Approval for publication Signed Date Number of amended pages returned Clin Drug Invest 2006; 26 (1): 1 CASE REPORT 1173-2563/06/0001-0001/$34.95/0  2006 Adis Data Information BV. All rights reserved. Acute Renal Failure Probably Induced by Prulifloxacin in an Elderly Woman A First Case Report L. Gallelli, 1 A. Gallelli, 2 G. Vero, 2 F. Roccia, 2 G. Pelaia, 2 G. De Sarro 1 and R. Maselli 2 1 Clinical Pharmacology and Pharmacovigilance Unit, Department of Experimental and Clinical Medicine, Faculty of Medicine and Surgery University ‘Magna Graecia’ of Catanzaro, ‘Mater Domini’ University Hospital, Catanzaro, Italy 2 Department of Experimental and Clinical Medicine, Chair of Respiratory Diseases, Faculty of Medicine and Surgery University ‘Magna Graecia’ of Catanzaro, ‘Mater Domini’ University Hospital, Catanzaro, Italy Prulifloxacin, the lipophilic prodrug of uliflox- tion, was prescribed prulifloxacin 600 mg/day for 10 acin, is an oral fluoroquinolone antibacterial agent days because of exacerbations of chronic bronchitis. that has a broad spectrum of activity in vitro against Ten days later, because of worsening of fever various Gram-negative and -positive bacteria. [1] Pru- (40°C) and the presence of cough and dyspnoea, she lifloxacin has a long half-life and, in patients with continued to take the prulifloxacin at a dosage of acute exacerbations of chronic bronchitis, showed 600 mg/day. Two days later (12 days after initiation both good compliance and clinical and bacteriologi- of prulifloxacin treatment), she was admitted to the cal efficacy. [2] Respiratory Disease Unit of the ‘Mater Domini’ Recently, in vitro studies showed that the active University Hospital of Catanzaro because of hyper- metabolite of prulifloxacin is able to modulate the tension (190/105mm Hg) and oliguria. Her history synthesis of several pro-inflammatory cytokines revealed that nausea, vomiting, hypertension and (i.e. interleukin [IL]-8, IL-1β, tumour necrosis oliguria started to manifest themselves 5 days after factor-α and IL-6), but not that of the anti-inflam- initiation of the prulifloxacin treatment. matory cytokine IL-10, [3] and to potentiate the She had smoked 20 cigarettes/day since 1960; phagocytic and microbicidal activities of macro- there was no history of alcohol or other illicit drug phages. [4] abuse. She was a known hypertensive, and was The most commonly reported adverse drug reac- treated with amlodipine (5 mg/day), and there was tions of prulifloxacin are gastric disturbances, diar- no significant past surgical history. On physical rhoea, nausea and skin rash. [5] In this report, we examination the patient’s temperature was 39.2°C, present the first case of acute renal failure probably blood pressure 190/105mm Hg, and heart rate induced by prulifloxacin treatment in an elderly 100 beats/min with normal sinus rhythm. Admission woman. biochemistry revealed acute renal failure with serum creatinine 7.8 mg/dL (normal range 0.5–1.4 mg/dL) Case Report and blood urea 188 mg/dL (normal range 10–50 mg/ dL); haematological indices showed anaemia A 75-year-old woman (bodyweight 62kg, height (haemoglobin 7.7 g/dL, normal range 12.0–18.0 g/ 163cm), without a medical history of adverse drug dL) and normal white blood cell and platelet counts. reactions and with adequate renal and hepatic func-