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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:  02/03/2016
 
Trade Name:  Prilosec
 
Generic Name or Proper Name (*):  omeprazole magnesium
 
Indications Studied:  Short term treatment of erosive esophagitis due to gastroesophageal reflux disease in patients 1 month to less than 1 year of age
 
Label Changes Summary:  * Safety and effectiveness have been established in pediatric patients 1 month to less than 1 year of age. * Use in this population is supported by adequate and well-controlled studies in adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients. * Safety and efficacy have not been establish in patients less than 1 month of age for any indication. *Adverse reactions frequently reported in the 1 month to <1 year age group include respiratory adverse reactions (42%), and otitis media (22%). Information on dosing, PK, adverse reactions. *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  AstraZeneca
 
NNPS:  FALSE
 
Therapeutic Category:  Antiulcerative
 
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