• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
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
 
-
-