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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:  05/05/2008
 
Trade Name:  Levaquin Tablets, 250 mg, 500 mg, and 750 mg Levaquin Oral Solution, 25 mg/mL Levaquin Injection and Levaquin Injection, 5 mg/mL
 
Generic Name or Proper Name (*):  levofloxacin levofloxacin in 5% dextrose injection
 
Indications Studied:  Reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis (inhalational anthrax post-exposure)
 
Label Changes Summary:  New indication Dosing information provided for children less than and greater than 50 kg Efficacy is based on plasma concentrations achieved in humans, a surrogate endpoint reasonably likely to predict clinical benefit, and animal studies were used to evaluate survival; the product has not been tested in humans for the post-exposure prevention of inhalation anthrax Safety in pediatric patients treated for more than 14 days has not been studied Long-term safety data, including effects on cartilage, following administration in pediatric patients is limited Due to possible side effects, use is not recommended for pediatric patients except in the prevention of anthrax after inhalational exposure Pharmacokinetics were investigated in pediatric patients 6 months to 16 years old
 
PREA(P):  P
 
Sponsor:  Ortho-McNeil-Janssen Pharmaceutical, Inc.
 
NNPS:  TRUE'
 
Therapeutic Category:  Antibiotic
 
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