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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
Sponsor:  Ortho-McNeil-Janssen Pharmaceutical, Inc.
Therapeutic Category:  Antibiotic