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 23,468 document(s) hit in 31,850,051 MEDLINE articles (0.00 seconds)

A safety profile of ofloxacin, a new fluoroquinolone antibiotic, was assessed in twelve healthy male volunteers. Ofloxacin was dosed at 400 mg twice daily over a 10-day course of treatment. This evaluation included chemistry and haematologic profiles, neurologic evaluations, ophthalmologic examinations, audiometric testing, and electrocardiogram before, during and the end of the study. In addition, plasma samples were analysed for ofloxacin prior to each morning dose and a complete plasma concentration profile was performed on day 6. Gastrointestinal complaints such as nausea, diarrhoea and upset were the most frequent side effects reported. The only other adverse event that occurred in more than one volunteer was headache. None of the subjects in this study developed a serious side effect and no physical or psychological changes were observed. Laboratory values remained in their normal ranges with the exception of one volunteer who developed a 3-fold rise in one liver function test at the end of the study. The subject was asymptomatic and this aberration resolved without sequelae. In summary, a 10-day course of ofloxacin was found to be safe and have a low potential for toxicity. The side effects observed in this study were mild and similar to those observed with other fluoroquinolones.
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PMID:Safety of multiple doses of ofloxacin in healthy volunteers. 184 Oct 44

Ofloxacin was administered orally at a daily dosage of 300 mg and 600 mg in three divided doses for 14 days to 24 and 60 patients with chronic complicated urinary infections, respectively, in order to evaluate the therapeutic efficacy. The clinical efficacy was evaluated according to the criterion proposed by the UTI Committee in Japan and its efficacy was evaluated in 84 cases. In the group of 24 patients receiving a daily dosage of 300 mg, the clinical effectiveness after a 5-day treatment was excellent in 13 cases and moderate in 7 cases. The overall clinical efficacy was 83.8%. In the group of 60 patients receiving a daily dosage of 600 mg, the rate of overall clinical efficacy after a 5-day treatment was 83.3%, being excellent in 23 cases and moderate in 27 cases. The eradication rate was 85.3% and 92.5% by 300 mg and 600 mg dosages of ofloxacin, respectively. As adverse reactions, anorexia and nausea occurred in 2 cases. Laboratory anomalies consisted of 1 case of slight and transient elevation of transaminase, and 1 case of elevated serum creatinine.
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PMID:[Clinical evaluation of ofloxacin in the treatment of chronic complicated urinary tract infection]. 223 69

We conducted an open randomized trial to compare the efficacy of parenteral and oral ofloxacin with that of amoxycillin/clavulanate. A total of 121 patients was studied; 92 were clinically evaluable. Of these, 59 patients were treated with ofloxacin and 33 with the comparator drug. Patients were given the drugs intravenously for a minimum of three days followed by oral preparations for the next seven to ten days. Ofloxacin was usually administered as a 200 mg dose bd. In the ofloxacin treated group all patients showed clinical improvement. In the comparator group 94% improved clinically (either a complete or partial response), while 6% were clinical failures. Of the bacteriologically evaluable patients 19 of 20 showed a satisfactory bacteriological response in the ofloxacin treated group, while in the comparator group the bacteriological response was judged satisfactory in 14 of 17 patients. A small proportion of patients (7%) treated with ofloxacin suffered mild adverse effects (nausea, vomiting, headache, hypotension and rash). On the whole, ofloxacin was well tolerated by our patients. The two deaths that occurred were in the comparator group. We conclude that ofloxacin in both oral and parenteral forms is an effective and safe drug in the treatment of lower respiratory tract infections.
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PMID:A comparative study of ofloxacin and amoxycillin/clavulanate in hospitalized patients with lower respiratory tract infections. 228 96

The safety profile of ofloxacin was evaluated on the basis of adverse reactions and abnormal laboratory values seen in United States clinical trials and phase I studies addressing specific issues. The most frequently reported adverse reactions occurring in 2,197 patients who received three to 10 days of ofloxacin in United States clinical trials were nausea (3.5 percent), insomnia (1.8 percent), headache (1.4 percent), and dizziness (1.2 percent). Adverse reactions were not serious and usually rapidly reversible. The incidence of adverse reactions did not increase with increasing age. There is no clinically significant interaction with methylxanthines (caffeine or theophylline). Crystalluria was not observed. Ofloxacin is a well-tolerated fluoroquinolone antimicrobial agent.
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PMID:The safety profile of ofloxacin. 269 Jun 23

