Rhinocort Aqua Patient Info

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Rhinocort Aqua - Patient Info [Budesonide]

Information for Patients

Patients being treated with RHINOCORT AQUA Nasal Spray should receive the following information and instructions. Patients who are on immuno-suppressant doses of corticosteroids should be warned to avoid exposure to chicken pox or measles and, if exposed, to obtain medical advice. Patients should use RHINOCORT AQUA Nasal Spray at regular intervals since its effectiveness depends on its regular use (see DOSAGE AND ADMINISTRATION).
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 efficacy 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.