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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 sub-analysis of adverse events in the respiratory studies demonstrated that concomitant administration of lomefloxacin and theophylline does not increase the incidence of adverse events when compared to lomefloxacin alone. An additional sub-analysis also showed that the incidence of adverse events in elderly patients was similar to that in younger patients. The results of the U.S. clinical program indicate that lomefloxacin administered orally once daily is effective and well tolerated in a variety of infections of bacterial origin.
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PMID:The U.S. clinical experience with lomefloxacin, a new once-daily fluoroquinolone. 131 63

The efficacy and safety of 7-10-day courses of lomefloxacin (single daily dose of 400 mg) or norfloxacin (twice-daily doses of 400 mg) for the treatment of uncomplicated urinary tract infections were compared in two large, multicenter, randomized trials. This article presents the combined results of these trials, which were conducted in a total of 27 centers throughout the United States. A total of 727 adults, mostly women, with symptoms of acute urinary tract infection were enrolled; 370 patients were randomized to lomefloxacin treatment, and 357 received norfloxacin. The bacteriologic cure rate at 5-9 days post-therapy was 98.2% in the lomefloxacin group and 96.3% in the norfloxacin group (p = nonsignificant). The clinical success rate of 99.1% in the lomefloxacin group was significantly higher than the success rate of 93.5% in the norfloxacin group (p = 0.002). Adverse events were reported by 157 lomefloxacin-treated patients and 129 patients receiving norfloxacin. Adverse events attributable to drug treatment occurred in 41 patients (11.1%) in the lomefloxacin group and 27 (7.6%) in the norfloxacin group. Eight lomefloxacin (2.2%) and three norfloxacin patients (0.8%) were withdrawn from treatment because of adverse events probably attributable to the drug. The incidence of dizziness, tremor, and photosensitivity rash was higher in the lomefloxacin group than in the norfloxacin group, while the incidence of nausea was higher in the norfloxacin group. The results of these trials demonstrate that once-daily administration of 400 mg lomefloxacin is as safe and effective clinically as, and superior bacteriologically to, twice-daily administration of 400 mg norfloxacin in the treatment of acute uncomplicated urinary tract infections in adult patients.
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PMID:Efficacy of lomefloxacin as compared to norfloxacin in the treatment of uncomplicated urinary tract infections in adults. 131 75

Photosensitivity has proved to be a useful model to study the acute effects of experimental antiepileptic drugs (AEDs). The photosensitivity range is usually diminished or even abolished after administration of a known or experimental AED. An increase in photosensitivity, an unexpected reaction, was found in four photosensitive epileptic patients after oral ingestion of 500, 100, or 50 mg of Org 6370. Moreover, the three patients receiving doses of 100 and 500 mg reported nausea, dizziness, restlessness, and an increase in spontaneous epileptic seizures (myoclonus and in one patient a generalized tonic-clonic convulsion). The side effects coincided with peak Org 6370 serum levels. Our findings indicate that in the photosensitivity model experimental drugs with proven anticonvulsant properties in animals may increase rather than decrease the degree of patient photosensitivity. Photosensitive patients may represent a special subgroup of epileptic patients and therefore need to be classified as such.
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PMID:Preliminary assessment of the efficacy of Org 6370 in photosensitive epileptic patients: paradoxical enhancement of photosensitivity and provocation of myoclonic seizures. 173 47

Safety and toleration of oral trovafloxacin has been assessed in Phase III trials in patients with acute lower respiratory tract infections. Patients were treated orally with either trovafloxacin 100 or 200 mg (n=881) or a comparator (500 or 1000 mg amoxicillin, or 625 mg amoxicillin/clavulanic acid; n = 593). Adverse events were recorded in 112 (12.7%) trovafloxacin- and 74 (12.5%) comparator-treated patients. Frequency of effects on the autonomic nervous, musculoskeletal, respiratory, special senses, urinary and reproductive systems was <1%. Photosensitivity reactions were not reported in trovafloxacin-treated patients. Central or peripheral nervous system adverse effects (headache and dizziness) were slightly more common in trovafloxacin-treated patients (4.4% vs 1.9%). Patients treated with comparators experienced gastrointestinal events more frequently (6.1% vs 8.3%). Comparable incidences of adverse events were reported in patients > or = 65-years-old. Most events were mild to moderate in severity. Treatment was discontinued because of an adverse event in 18 (2%) trovafloxacin- and four (0.7%) comparator-treated patients. Despite the high prevalence of risk factors, serious adverse events were rare and the mortality rate over the 35-day study period was low: trovafloxacin 0.8%, comparator agents 1.5%. Laboratory test abnormalities were recorded in less than 1% of patients in either treatment group.
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PMID:Safety of trovafloxacin in treatment of lower respiratory tract infections. 975 92

