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The antimicrobial activity of cefpodoxime, the active metabolite of the new cephalosporin ester cefpodoxime proxetil, in comparison to cefixime, cefotiam, cefuroxime, and cefotaxime was determined against a broad spectrum of freshly isolated gram-positive and gram-negative bacterial strains. Cefpodoxime was demonstrated to be inhibitory at concentrations of less than or equal to 1 mg/l against 90% of strains of Moraxella catarrhalis, Haemophilus influenzae, Escherichia coli (beta-lactamase- negative strains), Klebsiella spp., Serratia spp., Proteus mirabilis, Proteus vulgaris, Providencia spp., and Salmonella spp. This antimicrobial activity of cefpodoxime was generally superior to that of cefuroxime and similar to that of cefixime. Cefpodoxime was active at less than or equal to 1 mg/l against 50% of the members of beta-lactamase-producing Escherichia coli, Enterobacter cloacae, Enterobacter aerogenes, Citrobacter spp., and Morganella morganii. Cefpodoxime proved to be highly inhibitory against group A, B, and G streptococci and Streptococcus pneumoniae (MIC90 less than 0.015 mg/l). The MICs of cefpodoxime and those of the other cephalosporins were less than 2 mg/l for greater than or equal to 90% of the strains of Staphylococcus aureus and Staphylococcus epidermidis, with the exception of cefixime which had no activity with MICs below 8 mg/l against these bacteria. Pseudomonas spp., Acinetobacter spp., and Enterococcus spp. were resistant to cefpodoxime. The antibacterial activity of cefpodoxime was only to a minor degree influenced by different growth conditions with the exception of high inoculum sizes against some beta-lactamase producing strains of gram-negative bacilli.(ABSTRACT TRUNCATED AT 250 WORDS)
Cefpodoxime proxetil (CS-807) is an orally active prodrug of an oxime-type cephem antibiotic. The MIC60 values of cefpodoxime (R-3746) the active form of CS-807, were 3.13, 6.25, 0.05, 0.38, 0.2, 0.1, 3.13, 3.13, 6.25, 6.25, 0.1 and 12.5 micrograms/ml against S. aureus, coagulase-negative staphylococci, S. pneumoniae, E. coli carrying R plasmids, P. vulgaris, P. rettgeri, C. freundii, S. marcescens, A. calcoaceticus, P. cepacia, ampicillin-resistant H. influenzae and B. fragilis, respectively. Its activity was stronger than that of cefaclor and ampicillin. R-3746 manifested little activity against P. aeruginosa, methicillin-resistant S. aureus, and Enterococcus spp. R-3746 showed stronger binding affinity than cefaclor with the PBP2 of S. aureus, PBPs 1a, 1bs, 2 and 3 of E. coli, PBPs 1b, 1c and 3 of P. rettgeri, and the PBP3 of P. aeruginosa than cefaclor. Synergy of the bactericidal effect between R-3746 and serum complement was moderate, although the cells of E. coli NIHJ-JC2 and S. aureus 209P were well engulfed and rapidly digested by mouse-cultured macrophages in the presence of greater than 1/8 MIC of R-3746. Good clinical efficacy can be expected of CS-807 provided its pharmacokinetics prove to be good.
