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Lomefloxacin

A Review of its Antibacterial Activity, Pharmacokinetic Properties and Therapeutic Use

An Erratum to this article was published on 01 July 1992

Abstract

Synopsis

The antibacterial efficacy of oral lomefloxacin has been investigated in a wide variety of infections, including respiratory and uncomplicated and complicated urinary tract infections, obstetric, gynaecological, joint, skin, oral, ear, nose, throat and eye infections. It has also been used as an otic solution in patients with otitis media and as an ophthalmic solution in the treatment of eye infections. In clinical trials its efficacy is equivalent to that of other quinolones and it is at least as effective as other antibacterial drugs ordinarily used in these infections. Lomefloxacin offers certain advantages compared with other quinolone antibacterial drugs in that it may be conveniently administered once daily and theophylline dosage adjustment does not appear to be necessary in patients receiving this bronchodilator concomitantly. Thus, orally administered lomefloxacin should prove a useful broad spectrum antibacterial drug for a wide variety of clinical infections.

Antibacterial Activity

Lomefloxacin is a difluorinated quinolone with a piperazinyl group on the quinolone ring. In vitro it has been shown to be active against most Gram-negative bacteria, including Citrobacter, Enterobacter, Klebsiella, Proteus, Salmonella, Shigella, Yersinia, Campylobacter, and Haemophilus species, Escherichia coli and Neisseriaceae, with minimum concentrations required to inhibit 90% of strains (MIC90) ≤ 2 mg/L. Against such organisms lomefloxacin was as active as other quinolones, except ciprofloxacin, which was slightly more active in vitro. Compared with nonquinolone antibacterial drugs lomefloxacin was more potent than ampicillin or gentamicin, and at least as potent as cefotaxime, ceftazidime and cotrimoxazole against most Gram-negative organisms, including Enterobacteriaceae.

Lomefloxacin was more active against Pseudomonas aeruginosa than gentamicin, cefotaxime or ceftazidime and exhibited similar antibacterial activity to enoxacin, ofloxacin and norfloxacin against these isolates. However, Pseudomonas spp. were generally less susceptible to lomefloxacin and other quinolones than the majority of Gram-negative organisms. The activity of lomefloxacin against Providencia and Acinetobacter species was similar to that against P. aeruginosa. Chlamydia trachomatis, Legionella species (including L. pneumophila), Aeromonas species, Bordetella pertussis, Bordetella parapertussis, and both Vibrio cholerae and Vibrio parahaemolyticus were susceptible to lomefloxacin. Ureaplasma urealyticum and both Mycoplasma pneumoniae and Mycoplasma hominis were as susceptible to lomefloxacin as to ciprofloxacin.

Lomefloxacin was a less active inhibitor of Gram-positive than Gram-negative aerobic bacteria in vitro, but was considerably more effective against staphylococci than norfloxacin or nalidixic acid. Generally streptococci were only moderately susceptible to lomefloxacin.

Anaerobic bacteria were not generally susceptible to lomefloxacin. Lomefloxacin had similar antibacterial activity to enoxacin and norfloxacin against the anaerobes Bacteroides, Clostridium, Fusobacterium and Peptostreptococcus, but was less potent than ofloxacin or ciprofloxacin against these bacteria.

Growth media, inoculum size and the presence of serum were reported as having variable but minimal effects on the antibacterial activity of lomefloxacin, which nonetheless was reduced in acidic environments and urine. Although there have been some reports of reduced susceptibility of nalidixic acid resistant strains to lomefloxacin, bacterial resistance to nonquinolone antibacterial agents did not influence the activity of lomefloxacin. The incidence of development of resistance to lomefloxacin was generally similar to that for other quinolones. In in vitro studies the incidence of resistance in single step mutation studies was in the 10-10 range, although incidences were up to 8 x 10-7 for P. aeruginosa and other common bacterial isolates at 4 to 12 times the MIC. There is also increasing evidence of resistance to lomefloxacin and other quinolones among Pseudomonas spp., enterococci, Enterobacteriaceae and S. aureus isolates.

Pharmacological Effects

Preclinical toxicity studies in various species revealed no significant evidence of toxicity. In young rats lomefloxacin caused articular damage, but the clinical implications of these findings, if any, are unknown. In the gastrointestinal tract lomefloxacin markedly reduces Enterobacteriaceae numbers but has a lesser effect against streptococci or micrococci, and little or no effect on anaerobic bacteria.

The antibacterial activity of the quinolones has been attributed to inhibition of the enzyme DNA gyrase, a type II topoisomerase. However, lomefloxacin had no mutagenic effects in vitro and had cytotoxic effects on eukaryotic topoisomerases only at very high concentrations.