In clinical trials performed in Italy, 2,003 patients, suffering from various infectious diseases, have so far been treated with ofloxacin. In most cases dosages of 200 mg, 300 mg or 400 mg b. i. d. have been used. In all, 130 adverse reactions have been recorded in 116 patients (5.8%): gastrointestinal events (mostly nausea, vomiting and gastric pain) in 4.8% of the patients, neurological events (mostly headache and insomnia) in 0.7%, cutaneous reactions in 0.4% and others in 0.5% cases. The drug-event causal relationship was assessed by the investigators as unlikely in 5.0% of the events, as possible in 47.1%, as probable in 31.4% and as almost certain in 16.5%. The severity of adverse reactions was judged as mild in 55% of the cases, as moderate in 38% and as severe in 7%. In 30 patients (1.5%), treatment was discontinued because of occurrence of side effects. Abnormal laboratory values probably related to treatment were reported in 25 patients (2.1%). Ofloxacin is well tolerated and shows a safety profile comparable with that of the best tolerated oral antibacterials.
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PMID:Safety profile of ofloxacin: the Italian data base. 295 62

Eighteen episodes of peritonitis in 16 CAPD patients were treated with oral ofloxacin 400 mg initially, followed by 300 mg daily for a total of 10 days. The culture-positive rate was 72.2% with Staphylococcal species as the most frequent isolates. The overall cure rate as defined by negative cultures 1 and 2 months after discontinuation of antibiotics was 83.3%. The time taken for the peritoneal effluent to clear completely was 5 days. With such a dosing regime, there was a significant increase in the mean serum trough level of ofloxacin from 2.28 mg/l on day 1 to 5.83 mg/l on day 10 (P less than 0.001). There was no significant difference in the serum levels attained whether or not phosphate binders were concurrently given. Side-effects were nausea and non-specific dizziness. No patients had to discontinue treatment because of side-effects. Ofloxacin appeared to diffuse from the blood into the peritoneal fluid, and a highly significant correlation existed between simultaneous blood and peritoneal effluent ofloxacin levels (r = 0.88, P less than 0.0001).
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PMID:Oral treatment of peritonitis in CAPD patients with ofloxacin. 314 86

An open clinical study of ofloxacin in respiratory tract infections was conducted with patients receiving daily doses of ofloxacin 300 mg, 400 mg or 600 mg. The duration of treatment was 6 to 14 days for 70% of the patients. Ofloxacin was effective in 668 of 828 patients analysed (80.7%). Of 293 patients with upper respiratory infections, the efficacy rate was 85.3%. In 535 cases with lower respiratory infections, ofloxacin was effective in 78.1%. It is noteworthy that a 70% efficacy rate was obtained in 80 cases with intractable chronic diffuse panbronchiolitis primarily associated with Pseudomonas aeruginosa. There was no difference in the efficacy rate among various daily doses or severity of infections. In lower respiratory infections the bacterial eradication rate was 80.9% for Gram-positive aerobes (including 80% for Staphylococcus aureus and 76.5% for Streptococcus pneumoniae) and 72.1% for Gram-negative aerobes (including 92.6% for Klebsiella pneumoniae, 32.3% for P. aeruginosa and 97.1% for Haemophilus influenzae). Although there were no serious cases, adverse reactions were noted in 46 of 843 patients (5.5%): 38 cases (4.5%) of gastrointestinal tract reactions (nausea, vomiting, heartburn, etc.), 4 cases (0.5%) of hypersensitivity (e.g. eruption) and 19 (2.3%) of central nervous system effects (e.g. dizziness). Abnormal changes in laboratory findings included elevations of AST (1.2%) and ALT (1.5%) and an increase in the eosinophil count (1.7%).
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PMID:Ofloxacin in respiratory tract infection. A review of the results of clinical trials in Japan. 332 61