CS-834 is a novel oral carbapenem antibiotic. This compound is an ester-type prodrug of the active metabolite R-95867. The antibacterial activity of R-95867 was tested against 1,323 clinical isolates of 35 species and was compared with those of oral cephems, i.e., cefteram, cefpodoxime, cefdinir, and cefditoren, and that of a parenteral carbapenem, imipenem. R-95867 exhibited a broad spectrum of activity covering both gram-positive and -negative aerobes and anaerobes. Its activity was superior to those of the other compounds tested against most of the bacterial species tested. R-95867 showed potent antibacterial activity against clinically significant pathogens: methicillin-susceptible Staphylococcus aureus including ofloxacin-resistant strains, Streptococcus pneumoniae including penicillin-resistant strains, Clostridium perfringens, Neisseria spp., Moraxella catarrhalis, most members of the family Enterobacteriaceae, and Haemophilus influenzae (MIC at which 90% of strains are inhibited, < or =0.006 to 0.78 microg/ml). R-95867 was quite stable to hydrolysis by most of the beta-lactamases tested except the metallo-beta-lactamases from Stenotrophomonas maltophilia and Bacteroides fragilis. R-95867 showed potent bactericidal activity against S. aureus and Escherichia coli. Penicillin-binding proteins 1 and 4 of S. aureus and 1Bs, 2, 3, and 4 of E. coli had high affinities for R-95867. The in vivo efficacy of CS-834 was evaluated in murine systemic infections caused by 16 strains of gram-positive and -negative pathogens. The efficacy of CS-834 was in many cases superior to those of cefteram pivoxil, cefpodoxime proxetil, cefdinir, and cefditoren pivoxil, especially against infections caused by S. aureus, penicillin-resistant S. pneumoniae, E. coli, Citrobacter freundii, and Proteus vulgaris. Among the drugs tested, CS-834 showed the highest efficacy against experimental pneumonia in mice caused by penicillin-resistant S. pneumoniae.
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Twenty-seven randomized clinical trials (6463 patients), 6 systematic reviews, and 11 observational studies (252,934 patients) were included in our review. Acute uncomplicated cystitis in women can be diagnosed without an office visit or urine culture. Trimethoprim-sulfamethoxazole (160/800 mg twice daily for 3 days), nitrofurantoin monohydrate/macrocrystals (100 mg twice daily for 5-7 days), and fosfomycin trometamol (3 g in a single dose) are all appropriate first-line therapies for uncomplicated cystitis. Fluoroquinolones are effective for clinical outcomes but should be reserved for more invasive infections. β-Lactam agents (amoxicillin-clavulanate and cefpodoxime-proxetil) are not as effective as empirical first-line therapies. Immediate antimicrobial therapy is recommended rather than delayed treatment or symptom management with ibuprofen alone. Limited observational studies support 7 to 14 days of therapy for acute urinary tract infection in men. Based on 1 observational study and our expert opinion, women with diabetes without voiding abnormalities presenting with acute cystitis should be treated similarly to women without diabetes.
Three to six hours prior to surgery in the head and neck a single dose of 200 mg cefpodoxime proxetil was administered orally to 30 patients. During surgery serum and tissue samples (concha, mocosa, cartilage, bone, parotis and tonsil) were taken and the concentrations of cefpodoxime were determined by bioassay. The serum concentrations ranged from 0.72 mg/l (determined after 6 h 22 min) to 3.34 mg/l (3 h 15 min). The tissue concentrations were between 0.15 mg/l (determined in bone after 5 h 18 min) and 1.94 mg/l (concha 4 h 13 min). Analogously to recent in vitro data the concentrations reached in head and neck tissue were higher than the MIC90 values for most pathogens of upper respiratory tract infections.
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Concurrently with administering a newly developed cephem derivative antibiotic (CEP), cefpodoxime proxetil (CPDX-PR, CS-807) dry syrup, to children with skin and soft tissue infections, activities of 7 drugs against a group of microorganisms were tested. The drugs tested included 4 drugs of the cephem group, R-3746, a Na-salt form of CPDX, cefaclor (CCL), cephalexin (CEX) and cefadroxil (CDX), and 3 drugs of the penicillin group, ampicillin (ABPC), methicillin (DMPPC) and cloxacillin (MCIPC). The bacterial strains tested were 71 strains of Staphylococcus aureus and 1 strain of Streptococcus pyogenes, all isolated from the above cases of pediatric infections. Inoculum sizes used in these tests were 10(6) and 10(8) cfu/ml. Ages of children in those cases to which the drug was administered ranged from 2 months to 15 years. A total of 66 cases were treated, including 60 cases of impetigo, 5 cases of subcutaneous abscess and 1 case of phlegmon. The drug was administered for an average of 6 days with a daily average dose level of 9.4 mg/kg divided into 3 doses except 1 case where a twice daily dose regimen was used. Clinical and bacteriological effects were examined, and the occurrence of adverse reactions and abnormal laboratory test results were recorded. The results of these tests are summarized below. 