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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B) and PREA(P):
B
Sponsor:
Parke-Davis
Therapeutic Category:
Anticonvulsant
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