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Query: UMLS:C0917801 (insomnia)
 10,606 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

Fleroxacin (FLRX), a new quinolone oral antibacterial agent, was studied in the field of obstetrics and gynecology, and the following results were obtained. 1. Clinical efficacy was evaluated in 105 patients (intrauterine infection 38, adnexitis 28, extragenital organ infection 29, others 10), with an exclusion of 9 patients out of a total of 114 patients. FLRX was orally administered at 200 mg or 300 mg once daily. 2. Clinical efficacy rates were 37/38 (97.4%) in intrauterine infection, 26/28 (92.9%) in adnexitis, 29/29 (100%) in extragenital organ infection and 10/10 (100%) in others. 3. Efficacy rates classified by isolated organisms were 23/23 (100%) in single infections by Gram-positive organisms, 11/13 (84.6%) in those by Gram-negative organisms, 8/9 (88.9%) in those by anaerobic organisms and 15/19 (78.9%) in mixed infections. 4. Side effects were observed in 4 cases (3.5%); gastrointestinal disorder with diarrhea and diarrhea in 1 patient each and insomnia in 2 patients. In laboratory examination, eosinophilia and elevation of GOT and GPT were noted in 1 patient each (1.9%). Based on the above results, we consider that FLRX is a useful drug for the obstetrical and gynecological infections.
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PMID:[Clinical evaluation of fleroxacin in gynecological infections]. 190 63

Fleroxacin, 400 mg once daily, and norfloxacin, 400 mg twice daily, both administered orally, were compared for the treatment of serious urinary tract infections (UTIs). In total, 301 patients from multiple centers who had serious UTIs were randomized to receive fleroxacin or norfloxacin in a double-blind study. The demographic parameters of the two groups were similar. A total of 190 patients were evaluable for efficacy, 94 in the fleroxacin group and 96 in the norfloxacin group. The reasons for exclusion from the efficacy analysis were not significantly different in the two groups, but more patients receiving fleroxacin were prematurely withdrawn from the study. The majority (134) of the diagnoses were complicated UTI, and the pathogens were primarily Enterobacteriaceae. The clinical responses were cure or improvement in 98% of the fleroxacin group and 92% of the norfloxacin group and failure in 2% of the fleroxacin group and 7% of the norfloxacin group. The bacteriologic results by infection were cure in 98% of the fleroxacin group and 89% of the norfloxacin group (including cure with superinfection in 4% of the fleroxacin group and 5% of the norfloxacin group) and failure in 2% of the fleroxacin group and 11% of the norfloxacin group. Adverse events were more common in the fleroxacin group and were mostly nausea, insomnia, and headache. Fleroxacin, 400 mg once daily, was as effective as norfloxacin, 400 mg twice daily, in eradicating UTIs but was associated with more adverse events.
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PMID:Fleroxacin versus norfloxacin for oral treatment of serious urinary tract infections. 845 64

This study enrolled patients with complicated urinary tract infections (UTIs) in a trial to determine the efficacy and safety of sequential therapy with intravenous fleroxacin (first 3 days) followed by oral fleroxacin, for a total course of 7-14 days, both administered at a dosage of 400 mg once a day. We enrolled 68 patients with complicated UTIs or acute pyelonephritis, 32 of whom were evaluable for bacteriologic and clinical efficacy. The pathogens isolated included Escherichia coli, 15; enterococci, 9; miscellaneous, 15. Intravenous fleroxacin was given for a mean of 3.2 days, followed by oral fleroxacin for a mean of 5.3 days. A total of 27 patients were clinically cured (84%), two improved, and three failed. A total of 26 patients were bacteriologically cured (81%), and six failed (19%). The bacteria that were not eradicated included enterococci, 4; Staphylococcus epidermidis, 1; and Pseudomonas species, 1. One enterococcal isolate became resistant to fleroxacin. Four patients were bacteremic (E. coli, 3; Proteus mirabilis, 1); the pathogen was eradicated in all cases. Two patients developed urinary enterococcal superinfections. A total of 12 patients experienced 16 adverse reactions remotely, possibly, or probably related to fleroxacin (insomnia, 3; dizziness, 2; miscellaneous, 11). One patient had a grand mal seizure after aspirating gastric contents; the seizure was thought to be only remotely related to the study drug. Fleroxacin was discontinued in two patients because of adverse effects (phlebitis at intravenous access site, 1; anxiety and insomnia, 1). Only minor and asymptomatic laboratory abnormalities were observed. All clinical and laboratory abnormalities resolved with discontinuation of the study drug. Fleroxacin is a safe and effective antibiotic for sequential intravenous and oral treatment of acute pyelonephritis and complicated UTIs. Enterococci may be problematic pathogens, as reported with other fluoroquinolones.
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PMID:A sequential study of intravenous and oral fleroxacin in the treatment of complicated urinary tract infection. 845 68

