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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:  08/27/2010
 
Trade Name:  Augmentin XR
 
Generic Name or Proper Name (*):  amoxicillin/clavulanate potassium
 
Indications Studied:  Community-acquired pneumonia or acute bacterial sinusitis
 
Label Changes Summary:  Expanded indication from adults to children weighing e 40 kg who are able to swallow tablets Use in children is supported by evidence from trials of adults with additional data from a pediatric PK study Adverse events similar to adults Information on dose, and PK parameters Information added to Clinical Pharmacology and Pediatric Use
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  GlaxoSmithKline
 
NNPS:  FALSE'
 
Therapeutic Category:  Antibiotic
 
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