eosinophilic conditions). Some patients may experience symptoms of systemically active corticosteroid withdrawal (e.g., joint and/or muscular pain, lassitude, depression) despite maintenance or even improvement of respiratory function. 5.8 Hypercorticism and Adrenal Suppression 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. 5.9 Drug Interactions With Strong Cytochrome P450 3A4 Inhibitors The use of strong cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ADVAIR DISKUS is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur [see Drug interactions (7.1), Clinical Pharmacology (12.3)]. 5.10 Paradoxical Bronchospasm and Upper Airway Symptoms As with other inhaled 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. Upper airway symptoms of laryngeal spasm, irritation, or swelling, such as stridor and choking, have been reported in patients receiving fluticasone propionate and salmeterol. 5.11 Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of ADVAIR DISKUS, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm. There have been reports of anaphylactic reactions in patients with severe milk protein allergy; therefore, patients with severe milk protein allergy should not take ADVAIR DISKUS [see Contraindications (4)]. 5.12 Cardiovascular and Central Nervous System Effects Excessive beta-adrenergic stimulation has been associated with seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min, arrhythmias, nervousness, headache, tremor, palpitation, nausea, dizziness, fatigue, malaise, and insomnia [see Overdosage (10)]. Therefore, 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. 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. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs. 5.13 Reduction in Bone Mineral Density Decreases in bone mineral density (BMD) have been observed with long-term administration of products containing inhaled corticosteroids. The clinical significance of small changes in BMD with regard to long-term consequences such as fracture is unknown. Patients with major risk factors for decreased bone mineral content, such as prolonged immobilization, family history of osteoporosis, post-menopausal status, tobacco use, advanced age, poor nutrition, or chronic use of drugs that can reduce bone mass (e.g., anticonvulsants, oral corticosteroids) should be monitored and treated with established standards of care. Since patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is recommended prior to initiating ADVAIR DISKUS and periodically thereafter. If significant reductions in BMD are seen and ADVAIR DISKUS is still considered medically important for that patient’s COPD therapy, use of medication to treat or prevent osteoporosis should be strongly considered. 2-Year Fluticasone Propionate Study: A 2-year study of 160 patients (females aged 18 to 40 years, males 18 to 50) with asthma receiving CFC-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 regions L1 through L4. 3-Year Bone Mineral Density Study: Effects of treatment with ADVAIR DISKUS 250/50 or salmeterol 50 mcg on BMD at the L1-L4 lumbar spine and total hip were evaluated in 186 patients with COPD (aged 43 to 87 years) in a 3-year double-blind study. Of those enrolled, 108 patients (72 males and 36 females) were followed for the entire 3 years. BMD evaluations were conducted at baseline and at 6-month intervals. Conclusions cannot be drawn from this study regarding BMD decline in patients treated with ADVAIR DISKUS versus salmeterol due to the inconsistency of treatment differences across gender and between lumbar spine and total hip. In this study there were 7 non-traumatic fractures reported in 5 patients treated with ADVAIR DISKUS and 1 non-traumatic fracture in 1 patient treated with salmeterol. None of the non-traumatic fractures occurred in the vertebrae, hip, or long bones. 3-Year Survival Study: Effects of treatment with ADVAIR DISKUS 500/50, fluticasone propionate 500 mcg, salmeterol 50 mcg, or placebo on BMD was evaluated in a subset of 658 patients (females and males aged 40 to 80 years) with COPD in the 3-year survival study. BMD evaluations were conducted at baseline and at 48, 108, and 158 weeks. Conclusions cannot be drawn from this study because of the large number of drop outs (>50%) before the end of the follow-up and the maldistribution of covariates among the treatment groups that can affect BMD. Fracture risk was estimated for the entire population of patients with COPD in the survival study (N = 6,184). The probability of a fracture over 3 years was 6.3% for ADVAIR DISKUS, 5.4% for fluticasone propionate, 5.1% for salmeterol, and 5.1% for placebo. 