Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  01/25/2019
 
Trade Name:  Zovirax
 
Generic Name or Proper Name (*):  acyclovir sodium
 
Indications Studied:  Neonatal herpes virus infection (HSV)
 
Label Changes Summary:  *New dose: Post Menstrual Age (PMA) of at least 34 Weeks: 20 mg/kg every 8 hours for 21 days. PMA of less than 34 Weeks: 20 mg/kg every 12 hours for 21 days. Previously approved dose: Birth to 3 months: 10 mg/kg every 8 hours for 10 days. *In an open-label clinical trial, Zovirax 20 mg/kg every 8 hours (60 mg/kg/day) was compared with 15 mg/kg every 8 hours (45 mg/kg/day) to neonates =28 days old with suspected HSV infection. In total, 88 neonates were enrolled in the trial and received IV acyclovir for 21 days. The mean gestational ages (GA) were 37.5 and 37.9 weeks for the 45-mg/kg/day and 60-mg/kg/day doses, respectively. The number of premature infants (=37 weeks GA) receiving 45 mg/kg/day and 60 mg/kg/day were 7 (54%) and 22 (33%), respectively. *Among 69 patients with proven systemic (disseminated or CNS) herpes infection, 57 were randomized to receive Zovirax (20 mg/kg every 8 hours) while the remaining 12 patients received a lower dose of Zovirax every 8 hours. *Overall, the mortality among patients treated with Zovirax 20 mg/kg every 8 hours was lower compared with patients who received a lower dose of Zovirax. *Information on dosing and clinical trial. *Off-patent written request.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
-
-