The safety profile of grepafloxacin has been characterized in a number of preclinical and clinical studies. Preclinical investigations have shown that its toxicologic profile is similar to that of other fluoroquinolones, and phase I studies in humans have confirmed these data. A photosensitivity study demonstrated equivalence with ciprofloxacin, and a study in elderly patients taking the highest clinical dose of grepafloxacin indicated that prolongation of the QTc interval by grepafloxacin was less than 2 ms, 15 times less than that observed in a study of erythromycin. In phase II and III clinical investigations conducted in the United States and the United Kingdom, safety data have been gathered from more than 3000 patients with either community-acquired pneumonia or acute bacterial exacerbations of chronic bronchitis. The most common adverse events with grepafloxacin 400 or 600 mg were gastrointestinal, such as nausea, vomiting, and diarrhea. The frequency of these adverse events was similar to that seen with ciprofloxacin. Significantly more patients reported a mild, unpleasant metallic taste with grepafloxacin than with ciprofloxacin, but <1% of patients withdrew from therapy because of this. Headache was observed significantly more often in ciprofloxacin-treated patients than in grepafloxacin-treated patients. Recent postmarketing data confirm the good tolerability and safety profile of grepafloxacin. These data, from a case-report study of more than 9000 patients in Germany, demonstrated that only 2.3% of patients reported adverse events when grepafloxacin was used in routine clinical practice. The most frequently reported events were nausea (0.8%) and gastrointestinal symptoms (0.4%). Dizziness was reported by only 0.3% of patients, and only 4 patients (0.04%) reported photosensitization. Adverse events did not appear to be either dose dependent or related to diagnosis. More than 400,000 patients world-wide have received grepafloxacin treatment. No new safety issues have arisen from the spontaneous-report data and, with the exception of rare reports of an unpleasant taste, the most commonly reported events have been the same as those seen in clinical studies. These data support grepafloxacin as a well-tolerated fluoroquinolone suitable for the treatment of community-acquired respiratory tract infections.
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PMID:Grepafloxacin: a review of its safety profile based on clinical trials and postmarketing surveillance. 1009 Apr 25

Urinary tract infection (UTI) is a common illness, with > or =30% of all women experiencing a UTI during their lifetime. Less than a decade ago, the standard therapy for acute uncomplicated UTIs involved treatment with > or =7 days of an antibacterial agent, but recent studies using a variety of newly introduced antibiotics, including the fluoroquinolones, have demonstrated that a 1- to 5-day treatment regimen can be equally effective. This randomized, double-masked, multicenter study was conducted to compare the efficacy and tolerability of a single dose of sparfloxacin with those of a 3-day regimen of sparfloxacin and a 7-day regimen of ciprofloxacin in the treatment of women with community-acquired acute uncomplicated urinary tract infection. A total of 1175 women were enrolled; 395 received sparfloxacin as a single 400-mg dose on day 1, 394 received sparfloxacin as a 400-mg loading dose on day 1 followed by 200 mg once daily for 2 additional days, and 386 received ciprofloxacin 250 mg twice daily for 7 days. Patients were comparable with respect to demographic characteristics and underlying conditions. A total of 954 patients were clinically assessable; 490 of these were also bacteriologically assessable. All patients treated were included in the tolerability analysis. Escherichia coli (75.4%), Klebsiella pneumoniae (4.9%), Enterococcus faecalis (4.6%), and Staphylococcus saprophyticus (4.1%) were the most commonly isolated organisms. In the all-treated population, clinical success was achieved 5 to 9 days after therapy in 91.8%, 92.2%, and 91.6% of patients in the single-dose sparfloxacin, 3-day sparfloxacin, and 7-day ciprofloxacin groups, respectively; bacteriologic success was observed in 91.7%, 92.6%, and 96.6% of those in the 3 groups. Sustained clinical success rates 4 to 6 weeks after therapy were 76.6%, 80.2%, and 79.5% in the single-dose sparfloxacin, 3-day sparfloxacin, and 7-day ciprofloxacin groups, respectively; sustained bacteriologic success rates were 80.7%, 90.1%, and 92.6%. The most common adverse events were nausea, headache, vaginal thrush, dizziness, and diarrhea; >92% of adverse events were mild or moderate in severity. The 2 drugs had comparable frequencies of adverse events, except for photosensitivity, which occurred in 3.3% of the 3-day sparfloxacin group, 1.3% of the single-dose sparfloxacin group, and 0.3% of the ciprofloxacin group (P = 0.005). The 3-day sparfloxacin regimen was effective and well tolerated. The initial response to single-dose sparfloxacin treatment was comparable to the response to the other 2 regimens, but the single-dose regimen proved less effective over time, with higher rates of clinical recurrence and bacteriologic relapse. Sparfloxacin provides an alternative to ciprofloxacin for patients with acute uncomplicated urinary tract infection who are not at risk for photosensitivity reactions or adverse events associated with a prolonged corrected QT interval.
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PMID:Comparison of sparfloxacin and ciprofloxacin in the treatment of community-acquired acute uncomplicated urinary tract infection in women. Sparfloxacin Multicenter Uncomplicated Urinary Tract Infection Study Group. 1044 Jun 21