5.14 Effect on Growth Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth of pediatric patients receiving ADVAIR DISKUS routinely (e.g., via stadiometry). To minimize the systemic effects of orally inhaled corticosteroids, including ADVAIR DISKUS, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms. [See Dosage and Administration (2.1), Use in Specific Populations (8.4).] 5.15 Glaucoma and Cataracts 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, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts. Effects of treatment with ADVAIR DISKUS 500/50, fluticasone propionate 500 mcg, salmeterol 50 mcg, or placebo on development of cataracts or glaucoma was evaluated in a subset of 658 patients with COPD in the 3-year survival study. Ophthalmic examinations were conducted at baseline and at 48, 108, and 158 weeks. Conclusions about cataracts cannot be drawn from this study because the high incidence of cataracts at baseline (61% to 71%) resulted in an inadequate number of patients treated with ADVAIR DISKUS 500/50 who were eligible and available for evaluation of cataracts at the end of the study (n = 53). The incidence of newly diagnosed glaucoma was 2% with ADVAIR DISKUS 500/50, 5% with fluticasone propionate, 0% with salmeterol, and 2% with placebo. 5.16 Eosinophilic Conditions and Churg-Strauss Syndrome In rare cases, patients on inhaled fluticasone propionate may present with systemic eosinophilic conditions. Some of these patients have 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. 5.17 Coexisting Conditions ADVAIR DISKUS, like all medications containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines. Doses of the related beta2-adrenoceptor agonist albuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. 5.18 Hypokalemia and Hyperglycemia Beta-adrenergic agonist medications may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects [see Clinical Pharmacology (12.2)]. 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. Figure 1. Cumulative Incidence of Asthma-Related Deaths in the 28-Week Salmeterol Multi-center Asthma Research Trial (SMART), by Duration of Treatment
6 ADVERSE REACTIONS LABAs, such as salmeterol, one of the active ingredients in ADVAIR DISKUS, increase the risk of asthma-related death. Data from a large placebo-controlled US study that compared the safety of salmeterol (SEREVENT Inhalation Aerosol) or placebo added to usual asthma therapy showed an increase in asthma-related deaths in patients receiving salmeterol [see Warnings and Precautions (5.1)]. Currently available data are inadequate to determine whether concurrent use of inhaled corticosteroids or other long-term asthma control drugs mitigates the increased risk of asthma-related death from LABA. Available data from controlled clinical trials suggest that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients. Systemic and local corticosteroid use may result in the following: Candida albicans infection [see Warnings and Precautions (5.4)] Pneumonia in patients with COPD [see Warnings and Precautions (5.5)] Immunosuppression [see Warnings and Precautions (5.6)] Hypercorticism and adrenal suppression [see Warnings and Precautions (5.8)] Growth effects [see Warnings and Precautions (5.14)] Glaucoma and cataracts [see Warnings and Precautions (5.15)] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Most common adverse reactions (incidence ≥3%) are: Asthma: upper respiratory tract infection or inflammation, pharyngitis, dysphonia, oral candidiasis, bronchitis, cough, headaches, nausea and vomiting. (6.1) COPD: pneumonia, oral candidiasis, throat irritation, dysphonia, viral respiratory infections, headaches, musculoskeletal pain. (6.2) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience in Asthma Adult and Adolescent Patients Aged 12 Years and Older: The incidence of adverse reactions associated with ADVAIR DISKUS in Table 2 is based upon 2 placebo-controlled, 12-week, US clinical studies (Studies 1 and 2). A total of 705 adolescent and adult patients (349 females and 356 males) previously treated with salmeterol or inhaled corticosteroids were treated twice daily with ADVAIR DISKUS (100/50- or 250/50-mcg doses), fluticasone