• 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:  05/08/2009
Trade Name:  Lamictal
Generic Name or Proper Name (*):  lamotrigine
Indications Studied:  Adjunctive treatment for partial seizures in pediatric patients 1  24 months
Label Changes Summary:  * Safety and effectiveness as adjunctive treatment for partial seizures were not demonstrated in a small randomized, double-blind, placebo-controlled, withdrawal study in pediatric patients 1 - 24 months * Immediate release tablets were associated with an increased risk for infectious adverse reactions including bronchiolitis, bronchitis, ear infection, eye infection, otitis externa, pharyngitis, urinary tract infection, and viral infection (Lamictal 37%, Placebo 5%), and respiratory adverse reactions including nasal congestion, cough, and apnea. (Lamictal 26%, Placebo 5%)
Product Labeling:  Labeling  Opens a new window
Sponsor:  GlaxoSmithKline
Pediatric Exclusivity Granted Date:  02/14/2007
Therapeutic Category:  Anticonvulsant