A recently introduced optometric technique, colorimetry, enables the perceptual effects of ophthalmic tints to be evaluated subjectively, optimized, and then prescribed in tinted spectacles. The new technique is beneficial in reducing visual stress in patients with dyslexia and migraine. We describe an open trial designed to ascertain: (1) whether the colorimetry assessment, as it is now given, is safe for the investigation of photosensitive patients in optometry clinics where colorimetry equipment is most readily available, but where EEG control is not practical; (2) what proportion of patients with photosensitive epilepsy is likely to benefit to the extent already described in individual cases; (3) whether a tint selected by colorimetry could be shown to reduce the incidence of paroxysmal epileptiform EEG activity in response to flicker and patterns, thereby validating the subjective methods and corroborating the reported seizure reduction. Twenty-four females and nine males (aged 12-43 years) took part. All the patients had suffered visually-provoked seizures, had exhibited a photoparoxysmal response on at least one previous EEG recording, and had received a diagnosis of photosensitive epilepsy. Twenty-two were currently experiencing seizures. A further EEG was recorded in all except seven cases: a routine resting record, followed by hyperventilation. Colorimetry was performed after hyperventilation and before photic stimulation. Twenty-three (70%) reported beneficial effects during colorimetry and were prescribed glasses. There was a preponderance of lenses with a rose or purple colour, in contrast to patients with dyslexia. Seventeen of the 23 patients were available at follow-up, an average of 2.4 years later. Thirteen (57%) reported benefits, and said they were still using the lenses. In six of the 13 the benefits were pronounced, including a reduction of dizziness from fluorescent lighting, elimination of aura when using computer screens etc. Only in three cases was there a reduction in seizures that could reasonably be attributed to the use of lenses; in two of these cases no medications were prescribed, and in the third the medications remained unchanged for four years, two before and two after the introduction of the glasses. In an additional four cases a reduction in seizures was observed but medication had been changed. There was a modest reduction in EEG photosensitivity with the coloured lenses but also to an equivalent or lesser extent with grey in all of the eight patients examined in this way. One patient had seizures during colorimetry, but the seizures were not accompanied by scalp EEG changes.
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PMID:Treatment of photosensitive epilepsy using coloured glasses. 1062 5

Minocycline belongs to the second generation class of cyclines. It was synthesized in 1967 and marketed in 1972. Minocycline has an antiinfectious activity with a spectrum similar to that of other cyclines, notably against Chlamydias, Treonema and Proprionibacterium acenes. The antiinflammatory activity is associated with this antiinfectious action is greater than that of first generation cyclines with specifically a modulator effect on epidermal cytokines. The pharmokinetics of minocycline is characterized by an excellent absorption, a long half-life and an important lipophilic property inducing good tissue distribution. Clinical trials of minocycline have mainly been performed in sexually transmissible diseases and in acne, a field where randomized studies are the most frequent. These trials show that the effect of minocycline is not stronger than first generation cyclines or doxycycline, but that the action is quicker than that of tetracycline at the dose of 500 mg a day. Minocycline is also efficient in nocardiasis, mycobacteriosis, leprosy, Lyme disease, pyoderma gangrenosum, autoimmune bullous dermatitis, Carteaud disease, and prurigo. However, the effect of minocycline in these different conditions has always been evaluated in open trials with a small number of patients. The usual side effects of cyclines, i.e. digestive problems, fungal infections, are less frequent than with first generation cyclines. No photosensitivity has been demonstrated although pigmentations have been described. Dizziness is a specific side effect of minocycline. Furthermore, rare but severe side effects have been reported, including hypersensitivity syndrome, autoimmune hepatitis, and lupus. Regular indications for minocycline in dermatology are acne and three sexually transmissible diseases (mycoplasm, chlamydia, treponema). Proposed dosage is 100 mg per day in sexually transmissible disease with a reduction to 50 mg per day after 15 days in acne.
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PMID:[Minocycline]. 1142 98

This paper reviews the safety data for levofloxacin utilizing reports from clinical and post-marketing surveillance trials. The side effect incidence rates are 1.3% for nausea, 0.1% for anxiety, 0.3% for insomnia, and 0.1% for headache. No levofloxacin-related adverse events were reported at a rate higher than 1.3%, and most were lower. Four clinical trials were reported. Levofloxacin achieved superior clinical and microbiological results compared to ceftriaxone/macrolide combination, and was better tolerated. Results comparing IV azithromycin plus ceftriaxone versus 500 mg levofloxacin in hospitalised CAP demonstrated that levofloxacin performed better, with more adverse events associated with the comparators (levofloxacin 5.3%, comparators 9.3%). High-dose levofloxacin (750 mg) was also evaluated and found to be well tolerated. Surveillance data reported low ADR rates for levofloxacin: nausea 0.8%, rash 0.5%, abdominal pain 0.4%, and diarrhoea, dizziness, and vomiting 0.3%. Worldwide and US surveillance data confirmed that tendon rupture occurred in less than 4 per million prescriptions, taste perversion in less than 3 per million, convulsions in 2 per million, and photosensitivity, hepatitis, hepatic failure, QT prolongation, torsade de pointes or empyema all in less than 1 per million.
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PMID:Latest industry information on the safety profile of levofloxacin in the US. 1154 87

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.
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PMID:A worldwide clinical overview of lomefloxacin, a once-daily fluoroquinolone. 1861 22


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