Oral Norfloxacin Research Articles

5 Randomized, multicenter, controlled trial comparing oral norfloxacin vs intravenous ceftriaxone in the prevention of bacterial infections in cirrhotics with severe liver failure and gastrointestinal bleeding

5 Randomized, multicenter, controlled trial comparing oral norfloxacin vs intravenous ceftriaxone in the prevention of bacterial infections in cirrhotics with severe liver failure and gastrointestinal bleeding

Spontaneous bacterial peritonitis: a historical perspective: Kerr DNS, Pearson DT, Read AE. Infection of ascitic fluid in patients with hepatic cirrhosis [Gut 1963; 4: 394–398]; Conn HO. Spontaneous peritonitis and bacteremia in Laennec's cirrhosis caused by enteric organisms. A relatively common but rarely recognized syndrome [Ann Intern Med 1964; 60: 568–580

Spontaneous bacterial peritonitis: a historical perspective: Kerr DNS, Pearson DT, Read AE. Infection of ascitic fluid in patients with hepatic cirrhosis [Gut 1963; 4: 394–398]; Conn HO. Spontaneous peritonitis and bacteremia in Laennec's cirrhosis caused by enteric organisms. A relatively common but rarely recognized syndrome [Ann Intern Med 1964; 60: 568–580

Spontaneous bacterial peritonitis

Spontaneous bacterial peritonitis occurs in 30% of patients with ascites due to cirrhosis leading to high morbidity and mortality rates. The pathogenesis of spontaneous bacterial peritonitis is related to altered host defenses observed in end-stage liver disease, overgrowth of microorganisms, and bacterial translocation from the intestinal lumen to mesenteric lymph nodes. Clinical manifestations vary from severe to slight or absent, demanding analysis of the ascitic fluid. The diagnosis is confirmed by a number of neutrophils over 250/mm3 associated or not to bacterial growth in culture of an ascites sample. Enterobacteriae prevail and Escherichia coli has been the most frequent bacterium reported. Mortality rates decreased markedly in the last two decades due to early diagnosis and prompt antibiotic treatment. Third generation intravenous cephalosporins are effective in 70% to 95% of the cases. Recurrence of spontaneous bacterial peritonitis is common and can be prevented by the continuous use of oral norfloxacin. The development of bacterial resistance demands the search for new options in the prophylaxis of spontaneous bacterial peritonitis; probiotics are a promising new approach, but deserve further evaluation. Short-term antibiotic prophylaxis is recommended for patients with cirrhosis and ascites shortly after an acute episode of gastrointestinal bleeding.

Spontaneous Bacterial Peritonitis.

Spontaneous bacterial peritonitis (SBP) is the prototypical ascitic fluid infection occurring in patients with advanced liver disease and ascites. The key to successful treatment of SBP is a knowledge of appropriate antibiotic regimens and an understanding of the setting in which infection develops, particularly those individuals at high risk for infection. A high index of suspicion should lead to early diagnostic paracentesis and ascitic fluid analysis. Treatment of SBP involves the use of non-nephrotoxic broad-spectrum antibiotics expected to cover the typical bacterial flora associated with SBP. SBP typically involves infection with a single organism, with Escherichia coli, Klebsiella spp, and Streptococcus spp responsible for nearly three fourths of cases. The treatment of choice is cefotaxime 2 g given intravenously every 8 hours for a total of 5 days. The antibiotic regimen is adjusted based on the results of ascitic fluid cultures. Other antibiotic regimens for SBP are less well studied. Given the significant morbidity and mortality rates associated with SBP, efforts to prevent its development and recurrence with antibiotic prophylaxis are warranted. The most extensively studied form of prophylaxis involves selective intestinal decontamination (SID) with the oral fluoroquinolone norfloxacin. Individuals with low-protein ascites (ascitic fluid total protein < 1g/dL) benefit from SID with norfloxacin 400 mg daily during times of hospitalization. Long-term primary prophylaxis during outpatient management of individuals awaiting liver transplantation with severe ascites and advanced liver failure should also be considered. Patients with cirrhosis and upper gastrointestinal bleeding should receive norfloxacin 400 mg twice daily for 1 week following their bleed. Those individuals surviving an episode of SBP should be treated with norfloxacin 400 mg daily until the risk of SBP is removed by definitive resolution of the ascites or liver transplantation surgery. Although the infection-related mortality associated with SBP has decreased to less than 10%, hospitalization-related mortality remains as high as 30% as a result of the severe underlying liver disease in which the infection arises and the marked generation of cytokines and nitric oxide resulting from the infection. Recently, the simultaneous administration of intravenous albumin and antibiotics for SBP has been shown to result in the decreased development of azotemia and hospitalization-related mortality. Further improvement in the outcomes of SBP will require treatments targeting this cytokine cascade rather than the development of more potent antibiotics.

