Home » Drug Information » FDA-Approved Drugs » 1996
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: Hoechst Marion Roussel
Approval Status: Approved July 1996
Treatment Area: seasonal allergic rhinitis
Allegra has been approved as a treatment for seasonal allergic
rhinitis. The labeling of Allegra recommends dosing of one 60-mg
capsule, twice daily. The recommended starting dose for subjects
with decreased kidney function is 60 mg, once daily. Allegra is
available by prescription only.
The onset of action for Allegra was observed at one hour in a
controlled clinical trial. Additional studies demonstrated that
allergy sufferers continued feeling relief throughout the 12-hour
dosing period. Also, two-week trials showed that Allegra provided
significant symptom relief throughout the full course of
therapy.
Clinical trials have demonstrated significant relief without
sedating side effects. In clinical trials of more than 2,000
allergy sufferers, the incidence of adverse effects reported with
Allegra was similar to placebo. Alegra studies have found no
significant drug interactions with the macrolide antibiotic
erythromycin and the antifungal ketoconazole. These agents have
been known to interact with some other antihistamines. In addition,
cardiac side effects reported were similar to placebo. The most
commonly reported adverse experiences for Allegra and placebo are
cold or flu (2.5% vs. 1.5%), nausea (1.6% vs. 1.5%), and menstrual
pain (1.5% vs. 0.3%).