Safety profile of ofloxacin in elderly patients.

In clinical trials co-ordinated in Italy by Glaxo S.p.A. from May 1984 to February 1988, 553 patients aged over 65 years (376 men and 177 women), suffering from different infectious diseases (mostly LRTI and UTI), were treated with ofloxacin, a new broad-spectrum quinolone. Of the patients studied, 75% presented one or more concurrent diseases and 72.3% were receiving one or more concurrent therapies. Daily dose of the drug varied, in most cases, between 400 and 800 mg in two oral administrations. In all, 21 adverse events were recorded in 19 patients (3.44%): 13 gastrointestinal events (gastric pain, nausea, vomiting), 3 cutaneous events and 5 others. The severity of the events was judged as mild in 56.3% of the cases and moderate in 43.7%. The treatment was stopped because of adverse events in three patients (0.54%). Abnormal laboratory parameters, probably related to the drug, were observed in four patients. In conclusion, ofloxacin appears to be a very safe drug in the treatment of bacterial infections in elderly patients.