Pulse and continuous oral norfloxacin treatment of experimentally induced Escherichia coli infection in broiler chicks and turkey poults

Experimental colibacillosis was produced in 40 healthy, 7-day-old broiler chickens and turkeys by intratracheal injection of 1 x 10(8) CFU/chick and 1.23 x 10(9) CFU/poult bacteria of an O1:F11 strain of Escherichia coli, respectively. Two days before E. coli challenge all chicks were vaccinated with a live attenuated strain of infectious bronchitis virus (H-52). This model of infection--at least in chicken--proved to be useful for evaluating the efficacy of antimicrobial medication, by recording mortality, body weight gain, pathological alterations and frequency of reisolation of E. coli. Using this model, the efficacy of two different dosing methods of norfloxacin (continuous and pulse dosing) was evaluated. The once-per-day pulse dosing of norfloxacin administered via the drinking water at 15 mg/kg body weight proved to be more efficacious than the continuous dosing method of 100 mg/L for 5 days in chickens, while there were no convincing differences between the two treatment regimens in turkeys. The results confirmed earlier observations on the pharmacokinetic properties of norfloxacin in chicks and turkeys (Laczay et al., 1998).

The impact of norfloxacin, ciprofloxacin and ofloxacin on human gut colonization by Candida albicans.

We studied gastrointestinal (GI) colonization by Candida albicans in patients receiving oral norfloxacin, ciprofloxacin or ofloxacin as monotherapy for urinary tract infections. Quantitative stool cultures for C. albicans were performed before, at the end and 1 week after the end of treatment. All 3 quinolones increased GI colonization by C. albicans. Ciprofloxacin caused the highest increase, which was not statistically significant.

COST-EFFECTIVENESS OF DECONTAMINATION OF THE DIGESTIVE TRACT IN LIVER TRANSPLANTATION

728 Introduction Efficacy and cost-effectiveness of selective decontamination (SD) of the bowel to prevent infections in patients undergoing liver transplantation are still debated. Therefore, a randomised placebo-controlled trial was performed with an integrated economic evaluation. Results of the economic evaluation, which to our knowledge is the first full economic evaluation of SD in liver transplantation, will be presented. Patients and Methods Patients of two university hospitals in the Netherlands were randomised to receive either SD or placebo as soon as they were accepted for elective liver transplantation. Patients on SD had a preoperative regimen consisting of oral norfloxacin 400 mg once daily and lozenges containing 2 mg colistine, 1,8 mg tobramycin and 10 mg amphotericin B, four times daily. Postoperatively, patients received a suspension containing 200 mg colistine, 80 mg tobramycin and 500 mg amphotericin B, four times daily through the nasogastric tube, combined with an oral paste containing a 2% solution of the same drugs. Patients on placebo were on a similar regimen with placebo drugs. An economic evaluation was performed with postoperative infection episodes (till 30 days after transplantation) as effect parameter. As infection episodes did not differ between groups, a cost minimisation analysis was performed, in which incremental costs were assessed. Besides costs related to SD (medication and routine cultures) other direct medical costs (e.g. hospitalisation, outpatient visits, services, other medication) were determined, both pre- and postoperatively (till 30 days after transplantation). True resource costs were assessed against unit prices of 1997. Costs were compared with a Mann-Whitney U test. A p-value of <0.05 was considered significant. All analyses were by per protocol analysis. Results Pre-operative costs were based on 58 patients: 29 in the SD group and 29 in the placebo group. Post-operative costs and infections were based on 55 patients: 26 in the SD group and 29 in the placebo group (3 SD patients died during or immediately after transplantation and were excluded). Costs of SD medication and routine cultures were evidently higher in the SD group; on average $3,300 per patient. The other direct medical costs did not significantly differ between both groups, and became $28,900 and $29,200 in, respectively, the SD and the placebo group. As no differences in other costs existed, incremental costs of SD did not differ from the additional costs of SD medication and routine cultures. There was no significant difference in infection episodes. Conclusions SD leads to additional costs of SD medication and routine cultures, whereas no savings in other costs are realised. Besides that, no improvement in infection episodes is realised by SD. Consequently, SD is a non-efficient approach in liver transplants.

