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Treatment of acute bronchitis and pneumonia with cefaclor.

An open, non-comparative clinical trial of cefaclor in adults with acute exacerbations of chronic bronchitis (54 patients) or pneumonia (24 patients) is reported. The dosage of cefaclor used was either 250 mg or 500 mg taken orally three times daily. Clinical cure was obtained in 39 of 42 (93%) of patients on the lower dose and 32 of 33 (97%) on the higher dose. Side effects were minimal and the antibiotic was very well tolerated. Microbiological evaluation was possible in 32 of 75 (43%) of patients in whom potential pathogens were identified before treatment. Microbiological 'cure' was achieved in 17 of 32 (53%), the majority of whom had received the higher dose. The lack of correlation between the clinical and microbiological results cast further doubts on the value of the standard sputum culture methods in the diagnosis and management of lower respiratory tract infection. Cefaclor is useful in the management of acute lower respiratory tract infections by virtue of its excellent clinical efficacy and safety.

Acute Disease↗

Comparison of cefaclor and amoxycillin in the treatment of urinary infections in a chronic disease hospital.

The clinical efficacy and safety of cefaclor, a new oral cephalosporin, was compared with that of amoxycillin in the treatment of lower urinary tract infections in 61 patients with chronic non-urinary tract disease. Thirty-six patients received cefaclor and 25 received amoxycillin doses of 250 mg every 8 hours for 7 to 10 days. The therapeutic effectiveness of cefaclor was significantly better than that of amoxycillin, and it appeared to be well tolerated and free of adverse side effects. It produced no allergic reactions in 4 patients with a history of penicillin allergy and was effective against Klebsiella strains resistant to the ampicillins. There was no evidence of any haematological, renal or hepatic toxicity from either drug at the dosage used.

Adult↗

[Cefaclor in the treatment of respiratory tract infections in children].

61 children up to the age of 14 years with respiratory tract infections underwent therapy with Cefaclor. 52 patients (89%) had satisfactory results. 4 patients (7%) experienced prolonged signs of infection. Cefaclor was very well tolerated. Because of its wide spectrum of activity particularly against ampicillin resistant strains of H. influenzae and because of its good tolerance Cefaclor is very useful in treatment of respiratory tract infections in children.

Adolescent↗

Evaluation of cefaclor and amoxycillin in the treatment of acute otitis media.

Twenty-eight patients with acute otitis media were treated in a random double blind manner with either amoxycillin or cefaclor. The predominant organisms isolated were H. influenzae and S. pneumoniae. All patients responded satisfactorily except one, treated with cefaclor, whose compliance with the regimen was very doubtful. One instance of mild elevation of SGOT and one case of mild erythematous rash occurred in each treatment group. In this limited study, cefaclor appeared comparable to amoxycillin in the treatment of acute otitis media.

Acute Disease↗

Cefaclor: clinical and bacteriological evaluation in 45 cases.

This report deals with studies of the effectiveness, tolerance and toxicity of cefaclor in the treatment of 45 patients with urinary tract infections (40 cases) and pneumonia (5 cases) caused by susceptible pathogens. Cefaclor was administered orally in a dosage of 1 to 3 g per day for 7 to 11 days. Clinical and laboratory examinations were performed before, during, at the end of treatment, and 4 weeks later in cases of urinary infection. All 5 patients with pneumonia and bronchopneumonia were cured. Clinical and bacteriological cures were obtained in 28 (70%) of the 40 cases of urinary tract infections. Identification and typing of microorganisms, disk sensitivity tests, minimal inhibitory concentrations and cefaclor blood levels also were determined.

Adult↗

Cefaclor in the treatment of infections of the ears, nose, and throat.

Clinical experience and laboratory tests in 52 patients (14 to 77 years of age) who had moderate to severe ear, nose, and throat infections were evaluated in this study of cefaclor, a new cephalosporin antibiotic, The drug proved to be effective in the treatment of these infections, and the incidence of side effects was low. Patients received oral doses of 500 mg every 8 hr for three to five days after all signs of infection had disappeared. Therapeutic results were assessed as very good in 31 patients, good in 17, and unsatisfactory in one. Three were unevaluable. The rapid onset of the therapeutic effect obtained with cefaclor in these patients was particularly striking. Some side effects occurred, but they were essentially transient and minor. Cefaclor should become a major antibiotic for the treatment of infections of the ears, nose, and throat.

Adolescent↗

[Treatment of urinary tract infections by cefaclor, with special reference to the antibody-coated bacteria (ACB) detected by the immunoenzyme technique].

