Indication and Important Safety Information
RHINOCORT AQUA is indicated for the management of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children 6 years of age and older.
Maximum benefit may not be achieved until approximately 2 weeks after initiation of treatment. Effectiveness depends on regular use.
The replacement of systemic corticosteroid with a topical corticosteroid may be accompanied by signs of adrenal insufficiency, and some patients may experience symptoms of withdrawal such as joint and/or muscular pain, lassitude and depression.
Experience with RHINOCORT AQUA in pregnant women has not shown an increased risk of fetal abnormalities. Despite adverse events in animals reproductive studies, it would appear that the possibility of human fetal harm is remote. See PRECAUTIONS in full Prescribing Information. RHINCORT AQUA should be used in pregnancy only if clearly needed.
It is not known whether budesonide is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be exercised when RHINOCORT AQUA Nasal Spray is administered to nursing women.
The recommended starting dosage of RHINOCORT AQUA is 1 spray per nostril once daily (64 mcg total daily dose), with individualized dosing up to 256 mcg for adults (12 years of age and older) and 128 mcg for children aged 6 to 11 years. Prescribe the lowest amount necessary for control of symptoms.
The overall incidence of adverse events with RHINOCORT AQUA was similar to that observed with placebo vehicle. In clinical trials, commonly reported adverse events with RHINOCORT AQUA versus placebo vehicle were epistaxis (8% vs 5%), pharyngitis (4% vs 3%), bronchospasm (2% vs 1%), coughing (2% vs <1%), and nasal irritation (2% vs <1%).
Please click here for full Prescribing Information