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. Azelastine hydrochloride and fluticasone propionate nasal spray is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 6 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief.The recommended dosage of azelastine hydrochloride and fluticasone propionate nasal spray is 1 spray in each nostril twice daily.Administer azelastine hydrochloride and fluticasone propionate nasal spray by the intranasal route only.Avoid spraying azelastine hydrochloride and fluticasone propionate nasal spray into the eyes.

Azelastine hydrochloride and fluticasone propionate nasal spray contains an H 1-receptor antagonist and a corticosteroid, and is indicated for the relief of symptoms of seasonal allergic rhinitis in patients 6 years of age and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. 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. No evidence of tumorigenicity was observed in rats at doses up to 30 mg/kg/day (approximately 530 and 240 times the MRHDID for adults and children, respectively, on a mg/mAzelastine hydrochloride showed no genotoxic effects in the Ames test, DNA repair test, mouse lymphoma forward mutation assay, mouse micronucleus test, or chromosomal aberration test in rat bone marrow.There were no effects on male or female fertility and reproductive in male and female rats at oral doses up to 30 mg/kg (approximately 530 times the MRHDID in adults on a mg/mFluticasone propionate demonstrated no tumorigenic potential in mice at oral doses up to 1,000 mcg/kg (approximately 25 and 10 times the MRHDID in adults and children, respectively, on a mcg/mFluticasone propionate did not induce gene mutation in prokaryotic or eukaryotic cells in vitro. When you finish using azelastine hydrochloride and fluticasone propionate nasal spray, wipe the spray tip with a clean tissue or cloth. Overall, 1% of patients in both the azelastine hydrochloride and fluticasone propionate nasal spray and placebo groups discontinued due to adverse reactions.Table 1 contains adverse reactions reported with frequencies greater than or equal to 2% and more frequently than placebo in patients treated with azelastine hydrochloride and fluticasone propionate nasal spray in the seasonal allergic rhinitis controlled clinical trials.In the above trials, somnolence was reported in <1% of patients treated with azelastine hydrochloride and fluticasone propionate nasal spray (6 of 853) or vehicle placebo (1 of 861) [The safety data described below in children 6-11 years of age reflect exposure to azelastine hydrochloride and fluticasone propionate nasal spray in 152 patients (6 to 11 years of age; 57% male and 43% female) with seasonal allergic rhinitis in one double-blind, placebo-controlled clinical trial of 2-week duration. It may harm them.This Patient Information leaflet summarizes the most important information about azelastine hydrochloride and fluticasone propionate nasal spray.

This effect has been observed in the absence of laboratory evidence of HPA axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function.

In a drug interaction study, coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in increased fluticasone propionate exposure and reduced plasma cortisol AUC, but had no effect on urinary excretion of cortisol.

The primary efficacy endpoint was the mean change from baseline in combined AM+PM rTNSS over 2 weeks.

Overall, adverse reactions were 16% in the azelastine hydrochloride and fluticasone propionate nasal spray treatment group, and 12% in the placebo group. Due to the low intranasal bioavailability, pharmacokinetic data for fluticasone propionate were obtained via other routes of administration.

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