Ofloxacin, a new fluoroquinolone, was given to fifty patients (29 females and 21 males) aged 25 to 86 years with urinary tract infection or prostatitis. Urinary tract infections usually chronic and associated with urologic anomalies, included 17 cases of cystitis and 19 cases of pyelonephritis. 14 patients had prostatitis. Pathogens recovered from the urine were 26 E. coli, 2 Citrobacter, 4 Proteus mirabilis, 2 Klebsiella, 2 Enterobacter, 3 Serratia, 3 Staphylococcus aureus and 11 Pseudomonas. Minimal inhibitory concentrations of ofloxacin ranged from 0.03 to 0.12 microgram/ml (mean MIC: 0.6 microgram/ml) for 27 nalidixic acid-sensitive strains, and from 0.25 to 4 micrograms/ml (mean MIC: 1 microgram/ml) for 26 nalidixic acid-resistant strains. Ofloxacin was given as single drug therapy in all patients, in a daily dosage of 200 mg b.i.d. in 46 patients and 400 mg b.i.d. in 4 patients, for 7 to 97 days (average 40 days). Follow-up after discontinuation of treatment was 3 to 12 months. Therapeutic results were as follows: 17 cures for the 17 cystitis patients, 17 cures and 2 failures by relapse for the 19 cases of pyelonephritis, and 11 cures, 1 failure by persistence of bacteriuria and failure by relapse for the 14 cases of prostatitis. Digestive disorders, i.e. nausea, abdominal pain, constipation, occurred in 6 patients and required withdrawal of the drug in 1; candidiasis of the tongue was recorded in one patient and digestive complaints with neuropsychic disorders in another. Two patients had short-lived, moderate leukopenia with granulopenia and one had transient worsening of preexisting renal failure. Hepatic tolerance was good.
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PMID:[Ofloxacin (RU 43280): clinical evaluation in urinary and prostatic infections]. 353 29

32 hospitalized adult patients with infective episodes of bronchiectasis were enrolled in an ongoing double-blind, placebo-controlled study comparing ofloxacin with amoxicillin. They were randomized to receive either 200 mg ofloxacin or 1 g amoxicillin, both t.i.d. orally for ten days. In the ofloxacin group (15 patients), clinical response was excellent (clinical cure) in 11 and fair (clinical improvement or early reinfection) in three patients with one failure. In the amoxicillin group (17 patients), clinical response was excellent in six, fair in five, and poor (treatment failure) in six patients. Ofloxacin levels at 2 h (day 5) were 2.3 to 8.2 mg/l (mean 3.9 mg/l) for serum and 1.3 to 15 mg/l (mean 4.5 mg/l) for sputum. Sputum: serum ratio was 1.2:1. Amoxicillin levels at 2 h were 10 to 40 mg/l (mean 19.9 mg/l) for serum and 0 to 1.5 mg/l (mean 0.3 mg/l) for sputum, with no amoxicillin detected in sputum in 10 of 17 patients. Sputum: serum ratio was 0.02:1. One patient in the ofloxacin group had nausea. In the amoxicillin group, four patients had nausea and stomach pain, one had vertigo and one had transient peripheral eosinophilia. Ofloxacin thus yielded higher sputum concentration and appeared to be more effective and better tolerated than amoxicillin in infective episodes of bronchiectasis.
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PMID:A double-blind randomized study comparing ofloxacin and amoxicillin in treating infective episodes in bronchiectasis. 354 47

New antimycobacterial agents and combined treatment regimens are being introduced for the treatment of leprosy. Ofloxacin is one such broad spectrum antimicrobial agent. In this study rifampicin plus ofloxacin were administered daily for 4 weeks (daily supervised dose). Two patients (and possibly a third patient who refused all investigations) out of 125 patients developed leucocytopenia during the third week of therapy. It was associated with fever, malaise, nausea and loss of appetite. They recovered after cessation of drug treatment. Patients receiving ofloxacin should be monitored for constitutional symptoms suggestive of this complication even though the risk of such complication may be minimal.
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PMID:Leucocytopenia after rifampicin and ofloxacin therapy in leprosy. 912 26


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