Home » Drug Information » FDA-Approved Drugs » 2002
Medical Areas: Pediatrics/Neonatology | Pulmonary/Respiratory Diseases
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Drug Information
The following information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Ivax
Approval Status: Approved May 2002
Treatment Area: Asthma
Qvar has been approved by the FDA for the treatment of asthma in
children 5-11 years of age. This metered dose inhaler is currently
marketed for asthma in adults and children 12 years of age and
older.
Qvar utilizes a hydrofluoroalkane (HFA) propellant for the
delivery of a novel formulation of beclomethasone dipropionate.
Beclomethasone dipropionate is a corticosteroid that produces
anti-inflammatory activity. With Qvar, beclomethasone is delivered
in smaller-sized particles that allow the medication to reach the
small airways of the lung.
According to the American Academy of Allergy, Asthma &
Immunology, approximately 18 million Americans have asthma. Asthma
is the leading cause of hospitalization and school absenteeism
among children under the age of 15.
The following adverse events were reported in clinical trials
testing Qvar in individuals 12 years of age and older:
- Headache
- Pharyngitis (sore throat)
- Upper respiratory tract infection
- Rhinitis (nasal inflammation)
In rare instances, hypersensitivity reactions (such as hives,
rash and bronchospasm) have been reported following the oral and
intranasal inhalation of beclomethasone dipropionate.
Airway inflammation is known to be an important component in the
pathogenesis of asthma. Inflammation occurs in both large and small
airways. Corticosteroids have multiple anti-inflammatory effects,
inhibiting both inflammatory cells and release of inflammatory
mediators. It is presumed that these anti-inflammatory actions play
an important role in the efficacy of beclomethasone dipropionate in
controlling symptoms and improving lung function in asthma. Inhaled
beclomethasone dipropionate probably acts topically at the site of
deposition in the bronchial tree after inhalation. (from Qvar
Prescribing Information)
Qvar was originally developed by the company 3M. In April 2002,
Ivax and 3M reported the signing of an agreement that gives Ivax
exclusive US rights to the Qvar product.
For additional information on Qvar, please visit
www.qvar.com.