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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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