• 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:  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
Sponsor:  Schering
Pediatric Exclusivity Granted Date:  11/07/2001
Therapeutic Category:  Anti-inflammatory, topical