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An improvement in nasal symptoms may be noted in patients within 10 hours of first using RHINOCORT AQUA Nasal Spray. This time to onset is supported by an environmental exposure unit study in seasonal allergic rhinitis patients which demonstrated that RHINOCORT AQUA Nasal Spray led to a statistically significant improvement in nasal symptoms compared to placebo by 10 hours. Further support comes from a clinical study of patients with perennial allergic rhinitis which demonstrated a statistically significant improvement in nasal symptoms for both RHINOCORT AQUA Nasal Spray and for the active comparator (mometasone furoate) compared to placebo by 8 hours. Onset was also assessed in this study with peak nasal inspiratory flow rate and this endpoint failed to show effi-cacy for either active treatment. Although statistically significant improvements in nasal symptoms compared to placebo were noted within 8Ð 10 hours in these studies, about one half to two thirds of the ultimate clinical improvement with RHINOCORT AQUA Nasal Spray occurs over the first 1Ð 2 days, and maximum benefit may not be achieved until approxi-mately 2 weeks after initiation of treatment. Initial assessment for response should be made during this time frame and periodically until the patient's symptoms are stabilized. Directions for Use Text Continues Below
Illustrated Patient's Instructions for Use accompany each package of
RHINOCORT AQUA Nasal Spray 32 mcg . HOW SUPPLIED RHINOCORT AQUA Nasal Spray 32 mcg is available in a green coated glass bottle with a metered-dose pump spray and a green protection cap. RHINOCORT AQUA Nasal Spray 32 mcg provides 120 metered sprays after initial priming; net fill weight 8.6 g. The RHINOCORT AQUA Nasal Spray 32 mcg bottle has been filled with an excess to accommodate the priming activity. The bottle should be discarded after 120 sprays following initial priming, since the amount of budesonide delivered per spray there-after may be substantially less than the labeled dose. Each spray delivers 32 mcg of budesonide to the patient.
NDC 0186-1070-08 RHINOCORT AQUA Nasal Spray Page: << Prev | 1 | 2 | 3 | Next >>
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