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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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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  Opens a new window
 
BPCA(B):  B
 
Sponsor:  GlaxoSmithKline
 
Pediatric Exclusivity Granted Date:  12/01/2004
 
NNPS:  FALSE
 
Therapeutic Category:  Antiemetic
 
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