Product Description.:
ARNUITY ELLIPTA is a corticosteroid indicated for:
? once-daily maintenance treatment of asthma as prophylactic therapy in
patients aged 12 years and older. (1.1)
Important limitation:
? Not indicated for relief of acute bronchospasm. (1.1, 5.2)
For oral inhalation only. (2.1)
? Starting dosage is based on prior asthma therapy and disease severity.
(2.2)
? Treatment of asthma in patients aged 12 years and older: 1 inhalation of
ARNUITY ELLIPTA 100 mcg or ARNUITY ELLIPTA 200 mcg once
daily. (2.2)
Inhalation powder containing 100 or 200 mcg of fluticasone furoate per
actuation. (3)
Warning & Precautions.:
Localized infections: Candida albicans infection of the mouth and throat
may occur. Monitor patients periodically. Advise the patient to rinse
his/her mouth with water without swallowing after inhalation. (5.1)
? Deterioration of asthma and acute episodes: Do not use for relief of acute
symptoms. Patients require immediate re-evaluation during rapidly
deteriorating asthma. (5.2)
Immunosuppression: Potential worsening of existing tuberculosis, fungal,
bacterial, viral, parasitic infections or ocular herpes simplex. Use with
caution in patients with these infections. More serious or even fatal course
of chickenpox or measles can occur in susceptible patients. (5.3)
? Transferring patients from systemic corticosteroids: Risk of impaired
adrenal function when transferring from systemic corticosteroids. Wean
patients slowly from systemic corticosteroids if transferring to ARNUITY
ELLIPTA. (5.4)
? Hypercorticism and adrenal suppression: May occur with very high
dosages or at the regular dosage in susceptible individuals. If such
changes occur, discontinue ARNUITY ELLIPTA slowly. (5.5)
? Paradoxical bronchospasm: Discontinue ARNUITY ELLIPTA and
institute alternative therapy if paradoxical bronchospasm occurs. (5.7)
? Decreases in bone mineral density: Monitor patients with major risk
factors for decreased bone mineral content. (5.9)
? Monitor growth of adolescent patients. (5.10)
? Close monitoring for glaucoma and cataracts is warranted. (5.11)