Rhinocort Aqua (budesonide) Nasal Spray
Attributes of RHINOCORT AQUA

RHINOCORT AQUA Has a Pregnancy Category B Rating

RHINOCORT AQUA is the first and only intranasal steroid with a Pregnancy Category B rating

Over 60 million women in the United States are of childbearing age11

- A population "at risk" for pregnancy

- Allergic rhinitis affects approximately one third of these women12

Evaluated over 6 years—in three
birth and pregnancy registries

The impact of budesonide on human pregnancy:

  • Data from three Swedish registries covering ~99% of pregnancies from 1995 to 2001
  • Population-based, prospective, cohort epidemiologic studies

Pregnancy Category B Allergy

No head-to-head clinical studies comparing the safety of these products in pregnant women have been performed.

*Information about Nasonex and Nasacort AQ was obtained from the manufacturer's prescribing information.
†Adapted from 21CFR201.57, April 1, 2003.

Other products mentioned are registered trademarks of their respective owners and are not trademarks of the AstraZeneca group of companies. The makers of these brands are not affiliated with and do not endorse AstraZeneca or its products.

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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

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

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

©2008 AstraZeneca LP. All rights reserved. 257665 2/08