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The results of efficacy and safety of ciprofloxacin administered by parenteral and oral route in the treatment of severe infections-particularly, osteomyelitis and bacteremia-due to gram-negative bacilli are studied in the present work. The group consisted of 34 patients, there were 25 men and 9 women, whose age ranged from 5 to 84 years. Two patients were excluded from the study and did not enter in the efficacy analysis, although they accounted for the evaluation of incidence of side effects. Ten patients presented osteomyelitis, 16 patients had bacteremia (one of them, with endocarditis), and six patients suffered from other types of infection (one of them had meningitis). All patients recovered or presented clinical improvement with the treatment, except three of them, which accounted for a response rate of 90.6%. In 28 of the 32 evaluable cases, microbiologic eradication was achieved (eradication rate, 87.5%). Infection due to Pseudomonas aeruginosa persisted or recurred in three patients with chronic osteomyelitis; in two of them, the strain become resistant to ciprofloxacin, and in the third patient, the results of cultures persisted positive along the whole course, thus, the eradication of the microorganism was not achieved. One woman presented bacteremia due to Acinetobacter which persisted despite antibiotic therapy. Side effects were mild and obliged to withdraw the treatment in two cases (dizziness). Ciprofloxacin is a new fluoroquinolone that is easily administered by parenteral and oral route. In the present study, it has revealed as safe and highly efficacious, even in particularly severe or resistant bacterial infections.
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PMID:[Evaluation of ciprofloxacin for the treatment of severe bacterial infections]. 249 Jun 38

The efficacy and safety of ciprofloxacin in the treatment of 68 episodes of bacteremia were studied. Patients were treated intravenously (30 cases), orally (13 cases), or with sequential intravenous/oral therapy (25 cases). Intravenous doses ranged from 200 to 400 mg per day and oral doses ranged from 1,000 to 1,500 mg per day. According to the criteria of McCabe and Jackson, 39 cases had nonfatal and 29 had ultimately fatal underlying diseases. The clinical condition of patients at the start of therapy was critical or poor in 40 cases and fair or good in 28. Sixty-four of the 68 episodes of bacteremia were monomicrobial and the remaining four were polymicrobial. The causative micro-organisms were: Escherichia coli (18 episodes), Pseudomonas aeruginosa (13 episodes), Acinetobacter sp. (10 episodes), Salmonella sp. (seven episodes), Enterobacter sp. (six episodes), Proteus sp. (four episodes), Serratia sp. (four episodes), Haemophilus influenzae (three episodes), Klebsiella sp. (three episodes), Staphylococcus aureus (2 episodes), and Morganella morganii (two episodes). Overall clinical efficacy of ciprofloxacin was 94 percent (64 of 68 patients). Bacteremia persisted in four patients (failure rate of 6 percent). Five organisms persisted: Acinetobacter sp. (two patients), P. aeruginosa (one patient), Enterobacter sp. (one patient), and Serratia sp. (one patient). Side effects were phlebitis associated with intravenous administration (four cases), dizziness (four cases), and superinfection (six cases). Superinfecting organisms and sites were as follows: Enterococcus faecalis, wound (2 cases); Candida sp., urinary tract infection (one case); Acinetobacter anitratus (ciprofloxacin resistant), urinary tract infection (one case); Staphylococcus epidermidis, blood (one case); and Clostridium perfringens, blood (one case). Ciprofloxacin administered either intravenously, orally, or intravenously followed by the oral route is effective therapy in the treatment of severe bacteremic infections.
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PMID:Ciprofloxacin in patients with bacteremic infections. The Spanish Group for the Study of Ciprofloxacin. 258 66

