The efficacy and safety of the
antibiotic loracarbef have been demonstrated in a series of 22 clinical trials involving over 9,000 patients. The data compiled from these trials indicate that
loracarbef is well tolerated by the majority of patients, including children and elderly patients. Most adverse events in patients receiving
loracarbef were mild and transient in nature; only 1.5% of patients discontinued
therapy because of
drug-related adverse events. The frequency of adverse events associated with this agent compares favorably with that reported for the other
antibiotics in these trials. The most commonly reported adverse reaction in the
loracarbef study group was
diarrhea, but this condition occurred less frequently in patients who received
loracarbef than in those treated with the comparative agents. Other gastrointestinal events, such as
nausea and
vomiting, were reported infrequently.
Headache was the second most common adverse event reported and occurred at a slightly higher frequency in the
loracarbef-treated group than in patients receiving comparative
antibiotics. No clinically significant alterations in laboratory parameters or gastrointestinal flora were observed following
loracarbef administration. The compiled data indicate that
loracarbef is a safe therapeutic option for the treatment of a wide spectrum of
bacterial infections.