RHINOCORT AQUA Offers Significant Improvement in Nasal Allergy Symptoms

Allergy nasal spray improvement

^* The NIS is defined as the sum of symptom scores for nasal congestion, runny nose, and sneezing.
^† Mean change adjusted for center effect and baseline NIS. Patients recorded the severity of nasal symptoms according to the following 4 point scale: 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms.

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.
Same-day relief (based on treatment in the morning) of congestion and other nasal symptoms^‡2

Maximum benefit may not be achieved until approximately 2 weeks after initiation of treatment. For best results, use RHINOCORT AQUA daily.

‡This time to onset was demonstrated in a study of season allergic rhinitis patients who experienced significant improvements in nasal symptoms within 10 hours of initial treatment. Further support comes from a study in perennial allergic rhinitis patients which demonstrated significant improvements within 8 hours (for both RHINOCORT AQUA and the active comparator mometasone). Onset of action was also assessed in the second study with peak nasal inspiratory flow rate, and this endpoint did not show efficacy for either active treatment. Maximum benefit may not be achieved until approximately 2 weeks after initiation of treatment.

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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%).

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Legal Information

RHINOCORT AQUA is a registered trademark of the AstraZeneca group of companies.

This product information is intended for US Health Care Professionals only.