Data from 1,878 courses of intravenous ciprofloxacin therapy, administered to 1,869 patients in 59 clinical trials, were analyzed for drug safety. The 985 men and 884 women had a mean age of 50 years, and more than one third were over 60 years of age. An overwhelming majority had at least one accompanying systemic illness, and the condition of more than half the patients was only fair or poor at the onset of therapy. Ciprofloxacin was administered in a unit dose of either 200 mg (68 percent of the patients) or 300 mg (28 percent) by intravenous infusion, generally over 30 minutes every 12 hours, at a mean daily dosage of 456 mg. The duration of intravenous therapy ranged from one to 57 days, with a mean of seven days; over 1,000 patients were treated for more than five days. Adverse events considered probably or possibly related to intravenous ciprofloxacin were reported in 15.8 percent of the courses; therapy was discontinued prematurely in 3 percent. Local reactions at the site of infusion were the most common, occurring in 4.4 percent of the courses. Changes in blood chemistry values (4.1 percent) included increases in alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase. Reports of adverse effects referable to the gastrointestinal tract (3.0 percent) were primarily nausea and diarrhea. Central nervous system reactions (1.8 percent) included convulsive seizures, headache, and dizziness. In comparative trials, events considered probably or possibly drug related were reported for 17.3 and 13.6 percent of the ciprofloxacin- and ceftazidime-treated patients, respectively. The incidence of adverse events other than local reactions at the infusion site was not significantly different between the ciprofloxacin- and ceftazidime-treated patients (12.7 percent versus 11.0 percent, p greater than 0.2).
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PMID:Safety of intravenous ciprofloxacin. A review. 268 31

The chemistry, mechanism of action, antimicrobial spectrum, pharmacokinetics, clinical efficacy, adverse effects, and dosage and administration of ciprofloxacin and norfloxacin are reviewed, and mechanisms of antimicrobial resistance and drug and laboratory interactions are described. Norfloxacin is the first antimicrobial in the fluoroquinolone class to be marketed in the United States; ciprofloxacin is under investigation in clinical trials. The fluoroquinolones are structurally related to nalidixic acid. The activity and spectrum are enhanced by the addition of 6-fluoro and 7-piperazino substituents. Quinolone antimicrobials appear to inhibit DNA gyrase, an enzyme specific and essential for all bacteria, as their primary mechanism of action. As a result, DNA synthesis is inhibited. Ciprofloxacin and norfloxacin are active against gram-negative enteric bacteria, Pseudomonas aeruginosa, Haemophilus influenzae, and Neisseria gonorrhoeae. Ciprofloxacin has good activity against Staphylcoccus spp., including methicillin-resistant Staph. aureus. Norfloxacin generally is less potent than ciprofloxacin, particularly against Ps. aeruginosa and Staph. aureus. Peak concentrations occur about one to two hours after an oral administration of either drug. Both drugs are widely distributed in body fluids and tissues and are eliminated by renal excretion, metabolism, and biliary excretion. Dosage reductions are required in severe renal dysfunction. Ciprofloxacin and norfloxacin are effective agents for treating urinary-tract infections, including infections caused by Ps. aeruginosa. The recommended dosage of norfloxacin for urinary-tract infections in adults is 400 mg orally every 12 hours; the drug should be given for 7 to 10 days in uncomplicated infections and for 10 to 21 days in complicated ones. The fluoroquinolones may be useful for treating chronic bacterial prostatitis. Ciprofloxacin is potentially useful for treating sexually transmitted diseases. Ciprofloxacin is active against N. gonorrhoeae, including beta-lactamase-producing strains and strains that are resistant to tetracycline, and Chlamydia spp. Use of ciprofloxacin for treating gastrointestinal infections and for selective decontamination of the gastrointestinal tract is promising. In open studies, ciprofloxacin has been effective against a variety of infections caused by susceptible organisms. Resistance to ciprofloxacin has developed during treatment of infections caused by Ps. aeruginosa, Staph. aureus, and Serratia marcescens. The most frequently reported adverse effects of either drug are gastrointestinal complaints, headache, and dizziness.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:Ciprofloxacin and norfloxacin, two fluoroquinolone antimicrobials. 331 72

