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The contents of this Web site are copyrighted. AstraZeneca Pharmaceuticals LP and AstraZeneca LP, members of the AstraZeneca group of companies (collectively, the "Company"), hereby authorize you to copy documents published on this Web site for non-commercial personal use only, provided that any copy of these documents which you make shall retain all copyright and other proprietary notices and any disclaimer contained on the documents. Except as expressly provided above, you may not otherwise copy, display, download, distribute, modify, reproduce, republish or retransmit any information, text or documents contained in this Web site or any portion thereof in any electronic medium or in hard copy, or create any derivative work based on such images, text or documents, without the express written consent of the Company.

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Prescribing Information

Product information provided on this site is intended for use by U.S. residents only. The dissemination of this information may be subject to different medical and regulatory requirements in other countries. This information is available to the public for educational purposes only; it should not be used for diagnosing or treating a health problem or disease. It is not intended to substitute for consultation with a licensed healthcare provider. The Company cannot answer unsolicited emails requesting personal medical advice; please consult your healthcare provider.

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Submissions

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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%).

Please click here for full Prescribing Information

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.