propionate inhalation powder (100- or 250-mcg doses), salmeterol inhalation powder 50 mcg, or placebo. The average duration of exposure was 60 to 79 days in the active treatment groups compared with 42 days in the placebo group. Table 2. Adverse Reactions With ≥3% Incidence With ADVAIR DISKUS in Adult and Adolescent Patients With Asthma Adverse Event ADVAIR DISKUS 100/50 (N = 92)% ADVAIR DISKUS 250/50 (N = 84)% Fluticasone Propionate 100 mcg (N = 90)% Fluticasone Propionate 250 mcg (N = 84)% Salmeterol 50 mcg (N = 180)% Placebo (N = 175)% Ear, nose, & throat Upper respiratory tractinfection 27 21 29 25 19 14 Pharyngitis 13 10 7 12 8 6 Upper respiratory inflammation 7 6 7 8 8 5 Sinusitis 4 5 6 1 3 4 Hoarseness/dysphonia 5 2 2 4 <1 <1 Oral candidiasis 1 4 2 2 0 0 Lower respiratory Viral respiratory infections 4 4 4 10 6 3 Bronchitis 2 8 1 2 2 2 Cough 3 6 0 0 3 2 Neurology Headaches 12 13 14 8 10 7 Gastrointestinal Nausea & vomiting 4 6 3 4 1 1 Gastrointestinal discomfort& pain 4 1 0 2 1 1 Diarrhea 4 2 2 2 1 1 Viral gastrointestinal infections 3 0 3 1 2 2 Non-site specific Candidiasis unspecified site 3 0 1 4 0 1 Musculoskeletal Musculoskeletal pain 4 2 1 5 3 3 The types of adverse reactions and events reported in Study 3, a 28-week, non-US clinical study of 503 patients previously treated with inhaled corticosteroids who were treated twice daily with ADVAIR DISKUS 500/50, fluticasone propionate inhalation powder 500 mcg and salmeterol inhalation powder 50 mcg used concurrently, or fluticasone propionate inhalation powder 500 mcg, were similar to those reported in Table 2. Additional Adverse Reactions: Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by patients with asthma treated with ADVAIR DISKUS compared with patients treated with placebo include the following: lymphatic signs and symptoms; muscle injuries; fractures; wounds and lacerations; contusions and hematomas; ear signs and symptoms; nasal signs and symptoms; nasal sinus disorders; keratitis and conjunctivitis; dental discomfort and pain; gastrointestinal signs and symptoms; oral ulcerations; oral discomfort and pain; lower respiratory signs and symptoms; pneumonia; muscle stiffness, tightness, and rigidity; bone and cartilage disorders; sleep disorders; compressed nerve syndromes; viral infections; pain; chest symptoms; fluid retention; bacterial infections; unusual taste; viral skin infections; skin flakiness and acquired ichthyosis; disorders of sweat and sebum. Pediatric Patients Aged 4 to 11 Years: The safety data for pediatric patients aged 4 to 11 years is based upon 1 US trial of 12 weeks’ treatment duration. A total of 203 patients (74 females and 129 males) who were receiving inhaled corticosteroids at study entry were randomized to either ADVAIR DISKUS 100/50 or fluticasone propionate inhalation powder 100 mcg twice daily. Common adverse reactions (≥3% and greater than placebo) seen in the pediatric patients but not reported in the adult and adolescent clinical trials include: throat irritation and ear, nose, and throat infections. Laboratory Test Abnormalities: Elevation of hepatic enzymes was reported in ≥1% of patients in clinical trials. The elevations were transient and did not lead to discontinuation from the studies. In addition, there were no clinically relevant changes noted in glucose or potassium. 6.2 Clinical Trials Experience in Chronic Obstructive Pulmonary Disease Short-Term (6 Months to 1 Year) Trials: The short-term safety data are based on exposure to ADVAIR DISKUS 250/50 twice daily in one 6-month and two 1-year clinical trials. In the 6-month trial, a total of 723 adult patients (266 females and 457 males) were treated twice daily with ADVAIR DISKUS 250/50, fluticasone propionate inhalation powder 250 mcg, salmeterol inhalation powder, or placebo. The mean age of the patients was 64, and the majority (93%) was Caucasian. In this trial, 70% of the patients treated with ADVAIR DISKUS reported an adverse reaction compared with 64% on placebo. The average duration of exposure to ADVAIR DISKUS 250/50 was 141.3 days compared with 131.6 days for placebo. The incidence of adverse reactions in the 6-month study is shown in Table 3. Table 3. Overall Adverse Reactions With ≥3% Incidence With ADVAIR DISKUS 250/50 in Patients With Chronic Obstructive Pulmonary Disease Associated With Chronic Bronchitis Adverse Event ADVAIR DISKUS 250/50 (N = 178)% Fluticasone