as with AirDuo Digihaler, there is not a significant increase in the risk ofthese events.
Not for Acute Symptoms
Inform patients that AirDuo Digihaler is not meant to relieve acute asthma symptoms and extradoses should not be used for that purpose. Advise patients to treat acute asthma symptoms withan inhaled, short-acting beta2-agonist such as albuterol. Provide patients with such medicationand instruct them in how it should be used.
Instruct patients to seek medical attention if they experience any of the following:
Decreasing effectiveness of inhaled, short-acting beta2-agonists
Need for more inhalations than usual of inhaled, short-acting beta2-agonists
Significant decrease in lung function as outlined by the physician
Tell patients they should not stop therapy with AirDuo Digihaler without physician/providerguidance since symptoms may recur after discontinuation.
Do Not Use Additional Long-Acting Beta2-AgonistsInstruct patients not to use other LABA for asthma.
Local Effects
Inform patients that localized infections with Candida albicans occurred in the mouth andpharynx in some patients. If oropharyngeal candidiasis develops, treat it with appropriate local orsystemic (i.e., oral) antifungal therapy while still continuing therapy with AirDuo Digihaler, butat times therapy with AirDuo Digihaler may need to be temporarily interrupted under closemedical supervision. Rinsing the mouth with water without swallowing after inhalation isadvised to help reduce the risk of thrush.
Immunosuppression
Warn patients who are on immunosuppressant doses of corticosteroids to avoid exposure tochickenpox or measles and, if exposed, to consult their physicians without delay. Inform patientsof potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections; orocular herpes simplex.
Hypercorticism and Adrenal Suppression
Advise patients that AirDuo Digihaler may cause systemic corticosteroid effects ofhypercorticism and adrenal suppression. Additionally, inform patients that deaths due to adrenalinsufficiency have occurred during and after transfer from systemic corticosteroids. Patientsshould taper slowly from systemic corticosteroids iftransferring to AirDuo Digihaler.
Immediate Hypersensitivity Reactions
Advise patients that immediate hypersensitivity reactions (e.g., urticaria, angioedema, rashbronchospasm, hypotension), including anaphylaxis, may occur after administration of AirDuoDigihaler. Patients should discontinue AirDuo Digihaler if such reactions occur and contact theirhealthcare provider or get emergency medical help. There have been reports of anaphylacticreactions in patients with severe milk protein allergy after inhalation of powder productscontaining lactose; therefore, patients with severe milk protein allergy should not take AirDuoDigihaler.
Reduction in Bone Mineral Density
Advise patients who are at an increased risk for decreased BMD that the use of corticosteroidsmay pose an additional risk.
Reduced Growth Velocity
Inform patients that orally inhaled corticosteroids, including fluticasone propionate, may cause areduction in growth velocity when administered to adolescent patients. Physicians should closelyfollow the growth of adolescents taking corticosteroids by any route.
Ocular Effects
Long-term use of inhaled corticosteroids may increase the risk of some eye problems (ca |
