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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
Sponsor:  Sanofi-Aventis
Therapeutic Category:  Anti-inflammatory, topical