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:  12/20/2013
 
Trade Name:  Isentress
 
Generic Name or Proper Name (*):  raltegravir
 
Indications Studied:  HIV-1 infection
 
Label Changes Summary:  Packet for oral suspension: Approved for use in infants 4 weeks and older, weighing at least 3 kg to < 20 kg. Chewable tablet previously approved down to 2 yearsSafety and dosing information have not been established in infants less than 4 weeks Adverse reactions similar to those observed in adultsInformation on dosing,clinical trial and PK parametersInformation on preparation of a suspensionNew dosage form
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Merck Sharp & Dohme Corp.
 
NNPS:  FALSE'
 
Therapeutic Category:  Antiviral
 
-
-