1009 Efficacy and safety of fexofenadine HCl in fall seasonal allergic rhinitis

Tinkelman, D.; Falliers, Constantine J.; Bronsky, Edwin A.; Kaiser, Harold B.; Mason, Jolene

doi:10.1016/s0091-6749(96)81227-9

Cited by 15 publications

(13 citation statements)

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“…Peripheral anticholinergic effects such as dilated pupils, blurred vision, dry mouth, urinary retention, constipation, and impotence were reported at a similar incidence with fexofenadine and placebo [3 –8].…”

Section: Clinical Studiesmentioning

confidence: 99%

“…Peripheral anticholinergic effects such as dilated pupils, blurred vision, dry mouth, urinary retention, constipation, Incidence of treatment-related adverse events in patients with seasonal allergic rhinitis treated with fexofenadine (120 or 180 mg once a day), cetirizine (10 mg once a day), or placebo [3]. and impotence were reported at a similar incidence with fexofenadine and placebo [3][4][5][6][7][8].…”

Section: Clinical Studiesmentioning

confidence: 99%

“…In placebo‐controlled clinical trials involving 2461 patients, treatment with fexofenadine HCl 20–240 mg twice daily resulted in a similar incidence of adverse events in fexofenadine and placebo groups [3 –8]. The incidence of adverse events, including drowsiness, was not dose‐related, and a similar number of patients in the fexofenadine and placebo groups withdrew prematurely from clinical trials due to adverse events (2.2% and 3.3%, respectively) [3, 9].…”

Section: Clinical Studiesmentioning

confidence: 99%

“…Fexofenadine is a new, non‐sedating, long‐acting antihistamine with highly selective peripheral H 1 ‐receptor antagonist activity [3]. Fexofenadine provides fast‐acting and highly effective relief in the treatment of seasonal allergic rhinitis (SAR) [3 –7] and chronic idiopathic urticaria (CIU) [3, 8, 9]. This paper reviews the systemic safety of fexofenadine HCl, which has been assessed throughout the development programme.…”

Section: Introductionmentioning

confidence: 99%

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The systemic safety of fexofenadine HCl

Mason¹,

Reynolds²,

Rao³

1999

Clin Experimental Allergy

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Fexofenadine is a highly specific, H1-receptor antagonist with a safety profile similar to placebo. In placebo-controlled trials of seasonal allergic rhinitis (SAR) and chronic idiopathic urticaria (CIU), the type and incidence of adverse events were comparable in fexofenadine and placebo recipients. Fexofenadine does not impair performance in tests of driving or psychomotor performance and has been shown to improve quality of life in patients with SAR. Fexofenadine has a high margin of safety and is also well tolerated in subjects with renal or hepatic impairment, in children and the elderly. No clinically significant drug interactions have been identified. Fexofenadine is not associated with cardiotoxicity. Unlike some other antihistamines, such as loratidine or cetirizine [1, 2], fexofenadine is truly non-sedating, showing no dose-related increase in sedation, even at high doses [3, 4]. Fexofenadine is formulated and marketed as the hydrochloride salt. The recommended dose of fexofenadine HC1 is 120 mg daily for SAR (either as 120 mg once daily or 60 mg twice daily) or 180 mg once daily for CIU.

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Section: Clinical Studiesmentioning

confidence: 99%

Section: Clinical Studiesmentioning

confidence: 99%

Section: Clinical Studiesmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

The systemic safety of fexofenadine HCl

Mason¹,

Reynolds²,

Rao³

1999

Clin Experimental Allergy

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“…Placebo-controlled studies in adults have shown that fexofenadine is significantly superior to placebo in reducing SAR symptoms [3,9]. Fexofenadine HCl was well tolerated in all Phase I and clinical safety and efficacy trials with no evidence of dose-dependent increases in adverse events [3][4].…”

Section: Introductionmentioning

confidence: 99%

The utility of mixed‐effects covariate analysis in rapid selection of doses in pediatric subjects: A case study with fexofenadine hydrochloride

Krishna¹,

Krishnaswami²,

Kittner³

et al. 2004

Biopharm & Drug Disp

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Fexofenadine hydrochloride is a non-sedating antihistamine that is used in the treatment of symptoms associated with seasonal allergic rhinitis and chronic idiopathic urticaria. A pooled analysis of pharmacokinetic data from children 6 months to 12 years of age and adults was conducted to identify the dose(s) in children that produce exposures comparable to those in adults for the treatment of seasonal allergic rhinitis. The pharmacokinetic parameter database included peak and overall exposure data from 269 treatment exposures from 136 adult subjects, and 90 treatment exposures from 77 pediatric allergic rhinitis patients. The data were pooled and analysed using NONMEM software, version 5.0. A covariate model based on body weight and age and a power function model based on body weight were identified as appropriate models to describe the variability in fexofenadine oral clearance and peak concentration, respectively. Individual oral clearance estimates were on average 44%, 36% and 61% lower in children 6 to 12 years (n=14), 2 to 5 years (n=21), and 6 months to 2 years (n=42), respectively, compared with adults. Trial simulations (n=100) were carried out based on the final pharmacostatistical models and parameter estimates to identify the appropriate dose(s) in children relative to the marketed dose of 60 mg fexofenadine hydrochloride in adults. The trials were designed as crossover studies in 18 subjects comprising various potential dosing regimens with and without weight stratification. Pharmacokinetic parameter variability was assumed to have a log-normal distribution. Individual weights and ages were simulated using mean (SD) estimates derived from the studies used in this analysis and proportional measurement/model mis-specification errors derived from the analysis were incorporated into the simulation. The results indicated that a 30 mg dose of fexofenadine hydrochloride administered to children 1 to 12 years of age and weighing >10.5 kg and a 15 mg dose administered to children 6 months and older and weighing

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Dose Discrepancies Between the Physicians' Desk Reference and the Medical Literature, and Their Possible Role in the High Incidence of Dose-Related Adverse Drug Events

Cohen¹

2001

Arch Intern Med

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Optimal therapeutics depends on the availability of comprehensive information. However, the PDR contains only the limited dose information from package inserts. Because the PDR was originally developed as a promotional device, there is no mechanism by which all clinically relevant dose-response data or important postrelease discoveries are regularly and rapidly incorporated into it. Thus, a gap exists in the availability of current and comprehensive dose information for physicians. This article provides information on lower, effective doses for 48 major medications, with an extensive reference list-a compilation of low-dose information not previously published, to our knowledge, in the medical literature. Physicians must have a readily accessible source of current and complete dose-response information to individualize drug therapy and minimize the risks of ADEs.

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1009 Efficacy and safety of fexofenadine HCl in fall seasonal allergic rhinitis

Cited by 15 publications

References 0 publications

The systemic safety of fexofenadine HCl

The systemic safety of fexofenadine HCl

The utility of mixed‐effects covariate analysis in rapid selection of doses in pediatric subjects: A case study with fexofenadine hydrochloride

Dose Discrepancies Between the Physicians' Desk Reference and the Medical Literature, and Their Possible Role in the High Incidence of Dose-Related Adverse Drug Events

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