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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:  07/17/2002
 
Trade Name:  Nasonex-nasal Elocon - topical
 
Generic Name or Proper Name (*):  mometasone
 
Indications Studied:  Nasonex - Perennial and seasonal allergic rhinitis Elocon - Relief of inflammatory and pruritic manifestations of corticosteroid dermatose
 
Label Changes Summary:  * Nasonex Nasal Spray * Extended age range from 3 years down to 2 years * In a clinical study in which pediatric patients 2-5 years were treated with mometasone nasal spray for up to 42 consecutive days, no significant effect on adrenal function was found * Upper respiratory tract infection was more common with Nasonex (2/28) compared to placebo (0/28) * Elocon Cream & Ointment * Evidence of HPA axis suppression in pediatric patients 6-23 months of age * Outlined local AE's as well as skin atrophy in pediatric patients 6-23 months of age * Approved down to 2 years of age as in previous labeling * Elocon Lotion * Safety and effectiveness have not been established in pediatric patients below 12 years of age and use <12 year old is not recommended * Should not be used for the treatment of diaper dermatitis
 
Product Labeling:  Labeling  Opens a new window
 
BPCA(B):  B
 
Sponsor:  Schering
 
Pediatric Exclusivity Granted Date:  11/07/2001
 
NNPS:  FALSE
 
Therapeutic Category:  Anti-inflammatory, topical
 
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