1. The activity test for R-3746 (Na-salt of CPDX) against 71 strains of S. aureus performed at an inoculum level of 10(8) cfu/ml showed 2 peaks of MIC values, one in a range of 1.56 to 6.25 micrograms/ml and the other higher than 100 micrograms/ml. The most prevalent MIC value was 3.13 micrograms/ml with MIC against 51 strains or 71.8% of the strains tested showing this value, and MIC values of 25 micrograms/ml or higher were obtained for 13 strains or 18.3% of the strains tested. The MIC80 was 6.25 micrograms/ml. Thus, R-3746 showed an antibacterial activity slightly weaker than MCIPC and DMPPC but similar to CCL, CEX and CDX. MIC values obtained at an inoculum level of 10(6) cfu/ml also had 2 peaks, one in a range of 1.56 to 3.13 micrograms/ml and the other higher than 25 micrograms/ml. Strains against which R-3746 had the MIC value of 3.13 micrograms/ml were the most numerous with 47 strains or 66.2%, and strains against which the MIC value of higher than 25 micrograms/ml was obtained were next with 13 strains or 18.3%.(ABSTRACT TRUNCATED AT 400 WORDS)
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Cefdinir (FK482), a new oral cephalosporin, displayed potent oral activity versus induced infections in mice. In studies using beta-lactamase-nonproducing (beta LAC-) and -producing (beta LAC+) Staphylococcus aureus strains, respective PD50s (in mg/kg) were 11 and 24 for preventing subcutaneous abscess and 2.7 and 2.3 for preventing lethal systemic infection. In studies using beta LAC- and beta LAC+ Haemophilus influenzae, respective PD50s were 5.8 and 3.1 for preventing lethal systemic infection. Time-kill studies versus H. influenzae showed that 6- to 12-mg/kg dosing was effective in reducing viable counts of these strains in blood by > or = 100-fold by 24 h after challenge. This in vivo performance was comparable to or exceeded values generated by cefaclor, cefpodoxime proxetil, and ampicillin.
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There is a high rate of use of antimicrobial drugs for otitis media in children. This article reviews the diagnostic considerations for acute otitis media. An extensive review of literature on this subject has been carried out in order to address the issues of indications, choice, appropriate doses of antimicrobial agents and the duration for which they should be used. It is important to distinguish acute otitis media from otitis media with effusion because antibiotics are seldom indicated for the latter condition. Oral amoxicillin remains first-line therapy for uncomplicated acute otitis media, a short course of antimicrobial therapy (five to seven days) may be appropriate in children two years of age or older with uncomplicated presentations. For clinical treatment failures after 3 days of amoxicillin, recommended antimicrobial agents include oral amoxicillin/clavulanate, cefuroxime axetil, cefprozil, cefpodoxime proxetil, and intramuscular (i.m.) ceftriaxone. Tympanocentesis for identification of pathogens and susceptibility to antimicrobial agents is recommended for selection of third-line agents.
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The risk for a child to carry penicillin-resistant S. pneumoniae (MIC > or = 0.125 mg/l) did not increase after antibiotic treatment: 84 of 364 (23.1%) before, 70 of 364 (19.2%) after. There was a significant decrease of penicillin-susceptible S. pneumoniae carriage, 117 of 364 (32.1%) before treatment compared with 24 of 364 (6.6%) (P = 0.0001) after treatment. However, among the children carrying S. pneumoniae at the end of the treatment there was an increase in the percentage of penicillin-resistant pneumococci: 84 of 201 (41.8%) before treatment and 70 of 94 (74.5%) after treatment. Among the 94 children carrying S. pneumoniae at the end of the treatment, 22 did not harbor pneumococcus before, 16 carried another genotypically different serotype and 56 harbored the same serotype. Among these 56 children 2 patients harbored strains that had increased MICs for the tested beta-lactam antibiotics. The randomly amplified polymorphic DNA analysis showed that in one case, the strains were genetically different.
