In a placebo-controlled clinical study in the United States, which included 570 subjects aged 12 years and older receiving fexofenadine hydrochloride tablets at doses of 120 or 180 mg once daily, adverse events were similar in fexofenadine hydrochloride- and placebo-treated subjects. There are no adequate and wellcontrolled studies in women during lactation.
ALLEGRA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The clinical significance of these observations is unknown. The effectiveness of fexofenadine hydrochloride 30 mg twice daily for the treatment of seasonal allergic rhinitis in patients 2 to 5 years of age is based on the pharmacokinetic comparisons in adult and pediatric subjects and an extrapolation of the demonstrated efficacy of fexofenadine hydrochloride in adult subjects with this condition and the likelihood that the disease course, pathophysiology, and the drug’s effect are substantially similar in pediatric patients to those in adult patients.
There are no adequate and well controlled studies in pregnant women. The safety of ALLEGRA at a dose of 30 mg twice daily has been demonstrated in 438 pediatric subjects 6 years to 11 years of age in two placebo-controlled 2-week seasonal allergic rhinitis trials. The effectiveness of ALLEGRA for the treatment of chronic idiopathic urticaria in patients 6 months to 11 years of age is based on the pharmacokinetic comparisons in adults and children and an extrapolation of the demonstrated efficacy of ALLEGRA in adults with this condition and the likelihood that the disease course, pathophysiology and the drug’s
Allegra Tablets are substantially similar in children to that of adult patients. ALLEGRA tablets are coated with a peach colored film coating Allegra Tablet . Symptomatic and supportive treatment is recommended.
Other reported clinical experience has not identified differences in responses between the geriatric and younger subjects.
In placebo-controlled chronic idiopathic urticaria clinical trials, which included 726 subjects 12 years of age and older Allegra Tablet fexofenadine hydrochloride tablets at doses of 20 to 240 mg twice daily, adverse events were similar in fexofenadine hydrochloride- and placebo-treated Allegra Tablet Table 4 lists Allegra Tablet experiences in subjects aged 12 years and older which were reported by greater than 2% of subjects treated with fexofenadine hydrochloride 60 mg tablets twice daily in controlled clinical studies in the United States and Canada and that were more common with fexofenadine hydrochloride than placebo. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.