Parenteral antibiotic prophylaxis of bacterial infections does not improve cost-efficacy of oral norfloxacin in cirrhotic patients with gastrointestinal bleeding

Objective: Selective intestinal decontamination with norfloxacin is useful in the prevention of bacterial infections in cirrhotic patients with gastrointestinal bleeding. However, bleeding cirrhotic patients with ascites, encephalopathy, or shock are at high risk to develop bacterial infections in spite of prophylactic norfloxacin. The aim of this study was to assess whether the addition of intravenous ceftriaxone could improve the efficacy of prophylaxis with norfloxacin in these patients. Methods: Fifty-six cirrhotic patients with gastrointestinal hemorrhage and ascites, encephalopathy, or shock were randomized into two groups: Group 1 (n = 28) received oral norfloxacin 400 mg/12 h for 7 days, and group 2 (n = 28) received norfloxacin plus intravenous ceftriaxone 2 g daily during the first 3 days of admission. Results: Ten patients were excluded because of community-acquired infection, surgery, or death within the first 24 h. The incidence of bacterial infections during hospitalization was 18.1% in group 1 and 12.5% in group 2 ( p = NS). The incidence of severe infections (spontaneous bacterial peritonitis, bacteremia, or pneumonia) was also similar in both groups: 9% in group 1 versus 8.3% in group 2 ( p = NS). There were no statistical differences between the two groups with respect to duration of hospitalization or mortality. The cost of antibiotic therapy (including prophylaxis and treatment of infections) was significantly higher in group 2. Conclusion: These results suggest that the addition of intravenous ceftriaxone during the first 3 days of hospitalization does not improve the cost-efficacy of oral norfloxacin in the prevention of bacterial infections in cirrhotic patients with gastrointestinal bleeding and high risk of infection.

Spontaneous bacterial peritonitis.

Spontaneous bacterial peritonitis (SBP) is considered a bacterial infection of ascitic fluid without any intraabdominal, surgically treatable source of infection. Multiple variants of this infection with a different clinical setting and outcome have been described during the past decade. Bacterial translocation from the gut to mesenteric lymph nodes, depressed activity of the reticuloendothelial phagocytic system and decreased antimicrobial capacity of ascitic fluid seem to be the main steps in the pathogenesis of ascitic fluid infection. Diagnosis of ascitic fluid infection is based on clinical suspicion and analysis of ascitic fluid, especially white cell count and culture in blood culture bottles. A low threshold for performing an abdominal paracentesis is the key for an early diagnosis and treatment. A third-generation cephalosporin is the treatment of choice, achieving a cure rate higher than 80%. Nonazotemic patients with nonadvanced, uncomplicated SBP may be treated with oral ofloxacin. Prophylactic selective intestinal decontamination with oral norfloxacin is extremely useful in preventing SBP in patients that are at high risk for developing SBP, such as hospitalized cirrhotic patients with gastrointestinal hemorrhage or low ascitic fluid total protein. Primary or secondary long-term prophylaxis of SBP also decreases the incidence of SBP, but these patients should be carefully observed for detecting possible infections caused by quinolone-resistant organisms. Since long-term prognosis of SBP patients is poor, survivors should be considered for liver transplantation.

