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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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