Pharmacokinetics

Following oral administration of a 200mg dose of lomefloxacin peak serum concentrations ranging from 1.5 to 2.5 mg/L are achieved within 2 hours, while peak serum concentrations of about 3 to 5.2 mg/L are reached after a 400mg dose. Accumulation was not observed during multiple dose administration of either 400mg once daily or 300mg 3 times daily for 7 days. An administration regimen of 400mg once daily resulted in plasma concentrations above the MIC90 for susceptible Enterobacteriaceae for at least 12 hours compared with only 5 hours during a 200mg twice daily regimen. Food had no significant effect on the pharmacokinetics of lomefloxacin. The apparent volume of distribution of lomefloxacin has been calculated to be about 1.7 to 2.5 L/kg. Lomefloxacin is 10% protein bound and rapidly penetrates most tissues. Concentrations achieved in bile tissue or fluid, prostate and lung tissue, and bronchial mucosa were higher than those detected in serum.

Within 48 hours of administration of single doses of 200 and 400mg in healthy volunteers 70 to 80% of the drug was excreted unchanged in the urine, most of this within the first 24 hours. However, the urinary lomefloxacin concentration remained well above the MIC90 for most susceptible bacterial species 24 hours after administration. Small amounts of lomefloxacin glucuronide and 4 other metabolites have been detected in the urine and bile of healthy volunteers.

In such volunteers renal clearance of lomefloxacin following single 200 or 400mg doses ranged from 7 to 15 L/h and elimination half-life (t1/2) from about 6 to 9 hours. In patients with impaired renal function both the t1/2 and the area under the plasma concentration-time curve (AUC) are substantially increased. Thus, dosage adjustments are necessary for patients with severe renal impairment.

Therapeutic Efficacy

The efficacy of lomefloxacin has been investigated in both noncomparative and controlled comparative studies in patients with several types of infections.

Oral lomefloxacin 200mg 3 times daily had similar clinical efficacy to cefaclor 500mg 3 times daily in Japaneses patients with bacterial pneumonia or acute exacerbation of chronic respiratory tract infection: 71 to 73% of patients in either group had ‘good to excellent’ improvement in clinical symptoms. In studies conducted in Western countries 72 to 94% of patients with respiratory tract infections treated with lomefloxacin (400mg once daily) in comparative trials showed improvement of clinical symptoms: causative bacteria were eradicated from about 80 to 90% of such patients. Overall, lomefloxacin eradicated 85 to 100% of bacteria isolated from patients with respiratory tract infections, although a lower eradication rate was observed for Gram-positive bacteria (61 to 100%). Lomefloxacin 400mg once daily was at least as effective as amoxicillin 500mg or cefaclor 250mg 3 times daily in Western patients with acute exacerbation of chronic bronchitis.

In Japanese patients with either complicated or uncomplicated urinary tract infections, divided dose regimens of lomefloxacin (200mg 3 times daily) had comparable clinical (‘good to excellent’ improvement in clinical symptoms) and bacterial (eradication of isolated pathogen) efficacies to norfloxacin (300 to 800mg daily in divided doses). In Western patients with complicated urinary tract infections clinical efficacy rates (defined as amelioration of, or improvement in, clinical symptoms) achieved during treatment with lomefloxacin 400mg once daily (86 to 97%) were similar to those achieved during therapy with norfloxacin (400mg twice daily), ciprofloxacin (250 to 500mg twice daily) and cotrimoxazole (160/800mg twice daily) in controlled comparative studies. Higher clinical efficacy rates (93 to 100%) were, however, achieved in patients with uncomplicated urinary tract infections treated with lomefloxacin. Bacteria were eradicated from 93 to 100% of patients with uncomplicated urinary tract infections and 92 to 97% of patients with complications.

The antibacterial efficacy of lomefloxacin has also been evaluated in Japanese patients with other infections. Gynaecological infections as well as nongonococcal urethritis were responsive to treatment with lomefloxacin 300 to 600mg daily in divided doses (clinical efficacy rates of 70 to 100% were achieved in most studies). A single dose of lomefloxacin 200 or 400mg eradicated N. gonorrhoeae from 98 to 100% of patients with gonorrhoeal urethritis or cervicitis.

Clinical efficacy rates of 62 to 100% have been achieved using divided dosage regimens of oral lomefloxacin 300 to 600mg in Japanese patients with various oral, ear, nose or throat infections. In most noncomparative studies, all strains of isolated S. pneumoniae and Streptococcus spp. and 66 to 100% of S. aureus were eradicated from patients with various ear, nose and throat infections. Overall bacterial eradication rates of 72 and 82%, respectively, were achieved against Gram-positive cocci and Gram-negative bacteria in patients with acute, or exacerbation of chronic, otitis media.

