The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.


Approval Status:

Approved January 1998

Specific Treatments:

Pediatric otitis media

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General Information

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.

Clinical Results

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.