Twenty out-patients suffering from urinary tract infections (UTI) were treated with cefaclor. Cefaclor was administrated orally in daily doses of 1,500 mg for 7 days against 15 cases of simple UTI and 5 cases of complicated UTI. Of 20 cases with acute simple cystitis, acute pyelonephritis and complicated UTI, clinical responses were excellent in 10 cases, good in 6 cases and poor in 4 cases. The efficacy rate was 80%. No side effect was observed. The site of infection determined by the ACB detection method was in good agreement with that determined by clinical findings. Cefaclor appeared to be equally effective in the treatment of both ACB-positive and ACB-negative infections. The presence of absence of antibody-coated bacteria did not correlate with clinical symptoms or response to therapy.

Adult↗

Oral cefaclor for treatment of bronchitis--a comparative double-blind study versus amoxycillin.

Either 500 mg cefaclor or amoxycillin was administered at random thrice daily to 50 adult outpatients with acute or acute-to-chronic bronchitis. A total of 31 pathogens were isolated from sputum, mostly Streptococcus pneumoniae [17] or Haemophilus influenzae [3], or both [2]. All pathogens but one were susceptible to cefaclor; all but six were susceptible to amoxycillin. Satisfactory clinical results were obtained in 62.5% of the patients treated with cefaclor and 66% of the patients treated with amoxycillin.

Amoxicillin↗

Pharmacokinetic profile of cefaclor.

Cefaclor is a well-absorbed oral cephalosporin antibiotic. Peak concentrations in serum are attained within 30-60 minutes. Food intake reduces the rate, but not the extent of absorption. Cefaclor is not metabolized to a significant degree, but it degrades chemically in the body with an approximate half-life of 2 hours. Most of the drug is excreted unchanged in the urine, the serum half-life after oral administration is 0.5-0.7 hours. Due to the chemical degradation, cefaclor does not accumulate to the same degree as other cephalosporins in case of renal impairment.

Aged↗

Cefaclor therapy in uncomplicated cystitis.

Thirty patients with acute urinary tract infection were treated orally with 500 mg of cefaclor three times a day for 7 days. Urine cultures were made before treatment and after therapy. In 97 per cent (29/30) of these patients clinical success was achieved and in 90 per cent (27/30) of them, pathogens were eradicated. Our study showed that cefaclor was still active against most Enterobacteriaceae, such as Escherichia coli and Klebsiella species, the principle pathogens of urinary tract infection. No adverse effects of cefaclor were observed in this study.

Administration, Oral↗

Comparison of in vitro activity of cephalexin, cephradine, and cefaclor.

Inhibitory activity of cephalexin, cephradine, and cefaclor was compared by the WHO-ICS agar dilution technique. Cefaclor was substantially more active against staphylococci, streptococci, gonococci, meningococci, Haemophilus, Escherichia coli, Klebsiella pneumoniae, Citrobacter diversus, Proteus mirabilis, salmonellae, and shigellae than was cephalexin, which in turn was more active than cephradine. Cefaclor appeared to be less resistant to staphylococcal penicillinase than did the other two agents. None of these cephalosporins was active against Enterobacter, Serratia, indole-positive Proteeae, Pseudomonas, or Bacteroides fragilis.

Bacteroides↗

Comparative pharmacology of cefaclor and cephalexin.

Two cephalosporin antibiotics, cefaclor and cephalexin, were administered orally to healthy, adult male volunteers for comparison of their pharmacological properties. In doses of 250 mg orally, cefaclor produced a peak serum concentration of 6.01 +/- 0.55 (standard deviation [SD]) mug/ml compared with 9.43 +/- 2.36 mug/ml for cephalexin (P < 0.01). The half-lives were 0.58 +/- 0.07 (SD) h and 0.80 +/- 0.12 (SD) h, and elimination constants were 1.22 +/- 0.15 and 0.88 +/- 0.13 h(-1) for cefaclor and cephalexin, respectively (P < 0.001). Neither drug showed accumulation over the dosing period, and both were well tolerated.

Adult↗

Pharmacokinetics of cefaclor in normal subjects and patients with chronic renal failure.

We studied the pharmacokinetics of cefaclor, a new cephalosporin antibiotic, in normal subjects and subjects with chronic renal failure. Cefaclor was largely, but not entirely, eliminated by the kidneys. The cefaclor half-life in normal subjects was 40 to 60 min; in subjects with essentially no renal function, it increased to 3 h. In normal subjects, 50 to 70% of a 250-mg dose was excreted in the urine within 8 h. The linear relationship between the elimination constant and creatinine clearance allowed the construction of a useful dosage modification nomogram.

Animals↗

Stability and blood level determinations of cefaclor, a new oral cephalosporin antibiotic.