Effect of Norfloxacin, Trimethoprim-Sulfamethoxazole and Nitrofurantoin on Fecal Flora of Women with Recurrent Urinary Tract Infections

The effects of antibiotics used for prophylaxis in women with recurrent urinary tract infections (UTIs) on the aerobic intestinal flora were investigated. Twenty-one patients with recurrent UTIs were randomly divided into three groups. The patients of each group received monotherapy with oral norfloxacin, trimethoprim-sulfamethoxazole or nitrofurantoin for one month. Urine and stool quantitative aerobic cultures were performed before prophylaxis, 2 and 4 weeks after the initiation of therapy, and 2 weeks after antibiotics were discontinued. The gram-negative aerobic flora was strongly suppressed during the administration of norfloxacin and trimethoprim-sulfamethoxazole, while Enterococcus spp. were not affected. Resistant strains of Escherichia coli were detected in two patients, one in the norfloxacin and one in the trimethoprim-sulfamethoxazole group. The aerobic intestinal flora was not affected by nitrofurantoin. These findings help in the selection of the most appropriate antimicrobial agent for prophylaxis in recurrent UTIs, so as to reduce the possibility of emergence of resistant bacterial strains.

Effect of selective bowel decontamination with norfloxacin on spontaneous bacterial peritonitis, translocation, and survival in an animal model of cirrhosis

Selective bowel decontamination with the orally administered quinolone antibiotic, norfloxacin, has been shown to suppress gut gram-negative bacteria and help prevent gram-negative infections in cirrhotic patients who are at high risk of bacterial infection. Because this drug does not eradicate gram-positive organisms, it is conceivable that gram-positives could replace the suppressed gram-negatives in the gut and lead to subsequent infection. Also the effect of norfloxacin on translocation (as defined by culture positivity of mesenteric lymph nodes) has received little attention. In this study, the effect of oral norfloxacin on translocation, bacterial peritonitis, and survival was investigated in an animal model of carbon tetrachloride—induced cirrhosis and ascites. Treated rats received daily doses of orally administered norfloxacin from the onset of cirrhosis until they died or were killed. Controls received no antibiotic. Norfloxacin led to a reduction in bacterial peritonitis from 70% in untreated cirrhotic controls to 28% in treated cirrhotic rats; these data were statistically significant (P = 0.012). There was no effect on overall translocation rate (28% with norfloxacin vs. 50% without norfloxacin) (P &gt; 0.1). Gram-positives were isolated in 100% of the bacterial peritonitis episodes and in 71.4% of culture-positive mesenteric lymph nodes in treated animals compared with only 25% of peritonitis episodes and 10% of culture-positive mesenteric lymph nodes of untreated cirrhotic controls (P &lt; 0.01 for peritonitis and P &lt; 0.05 for translocation). The survival rate was not different between groups (P &gt; 0.1). Although norfloxacin was associated with a 60% reduction in the overall rate of peritonitis, this drug increased the risk of gram-positive translocation and gram-positive peritonitis, and did not prolong survival in this animal model.

Effect of selective bowel decontamination with norfloxacin on spontaneous bacterial peritonitis, translocation, and survival in an animal model of cirrhosis

Selective bowel decontamination with the orally administered quinolone antibiotic, norfloxacin, has been shown to suppress gut gram-negative bacteria and help prevent gram-negative infections in cirrhotic patients who are at high risk of bacterial infection. Because this drug does not eradicate gram-positive organisms, it is conceivable that gram-positives could replace the suppressed gram-negatives in the gut and lead to subsequent infection. Also the effect of norfloxacin on translocation (as defined by culture positivity of mesenteric lymph nodes) has received little attention. In this study, the effect of oral norfloxacin on translocation, bacterial peritonitis, and survival was investigated in an animal model of carbon tetrachloride—induced cirrhosis and ascites. Treated rats received daily doses of orally administered norfloxacin from the onset of cirrhosis until they died or were killed. Controls received no antibiotic. Norfloxacin led to a reduction in bacterial peritonitis from 70% in untreated cirrhotic controls to 28% in treated cirrhotic rats; these data were statistically significant ( P = .012). There was no effect on overall translocation rate (28% with norfloxacin vs. 50% without norfloxacin) ( P > .1). Gram-positives were isolated in 100% of the bacterial peritonitis episodes and in 71.4% of culture-positive mesenteric lymph nodes in treated animals compared with only 25% of peritonitis episodes and 10% of culture-positive mesenteric lymph nodes of untreated cirrhotic controls ( P < .01 for peritonitis and P < .05 for translocation). The survival rate was not different between groups ( P > .1). Although norfloxacin was associated with a 60% reduction in the overall rate of peritonitis, this drug increased the risk of gram-positive translocation and gram-positive peritonitis, and did not prolong survival in this animal model.

