Company:

GlaxoSmithKline

Corticosteroid

Fluticasone furoate 27.5micrograms/spray; alcohol-free.

Seasonal and perennial allergic rhinitis.

Fluticasone furoate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. The exact mechanism by which this corticosteroid exerts its effects in the treatment of allergic rhinitis is unknown. Corticosteroids have been shown to have a wide range of actions on multiple cell types (eg, mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (eg, histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.

Although significant improvement with Veramyst is usually achieved within 24 hours in patients with seasonal allergic rhinitis and four days in patients with perennial allergic rhinitis, maximum benefit may not be reached for several days.

The efficacy and safety of Veramyst was evaluated in 5 randomized, double-blind, placebo-controlled studies of 2 to 4 weeks’ duration involving 1,829 patients ≥12 years old with symptoms of seasonal or perennial allergic rhinitis. Assessment of efficacy was based on total nasal symptom score. Secondary efficacy variables included the total ocular symptom score (TOSS), and rhinoconjunctivitis quality of life questionnaire (RQLQ). In each study, Veramyst was shown to be more effective than placebo in relieving overall nasal allergy symptoms. In addition, 3 seasonal allergy studies showed that Veramyst was significantly better than placebo in relieving ocular symptoms and in providing a significant and clinically meaningful improvement in overall RQLQ; these effects were not seen in the perennial allergic rhinitis trials. In all studies, Veramyst sustained its effectiveness for a full 24 hours.

Veramyst was also shown to be effective in treating overall nasal symptoms in children 2–11 years old with seasonal and perennial allergic rhinitis. Changes in TOSS in the seasonal allergic rhinitis trial were not statistically significant; TOSS was not assessed in the perennial allergic rhinitis trial.

Initially 2 sprays in each nostril once daily. Maintenance: may reduce to 1 spray in each nostril daily.

>2 years: not recommended. 2–11 years: initially 1 spray in each nostril once daily; may increase to 2 sprays in each nostril once daily. Maintenance: 1 spray in each nostril once daily.

Maintain regular regimen. Respiratory tract tuberculosis. Infection (eg, ocular herpes simplex). Severe hepatic impairment. Nasal surgery, ulcers, or trauma (may impair wound healing). If exposed to measles or chickenpox, consider anti-infective prophylactic therapy. If adrenal insufficiency exists following systemic corticosteroid therapy, replacement with topical corticosteroids may exacerbate symptoms of adrenal insufficiency. Monitor for growth suppression in children. Monitor for hypercorticism and HPA axis suppression (if occur discontinue gradually), candida infection or other nasal mucosal changes, vision changes. Avoid eyes. Pregnancy (Cat.C). Nursing mothers.

Avoid ritonavir. Caution with potent CYP3A4 inhibitors (eg, ketoconazole).

Headache, epistaxis, nasopharyngitis, pharyngolaryngeal pain, nasal ulceration, back pain, pyrexia, cough.

Spray—10g (120 sprays)

For more information call (888) 825-5249 or visit www.Veramyst.com.

5/25/07