Cefaclor solutions in pH 2.5 and 4.5 buffers contained at least 90% of their initial activity after 72 h at 4 degrees C. Samples in pH 6.0, 7.0, and 8.0 buffers contained 70, 46, and 34%, respectively, of their initial activity after 72 h at 4 degrees C. After 72 h at 25 degrees C, samples prepared with pH 2.5, 4.5, 6.0, 7.0, and 8.0 buffers contained 95, 69, 16, 5, and 3%, respectively, of their initial activity. After 72 h at 37 degrees C, cefaclor solutions in pH 2.5 buffer contained 80% of the initial activity, whereas samples prepared in pH 4.5, 6.0, 7.0, and 8.0 buffers contained less than 20%. Laboratory-prepared plasma and serum samples showed an 8% loss in activity when incubated for 6 h at 4 degrees C, a 51% loss when incubated for 6 h at 25 degrees C, and a 48% loss when incubated for 2 h at 37 degrees C. Clinical samples demonstrated a similar stability pattern. Degradation rates for cefaclor in commercially prepared serum increased from 4- to 10-fold in comparison to rates obtained when samples were made in human serum freshly prepared in our laboratory. Consequently, serum standards should be made in freshly prepared human serum.

Cephalosporins↗

Pharmacology of cefaclor in normal volunteers and patients with renal failure.

After a 500-mg dose of cefaclor, the mean peak plasma level was 12.4 mug/ml and after a 250-mg dose it was 5 mug/ml in normal volunteers. Food intake significantly reduced absorption. Probenecid prolonged plasma levels. Mean plasma half-life in normal volunteers was 0.8 h. Only about 50% of the dose was excreted in the urine within 4 h in normal volunteers. Plasma half-life in patients with renal insufficiency was only about 3 h, which suggests that cefaclor may be eliminated by nonrenal mechanisms in humans. Urinary levels of cefaclor were adequate to inhibit susceptible pathogens even in patients with moderately severe renal failure. Plasma half-life during hemodialysis was 2.1 h and rose to 2.8 h after dialysis.

Adult↗

[Efficacy and safety of cefprozil versus cefaclor in the treatment of acute otitis media in pediatric patients]

OBJECTIVE: To evaluate the efficacy and safety of two oral cephalosporins, cefprozil and cefaclor, in the treatment of acute otitis media in children.METHODS: Forty children with clinical diagnosis of acute otitis media were randomized in two groups. Twenty-one children were given cefprozil at the dose of 30/mg/kg/day, in two equally divided doses every twelve hours, for ten days. Nineteen children were given cefaclor at the dose of 40/mg/kg/day in three divided doses every eight hours, for ten days. Efficacy evaluation of the antibiotic was analyzed by the presence or absence of symptoms, fever and otoscopic abnormalities while the safety and tolerability were evaluated by spontaneous information for possible adverse events.RESULTS: There was a significant decrease in the number of observed alterations between days 3 and 5 of treatment among those of the cefprozil group in comparison to the cefaclor group, while between days 10 and 14 of treatment the observed cure rate was clinically similar in both groups. Both medications presented adequate safety profiles. Only three children receiving cefprozil presented mild adverse events, such as nausea and vomit, none of which required treatment interruption.CONCLUSIONS: The clinical efficacy of both cephalosporins was similar although a more rapid activity was observed for cefprozil between days 3 and 5 of treatment. The favorable clinical results, the low incidence of adverse events and the twice a day dose regimen suggest that cefprozil is one more antimicrobial of choice for the treatment of acute otitis media in children, when this therapeutic is indicated.

Journal Article↗

[Treatment of streptococcal tonsillo-pharyngitis in paediatric patients: short-course therapy with cefaclor]

Short-course treatments of streptococcal pharyngotonsillitis with oral cephalosporins and macrolides have resulted in a similar bacteriologic and clinical cure rate and in better compliance compared to the conventional 10-day course. Cefaclor has never been investigated for this purpose. 138 patients out of 420 recruited patients had a positive culture for S. pyogenes and were randomly assigned to receive cefaclor (25 mg/kg/bid) for a 5- (70 pts) or 10-day (68 pts) course. Patients were assessed clinically and bacteriologically 2-3 days after completing the course and followed up after 20-30 days. All 420 recruited patients belonged to a population of 2,800 children who had been previously screened for a streptococcal carrier state to exclude carriers from final evaluation. Clinical cure and bacteriological eradication was recorded in 92.8% and 92.6% of patients in groups A and B respectively. Therefore, short-course therapy with cefaclor may offer an effective alternative treatment to conventional regimens, with potential for better compliance.

Journal Article↗

In vitro susceptibility of selected bacteria to cefaclor.

Cefaclor is an orally absorbed cephalosporin antibiotic chemically and pharmacologically similar to cephalexin. It appears to be more active than cephalexin against susceptible strains. The in vitro sensitivity of 230 clinical bacterial isolates to cefaclor was studied. Most isolates of S. aureus, K. pneumoniae, E. coli, and indole negative Proteus species were inhibited at clinically attainable serum and urine concentrations. Like cephalexin, cefaclor was less active against isolates of Enterobacter species, indole positive Proteus species and enterococci although many of these isolates were inhibited at concentrations achievable in urine.

Bacteria↗