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Penicillin (PC) resistance of Streptococcus pneumoniae was tested by oxacillin disk method (Bauer-Kirby method) of the strains collected at the primary pediatric office. The rate of oxacillin resistance of S. pneumoniae was 36.4% in 1990, 41.4% in 1991, and 51.9% in 1992, respectively. The efficacy of oral antibiotics in the treatment of PC-insensitive S. pneumoniae infections was also studied retrospectively in 234 cases. Treatment failure rate was 17.7% in the amoxicillin group, 8.7% in the cefpodoxime proxetil group, while it was 42.9% in the cefixime group. These differences were statistically significant. From these data prevalence of PC-insensitive S. pneumoniae is very high in Japanese children, and amoxicillin and cefpodoxime proxetil can be used for the treatment of outpatients with PC-insensitive S. pneumoniae infections.
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Cefpodoxime proxetil (CPDX-PR, CS-807) was given orally to 18 children with acute bacterial infections including 10 with acute tonsillitis, 3 with acute bronchitis, 1 with pneumonia, 3 with staphylococcal scalded skin syndrome and 1 with infectious impetigo. Daily dosages per kg bodyweight ranging from 7.5 to 18 mg were given in 2 or 3 divided doses per day for 5 to 15 days. Clinical responses were excellent in 3 (16.7%), good in 11 (61.1%), fair in 4 (22.2%) and poor in 0 (0%), with an overall efficacy rate of 77.8%. Good bacteriological responses were obtained in 6 out of the 7 cases from which pathogens were identified. No side effect was observed. The above results suggest that CPDX-PR is a useful new oral cephalosporin derivative for the treatment of bacterial infections in children.
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The comparative pharmacokinetics of the new oral cephalosporins (ester and nonester types), together with that of the first generation carbacephem, loracarbef, are considered in healthy volunteers. Also in this review, pharmacokinetic and microbiological data are combined in order to predict the possible clinical efficacy of this group of agents. Despite apparent similarities in the structure of these agents, single dose studies have revealed marked differences in the pharmacokinetics of the oral cephalosporins. Multiple dose studies showed no evidence of accumulation with these agents. In the elderly, only minor changes in the pharmacokinetics of the oral agents were observed, and were insufficient to warrant dosage adjustment. Unlike that of the nonester compounds, the bioavailability of the ester cephalosporins is increased when they are administered after food. Variable effects are observed when the ester agents are coadministered with antacids or H2-antagonists; while the absorption of cefetamet pivoxil was unaffected by coadministered antacids or H2-antagonists, the absorption of cefpodoxime proxetil was reduced.
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Analysis of the mean acceptability/ preference rating from 769 children demonstrated that the flavor of azithromycin was rated significantly higher than that of cefpodoxime (4.3 vs. 2.8), cefprozil (4.0 vs. 3.4) and clarithromycin (4.3 vs. 2.7) and was comparable to that of cefixime (4.0 vs. 4.2) and loracarbef (4.4 vs. 4.5). A greater percentage of children preferred the taste of azithromycin to that of cefpodoxime (90.0% vs. 5.2%), cefprozil (63.0% vs. 33.1%) and clarithromycin (89.0% vs. 11.0%). The taste of azithromycin was not preferred to that of cefixime (39.0% vs. 53.9%) or loracarbef (36% vs. 58.5%).
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Acute otitis media (AOM) is not only the most common bacterial infection in children in the United States, it is also the most common indication for the prescription of antibiotics. Unfortunately, antibiotic resistance to pathogens (Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis) typically causative of AOM, continues to increase. More than 30% of the beta-lactamase producing H. influenzae are resistant to amoxicillin and virtually all strains of M. catarrhalis are beta-lactamase-positive. The emergence of multidrug-resistant strains, particularly S. pneumoniae, complicates the management of AOM and increases the risk for treatment failure. Because of growing resistance, the Centers for Disease Control and the American Academy of Pediatrics promote the judicious use of antibiotics in the treatment of AOM. Their recommendations emphasize the importance of distinguishing AOM from otitis media with effusion, minimizing the use of antibiotics, and discerning between first- and second-line antibiotics in the treatment of simple uncomplicated AOM versus non-responsive/recurrent AOM. Because spontaneous cure rates are lower in complicated AOM and AOM secondary to S. pneumoniae infection, antibiotic therapy remains an appropriate treatment option for most children with AOM. When amoxicillin, the treatment of choice in AOM, is not effective or not tolerated in children, the prescriber should consider an alternative that displays not only excellent antimicrobial activity against the suspected pathogens, but also characteristics, such as convenient dosing, tolerability, and palatability, that promote compliance and adherence in children. The cephalosporins offer an alternative to penicillins. Cephalosporins such as cefuroxime axetil (second-generation) and cefdinir and cefpodoxime proxetil (third-generation), offer a broad spectrum of activity and are approved for use in a convenient once- or twice-daily dosing schedule, thus increasing the likelihood of compliance with the full course of therapy. Cefdinir is a possible second-line alternative to amoxicillin for children with AOM, particularly among children who are likely to be noncompliant with a two- to three-times-daily dosing schedule, and those instances where there is a high likelihood for, or a known infection with an amoxicillin-resistant pathogen.
