INDICATIONS AND USAGE BECONASE AQ Nasal Spray is indicated for the relief of the symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis. Results from 2 clinical trials have shown that significant symptomatic relief was obtained within 3 days. However, symptomatic relief may not occur in some patients for as long as 2 weeks. BECONASE AQ Nasal Spray should not be continued beyond 3 weeks in the absence of significant symptomatic improvement. BECONASE AQ Nasal Spray should not be used in the presence of untreated localized infection involving the nasal mucosa. BECONASE AQ Nasal Spray is also indicated for the prevention of recurrence of nasal polyps following surgical removal. Clinical studies have shown that treatment of the symptoms associated with nasal polyps may have to be continued for several weeks or more before a therapeutic result can be fully assessed. Recurrence of symptoms due to polyps can occur after stopping treatment, depending on the severity of the disease.
CONTRAINDICATIONS Hypersensitivity to any of the ingredients of this preparation contraindicates its use.
ADVERSE REACTIONS In general, side effects in clinical studies have been primarily associated with irritation of the nasal mucous membranes. Adverse reactions reported in controlled clinical trials and open studies in patients treated with BECONASE AQ Nasal Spray are described below. Mild nasopharyngeal irritation following the use of beclomethasone aqueous nasal spray has been reported in up to 24% of patients treated, including occasional sneezing attacks (about 4%) occurring immediately following use of the spray. In patients experiencing these symptoms, none had to discontinue treatment. The incidence of transient irritation and sneezing was approximately the same in the group of patients who received placebo in these studies, implying that these complaints may be related to vehicle components of the formulation. Fewer than 5 per 100 patients reported headache, nausea, or lightheadedness following the use of BECONASE AQ Nasal Spray. Fewer than 3 per 100 patients reported nasal stuffiness, nosebleeds, rhinorrhea, or tearing eyes. Rare cases of ulceration of the nasal mucosa and instances of nasal septum perforation have been spontaneously reported (see PRECAUTIONS). Reports of dryness and irritation of the nose and throat and unpleasant taste and smell have been received. There are rare reports of loss of taste and smell. Rare instances of wheezing, cataracts, glaucoma, and increased intraocular pressure have been reported following the use of intranasal beclomethasone dipropionate (see PRECAUTIONS). Rare cases of immediate and delayed hypersensitivity reactions, including anaphylactoid/anaphylactic reactions, urticaria, angioedema, rash, and bronchospasm, have been reported following the oral and intranasal inhalation of beclomethasone dipropionate. Cases of growth suppression have been reported for intranasal corticosteroids, including BECONASE AQ (see PRECAUTIONS: Pediatric Use).