Improved clinical symptoms were observed in about 90% of patients with either biliary tract infections or infectious enteritis treated with oral lomefloxacin 200mg 3 times daily.

A clinical efficacy rate of 97% has been achieved using a topical ophthalmic solution in patients with various eye infections. Treatment with oral lomefloxacin 200mg 3 times daily was associated with a reduction in clinical symptoms in 74 to 86% of Japanese patients with eye infections and 75 to 91% of patients with skin, soft tissue or joint infections. Bacteria were eradicated from 64 to 100% of the latter group of patients.

Tolerability

Lomefloxacin is generally well tolerated, with most adverse effects being of mild to moderate severity and transient in nature. Gastrointestinal symptoms, mainly nausea, diarrhoea, pain/discomfort, were reported most frequently. Headache, dizziness, transient sleeplessness, dermatological or hypersensitivity reactions and photosensitivity have also been reported, although in fewer patients. In comparative studies the overall incidence of adverse events during treatment with lomefloxacin was similar to that with norfloxacin, amoxicillin, cefotaxime, and cefaclor, but tended to be lower than that for cotrimoxazole. Serious reactions necessitating withdrawal were rare: in comparative studies, treatment associated adverse events necessitating withdrawal occurred in ≤ 1% of both lomefloxacin and norfloxacin recipients. Changes in laboratory values have been reported in patients treated with lomefloxacin in clinical studies but were not considered to be drug related.

Dosage and Administration

The recommended dosage of lomefloxacin is 400mg administered orally, once daily. In Japan the recommended dosage is 200mg 3 times daily. In most cases 7 to 14 days’ of therapy are required, although 3 to 4 days therapy have been used in the treatment of uncomplicated urinary tract infections. Prolonged administration may, however, be necessary in patients with severe and complicated infections.

Treatment with single doses of 200 to 400mg is usually sufficient for patients with gonorrhoeal urethritis or cervicitis, although more severe infections may require up to 14 days’ treatment. A single oral 400mg dose has been used as prophylaxis 2 to 6 hours prior to transurethral surgery, and twice daily administration of 0.3 to 0.5ml of a 0.3% solution has been used as topical treatment for otitis media.

Dosage adjustment is required for patients with severely compromised renal function. In patients with a creatinine clearance ≤ 2 L/h (≤ 30 ml/min) the recommended dosage is 400mg on day 1 and 200mg daily thereafter.

Antacids containing magnesium and/or aluminium hydroxide interfere with the absorption of lomefloxacin, resulting in subtherapeutic serum and urine concentrations. Thus, if concomitant antacids are required concurrent administration of these antacids with lomefloxacin should be avoided by separating the ingestion of these agents by more than 2 hours. Lomefloxacin does not interact with either theophylline or caffeine.

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Various sections of the manuscript reviewed by: C. Albera, Dipartimento di Scienze Cliniche e Biologiche, Università di Torino, Torino, Italy; K.E. Aldridge, Department of Medicine Section of Infectious Diseases, School of Medicine in New Orleans, Louisiana State University Medical Center, New Orleans, Louisiana, USA; D. Höffler, Städtische Kliniken Darmstadt, Darmstadt, Federal Republic of Germany; R.N. Jones, Anti-Infectives Research Center and Special Microbiological Laboratory, The University of Iowa College of Medicine, Iowa City, Iowa, USA; R.W. Lacey, Professor of Medical Microbiology, The University of Leeds, Leeds, England; P. Martino, Università degli Studi ‘La Sapienza’, Dipartimento di Bioparologia Umana, Rome, Italy; H.C. Neu, Division of Infectious Diseases, College of Physicians and Surgeons of Columbia University, New York, New York, USA; P. Van der Auwera, Institut Jules Bordet, Centre des Tumeurs de L’Université de Bruxelles, Service de Médecine Interne et Laboratoire d’Investigation Clinique HJ Tagnon, Bruxelles, Belgium; M. Venditti, Servizio di Consulenze Infettivologiche, Università ‘La Sapienza’, Rome, Italy; R. Robson, Department of Nephrology, Christchurch Hospital, Christchurch, New Zealand; K. Shimada, Institute of Medicai Technology, University of Tokyo, Tokyo, Japan; L. Weinstein, Infectious Disease Division, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts, USA; R. Wise, Department of Medical Microbiology, Dudley Road Hospital, Birmingham, England

An erratum to this article is available at http://dx.doi.org/10.1007/BF03259098.

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Wadworth, A.N., Goa, K.L. Lomefloxacin. Drugs 42, 1018–1060 (1991). https://doi.org/10.2165/00003495-199142060-00009

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Keywords

  • Ofloxacin
  • Norfloxacin
  • Nalidixic Acid
  • Cefaclor
  • Enoxacin