CLINICAL TRIALS:
The effectiveness of NASAREL was tested in 289 patients for up to 6 weeks at doses up to 300 mcg per day. NASAREL was shown to be effective in treating the symptoms of allergic rhinitis, including rhinorrhea, nasal congestion and sneezing.
A pivotal, 3-center trial involved 196 patients with seasonal allergic rhinitis randomized to NASALIDE, the vehicle of NASALIDE, NASAREL and the vehicle of NASAREL. Both active treatments were statistically significantly more effective than the vehicles. There was not statistically significant difference in efficacy between NASALIDE and NASAREL.
The two formulations do differ in the nature and incidence of adverse complaints. There were more reports of nasal burning and stinging with NASALIDE and more problems related to taste, such as aftertaste, with NASAREL, owing to the differences in their respective vehicles. Some patients may prefer one formulation to the other.
INDIVIDUALIZATION OF DOSAGE:
The therapeutic effects of corticosteroid nasal sprays, unlike those of decongestants, are not immediate. This should be explained to the patient in advance in order to ensure cooperation and continuation of treatment with the prescribed dosage regimen. Full therapeutic benefit requires regular use and is usually evident within a few days. A longer period of therapy may be required for some patients. However, NASAREL should not be continued beyond 3 weeks in the absence of significant symptomatic improvement (see PRECAUTIONS, WARNINGS, DIRECTIONS FOR USE and ADVERSE REACTIONS sections).
A starting dose of 2 sprays in each nostril twice daily is recommended. If greater control of symptoms is needed, the dose may be increased to 2 sprays in each nostril 3 times a day. For adults, maximum total daily doses should not exceed 8 sprays in each nostril per day (464 mcg/day).
After the desired clinical effect is obtained, the maintenance dose should be reduced to the smallest amount necessary to control the symptoms. Some patients with perennial rhinitis may be maintained on as little as 1 spray in each nostril per day. It is always desirable to titrate an individual patient to the minimum effective dose to reduce the possibility of side effects.
NASAREL and NASALIDE should not be considered to be identical. Physicians should consider the observed differences in the mean responses in terms of side effects (see Adverse Reactions ) and flunisolide absorption (see Pharmacokinetics ) in treating individual patients.
For pediatric patients 6 to 14 years of age, the recommended starting dose of NASAREL is one spray (29 mcg) in each nostril 3 times a day (total dose 174 mcg/day) or 2 sprays (58 mcg) in each nostril 2 times a day (total dose 232 mcg/day). Maximum daily doses should not exceed 4 sprays in each nostril per day (total dose 232 mcg/day) as the safety and efficacy of higher doses have not been established. NASAREL is not recommended for use in pediatric patients less than 6 years of age as the safety and efficacy have not been assessed in this age group.
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