Short-course ciprofloxacin treatment of acute uncomplicated urinary tract infection in women. The minimum effective dose. The Urinary Tract Infection Study Group [corrected

Three studies were undertaken to determine the minimum effective dosing regimen of ciprofloxacin for the treatment of acute, symptomatic, uncomplicated lower urinary tract infection. All studies were multicenter, prospective, randomized, double-blind trials. A total of 970 evaluable patients with a diagnosis of urinary tract infection received oral ciprofloxacin (200 mg to 500 mg daily in one or two divided doses for 1, 3, 5, or 7 days) or norfloxacin (400 mg twice daily [BID] for 7 days). The primary measure of efficacy was bacteriologic eradication at the end of therapy. In study 1, bacteriologic eradication was reported in 95 (89%) and 101 (98%) of patients in the groups who received ciprofloxacin, 500-mg single dose and 250 mg BID for 7 days, respectively. Clinical success occurred in 101 patients (94%) who received a 500-mg single dose and in 103 patients (100%) who were administered 250 mg BID for 7 days. In study 2, eradication rates in the groups who received ciprofloxacin, 100 mg BID for 3 days, 250 mg BID for 3 days, and 250 mg BID for 7 days, were 98 (93%), 95 (90%), and 98 (93%), respectively. Clinical success was reported in 102 (97%), 105 (100%), and 104 (98%) of the patients, respectively. In study 3, the eradication rates in the groups who received ciprofloxacin in dosages of 500 mg once daily for 3 days and 500 mg once daily for 5 days and norfloxacin in a dosage of 400 mg BID for 7 days were 137 (92%), 134 (90%), and 133 (94%) of the women, respectively. Clinical success was the same (97%) in all three groups. Overall, short-course (either 3- or 5-day) therapy with ciprofloxacin was statistically equivalent to conventional (7-day) therapy with either ciprofloxacin or norfloxacin. Single-dose ciprofloxacin therapy was statistically less effective than conventional treatment. Ciprofloxacin at a dosage of 100 mg BID for 3 days was the minimum effective dose for the treatment of uncomplicated urinary tract infection in women.

Short-Course Ciproflox Treatment of Acute Uncomplicated Urinary Tract Infection in Women

Background: Three studies were undertaken to determine the minimum effective dosing regimen of ciprofloxacin for the treatment of acute, symptomatic, uncomplicated lower urinary tract infection. Methods: All studies were multicenter, prospective, randomized, double-blind trials. A total of 970 evaluable patients with a diagnosis of urinary tract infection received oral ciprofloxacin (200 mg to 500 mg daily in one or two divided doses for 1, 3, 5, or 7 days) or norfloxacin (400 mg twice daily [BID] for 7 days). The primary measure of efficacy was bacteriologic eradication at the end of therapy. Results: In study 1, bacteriologic eradication was reported in 95 (89%) and 101 (98%) of patients in the groups who received ciprofloxacin, 500-mg single dose and 250 mg BID for 7 days, respectively. Clinical success occurred in 101 patients (94%) who received a 500-mg single dose and in 103 patients (100%) who were administered 250 mg BID for 7 days. In study 2, eradication rates in the groups who received ciprofloxacin, 100 mg BID for 3 days, 250 mg BID for 3 days, and 250 mg BID for 7 days, were 98 (93%), 95 (90%), and 98 (93%), respectively. Clinical success was reported in 102 (97%), 105 (100%), and 104 (98%) of the patients, respectively. In study 3, the eradication rates in the groups who received ciprofloxacin in dosages of 500 mg once daily for 3 days and 500 mg once daily for 5 days and norfloxacin in a dosage of 400 mg BID for 7 days were 137 (92%), 134 (90%), and 133 (94%) of the women, respectively. Clinical success was the same (97%) in all three groups. Overall, short-course (either 3- or 5-day) therapy with ciprofloxacin was statistically equivalent to conventional (7-day) therapy with either ciprofloxacin or norfloxacin. Single-dose ciprofloxacin therapy was statistically less effective than conventional treatment. Conclusions: Ciprofloxacin at a dosage of 100 mg BID for 3 days was the minimum effective dose for the treatment of uncomplicated urinary tract infection in women. (Arch Intern Med. 1995;155:485-494)

