Important Safety Information

  • People with asthma who take long-acting beta2-adrenergic agonist (LABA) medicines, such as salmeterol (one of the medicines in AirDuo RespiClick), have an increased risk of death from asthma problems. It is not known whether fluticasone propionate, the other medicine in AirDuo RespiClick, reduces the risk of death from asthma problems seen with LABA medicines, such as salmeterol.
  • Call your healthcare provider if breathing problems worsen over time while using AirDuo RespiClick. You may need different treatment.
  • Get emergency medical care if:
    • your breathing problems worsen quickly
    • you use your rescue inhaler, but it does not relieve your breathing problems
  • AirDuo RespiClick should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid.
  • When your asthma is well controlled, your healthcare provider may tell you to stop taking AirDuo RespiClick. Your healthcare provider will decide if you can stop AirDuo RespiClick without loss of asthma control. Your healthcare provider may prescribe a different asthma control medicine for you, such as an inhaled corticosteroid.
  • Adolescents who take LABA medicines may have an increased risk of hospitalization for asthma problems.
  • Do not use AirDuo RespiClick to treat sudden breathing problems from asthma. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use AirDuo RespiClick if you have a severe allergy to milk proteins or if you are allergic to any of the ingredients in the product. Ask your healthcare provider if you are not sure.
  • Do not use AirDuo RespiClick more often than prescribed.
  • Do not take AirDuo RespiClick with other medicines that contain a LABA for any reason.
  • Tell your healthcare provider about all the medicines you take and about all of your health conditions.
  • AirDuo RespiClick can cause serious side effects, including:
    • fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using AirDuo RespiClick to help reduce your chance of getting thrush.
    • weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur.
    • reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as AirDuo RespiClick). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
      • feeling tired
      • lack of energy
      • weakness
      • nausea and vomiting
      • low blood pressure
    • sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using AirDuo RespiClick and call your healthcare provider right away.
    • serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
      • rash
      • hives
      • swelling of your face, mouth, and tongue
      • breathing problems
    • effects on heart
      • increased blood pressure
      • a fast or irregular heartbeat
      • chest pain
    • effects on nervous system
      • tremor
      • nervousness
    • bone thinning or weakness (osteoporosis)
    • slowed growth in children. A child's growth should be checked often.
    • eye problems including glaucoma and cataracts. You should have regular eye exams while using AirDuo RespiClick.
    • changes in laboratory blood values (sugar, potassium, certain types of white blood cells)
  • Common side effects of AirDuo RespiClick include:
    • Infection of nose and throat (nasopharyngitis)
    • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
    • back pain
    • headache
    • cough
  • These are not all the possible side effects of AirDuo RespiClick. Call your healthcare provider for medical advice about side effects.
  • You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Approved Use

AirDuo RespiClick is a prescription medicine used to treat asthma in patients 12 years and older.

AirDuo RespiClick is not used to relieve sudden breathing problems from asthma and won't replace a rescue inhaler.

The above Important Safety Information and Approved Use apply to both AirDuo RespiClick and its Authorized Generic, Fluticasone Propionate and Salmeterol Inhalation Powder (Multidose Dry Powder Inhaler).

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide, for AirDuo RespiClick.

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide, for Fluticasone Propionate and Salmeterol Inhalation Powder (MDPI).