• 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:  10/15/1998
Trade Name:  Versed
Generic Name or Proper Name (*):  midazolam
Indications Studied:  Sedation/anxiolysis/ amnesia
Label Changes Summary:  * Specified the effective dose, effective dose range, and time of onset * Defined volume of distribution and similarity to adult protein binding and elimination * Additional information on AE's and warnings about concomitant medications * Identified a subpopulation (children with congenital heart disease and pulmonary hypertension) at higher risk for AE's and the need to start therapy at the lower end of the dosing range
Product Labeling: