Pharmacokinetics, safety and tolerability of an oral suspension of fexofenadine for children with allergic rhinitis

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Abstract:

Allergic rhinitis (AR) is a common chronic condition in children and may impact a child's quality of life. Increasing treatment compliance may improve quality of life. An oral suspension of fexofenadine hydrochloride (HCl) has been developed to ease administration to children and may, therefore, improve treatment compliance. The purpose of this study was to assess the pharmacokinetic behavior, safety, and tolerability of a single dose of fexofenadine HCl oral suspension administered to children aged 2–5 years with allergic rhinitis. Children (aged 2–5 years) with AR were recruited in a multicenter, open-label, single-dose study. Fexofenadine HCl (30 mg) was administered as a 6-mg/mL suspension (5 mL). Plasma samples were collected up to 24 hours postdose. Adverse events (AEs); electrocardiograms (ECGs); vital signs; and clinical laboratory tests for hematology, blood chemistry, and urinalysis were analyzed to evaluate safety and tolerability. Fifty subjects completed the study. Mean maximum plasma concentration of fexofenadine was 224 ng/mL, and mean area under the plasma concentration curve was 898 ng ยท hour/mL. Treatment-emergent AEs were mild in intensity and reported in a total of seven subjects. No trends or clinically meaningful changes in mean ECG, vital sign, or clinical laboratory test data occurred during the study. In children aged 2–5 years, the exposure after a 30-mg dose of fexofenadine HCl suspension was similar to the exposures previously seen after a 30- and 60-mg dose of fexofenadine HCl in children aged 6–11 years and in adults, respectively. The suspension was also well tolerated.

Keywords: Allergic rhinitis; antihistamine; children; fexofenadine; oral suspension; pharmacokinetics; quality of life; safety; tolerability; treatment compliance

Document Type: Research Article

DOI: http://dx.doi.org/10.2500/aap.2008.29.3136

Affiliations: 1: Clinical Research Atlanta, Stockbridge, Georgia 2: Center of Research Excellence, Oxford, Alabama 3: Spartanburg Pharmaceutical Research, Spartanburg, South Carolina 4: Northeast Georgia Research Center, Gainesville, Georgia 5: Sneeze, Wheeze, and Itch Associates, Normal, Illinois 6: Sanofi-Aventis US, Bridgewater, New Jersey 7: West Coast Clinical Trials, Long Beach, California

Publication date: July 1, 2008

More about this publication?
  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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