Spontaneous bacterial peritonitis in liver cirrhosis: treatment and prophylaxis.

Spontaneous bacterial peritonitis in liver cirrhosis is due to the passage of intestinal bacteria into intestinal lymph vessels, systemic circulation and ascitic fluid. It may occur in patients with severe portal hypertension and hepatic failure, impaired reticuloendothelial phagocytic activity and low ascitic fluid opsonic activity. Spontaneous bacterial peritonitis is a monomicrobial infection usually caused by gram-negative bacteria. The treatment of choice of spontaneous bacterial peritonitis is cefotaxime. Several subgroups of cirrhotic patients have been shown to be predisposed to develop spontaneous bacterial peritonitis, including cases with gastrointestinal hemorrhage, patients with high serum bilirubin and low ascitic fluid protein concentration (< 1 g/dl), and patients who had recovered from an episode of spontaneous bacterial peritonitis. Since spontaneous bacterial peritonitis is associated with a relatively high in-hospital mortality rate (20-40%), prophylactic measures to prevent this infection are required. Short-term and long-term selective intestinal decontamination with oral norfloxacin has proved highly effective in preventing bacterial infection and spontaneous bacterial peritonitis in bleeding cirrhotic patients as well as recurrence of spontaneous bacterial peritonitis.

Fine‐needle aspiration of cutaneous malakoplakia

A 99-yr-old Chinese woman with cutaneous malakoplakia and concomitant urinary tract infection was reported. The patient presented with an ulcerated right lower quadrant mass and computerized tomography showed that it was limited to the skin and subcutaneous tissue with no extension to the pelvic or abdominal structures. The patient also suffered from urinary tract infection and was treated with oral norfloxacin. The ulcerated subcutaneous mass disappeared on follow-up visit 6 months after presentation. The cytologic (fine-needle aspiration), histologic (trucut biopsy) and ultrastructural features of cutaneous malakoplakia were described. The possible usefulness of fine-needle aspiration in the diagnosis of this condition was discussed.

Effects of Six Antimicrobial Drugs on Rat Intestinal Flora: Is the Rat Model of Predictive Value in Clinical Practice?

The effects of six antimicrobial agents on rat intestinal microflora after oral and/or parenteral administration were studied in parallel. Antimicrobial drugs were administered by the oral (norfloxacin, pefloxacin, ciprofloxacin) and parenteral routes (pefloxacin, imipenem, aztreonam, teicoplanin) at the doses used in clinical practice. Faecal specimens were collected before and after two, four, seven or 1 1 treatments. Qualitative and quantitative determination of flora composition was performed using a modified version of standard methods. Fluoroquinolones reduced the levels of enterobacteria, while gram-positive bacteria (enterococci, staphylococci, lactobacilli) were little affected. Comparable effects were observed after intraperitoneal and oral administration of pefloxacin. The changes induced by fluoroquinolones on intestinal flora showed a uniform trend: certain differences may be ascribed to different pharmacokinetic properties such as bioavailability and melabolism. lmipenem caused a significant decrease in mean concentrations of E. coli , clostridia and fungi. Aztreonam induced a prompt and marked inhibition of E. coli and Proteus spp., while prolonged treatment induced an overgrowth of fungi and bacteroides. Teicoplanin caused a significant decrease in the levels of clostridia and anaerobic lactobacilli. Irregular concentrations of all drugs, with great intersubject variability, were detected at different times. These results are comparable to those observed in humans. The potential of an antimicrobial agent to change the intestinal microflora is related to its antibacterial activity, route of administration and pharmacokinetic properties. The parenteral route induced changes in the intestinal ecosystem, as did oral administration. The rat appears to be a useful experimental model for studying the effects of antimicrobial drugs on intestinal flora. Keywords - Intestinal microflora; Antibiotics; Fluoroquinolones; Imipenem; Teicoplanin; Aztreonam; Rat.

