ArmonAir RespiClick (fluticasone propionate)

ArmonAir RespiClick is a prescription inhaled corticosteroid (ICS) medicine for the long-term treatment of asthma in people aged 12 years and older.

• ICS medicines such as fluticasone propionate help to decrease inflammation in the lungs. Inflammation in the lungs can lead to breathing problems.
• ArmonAir RespiClick is not used to relieve sudden breathing problems.
• It is not known if ArmonAir RespiClick is safe and effective in children younger than 12 years of age.

Before using ArmonAir RespiClick, tell your healthcare provider about all of your medical conditions, including if you:

• have liver problems.
• have weak bones (osteoporosis).
• have an immune system problem.
• have eye problems such as glaucoma or cataracts.
• have tuberculosis, a viral, bacterial, fungal or parasitic infection, or herpes simplex.
• are exposed to chickenpox or measles.

ArmonAir RespiClick can cause serious side effects, including:

• Fungal infection in your mouth and throat (thrush). Rinse your mouth with water without swallowing after using ArmonAir RespiClick to help reduce your chance of getting thrush.
• Weakened immune system and increased chance of getting infections (immunosuppression).
• Reduced adrenal function (adrenal insufficiency). Adrenal insufficiency is a condition where the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines (such as prednisone) and start taking a medicine containing an inhaled steroid (such as ArmonAir RespiClick). 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
• Serious allergic reactions. Call your healthcare provider or get emergency medical help if you get any of the following signs or symptoms of a serious allergic reaction:
  • rash
  • hives
  • swelling of your face, mouth, and tongue
  • breathing problems
• 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 ArmonAir RespiClick.
• Increased wheezing (bronchospasm). Increased wheezing can happen right away after using ArmonAir RespiClick. If this occurs, stop using ArmonAir RespiClick and call your healthcare provider. Always have a rescue inhaler with you to treat sudden wheezing.

Common side effects of ArmonAir RespiClick include:

• infection or inflammation of nose and throat (nasopharyngitis)
• upper respiratory tract infection
• thrush in your mouth or throat
• headache
• cough

These are not all the possible side effects with ArmonAir RespiClick. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the step-by-step instructions for using ArmonAir RespiClick at the end of this Patient Information leaflet.

• ArmonAir RespiClick is for oral inhalation use only.
• Rinse your mouth with water without swallowing after each dose of ArmonAir RespiClick.
• Children should use ArmonAir RespiClick with an adult’s help, as instructed by the child’s healthcare provider.
• ArmonAir RespiClick comes in 3 different strengths. Your healthcare provider prescribed the strength that is right for you.
• Use ArmonAir RespiClick exactly as your healthcare provider tells you to use it. Do not use ArmonAir RespiClick more often than prescribed.
• Use ArmonAir RespiClick 2 times a day (about 12 hours apart) at the same time everyday
• ArmonAir RespiClick does not need priming. Do not use a spacer or volume holding chamber with ArmonAir RespiClick.
• Do not open the cap on your ArmonAir RespiClick inhaler until you are ready for your dose because this will waste your medicine or may damage your inhaler.
• It may take 1 to 2 weeks or longer after you start ArmonAir RespiClick for your asthma symptoms to get better. You must use ArmonAir RespiClick regularly.
• Do not stop using ArmonAir RespiClick, even if you are feeling better, unless your healthcare provider tells you to.
• If you miss a dose of ArmonAir RespiClick, just skip that dose. Take your next dose at your usual time. Do not take 2 doses at 1 time.
• ArmonAir RespiClick does not relieve sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
• Call your healthcare provider or get medical care right away if:
  • your breathing problems get worse.
  • you need to use your rescue inhaler more often than usual.
  • your rescue inhaler does not work as well to relieve your symptoms.
  • you need to use 4 or more inhalations of your rescue inhaler in 24 hours for 2 or more days in a row.
  • you use 1 whole canister of your rescue inhaler in 8 weeks.
  • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ArmonAir RespiClick and certain other medicines may affect each other causing serious side effects. Especially tell your healthcare provider if you take antifungal or anti-HIV medicines.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Inhibitors Of Cytochrome P450 3A4

Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with ArmonAir RespiClick is not recommended because increased systemic corticosteroid adverse effects may occur.

Ritonavir

A drug interaction trial 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. 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

Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.

Before using ArmonAir RespiClick, tell your healthcare provider about all of your medical conditions, including if you:

• are pregnant or plan to become pregnant. It is not known if ArmonAir RespiClick may harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if ArmonAir RespiClick passes into your breast milk and can harm your baby.