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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:  03/01/2017
 
Trade Name:  Cerebyx
 
Generic Name or Proper Name (*):  fosphenytoin sodium
 
Indications Studied:  Treatment of generalized tonic-clonic status epilepticus, for the prevention and treatment of seizures occurring during neurosurgery, and for short-term substitution for oral phenytoin in pediatric patients birth to less than 17 years of age
 
Label Changes Summary:  *Approved for use in pediatric patients birth to less than 17 years. *Because rapid intravenous administration of Cerebyx increases the risk of adverse cardiovascular reactions, the rate of administration should not exceed 2 mg PE/kg/min ((or 150 mg PE/min, whichever is slower) in pediatric patients. * Intramuscular administration of Cerebyx should ordinarily not be used in pediatric patients. * Adverse reactions in pediatric patients were similar to those observed in adults. *Information on dosing, adverse reactions, and PK.
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B) and PREA(P):  B
 
Sponsor:  Parke-Davis
 
Therapeutic Category:  Anticonvulsant
 
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