A worldwide clinical overview of lomefloxacin, a once-daily fluoroquinolone

Lomefloxacin, an orally active difluorinated quinolone, is active against a wide variety of clinically relevant Gram-negative and Gram-positive organisms. A totoal of 3387 evaluable patients received (both complicated and uncomplicated), acute exacerbations of chronic bronchitis, acute bacterial diarrhea, skin and skin structure infections, or for prophylaxis during urinary tract surgery or instrumentation. In these studies lomefloxacin was compared with oral norfloxacin, ciprofloxacin, trimethoprim/sulfamethoxazole, amoxicillin and cefaclor, and the parenteral agents cefotaxime and cefuroxime. Once-daily oral administration of lomefloxacin was either equally effective or statistically significantly superior in clinical and/or bacteriologic efficacy to comparative agents that were administered two or three times per day (except for prophylaxis studies, in which single doses of each antibiotic were administered preoperatively). The safely of lomefloxacin was assessed in 3246 patients and subjects. Most adverse events were mild to moderate in severity. In general, the incidence of adverse events for patients and subjects receiving lomefloxacin was comparable to that observed in patients treated with comparative drugs. The incidence of adverse events in elderly patients was similar to that observed in younger patients. Concurrent administratopm of the ophylline did not increase the incidence of adverse events. The most common adverse events were related tothe gastrointestinal tract (nausea), the skin and appendages (photosensitivity) and the central nervous system (dizziness). Lomefloxacin, administered orally once daily, is effective and well tolerated in patients with a variety of infections of bacterial origin.

The U.S. clinical experience with lomefloxacin, a new once-daily fluoroquinolone

Lomefloxacin is a new fluoroquinolone antimicrobial agent that has undergone extensive worldwide clinical evaluation. This report summarizes the safety and efficacy of lomefloxacin in the treatment of uncomplicated urinary tract infections, complicated urinary tract infections, acute exacerbations of chronic bronchitis, and for prophylaxis during urinary tract surgery. The clinical data presented are an overview of all clinical studies conducted in the United States to date. The results have been derived from multiple studies in which patients received lomefloxacin or a comparative agent in either blinded or open-label studies. During the course of the clinical program in the United States, lomefloxacin has been compared with oral norfloxacin, ciprofloxacin, and cefaclor, as well as parenteral cefotaxime. In all instances, the once-daily oral administration of lomefloxacin was either equally effective or statistically significantly superior in clinical and/or bacteriologic efficacy to these comparative agents. In addition, the comparators were administered either two or three times per day, except in the surgical prophylaxis studies, in which single doses of each antibiotic were administered preoperatively. These results attest to the value of the convenience and simplicity of the oral dosing regimen for lomefloxacin. During the course of the clinical program, lomefloxacin was well tolerated, with most adverse events of mild to moderate severity. In general, the incidence of adverse events for patients and subjects receiving lomefloxacin was comparable to that observed in patients treated with comparator drugs. The most common adverse events were related to the gastrointestinal tract (nausea and diarrhea), the skin and appendages (photosensitivity), and the central nervous system (dizziness and headache).

A new method for assaying antimicrobials in the prostate

In this study we collected prostatectomy specimens from 20 men receiving selected preoperative antimicrobials: oral carbenicillin, norfloxacin, or ciprofloxacin. The prostatectomy specimens were then individually separated into stroma and epithelium. The intraprostatic differential concentrations were determined using High Performance Liquid Chromatography. The ratio of stromal to epithelial concentrations of the antimicrobials were calculated for carbenicillin (0.95), norfloxacin (1.28), and ciprofloxacin (1.1). The quinolones tended to have higher stromal concentrations (although this was not statistically significant). Carbenicillin was found in levels three times its MIC90 for Escherichia coli while the quinolones were detected in concentrations which greatly exceeded their E. coli MIC90S.