Adverse Reactions with Fluticasone Propionate/Salmeterol DISKUS with ≥3% Incidence and More Common than Placebo in Adult and Adolescent Subjects with AsthmaTable 3. Rinsing your mouth with water after each dose may help prevent hoarseness, throat irritation, and infection in the mouth. No significant differences in ventricular or supraventricular arrhythmias and heart rate were observed among the groups treated with fluticasone propionate/salmeterol DISKUS 500/50 mcg, the individual components, or placebo. Follow all instructions closely. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. The combination of fluticasone and salmeterol (Advair HFA, AirDuo Respiclick) is used in children 12 years of age and older. Do not use Fluticasone Propionate/Salmeterol DISKUS for a condition for which it was not prescribed. Very rare anaphylactic reaction in patients with severe milk protein allergy.Agitation, aggression, depression. These trials were primarily designed to evaluate the efficacy of fluticasone propionate/salmeterol DISKUS on lung function (3 trials), exacerbations (2 trials), and survival (1 trial).Two (2) of the 3 clinical trials primarily designed to evaluate the efficacy of fluticasone propionate/salmeterol DISKUS on lung function were conducted in 1,414 subjects with COPD associated with chronic bronchitis. (Treatment of asthma in patients aged 12 years and older: 1 inhalation of Fluticasone Propionate/Salmeterol DISKUS inhalation powder 100/50 mcg, Fluticasone Propionate/Salmeterol DISKUS inhalation powder 250/50 mcg, and Fluticasone Propionate/Salmeterol DISKUS inhalation powder 500/50 mcg twice daily. Ask your pharmacist any questions you have about refilling your prescription.It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. 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). It is not known if LABA medicines such as salmeterol increase the risk of death in people with COPD.Call your healthcare provider if breathing problems worsen over time while using ADVAIR DISKUS.What should I tell my healthcare provider before using ADVAIR DISKUS?Tell your healthcare provider about all of your health conditions, including if you:Tell your healthcare provider about all the medicines you take,Read the step-by-step instructions for using ADVAIR DISKUS at the end of this Medication Guide.Do not use other medicines that contain a LABA for any reason.ADVAIR DISKUS does not relieve sudden breathing problems.What are the possible side effects of ADVAIR DISKUS?ADVAIR DISKUS can cause serious side effects, including:See “What is the most important information I should know about ADVAIR DISKUS?”weakened immune system and increased chance of getting infections (immunosuppression).sudden breathing problems immediately after inhaling your medicine.changes in laboratory blood levels (sugar, potassium, certain types of white blood cells)Keep ADVAIR DISKUS and all medicines out of the reach of children.General information about the safe and effective use of ADVAIR DISKUS.Important information about your ADVAIR DISKUS inhaler:Follow these steps every time you use ADVAIR DISKUS.Breathe out slowly as long as you can. There may be new information. Ask your healthcare provider or pharmacist for more information.Call your doctor for medical advice about side effects. These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma.Inflammation is also a component in the pathogenesis of COPD. These highlights do not include all the information needed to use Fluticasone Propionate/Salmeterol DISKUS safely and effectively.
Since patients with COPD often have multiple risk factors for reduced BMD, assessment of BMD is recommended prior to initiating Fluticasone Propionate/Salmeterol DISKUS and periodically thereafter. Practice using your inhaler while they watch, so you are sure you are doing it the right way.If your child will be using fluticasone and salmeterol inhalation, be sure that he or she knows how to use it. Use this medicine only as directed by your doctor. In another trial in subjects with COPD, peak steady-state fluticasone propionate plasma concentrations averaged 115 pg/mL (range: 52.6 to 366.0 pg/mL) after treatment with 500 mcg twice daily via the fluticasone propionate DISKUS inhaler (n = 15) and 105 pg/mL (range: 22.5 to 299.0 pg/mL) via fluticasone propionate/salmeterol DISKUS (n = 24).Following administration of fluticasone propionate/salmeterol DISKUS to healthy adult subjects, peak plasma concentrations of salmeterol were achieved in about 5 minutes.In 15 healthy subjects receiving ADVAIR HFA 230/21 Inhalation Aerosol (920/84 mcg) and fluticasone propionate/salmeterol DISKUS 500/50 mcg (1,000/100 mcg), systemic exposure to salmeterol was higher (317 versus 169 pg•h/mL) and peak salmeterol concentrations were lower (196 versus 223 pg/mL) following ADVAIR HFA compared with fluticasone propionate/salmeterol DISKUS, although pharmacodynamic results were comparable.The percentage of fluticasone propionate bound to human plasma proteins averages 99%.