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Cefpodoxime proxetil is an orally administered prodrug which is converted in vivo to the third generation cephalosporin cefpodoxime. Cefpodoxime has a similar spectrum of antibacterial activity to the parenteral cephalosporins ceftriaxone and cefotaxime and a long elimination half-life, which allows once- or twice-daily administration. Cefpodoxime proxetil has proven efficacy in the treatment of community-acquired pneumonia and upper respiratory tract, skin and soft tissue and urinary tract infections. It has been evaluated for use in cost-containment programmes, as stepdown (parenteral-to-oral conversion) therapy in the treatment of community-acquired pneumonia and as abbreviated therapy in upper respiratory tract infections. Substituting oral for parenteral therapy can achieve considerable savings (in acquisition, delivery and labour costs). Moreover, oral administration has advantages for the patient in terms of comfort and mobility, avoids the hazards of parenteral delivery and may allow earlier discharge from hospital, or even allow home treatment from the outset in low-risk patients. As hospitalisation is usually the major cost component in treating serious infections, considerable savings can be made in this way. Pharmacy-driven stepdown programmes in 2 US hospitals have achieved cost savings by targeting patients with community-acquired pneumonia for early conversion from intravenous ceftriaxone therapy to oral cefpodoxime proxetil. Costs were compared with those from a control group of patients who continued to receive intravenous ceftriaxone until physicians deemed that oral therapy (with various agents) was appropriate. In one study, duration of parenteral therapy in the cefpodoxime proxetil group was reduced from 6.18 to 3.82 days and duration of hospitalisation was reduced from 10.06 to 6.23 days (p < 0.02), with corresponding hospitalisation cost reductions of $US7300 per patient. However, clinical trial data relating to the efficacy of cefpodoxime proxetil as stepdown therapy in patients initially requiring parenteral antibacterials are lacking. Abbreviated (4-to 7-day) cephalosporin regimens appear to be as effective as traditional 10-day penicillin regimens in the treatment of upper respiratory tract infections. Short regimens may improve patient compliance and tolerability, thereby reducing the costs of adverse effects and treatment failures. Data from preliminary clinical studies suggest that a 5-day course of cefpodoxime proxetil is as effective as an 8-day course of amoxicillin/clavulanic acid in treating either acute otitis media or sinusitis, and as effective as a 10-day course of amoxicillin/ clavulanic acid and more effective than a 10-day course of phenoxymethyl- penicillin in the treatment of pharyngotonsillitis. Cefpodoxime proxetil tended to be better tolerated and was associated with better compliance than penicillin-based regimens. Indeed, a pharmacoeconomic study showed that a 10-day regimen of cefpodoxime proxetil was associated with lower costs for treating adverse effects and treatment failures than a 10-day regimen of amoxicillin/clavulanic acid in the treatment of acute otitis media in children. A 5-day course of cefpodoxime proxetil had a lower cost per patient treated per month free of recurrence than a 10-day course of phenoxymethylpenicillin (non-generic) or amoxicillin/clavulanic acid in the treatment of recurrent pharyngotonsillitis. Thus, evidence to date suggests that cefpodoxime proxetil has potential for use as stepdown therapy in community-acquired pneumonia and in abbreviated therapy courses in upper respiratory tract infections. These preliminary observations require confirmation in well designed studies.
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Among women with uncomplicated cystitis, a 3-day regimen of cefpodoxime compared with ciprofloxacin did not meet criteria for noninferiority for achieving clinical cure. These findings, along with concerns about possible adverse ecological effects associated with other broad-spectrum β-lactams, do not support the use of cefpodoxime as a first-line fluoroquinolone-sparing antimicrobial for acute uncomplicated cystitis.
