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The efficacy of cefpodoxime proxetil has been studied in ten clinical trials conducted in adults suffering from lower respiratory tract infections (pneumonia, acute bronchitis or acute on chronic bronchitis) and upper respiratory tract infections (tonsillitis/pharyngitis or sinusitis). All the trials were controlled, randomized, multicentre and international and seven were double-blind, double-dummy designed. Over a period of 18 months from July 1988 to December 1989, 2448 patients were included. Among them, 2429 (99%) were evaluated for tolerance, 2101 (86%) for tolerance and clinical efficacy and 1018 (42%) for tolerance and clinical and bacteriological efficacy. The clinical response was judged satisfactory in 1205/1263 (95.4%) patients treated with cefpodoxime proxetil and in 788/838 (94%) patients treated with comparative antibiotics. The bacteriological response was judged satisfactory for 662/699 (95%) pathogens for cefpodoxime proxetil treatment versus 427/463 (92, 2%) for comparators. Cefpodoxime proxetil has been given to 7351 patients in the course of its international development with no severe side-effect being observed. Common reactions have been noted with a similar frequency to that seen with the other beta-lactams. No pseudomembranous colitis has been observed during clinical trials. On this basis, cefpodoxime proxetil appears to be efficacious and well tolerated and could be an antibiotic of first choice in the treatment of lower and upper respiratory tract infections in adults and adolescents.
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The clinical success rates at day 12-19 in the per-protocol population (primary analysis) were 92.3% (215/233) in the cefpodoxime-proxetil group and 93.6% (204/218) in the amoxicillin-clavulanic acid group. The 95% confidence interval of [6.5%; 3.9%] demonstrated that cefpodoxime-proxetil was not inferior to amoxicillin-clavulanic acid. Cure rates at follow-up (day 25-30) were 90.6% and 92.7%, respectively. Results were similar in the intent-to-treat population. Compliance was significantly better in the cefpodoxime-proxetil group (99.2% versus 95.5%; p=0.011). Tolerance was also significantly better: 1.2% (3/247) of cefpodoxime-proxetil patients reported a treatment-related adverse event, compared with 10.7% (26/244) in the amoxicillin-clavulanic acid group (p<0.001). Most events were gastrointestinal and of mild to moderate intensity.
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Oral administration at a dosage of 10 mg/kg every 6 to 12 hours would appear appropriate for the treatment of equine neonates with bacterial infections.
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In this study, a selective and sensitive LC/MS/MS method for the determination of trace amounts of cefmetazole (CMZ) and cefpodoxime proxetil (CPDXPR) contaminants in manufacturing environments was developed. The necessary sensitivity of this method was estimated based on the detection limit for Penicillin G required by the FDA and the total surface area and volume of the manufacturing facility. The detection limits of this method were estimated to be 10 pg/ml for CMZ and 5 pg/ml for CPDXPR from the signal to noise ratio and as a result satisfactory sensitivity was achieved. The method was linear in a concentration range from 0.20 to 3.20 ng/ml. The accuracy and precision were verified by the determination of the amount of CMZ and CPDXPR added to the sampling materials, a glass plate and a silica fiber filter. The mean recoveries of nine replicated determinations from the glass plate were 99.1% with 5.58%R.S.D. for CMZ and 97.1% with 3.80%R.S.D. for CPDXPR, and those from the silica fiber filter were 100.7% with 4.50%R.S.D. for CMZ and 95.4% with 2.85%R.S.D. for CPDXPR. This method has been successfully applied to the determination of CMZ and CPDXPR contaminants in samples collected from an actual manufacturing environment.
We aimed to evaluate the efficacy of second-generation cephalosporins in the prophylaxis of recurrent pharyngotonsillitis in children.
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AOM accounted for 5.8% of the 43 433 visits or 6.2 cases/week per pediatrician. Among 3141 evaluable AOM cases (mean age 16.7±8 months, peak incidence at 10 months), 99% had been vaccinated with PCV7 and 42.1% attended day care (DCC). Recurrent AOM comprised 24.5% of cases and 51% of children had received ATB in the last 3 months. At the time of diagnosis, 47.1% had fever≥38,5°C, 74.5% otalgia and 4.7% otorrhea. Febrile and painful AOM accounted for 29.5% of cases and cunjunctivitis-otitis syndrome for 18.2%. ATB was prescribed in 98.7% of cases (cefpodoxime proxetil, 59% and amoxicillin/clavulanate, 37%). The failure rate was 6.4% and failure risk was greater in children in DCC (OR=1.50, [1.10;2.05]), young age<18 months (OR=1.47, [1.06;2.04]) and history of recurrent AOM (OR=1.45, [1.02;2.06]).
