Vanceril 84 mcg Double Strength (beclomethasone dipropionate, 84 mcg) Inhalation Aerosol

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved January 1997

Specific Treatments:


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General Information

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.

Clinical Results

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.

Additional Information

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.