Product Description.:
Seasonal allergic rhinitis.
Pharmacology:
Azelastine HCl is an antihistamine that antagonizes H1-receptor activity by interfering with the inflammatory response to the allergens. The major active metabolite of azelastine HCl, desmethylazelastine, also possesses H1-receptor antagonist activity.
Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity. The precise mechanism through which fluticasone propionate affects allergic rhinitis symptoms is not known.
Clinical Trials:
The efficacy and safety of Dymista in seasonal allergic rhinitis was evaluated in 3 randomized, multicenter, double-blind, placebo-controlled clinical trials in 853 patients �� years with seasonal allergic rhinitis. Patients were randomized to one of four treatment groups: one spray per nostril twice daily of Dymista, azelastine HCl nasal spray, fluticasone propionate nasal spray, and vehicle placebo.
Assessment of efficacy was based on the reflective total nasal symptom score (rTNSS), in addition to the instantaneous total nasal symptom score (iTNSS) and other supportive secondary efficacy variables. TNSS is calculated as the sum of the patients? scoring of the 4 individual nasal symptoms (rhinorrhea, nasal congestion, sneezing, and nasal itching) on a 0 to 3 categorical severity scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). Patients were required to record symptom severity daily reflecting over the previous 12 hours (AM and PM). For the primary efficacy endpoint, the combined AM+PM rTNSS (maximum score of 24) was assessed as a change from baseline for each day and then averaged over a 2 week treatment period. The primary efficacy endpoint was the mean change from baseline in combined AM+PM rTNSS over 2 weeks. The iTNSS was recorded immediately prior to the next dose.
In these trials, Dymista demonstrated statistically significant greater decreases (change from baseline) in rTNSS (-5.6) as compared to azelastine HCl (-4.3) and to fluticasone propionate (-4.7), as well as to placebo (-2.9).
In these trials, Dymista also demonstrated statistically significant, greater decreases (change from baseline) in iTNSS (-5.2) as compared to placebo (-2.7), as did the azelastine HCl (-3.9) and fluticasone propionate (-4.5) comparators.
Legal Classification:
Rx
Adults:
1 spray per nostril twice daily.
Children:
Not established.
Warnings/Precautions:
Avoid use in recent nasal ulcers, nasal surgery, or nasal trauma. Respiratory tract tuberculosis. Infections (eg, fungal, bacterial, viral, ocular herpes simplex). Avoid exposure to chickenpox and measles if exposed, consider anti-infective prophylactic therapy. If adrenal insufficiency exists following systemic corticosteroid therapy, replacement with topical corticosteroids may exacerbate symptoms of adrenal insufficiency (eg, lassitude, depression). Monitor growth routinely in children. Monitor for hypercorticism and HPA axis suppression (if occur discontinue gradually), and Candida infection or other nasal mucosal changes. History of increased intraocular pressure, glaucoma, and/or cataracts monitor any change in vision. Avoid eyes. Pregnancy (Cat. C). Nursing mothers.
Interaction(s)
Avoid alcohol or other CNS depressants. Concomitant ritonavir: not recommended. Caution with other potent CYP3A4 inhibitors (eg, ketoconazole).
Adverse Reaction(s)
Dysgeusia, epistaxis, headache somnolence
