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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:  05/31/2013
 
Trade Name:  Bloxiverz
 
Generic Name or Proper Name (*):  neostigmine methylsulfate
 
Indications Studied:  Reversal of the effects of non-depolarizing neuromuscular-blocking agents after surgery
 
Label Changes Summary:  "*Approved for use in pediatric patients of all ages *The evidence for efficacy of neostigmine is derived from the published literature * Recovery of neuromuscular activity occurs more rapidly with smaller doses of cholinesterase inhibitors in infants and children than in adults. However, infants and small children may be at greater risk of complications from incomplete reversal of neuromuscular blockade due to decreased respiratory reserve. The risks associated with incomplete reversal outweigh any risk from giving higher doses of neostigmine *Since the blood pressure in pediatric patients, particularly infants and neonates is sensitive to changes in heart rate, the effects of an anticholinergic agent (e.g., atropine) should be observed prior to administration of neostigmine to lessen the probability of bradycardia and hypotension *Information on dose, and pk *New drug
 
Product Labeling:    Opens a new window
 
PREA(P):  P
 
Sponsor:  Eclat Pharmaceuticals, LLC
 
NNPS:  FALSE
 
Therapeutic Category:  Neuromuscular blockade reversal
 
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