Propionate 250 mcg (N = 183)% Salmeterol 50 mcg (N = 177)% Placebo (N = 185)% Ear, nose, & throat Candidiasis mouth/throat 10 6 3 1 Throat irritation 8 5 4 7 Hoarseness/dysphonia 5 3 <1 0 Sinusitis 3 8 5 3 Lower respiratory Viral respiratory infections 6 4 3 3 Neurology Headaches 16 11 10 12 Dizziness 4 <1 3 2 Non-site specific Fever 4 3 0 3 Malaise & fatigue 3 2 2 3 Musculoskeletal Musculoskeletal pain 9 8 12 9 Muscle cramps & spasms 3 3 1 1 In the two 1-year studies, ADVAIR DISKUS 250/50 was compared with salmeterol in 1,579 patients (863 males and 716 females). The mean age of the patients was 65, and the majority (94%) was Caucasian. To be enrolled, all of the patients had to have had a COPD exacerbation in the previous 12 months. In this trial, 88% of the patients treated with ADVAIR DISKUS and 86% of the patients treated with salmeterol reported an adverse event. The most common events that occurred with a frequency of >5% and more frequently in the patients treated with ADVAIR DISKUS were nasopharyngitis, upper respiratory tract infection, nasal congestion, back pain, sinusitis, dizziness, nausea, pneumonia, candidiasis, and dysphonia. Overall, 55 (7%) of the patients treated with ADVAIR DISKUS and 25 (3%) of the patients treated with salmeterol developed pneumonia. The incidence of pneumonia was higher in patients over 65 years of age, 9% in the patients treated with ADVAIR DISKUS compared with 4% in the patients treated with ADVAIR DISKUS less than 65 years of age. In the patients treated with salmeterol, the incidence of pneumonia was the same (3%) in both age-groups. [See Warnings and Precautions (5.5), Use in Specific Populations (8.5).] Long-Term (3-Year) Trial: The safety of ADVAIR DISKUS 500/50 was evaluated in a randomized, double-blind, placebo-controlled, multicenter, international, 3-year study in 6,184 adult patients with COPD (4,684 males and 1,500 females). The mean age of the patients was 65, and the majority (82%) was Caucasian. The distribution of adverse events was similar to that seen in the 1-year trials with ADVAIR DISKUS 250/50. In addition, pneumonia was reported in a significantly increased number of patients treated with ADVAIR DISKUS 500/50 and fluticasone propionate 500 mcg (16% and 14%, respectively) compared with patients treated with salmeterol 50 mcg or placebo (11% and 9%, respectively). When adjusted for time on treatment, the rates of pneumonia were 84 and 88 events per 1,000 treatment-years in the groups treated with fluticasone propionate 500 mcg and with ADVAIR DISKUS 500/50, respectively, compared with 52 events per 1,000 treatment-years in the salmeterol and placebo groups. Similar to what was seen in the 1-year studies with ADVAIR DISKUS 250/50, the incidence of pneumonia was higher in patients over 65 years of age (18% with ADVAIR DISKUS 500/50 versus 10% with placebo) compared with patients less than 65 years of age (14% with ADVAIR DISKUS 500/50 versus 8% with placebo). [See Warnings and Precautions (5.5), Use in Specific Populations (8.5).] Additional Adverse Reactions: Other adverse reactions not previously listed, whether considered drug-related or not by the investigators, that were reported more frequently by patients with COPD treated with ADVAIR DISKUS compared with patients treated with placebo include the following: syncope; ear, nose, and throat infections; ear signs and symptoms; laryngitis; nasal congestion/blockage; nasal sinus disorders; pharyngitis/throat infection; hypothyroidism; dry eyes; eye infections; gastrointestinal signs and symptoms; oral lesions; abnormal liver function tests; bacterial infections; edema and swelling; viral infections. Laboratory Abnormalities: There were no clinically relevant changes in these trials. Specifically, no increased reporting of neutrophilia or changes in glucose or potassium was noted. 6.3 Postmarketing Experience In addition to adverse events reported from clinical trials, the following events have been identified during worldwide use of any formulation of ADVAIR, fluticasone propionate, and/or salmeterol regardless of indication. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to ADVAIR DISKUS, fluticasone propionate, and/or salmeterol or a combination of these factors. Cardiac Disorders: Arrhythmias (including atrial fibrillation, extrasystoles, supraventricular tachycardia), ventricular tachycardia. Endocrine Disorders: Cushing’s syndrome, Cushingoid features, growth velocity reduction in children/adolescents, hypercorticism. Eye Disorders: Glaucoma. Gastrointestinal Disorders: Abdominal pain, dyspepsia, xerostomia. Immune System Disorders: Immediate and delayed hypersensitivity reaction (including very rare anaphylactic reaction). Very rare anaphylactic reaction in patients with severe milk protein allergy. Metabolic and Nutrition Disorders: Hyperglycemia, weight gain. Musculoskeletal, Connective Tissue, and Bone Disorders: Arthralgia, cramps, myositis, osteoporosis. Nervous System Disorders: Paresthesia, restlessness. Psychiatric Disorders: Agitation, aggression, depression. Behavioral changes, including hyperactivity and irritability, have been reported very rarely and primarily in children. Reproductive System and Breast Disorders: Dysmenorrhea. Respiratory, Thoracic, and Mediastinal Disorders: Chest congestion; chest tightness; dyspnea; facial and oropharyngeal edema, immediate bronchospasm; paradoxical bronchospasm; tracheitis; wheezing; reports of upper respiratory symptoms of laryngeal spasm, irritation, or swelling such as stridor or choking. Skin and Subcutaneous Tissue Disorders: Ecchymoses, photodermatitis. Vascular Disorders: Pallor.
7 DRUG INTERACTIONS ADVAIR DISKUS has been used concomitantly with other drugs, including short-acting beta2-agonists, methylxanthines, and intranasal corticosteroids, commonly used in patients with asthma or COPD, without adverse drug reactions. No formal drug interaction studies have been performed with ADVAIR DISKUS. Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Use not recommended. May cause systemic corticosteroid and cardiovascular effects. (7.1) Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate effect of salmeterol on vascular system. (7.2) Beta-blockers: Use with caution. May block bronchodilatory effects of beta-agonists and produce severe bronchospasm. (7.3) Diuretics: Use with caution. Electrocardiographic changes and/or hypokalemia associated with nonpotassium-sparing diuretics may worsen with concomitant beta-agonists. (7.4) 7.1 Inhibitors of Cytochrome P450 3A4 Fluticasone propionate and salmeterol, the individual components of ADVAIR DISKUS, are substrates of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ADVAIR DISKUS is not recommended because increased systemic corticosteroid and increased cardiovascular adverse effects may occur. Ritonavir: Fluticasone Propionate: A drug interaction study with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations [see Clinical Pharmacology (12.3)]. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression. Ketoconazole: Fluticasone Propionate: Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in increased plasma fluticasone propionate exposure and reduced plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol. Salmeterol: In a drug interaction study in 20 healthy subjects, coadministration of inhaled salmeterol (50 mcg twice daily) and oral ketoconazole (400 mg once daily) for 7 days resulted in greater systemic exposure to salmeterol (AUC increased 16-fold and Cmax increased 1.4-fold). Three (3) subjects were withdrawn due to beta2-agonist side effects (2 with prolonged QTc and 1 with palpitations and sinus tachycardia). Although there was no statistical effect on the mean QTc, coadministration of salmeterol and ketoconazole was associated with more frequent increases in QTc duration compared with salmeterol and placebo administration. 7.2 Monoamine Oxidase Inhibitors and Tricyclic Antidepressants ADVAIR DISKUS should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of salmeterol, a component of ADVAIR DISKUS, on the vascular system may be potentiated by these agents. 7.3 Beta-Adrenergic Receptor Blocking Agents Beta-blockers not only block the pulmonary effect of beta-agonists, such as salmeterol, a component of ADVAIR DISKUS, but may also produce severe bronchospasm in patients with reversible obstructive airways disease. Therefore, patients with asthma or COPD should not normally be treated with beta-blockers. However, under certain circumstances, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents for these patients; cardioselective beta-blockers could be considered, although they should be administered with caution. 7.4 Diuretics The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical relevance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.
