Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
03/25/2005
Trade Name:
Zofran
Generic Name or Proper Name (*):
ondansetron
Indications Studied:
Prevention of chemotherapy-induced and postoperative induced nausea and vomiting
Label Changes Summary:
Established dosing for surgical patients down to 1 month from 2 years of age Established dosing for cancer patients down to 6 months from 4 years of age Surgical and cancer patients < 18 years tend to have a higher ondansetron clearance compared to adults leading to a shorter half-life in most pediatric patients The clearance of ondansetron in patients 1- 4 months of age is slower and the half-life is approximately 2.5 fold longer than patients who are > 4 24 months of age Patients < 4 months of age receiving this drug should be closely monitored Additional information on dose, PK parameters, AE profile and safety
Product Labeling:
Labeling
BPCA(B):
B
Sponsor:
GlaxoSmithKline
Pediatric Exclusivity Granted Date:
12/01/2004
NNPS:
FALSE'
Therapeutic Category:
Antiemetic
-
-