Approval Status: Approved January 1998
Treatment for: Pediatric otitis media
Areas: ENT (Ear, Nose and Throat); Pediatrics
Possible similar drugs: Rocephin
Hoffmann-LaRoche's antibiotic Rocephin (ceftriaxone sodium) has been approved as a one dose injection for the treatment of bacterial otitis media in children. The drug was previously approved for use as a 10-day multiple dose oral treatment.
In clinical trials involving 2.450 children demonstrated that the drug, when administered intramuscularly as a single dose, is comparable to standard 10-day multiple dose oral treatments. The injectable form was found to be 100% effective in eradicating Hemophilus influenzae, Moraxella catarrhalis and susceptible Streptococcus pneumoniae.
Rocephin Drug Information
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