SAFETY AND EFFICACY OF INTRAVENOUS PEFLOXACIN IN SURGICAL PATIENTS - PROPHYLACTIC AND THERAPEUTIC USE

This report of the first phase IV computerized study on pefloxacin inf usion in Indian patients includes completed, comprehensive patient rec ord sheets (N = 2171) compiled by 290 doctors in various surgical spec ialties. Ready-to-use pefloxacin (RTUP) was given prophylactically to 1347 patients undergoing clean, clean contaminated, or contaminated su rgical procedures. Some patients received one 400-mg dose of RTUP befo re surgery and some received one 400-mg dose before surgery and one 12 hours after surgery. Total dose in 24 hours was 800 mg (maximum). In 770 patients with postoperative infections, RTUP was administered twic e daily for 6 days. Fever, pain, swelling, and exudates were assessed on days 1 through 7 and 10 days after therapy. All side effects were n oted. Proportions were expressed as percentages in computerized data e ntry and statistical analyses (95% confidence interval). The 2171 pati ents were categorized as having undergone: gastrointestinal (893), ort hopedic (497), urologic (223), gynecologic (112), minor surgery (280), or other (166) procedures. RTUP was uniformly effective and 84% of pa tients treated for infection and 91% of patients treated prophylactica lly responded favorably. Overall response rates showed that fever disa ppeared in 3.5 to 5.3 days, swelling in 3.6 to 5.1 days, pain in 3.4 t o 4.7 days, and exudate in 5.3 to 6.7 days. A total of 44 patients (2% ) reported side effects, 18 of whom (40%) had nausea and vomiting. Oth er side effects were diarrhea (5/44), gastric upset (7/44), abdominal pain (6/44), dizziness (4/44), and chills (4/44). No patient discontin ued therapy because of an adverse reaction. Study results of this firs t computerized phase IV evaluation of RTUP indicate that it is safe an d effective in Indian patients.