A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children

Summary

Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.

Timeline

Start

2003-01-25

Primary completion

2007-02-28

Completion

2007-02-28

Publications

• Background Bradley J, Scholtz F, Brennan C, Zhao H, Weller S. Pharmacokinetics and safety of single-dose valacyclovir oral suspension in infants and children with current or potential herpesvirus infection. Poster presentation, 45th Annual Meeting Infectious Disease
• Background Kimberlin DW, Jacobs RF, Weller S, van der Walt JS, Heitman CK, Man CY, Bradley JS. Pharmacokinetics and safety of extemporaneously compounded valacyclovir oral suspension in pediatric patients from 1 month through 11 years of age. Clin Infect Dis. 2010 Jan 15;50(2):221-8. doi: 10.1086/649212.

Drugs

Indications