8 USE IN SPECIFIC POPULATIONS Hepatic impairment: Monitor patients for signs of increased drug exposure. (8.6) Revised: 8.1 Pregnancy Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies with ADVAIR DISKUS in pregnant women. ADVAIR DISKUS was teratogenic in mice and not in rats, although it lowered fetal weight in rats. Fluticasone propionate alone was teratogenic in mice, rats, and rabbits, and salmeterol alone was teratogenic in rabbits and not in rats. From the reproduction toxicity studies in mice and rats, no evidence of enhanced toxicity was seen using combinations of fluticasone propionate and salmeterol when compared with toxicity data from the components administered separately. ADVAIR DISKUS should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. ADVAIR DISKUS: In the mouse reproduction assay, fluticasone propionate by the subcutaneous route at a dose approximately 3/5 the maximum recommended human daily inhalation dose (MRHD) on an mg/m2 basis combined with oral salmeterol at a dose approximately 410 times the MRHD on an mg/m2 basis produced cleft palate, fetal death, increased implantation loss, and delayed ossification. These observations are characteristic of glucocorticoids. No developmental toxicity was observed at combination doses of fluticasone propionate subcutaneously up to approximately 1/6 the MRHD on an mg/m2 basis and oral doses of salmeterol up to approximately 55 times the MRHD on an mg/m2 basis. In rats, combining fluticasone propionate subcutaneously at a dose equivalent to the MRHD on an mg/m2 basis and an oral dose of salmeterol at approximately 810 times the MRHD on an mg/m2 basis produced decreased fetal weight, umbilical hernia, delayed ossification, and changes in the occipital bone. No such effects were seen when combining fluticasone propionate subcutaneously at a dose less than the MRHD on an mg/m2 basis and an oral dose of salmeterol at approximately 80 times the MRHD on an mg/m2 basis. Fluticasone Propionate: Subcutaneous studies in mice at a dose less than the MRHD on an mg/m2 basis and in rats at a dose equivalent to the MRHD on an mg/m2 basis revealed fetal toxicity characteristic of potent corticosteroid compounds, including embryonic growth retardation, omphalocele, cleft palate, and retarded cranial ossification. In rabbits, fetal weight reduction and cleft palate were observed at a subcutaneous dose less than the MRHD on an mg/m2 basis. However, no teratogenic effects were reported at oral doses up to approximately 5 times the MRHD on an mg/m2 basis. No fluticasone propionate was detected in the plasma in this study, consistent with the established low bioavailability following oral administration [see Clinical Pharmacology (12.3)]. Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. In addition, because there is a natural increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy. Salmeterol: No teratogenic effects occurred in rats at oral doses approximately 160 times the MRHD on an mg/m2 basis. In pregnant Dutch rabbits administered oral doses approximately 50 times the MRHD based on comparison of the AUCs, salmeterol exhibited fetal toxic effects characteristically resulting from beta-adrenoceptor stimulation. These included precocious eyelid openings, cleft palate, sternebral fusion, limb and paw flexures, and delayed ossification of the frontal cranial bones. No such effects occurred at an oral dose approximately 20 times the MRHD based on comparison of the AUCs. New Zealand White rabbits were less sensitive since only delayed ossification of the frontal cranial bones was seen at an oral dose approximately 1,600 times the MRHD on an mg/m2 basis. Extensive use of other beta-agonists has provided no evidence that these class effects in animals are relevant to their use in humans. 8.2 Labor and Delivery There are no well-controlled human studies that have investigated effects of ADVAIR DISKUS on preterm labor or labor at term. Because of the potential for beta-agonist interference with uterine contractility, use of ADVAIR DISKUS during labor should be restricted to those patients in whom the benefits clearly outweigh the risks. 8.3 Nursing Mothers Plasma levels of salmeterol, a component of ADVAIR DISKUS, after inhaled therapeutic doses are very low. In rats, salmeterol xinafoate is excreted in the milk. There are no data from controlled trials on the use of salmeterol by nursing mothers. It is not known whether fluticasone propionate, a component of ADVAIR DISKUS, is excreted in human breast milk. However, other corticosteroids have been detected in human milk. Subcutaneous administration to lactating rats of tritiated fluticasone propionate resulted in measurable radioactivity in milk. Since there are no data from controlled trials on the use of ADVAIR DISKUS by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue ADVAIR DISKUS, taking into account the importance of ADVAIR DISKUS to the mother. Caution should be exercised when ADVAIR DISKUS is administered to a nursing woman. 