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Pathogenic bacteria were isolated from 90% of patients with acute otitis media. This higher-than-expected rate of positive cultures was probably related to the meticulous bacteriologic techniques used.
In a crossover study design, 25 mg of cephalexin/kg or 9.6 mg of cefpodoxime/kg was administered orally. Blood samples were collected before (time 0) and 0.33, 0.66, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after treatment. An ultrafiltration device was used in vivo to collect ISF at 0, 2, 4, 6, 8, 10, 12, 16, and 24 hours. Plasma and ISF concentrations were analyzed with high-pressure liquid chromatography. Plasma protein binding was measured by use of a microcentrifugation technique.
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Ceftriaxone-related haemolysis resulted in the death of one of our patients (patient 2), and caused acute renal failure in the other (patient 1). The DATwas strongly positive for anti-C3d and anti-IgG in one case (patient 2), and for anti-C3d alone in the other (patient 1). The serum of patient 1 reacted with red blood cells only in the presence of ex vivo antigens, while that of patient 2 reacted positively to native ceftriaxone and its ex vivo antigen. In the latter patient, the antibodies appeared to cross-react with native cefotaxime whereas, in the first patient, they weakly cross-reacted only with the ex vivo antigens of cefotaxime and cefpodoxime proxetil.
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Cefpodoxime proxetil is an oral cephem antibiotic of a new ester type, developed by Sankyo Co., Ltd in Japan. It has a broad antibacterial spectrum, which includes Staphylococcus, and a long half-life, allowing twice-daily administration. In Japan, clinical studies on this drug were performed in various fields, including internal medicine, surgery, urology, otorhinolaryngology, and obstetrics and gynaecology. Good or excellent clinical responses were observed in 2275 of 2902 patients analysed, giving a 78.4% efficacy rate overall. Side effects occurred in 98 patients (2.7%); these were mainly gastrointestinal and included diarrhoea, nausea, and vomiting. Abnormal laboratory test results observed included increased AST in 2.8% (55 of 1973), increased ALT in 3.2% (63 of 1965), and eosinophilia in 2.4% (36 of 1521).
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Cefpodoxime is a new oral prodrug antibiotic. Following absorption from the proximal intestine, non-specific esterases hydrolyze this cleavable ester, releasing cefpodoxime, a new broad-spectrum third-generation cephalosporin with sustained plasma levels in humans. Cefpodoxime killing kinetics were studied using an in vitro model which simulates the pharmacokinetic profile obtained in healthy volunteers given a single oral dose of cefpodoxime proxetil providing 100, 200 or 400 mg active cefpodoxime. Cefpodoxime exhibited strong antibacterial activity against tested strains of Escherichia coli, Streptococcus pneumoniae and Staphylococcus aureus. These results suggest that use of two daily doses of 100 or 200 mg each are appropriate for the treatment of E. coli and S. pneumoniae infections in view of the pharmacokinetic properties of cefpodoxime. Less intensive therapy is probably adequate in uncomplicated community-acquired urinary tract infections. The bactericidal effect of cefpodoxime against S. aureus is prolonged due to a postantibiotic effect.
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A total of 260 children, 3 months to 11 years old (median age 24 months), with acute otitis media (AOM) received either cefpodoxime proxetil (CP) 8 mg/kg/d b.i.d. or amoxicillin/clavulanic acid (ACA) 40/10 mg/kg/d t.i.d. for 8 days. A significant difference in clinical cure rates was observed between the CP group 71/118 (60%) and the ACA group 42/105 (40%), p = 0.003. At the follow-up visit (20-30 days after the start of treatment), significant advantages were recorded with the CP vs. ACA therapy, in terms of satisfactory clinical response [90/111 (81%) vs 60/94 (63.8%), p = 0.005] residual middle ear effusion (14.4% vs 28.7%, p = 0.01) and normal tympanometry (78% vs 61.4%, p = 0.017). Compliance and adverse event frequency were the same in both treatment groups. The higher clinical cure rate and equivalent safety profile of CP indicates that it is an acceptable alternative to ACA for the treatment of AOM in children.