Clarinex - Side Effects & Drug Interactions

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Clinical Trials:

Seasonal Allergic Rhinitis:

The clinical efficacy and safety of CLARINEX Tablets were evalu-ated in over 2,300 patients 12 to 75 years of age with seasonal allergic rhinitis. A total of 1,838 patients received 2.5-20 mg/ day of CLARINEX in 4 double-blind, randomized, placebo-controlled clinical trials of 2 to 4 weeks' duration conducted in the United States. The results of these studies demonstrated the efficacy and safety of CLARINEX 5 mg in the treatment of adult and adolescent patients with seasonal allergic rhinitis. In a dose ranging trial, CLARINEX 2.5-20 mg/ day was studied. Doses of 5, 7.5, 10, and 20 mg/ day were superior to placebo; and no additional benefit was seen at doses above 5.0 mg.

In the same study, an increase in the incidence of somnolence was observed at doses of 10 mg/ day and 20 mg/ day (5.2% and 7.6%, respectively), compared to placebo (2.3%). In 2 four-week studies of 924 patients (aged 15 to 75 years) with seasonal allergic rhinitis and concomitant asthma, CLARINEX Tablets 5 mg once daily improved rhinitis symptoms, with no decrease in pulmonary function. This supports the safety of administering CLARINEX Tablets to adult patients with seasonal allergic rhinitis with mild to moderate asthma. CLARINEX Tablets 5 mg once daily significantly reduced the Total Symptom Scores (the sum of individual scores of nasal and non-nasal symptoms) in patients with seasonal allergic rhinitis. See Table 2.

Table 2

TOTAL SYMPTOM SCORE (TSS) Changes in a 2 Week Clinical Trial in Patients with Seasonal Allergic Rhinitis

Treatment Mean Change from Placebo Group Baseline* Baseline** Comparison

(n) (sem) (sem) (P-value)

CLARINEX 5.0 mg (171) 14.2 (0.3) -4.3 (0.3) P< 0.01

Placebo (173) 13.7 (0.3) -2.5 (0.3)

*At baseline, a total nasal symptom score (sum of 4 individual symptoms) of at least 6 and a total non-nasal symptom score (sum of 4 individual symptoms) of at least 5 (each symptom scored 0 to 3 where 0= no symptom and 3= severe symptoms) was required for trial eligibility. TSS ranges from 0= no symptoms to 24= maximal symptoms.