8.4 Pediatric Use Use of ADVAIR DISKUS 100/50 in patients aged 4 to 11 years is supported by extrapolation of efficacy data from older patients and by safety and efficacy data from a study of ADVAIR DISKUS 100/50 in children with asthma aged 4 to 11 years [see Adverse Reactions (6.1), Clinical Studies (14.1)]. The safety and effectiveness of ADVAIR DISKUS in children with asthma less than 4 years of age have not been established. Inhaled corticosteroids, including fluticasone propionate, a component of ADVAIR DISKUS, may cause a reduction in growth velocity in children and adolescents [see Warnings and Precautions (5.14)]. The growth of pediatric patients receiving orally inhaled corticosteroids, including ADVAIR DISKUS, should be monitored. A 52-week placebo-controlled study to assess the potential growth effects of fluticasone propionate inhalation powder (FLOVENT® ROTADISK®) at 50 and 100 mcg twice daily was conducted in the US in 325 prepubescent children (244 males and 81 females) aged 4 to 11 years. The mean growth velocities at 52 weeks observed in the intent-to-treat population were 6.32 cm/year in the placebo group (N = 76), 6.07 cm/year in the 50-mcg group (N = 98), and 5.66 cm/year in the 100-mcg group (N = 89). An imbalance in the proportion of children entering puberty between groups and a higher dropout rate in the placebo group due to poorly controlled asthma may be confounding factors in interpreting these data. A separate subset analysis of children who remained prepubertal during the study revealed growth rates at 52 weeks of 6.10 cm/year in the placebo group (n = 57), 5.91 cm/year in the 50-mcg group (n = 74), and 5.67 cm/year in the 100-mcg group (n = 79). In children aged 8.5 years, the mean age of children in this study, the range for expected growth velocity is: boys – 3rd percentile = 3.8 cm/year, 50th percentile = 5.4 cm/year, and 97th percentile = 7.0 cm/year; girls – 3rd percentile = 4.2 cm/year, 50th percentile = 5.7 cm/year, and 97th percentile = 7.3 cm/year. The clinical relevance of these growth data is not certain. If a child or adolescent on any corticosteroid appears to have growth suppression, the possibility that he/she is particularly sensitive to this effect of corticosteroids should be considered. The potential growth effects of prolonged treatment should be weighed against the clinical benefits obtained. To minimize the systemic effects of orally inhaled corticosteroids, including ADVAIR DISKUS, each patient should be titrated to the lowest strength that effectively controls his/her asthma [see Dosage and Administration (2.1)]. 8.5 Geriatric Use Clinical studies of ADVAIR DISKUS for asthma did not include sufficient numbers of patients aged 65 years and older to determine whether older patients with asthma respond differently than younger patients. Of the total number of patients in clinical studies receiving ADVAIR DISKUS for COPD, 1,621 were aged 65 years or older and 379 were aged 75 years or older. Patients with COPD aged 65 years and older had a higher incidence of serious adverse events compared with patients less than 65 years of age. Although the distribution of adverse events was similar in the 2 age-groups, patients over 65 years of age experienced more severe events. In two 1-year studies, the excess risk of pneumonia that was seen in patients treated with ADVAIR DISKUS compared with those treated with salmeterol was greater in patients over 65 years of age than in patients less than 65 years of age [see Adverse Reactions (6.2)]. As with other products containing beta2-agonists, special caution should be observed when using ADVAIR DISKUS in geriatric patients who have concomitant cardiovascular disease that could be adversely affected by beta2-agonists. Based on available data for ADVAIR DISKUS or its active components, no adjustment of dosage of ADVAIR DISKUS in geriatric patients is warranted. No relationship between fluticasone propionate systemic exposure and age was observed in 57 patients with COPD (aged 40 to 82 years) given 250 or 500 mcg twice daily. 8.6 Hepatic Impairment Formal pharmacokinetic studies using ADVAIR DISKUS have not been conducted in patients with hepatic impairment. However, since both fluticasone propionate and salmeterol are predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of fluticasone propionate and salmeterol in plasma. Therefore, patients with hepatic disease should be closely monitored. 8.7 Renal Impairment Formal pharmacokinetic studies using ADVAIR DISKUS have not been conducted in patients with renal impairment.

