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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:  11/02/2010
 
Trade Name:  Ofirmev
 
Generic Name or Proper Name (*):  acetaminophen
 
Indications Studied:  Management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever
 
Label Changes Summary:  * The safety and effectiveness of Ofirmev for the treatment of acute pain and fever in pediatric patients ages 2 years and older is supported by evidence from adequate and well-controlled studies of Ofirmev in adults. Additional safety and PK data was collected in 355 from premature neonates to adolescents. * The effectiveness of Ofirmev for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.* The PK exposure of Ofirmev observed in children and adolescents is similar to adults, but higher in neonates and infants. Dosing simulations from PK data in infants and neonates suggest that dose reductions of 33% in infants 1 month to < 2 years of age, and 50% in neonates up to 28 days, with a minimum dosing interval of 6 hours, will produce a PK exposure similar to that observed in children age 2 years and older* Most common adverse reactions in pediatric patients were nausea, vomiting, constipation, pruritus, agitation, and atelectasis.* Information on dosing, clinical studies, adverse reactions and PK parameters* New dosage form and route of administration
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Cadence
 
NNPS:  FALSE
 
Therapeutic Category:  Analgesic; Antipyretic
 
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