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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:  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
 
BPCA(B):  B
 
Sponsor:  Novartis
 
Pediatric Exclusivity Granted Date:  12/04/2006
 
NNPS:  FALSE'
 
Therapeutic Category:  Antifungal, topical
 
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