• 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:  09/28/2007
Trade Name:  Lamisil Oral Granules
Generic Name or Proper Name (*):  terbinafine
Indications Studied:  Tinea capitis
Label Changes Summary:  * New indication in 4 years and older * Two randomized safety and efficacy trials were conducted in patients 4 to 12 years old with tinea capitis. Terbinafine was dosed on a mg/kg basis and treated for 6 weeks * Although no hepatotoxicity was seen during trials, pre-treatment serum transaminases tests are advised. * The most common adverse events observed in the trials were nasopharyngitis, headache, pyrexia, cough, vomiting, and upper respiratory tract infection * New 125 mg and 187.5 mg oral granule formulations developed; take with food * Information on dose, PK parameters, AE profile, and instructions for use
Product Labeling:  Labeling  Opens a new window
Sponsor:  Novartis
Pediatric Exclusivity Granted Date:  12/04/2006
Therapeutic Category:  Antifungal, topical