References

ACAAI. Member information. American College of Allergy, Asthma and Immunology. Available at: http://www.acaai.org/Member/CHASM+letter.htm . Accessed November 3, 2006.
Testimony of the American Pharmacists Association On Federal and State Role in Pharmacy Compounding and Reconstitution: Exploring the Right Mix to Protect Patients. Before the Committee on Health, Education, Labor and Pensions, United States Senate. October 23, 2003. Available at:
http://www.aphanet.org/AM/Template.cfm?Section=Search§ion=Compounding&template=/CM/ContentDisplay.cfm&
ContentFileID=381. Accessed September 19, 2006.
Nordenberg T. Pharmacy Compounding: customizing prescription drugs FDA Consumer Magazine. 2000;34(4). Available at http://www.fda.gov/fdac/features/2000/400_compound.html. Accessed September 19, 2006.
Are there fakes and frauds in your nebulizer? Allergy and Asthma Today. 2004; Fall. Available at: http://www.breatherville.com/pdf/pu_fakes_frauds.pdf Accessed September 19, 2006.
Consumer Health Allience for Safe Medication (CHASM). About ANNMA/CHASM (PDF). Available at: http://www.aanma.org/pdf/chasm_about.pdf Accessed November 16, 2006
Appleby J. Safety concerns grow over pharmacy-mixed drugs. USA Today. March 23, 2005. Available at:http://www.usatoday.com/news/health/2005-03-23-cover-compounding_x.htm. Accessed April 1, 2005.
Report: limited FDA survey of compounded drug products. Available at:http://www.fda.gov/cder/pharmcomp/survey.htm. Accessed April 26, 2005.
Data on file, DA–RES–23. AstraZeneca LP, Wilmington, DE.
Compliance Policy Guides Manual, Section 460.200 Pharmacy Compounding. Rockville, MD: US Dept of Health and Human Services; May 2002.
Food and Drug Administration Modernization Act of 1997. Available at http://www.fda.gov/cdrh/modact97.pdf. Accessed September 19, 2006 Food, Drug, and Cosmetic Act, 21 USC §510 §§360 (g[1]) (1999).
Morris M, McGuire D. Some pharmacists who mix medicines dispense unsafe drugs. The Kansas City Star. October 6, 2002.

Indication and Important Safety Information

PULMICORT RESPULES is indicated for the maintenance treatment of asthma and as prophylactic therapy in children ages 12 months to 8 years.

PULMICORT RESPULES is not a bronchodilator and is NOT indicated for the relief of acute bronchospasm.

The most common adverse events reported in clinical trials, regardless of relationship to treatment, include respiratory infection, rhinitis, coughing, and otitis media.

Inhaled corticosteroids may cause a reduction in growth velocity. The long-term effect on final adult height is unknown.

PULMICORT RESPULES, like other inhaled corticosteroids, may impact the hypothalamic-pituitary-adrenal axis, especially in susceptible individuals, in young children, and in patients given high doses for prolonged periods.

Adrenal insufficiency may occur when transferring patients from systematic corticosteroids (see WARNING in full Prescribing Information).

Patients taking immunosuppressant doses of corticosteroids should avoid exposure to infections such as chicken pox and measles.

Please see accompanying full Prescribing Information.

This Web site is intended for US Health Care professionals only.

PULMICORT RESPULES is a registered trademark of the AstraZeneca group of companies.