A report of "susceptible" implies that the pathogen is likely to be inhibited by generally achievable blood concentrations. A report of "moderately susceptible" indicates that inhibitory concentrations of the antibiotic may be achieved if high dosage is used or if the infection is confined to tissues and fluids (e.g., urine) in which high antibiotic concentrations are attained. A report of "resistant" indicates that achievable concentrations of the antibiotic are unlikely to be inhibitory and other therapy should be selected.

Standardized procedures require the use of laboratory control organisms. The 30-mcg loracarbef disk should give the following zone diameters with the NCCLS approved procedure (TABLE 3).

Dilution Techniques: Use a standardized dilution method² (broth, agar, or microdilution) or equivalent with loracarbef powder. The MIC values obtained should be interpreted according to the following criteria (TABLE 4).

As with standard diffusion methods, dilution procedures require the use of laboratory control organisms. Standard loracarbef powder should give the following MIC values with the NCCLS approved procedure (TABLE 5):

CLINICAL STUDIES

Acute Otitis Media

Study 1: In a controlled clinical study of acute otitis media performed in the United States where significant rates of b-lactamase-producing organisms were found, loracarbef was compared to an oral antimicrobial agent that contained a specific b-lactamase inhibitor. In this study, using very strict evaluability criteria and microbiologic and clinical response criteria at the 10- to 16-day post therapy follow-up, the following presumptive bacterial eradication/clinical cure outcomes (i.e., clinical success) and safety results were obtained (see TABLE 6).

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