Never throw canister into fire or incinerator.Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. There have been reports of anaphylactic reactions in patients with severe milk protein allergy after inhalation of powder products containing lactose; therefore, patients with severe milk protein allergy should not take ADVAIR DISKUS.Advise patients who are at an increased risk for decreased BMD that the use of corticosteroids may pose an additional risk.Inform patients that orally inhaled corticosteroids, including fluticasone propionate, may cause a reduction in growth velocity when administered to pediatric patients. Systemic exposure to salmeterol xinafoate was similar for Advair HFA, Advair HFA delivered with a spacer, and Advair DISKUS while the systemic exposure to fluticasone propionate was lower with Advair HFA compared with that of Advair HFA delivered with a spacer or Advair DISKUS.
Signs and symptoms of neutropenia include gum pain and swelling, skin Select one or more newsletters to continue. Fluticasone propionate is weakly and reversibly bound to erythrocytes and is not significantly bound to human transcortin.An in vitro study using human liver microsomes showed that salmeterol is extensively metabolized to α-hydroxysalmeterol (aliphatic oxidation) by CYP3A4. Trial 5 enrolled subjects with a diagnosis of asthma and a history of at least 1 asthma exacerbation in the previous year treated with systemic corticosteroid. The estimated risk of major birth defects and miscarriage for the indicated population is unknown.
Inform patients of potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.Advise patients that ADVAIR DISKUS may cause systemic corticosteroid effects of hypercorticism and adrenal suppression.
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.
Serious Asthma-Related Events in the 26-Week Trials 4 and 5(fluticasone propionate and salmeterol inhalation powder)ADVAIR DISKUS is not used to relieve sudden breathing problemsBefore using ADVAIR DISKUS, tell your healthcare provider about all of your medical 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 Patient Information.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: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. Treatment of overdosage consists of discontinuation of ADVAIR DISKUS together with institution of appropriate symptomatic and/or supportive 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. Additionally, inform patients that deaths due to adrenal insufficiency have occurred during and after transfer from systemic corticosteroids. The population pharmacokinetic analyses for fluticasone propionate and salmeterol showed no clinically relevant effects of age, gender, race, body weight, body mass index, or percent of predicted FEVIn the repeat- and single-dose trials, there was no evidence of significant drug interaction in systemic exposure between fluticasone propionate and salmeterol when given alone or in combination via the DISKUS. 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.The ECG changes and/or hypokalemia that may result from the administration of non–potassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, such as salmeterol, a component of Advair HFA, especially when the recommended dose of the beta-agonist is exceeded. The strip contains a combination of fluticasone propionate 100, 250, or 500 mcg and salmeterol 50 mcg per blister.The use of ADVAIR DISKUS is contraindicated in the following conditions:Use of LABA as monotherapy (without ICS) for asthma is associated with an increased risk of asthma-related death Four (4) large, 26-week, randomized, double-blind, active-controlled clinical safety trials were conducted to evaluate the risk of serious asthma-related events when LABA were used in fixed-dose combination with ICS compared with ICS alone in subjects with asthma.