Ciprofloxacin is a new quinolone antimicrobial agent with activity against a broad spectrum of gram-negative and gram-positive organisms, including Pseudomonas aeruginosa and methicillin-resistant strains of staphylococci. The efficacy and safety results of 80 clinical studies of the oral form of ciprofloxacin are reported. Drug safety was assessed in 2236 courses in 2203 adult patients treated primarily in the United States. Data from 1676 courses were suitable for analysis of drug efficacy. The unit dose for most patients ranged from 250 mg to 750 mg (median, 500 mg), usually given every 12 hours. The duration of treatment ranged from 3 to 231 days (median, 10 days). Predominant among 1722 infections were those of the urinary tract (43%), skin structures (29%), and respiratory tract (19%); the remainder were bone and joint infections (5%), bacteremias (2%), and intra-abdominal (1%), gastrointestinal (1%), and pelvic infections (less than 1%). Signs and symptoms of infection resolved in 79% of all cases; a further 15% improved, and 5% failed to improve. Pathogens were eradicated in 89% of urinary tract infections and persisted in 5%; 80% of patients still had sterile urine at the 3-to 6-week follow-up. In 81% of nonurinary tract infections, pathogens were eradicated; they persisted in 11%, and superinfection occurred in less than 5%. After treatment, 89% of the 2253 causative organisms were eradicated and 2% were reduced to clinically insignificant counts; 8% persisted. Of 411 isolates of P. aeruginosa, 77% were eradicated, as were 97% of 421 Escherichia coli and 80% of 248 Staphylococcus aureus isolates. Also eradicated were 95% of 166 Klebsiella, 96% of 139 Proteus mirabilis, 100% of 20 other Proteus, 94% of 123 Enterobacter, 100% of 68 Haemophilus influenzae, 96% of 49 Citrobacter, 89% of 45 Serratia, 95% of 41 Streptococcus pneumoniae, 91% of 43 Salmonella, 100% of 38 Morganella morganii, and 100% of 35 Providencia isolates. Adverse reactions were judged probably or possibly drug-related in 14.8% of courses; drug treatment had to be stopped prematurely in 3.5%. The most frequent reactions were gastrointestinal complaints (chiefly nausea, diarrhea, and vomiting), metabolic disorders (elevated SGOT, SGPT, serum creatinine, or blood urea nitrogen), and nervous system effects (dizziness, light-headedness, restlessness, tremor, and headache). Crystalluria, judged to be related to ciprofloxacin, occurred in two patients.(ABSTRACT TRUNCATED AT 400 WORDS)
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PMID:A survey of clinical experience with ciprofloxacin, a new quinolone antimicrobial. 336 Sep 68

This review summarizes adverse reactions probably or possibly attributable to oral ciprofloxacin therapy in worldwide clinical experience involving over 6500 patients. In Europe and Japan the overall incidence of adverse reactions amongst patients receiving ciprofloxacin is reported to be 3.0% and 6.5%, respectively. An increased incidence (13.4%) has been reported from the U.S.A., possibly relating to the use of higher dosages. Very few reactions have necessitated withdrawal of treatment. The most common adverse effects involve the gastro-intestinal system (2-8% of patients treated) and usually comprise nausea, vomiting, diarrhoea and abdominal discomfort. CNS effects are seen in 1-4% of patients but are usually minor dizziness or mild headache only. Hypersensitivity reactions, most commonly skin rashes or pruritus, affect about 1% of patients. There is little evidence of significant haematological or biochemical toxicity, other than a few reports of transient neutropenia and the finding, in a minority of clinical studies, of equally transient, usually trivial and invariably reversible elevations of serum aminotransferases. Serious, ciprofloxacin-related toxicity has been observed in only three patients: one who developed pseudomembranous colitis, another who developed interstitial nephritis and a third who had a grand-mal convulsion during concomitant administration of theophylline. Ciprofloxacin appears to have an excellent safety profile.
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PMID:Ciprofloxacin: an overview of adverse experiences. 354 45

Significant safety issues that have arisen with fluoroquinolones include phototoxicity, cardiotoxicity, tendinitis, CNS effects and drug interactions. Ciprofloxacin is well tolerated; the incidence of adverse events is low and serious adverse events are rare. Levofloxacin has a reduced CNS adverse event rate compared with ofloxacin. Sparfloxacin has significant phototoxicity and potential cardiac toxicity. Grepafloxacin has significantly increased adverse event rates, particularly gastrointestinal intolerance. Taste perversion and nausea are common. Trovafloxacin has an increased potential for CNS adverse reactions, notably dizziness. Post-marketing surveillance data indicate the possibility of serious hepatic reactions and pancreatitis. Interactions between fluoroquinolones and drugs metabolised by the hepatic cytochrome P450 system affect the clearance of theophylline and caffeine. Quinolone absorption is significantly reduced by co-administration of antacids. Hospitalised patients are likely to be receiving multiple-drug therapy, but drug interactions are avoidable. The interactions of specific fluoroquinolones should be checked prior to prescription.
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PMID:Safety of the new fluoroquinolones compared with ciprofloxacin. 1141 83