In a multicenter study the efficacy and safety of oral fleroxacin at 400 mg once a day and amoxicillin at 500 mg three times daily for 7 days were compared for the treatment of patients with acute bacterial exacerbations of chronic bronchitis due to drug-susceptible bacteria. A total of 194 patients were enrolled, 102 in the fleroxacin group and 92 in the amoxicillin group. Of those enrolled, 22 in the fleroxacin group and 30 (29 for clinical efficacy) in the amoxicillin group were included in the efficacy analysis. All were included in the safety analysis. Clinical success was noted in 21 (95%) of 22 fleroxacin-treated patients and 22 (76%) of 29 amoxicillin-treated patients. Bacteriologic cure was obtained in 21 (95%) of 22 of the fleroxacin group and 18 (60%) of 30 of the amoxicillin group. One Haemophilus parainfluenzae strain persisted with fleroxacin. Persisting organisms with amoxicillin included Haemophilus influenzae (four), Haemophilus parainfluenzae (three), Escherichia coli (two), Streptococcus pneumoniae (one), Neisseria species (one), and Proteus mirabilis (one). Adverse events were reported by 41% of 102 patients receiving fleroxacin and 15% of 92 patients receiving amoxicillin. Insomnia, dizziness, and nausea occurred more frequently with fleroxacin. Fleroxacin may be indicated for the treatment of acute bacterial infection in chronic bronchitis known to be due to Haemophilus species and Moraxella catarrhalis. The 92% incidence of resistance among the S. pneumoniae isolates recovered from all enrolled patients suggests that fleroxacin may not be useful for such infections.
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PMID:Efficacy of fleroxacin versus amoxicillin in acute exacerbations of chronic bronchitis. 845 69

The object of this open-label, noncomparative, multicenter study was to evaluate the efficacy and safety of 400 mg of fleroxacin administered orally once daily for 2-12 weeks to patients with bone and joint infections (osteomyelitis, septic arthritis, and prosthetic joint infection). A total of 90 adult patients (56 men and 34 women) were treated at 11 centers. Patients returned on days 5-9 of treatment, subsequently every 2 weeks during treatment, and 0-3 days and 28-42 days (compulsory follow-up) after treatment for assessment of bacteriologic, clinical, and safety parameters. A total of 19 patients (13 with osteomyelitis, 5 with septic arthritis, and 1 with prosthetic joint infection) were bacteriologically evaluable. Staphylococcus aureus was the predominant pathogen isolated in all evaluable infections. Of the 13 patients with osteomyelitis, 11 (85%) were bacteriologically cured and 10 (77%) were clinically cured. Three of the five patients with septic arthritis and the single patient with a prosthetic joint infection were both bacteriologically and clinically cured. Clinical adverse events related to fleroxacin were reported by 25 (28%) of the 90 patients. Most of these events involved the digestive system (primarily constipation and nausea) and the central nervous system (primarily insomnia and headache). The majority of these were of mild or moderate intensity and occurred during the first 2 weeks of treatment. Adverse events led to premature discontinuation of treatment in seven patients. Bone and joint infections continue to represent a therapeutic challenge. Treatment is based mainly on surgical procedures (drainage, sequestrectomy, ablation of implants, and implantation of cement impregnated with antibiotics) and on parenteral administration of antibiotics, requiring hospitalization of the patient. Fleroxacin, a new fluoroquinolone, has proven in vitro activity against bacteria involved in bone and joint infections. Its oral, once-daily administration, which eliminates hospitalization and its attendant costs, makes this drug an effective outpatient treatment of bone and joint infections.
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PMID:A pilot study of oral fleroxacin given once daily in patients with bone and joint infections. 845 77

The clinical efficacy and safety of single-dose and multiple-dose fleroxacin were assessed and compared with those of ciprofloxacin in women with uncomplicated urinary tract infection (UTI) in this clinical study. This multicenter, randomized, double-blind, prospective study compared single-dose therapy with fleroxacin, 400 mg, with 7-day courses of fleroxacin, 200 mg once a day, and ciprofloxacin, 250 mg twice a day, in the treatment of uncomplicated symptomatic UTI in women at 18 centers in the United States. Of 961 patients enrolled, 316 were in the fleroxacin single-dose group, 321 in the fleroxacin 7-day group, and 324 in the ciprofloxacin group. Of these patients, 943 met the criteria for inclusion in the safety analysis and 556 met those for inclusion in the efficacy analysis. Bacteriologic cure rates at 5-9 days after therapy in patients evaluable for efficacy were 88%, 96%, and 96% in the single-dose fleroxacin group, 7-day fleroxacin group, and 7-day ciprofloxacin group, respectively (p < 0.05). Clinical cures occurred in 93.6%, 97.2%, and 98% of the groups, respectively (difference not significant). At 4-6 weeks after therapy, the rates of bacteriologic cure in the single-dose fleroxacin group, 7-day fleroxacin group, and 7-day ciprofloxacin group were 91%, 89%, and 93%, respectively (difference not significant). Adverse events were similar to those with other new quinolones and comparable among the treatment groups. Insomnia was more frequent in patients who received fleroxacin. Fleroxacin and ciprofloxacin as multidose regimens are similarly safe and effective in the treatment of uncomplicated UTI in women. Single-dose fleroxacin achieved a clinical response rate comparable to that achieved by the multiple-dose regimens, whereas its bacteriologic eradication rate was inferior.
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PMID:Multicenter study of single-dose and multiple-dose fleroxacin versus ciprofloxacin in the treatment of uncomplicated urinary tract infections. 845 89