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Fexofenadine in pediatrics: oral tablet and suspension formulations

Lyndon E Mansfield1

  • 1Texas Tech Regional Health Science Center, 1901 Arizona Avenue, El Paso, Texas 79902, USA. immunman@pol.net

Expert Opinion on Pharmacotherapy
|January 19, 2008
PubMed

Insights

A new oral suspension of fexofenadine offers an effective and safe option for treating allergic rhinitis in children. This formulation provides bioequivalence to tablets, improving medication adherence for pediatric patients.

Area of Science:

  • Pediatric Allergy and Immunology
  • Pharmacology and Therapeutics
  • Drug Formulation Science

Background:

  • Allergic rhinitis is a prevalent chronic condition in children, often managed with oral antihistamines.
  • Fexofenadine, a second-generation antihistamine, is a first-line treatment with established efficacy and safety in pediatric populations.
  • Administration challenges in young children necessitate alternative formulations.

Purpose of the Study:

  • To evaluate the efficacy and safety of a new oral suspension formulation of fexofenadine in children.
  • To establish bioequivalence between the fexofenadine oral suspension and its tablet formulation.
  • To assess the tolerability profile of the oral suspension in pediatric patients.

Main Methods:

  • Clinical studies were conducted to compare the fexofenadine oral suspension with the 30 mg tablet formulation.
  • Bioequivalence studies were performed to assess pharmacokinetic parameters.
  • Safety and tolerability assessments were integral to the study design.

Main Results:

  • The fexofenadine oral suspension demonstrated bioequivalence to the 30 mg tablet formulation.
  • The new formulation exhibited a favorable safety and tolerability profile in children.
  • The oral suspension is indicated for seasonal allergic rhinitis and chronic idiopathic urticaria in specific pediatric age groups.

Conclusions:

  • The fexofenadine oral suspension provides a viable and effective alternative for pediatric allergic rhinitis treatment.
  • Bioequivalence supports interchangeable use with the established tablet formulation.
  • The favorable safety profile supports its use in children aged 6 months to 11 years.

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