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No, unfortunately insurance companies don't allow "double-savings". However, if your insurance does not cover certain drugs (ex - cosmetic drugs, brand names, prenatal vitamins, etc) then this card may save you money. Also if your insurance requires you to pay a deductible on your brand name drugs before covering them, then this card may also provider greater savings!
How Much Will This Card Save Me?
You can expect to save between 10% - 75% off standard retail pricing. The discount varies depending on what type and brand of drug (generic or brand-name) you are purchasing.
This Sounds Too Good To Be True. Is This A Scam?
Absolutely not. As you can see there are no fees, ever. We will never ask for credit card information at any time. The reason this card works is simply because pharmacies are willing to provide a discount in order to earn your business.
My Pharmacy Isn't Included. Can They Participate?
Yes! There are pharmacies who accept the pharmacy savings card that are not on our list. If you find one please email us and we'll update the list. If they are not a current partner and are interested, email us and we'll contact them to try and convince them to participate. You may also choose to call around and see if someone else in your area accepts it.
Is this the same as an Advair Diskus copay card?
No this is not a copay card, It is good for the cash paying customer and cannot be used to reduce your copay.
Savings of 70%!
I want to thank you for your prescription card. My thyroid medicine was going to cost me $118 a month. Well, naturally, I thought of your card. Your site said for my 240 tablets a month it would be about $36. A savings of $82, or roughly 70%. Thank you for the relief your card has previously given to me now and in the past. - J. Donaldson
Savings of over $200!
Thank you for putting the medication discount card on the internet. I saved over 200 dollars On my prescription. I would have never been able to afford it had it not been for this product. Again I cannot thank you enough and keep up the good work!! - M. Axler
Savings of over 50%!
I had printed out 3 different discount cards on the internet and asked the pharmacist to check prices. The lowest price was $289. I searched the internet some more, I found this site, gave the pharmacy your card and the cost was $130. What a big savings, I can't thank this site enough. - Linda S.

Accepted at over 59,000 pharmacies nationwide including

Accepted At Over 59,000 Pharmacies Nationwide!

Including...
  • Including...
  • Cub Pharmacy
  • Kmart
  • HEB
  • Target
  • Winn Dixie
  • Costco
  • Safeway
  • Kroger
  • Tom Thumb
  • CVS
  • Brookshire`s
  • Rite Aid
  • Fred`s Pharmacy
  • Walmart
  • Long Drugs
  • Walgreens
  • Giant
  • Save Mart Pharmacy
  • Fred Meyer
  • We Care Pharmacy
  • Albertsons

And thousands of independent pharmacies nationwide!

Advair Diskus Coupon

Currently we do not have any available, however you can receive an instant discount at your pharmacy with our Advair Diskus discount card. Create one instantly

Important Note

The information on this website is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

This prescription discount card cannot be used in conjunction with insurance. However, some members find they save more when using the card rather than there prescription coverage.

This Advair Diskus discount should not be confused with an Advair Diskus coupon while they are essentially the same this discount card only needs to be handed to your pharmacist once and will provide continuous savings every time your prescription is filled. The only time you will need to use it again is if you change pharma

MedicationDiscountCard.com offers Average Savings of
60.04%
Compare us with the competition
  • Free Membership
  • No Health Restrictions
  • Use Immediately
  • Easy To Use
  • No Paperwork
  • Unlimited Use
  • Never Expires
"While I am blessed to be a Medicaid patient, I know plenty of people which could include me if I didn’t have Medicaid who rely heavily on the WalMart and Target $4 lists. After comparing prices on this and other sites I have seen that there is the greatest free drug card savings potential on this site. I have already printed out 3 cards for loved ones." - Jacques M.
Save up to 75% on your medication
Save up to 75% on your medication