Home » Drug Information » FDA-Approved Drugs » 1997
Medical Areas: 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: Schering-Plough
Approval Status: Approved January 1997
Treatment Area: asthma
Vanceril 84 mcg Double Strength has been approved for the
treatment of asthma.
As a concentrated, twice-daily formulation with the same active
ingredient as Vanceril, Vanceril 84 mcg Double Strength represents
a significant step forward in simplifying asthma therapy. Available
by prescription as a metered dose inhaler, Vanceril 84 mcg Double
Strength is indicated in the maintenance treatment of asthma as
prophylactic therapy and for asthma patients who require systemic
corticosteroid administration, where adding Vanceril 84 Double
Strength may reduce or eliminate the need for systemic
corticosteroids.
The efficacy of Vanceril 84 mcg Double Strength was demonstrated
in randomized, double-blind, placebo-controlled clinical trials
involving 423 subjects with bronchial asthma who had been switched
form other oral inhaled steroids. Vanceril 84 mcg Double Strength
dosed two puffs, twice daily (BID) was shown to significantly
improve pulmonary function and control other asthma symptoms. The
usual recommended starting dosage for Vanceril 84 mcg Double
Strength is two puffs, twice daily for adults and children as young
as six years old.
In a randomized, four-week clinical trial, the incidence of
adverse events for Vanceril 84 mcg Double Strength was similar to
that reported for placebo. The incidence of oral candidiasis was
less than one percent. No hypothalamus-pituitary-adrenal (HPA) axis
suppression was reported in a clinical study of adult subjects who
received daily doses of 840 mcg for 35.5. days. In 20 years of U.S.
clinical experience, beclomethasone dipropionate (BDP), the active
ingredient in Vanceril and Vanceril 84 mcg Double Strength, has
demonstrated a favorable systemic safety profile with regard to HPA
axis suppression, bone metabolism, long-term growth in children and
adverse events.
An estimated 14 million Americans suffer from asthma, including
four million children under the age of 18. A lung disease
characterized by inflammation and obstruction of the airways that
transport air from the nose and mouth to the lungs, asthma
interferes with the lungs’ life-supporting functions of removing
carbon dioxide from the blood and replacing it with oxygen. While
there is no known cure, asthma can be controlled with
medication.