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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:  09/19/2008
 
Trade Name:  Nasacort AQ
 
Generic Name or Proper Name (*):  triamcinolone
 
Indications Studied:  Treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older
 
Label Changes Summary:  Expands pediatric use, or age range, to include patients 2 to 5 years of age Dosing and administration information provided Not recommended for children under 2 years of age An effect on adrenal function in children 2 to 5 years of age cannot be ruled out Pharmacokinetics were evaluated in children 2 to 5 years of age Safety and efficacy were evaluated in one clinical study involving pediatric patients 2 to 5 years old Studies in children >6 months and less than 2 years of age were not performed due to safety concerns since controlled clinical studies have shown that intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Sanofi-Aventis
 
NNPS:  FALSE'
 
Therapeutic Category:  Anti-inflammatory, topical
 
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