In France the current consensus for the treatment of community-acquired pneumonia is based on the French Society for Infectious Diseases 1991 guidelines. In healthy adults without signs of severe disease, oral amoxicillin is recommended at the dose of 3 g per day for 8 to 10 days. This empirical choice is warranted by the prevalence of pneumococcal infections, found as causal agents in half to two-thirds of the bacteriologically proven cases. The 3 g dose is recommended due to the increasing risk of penicillin-resistant S. pneumoniae with MIC > 1 microgram/ml and exceptionally > 2 micrograms/ml. Clinical experience has shown that with a threshold at 2 micrograms/ml, 3 g of amoxicillin is a safe and sure choice. The duration is undoubtedly too long for most patients, but is a prudent measure due to the lack of clinical signs distinguishing between patent infection and its prolongation by inflammatory processes. Indiscriminate prescription of amoxicillin alone is however unacceptable as aminopenicillin is not effective against all microbial agents responsible for community-acquired pneumonia. The risk of selecting resistant strains is very real. Use of a large spectrum antibiotic could be indicated as first line treatment in patients with risk factors (underlying chronic disease, institutionalization, exposure to Gram negatives or S. aureus). For such patients, combination with a beta-lactamase inhibitor (coamoxiclav) or a cephalosporin with a MIC similar to that for penicillin G (cefpodoxime proxetil, cefuroxime axetil) could be recommended. In case of severe disease, Legionella pneumophila must be taken into consideration, implicating adjuction of a macrolide. Wide spectrum fluoroquinolones such as the soon to be available trovafloxacin offer a safe alternative, covering the main microorganisms responsible for community acquired pneumonia. Widespread use would however increase the risk of microbial resistance. In the current epidemiological situation in France, prescription of an aminopenicillin alone for alveolar community-acquired pneumonia in healthy adults remains the gold standard for first line therapy.
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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This prospective randomized trial was conducted to investigate the prevention of major operating site infections after nonlaparotomy surgery, with treatment regimens as follows: the first group of patients received 2 g of intravenous cefotiam dihydrochloride (CTM) on the induction of anesthesia, while the second group received 100 mg of oral cefpodoxime proxetil (CPDX- PR) twice daily, from day 0 to day 2.
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Forty patients who began receiving intravenous ceftriaxone for either a community-acquired pneumonia or a complicated urinary tract infection.
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Cefpodoxime proxetil (CPDX-PR, CS-807) dry syrup was administered orally to 31 patients with various infections at daily dose levels between 5.4 and 10.9 mg/kg divided into three doses. 1. The subjects were 3 patients with urinary tract infections, 25 with tonsillitis and 1 patient each with bronchitis, pneumonia, and cervical lymphadenitis. Clinical effects were excellent in 16 cases, good in 14, and fair in 1 (tonsillitis), with an overall efficacy rate of 96.8%. 2. Organisms suspected as pathogens were 32 strains (6 strains of Staphylococcus aureus, 2 of Streptococcus pyogenes, 1 of Enterococcus faecalis, 15 of Haemophilus influenzae, 5 of Haemophilus parainfluenzae and 3 of Escherichia coli). Bacteriologically, eradication of pathogens were observed in 30 strains, decrease in one (H. parainfluenzae), and no change in another (E. faecalis), thus the eradication rate was 93.8%. 3. Side effect was observed in 1 case (slight eruption) but it was possible continue the treatment. Abnormal laboratory test values were observed in 1 case of a slight prolongation of prothrombin time and eosinophilia, but they were not serious. Diarrhea was not observed in any patients. 4. All the medication was done on schedule. No refusal of the drug occurred due to its taste or odor.
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Between September 2006 and September 2007, 91 physicians enrolled 2400 children and 1482 patient records are fully assessable. The two factors that improve significantly compliance are administration in two doses by day (OR 2.2 [95% CI 1 6-3]) and acceptability ≥80% (OR 2.6, [95% CI 1.9-3.7]). The acceptability was better for amoxicillin-clavulanic acid 65.4% (95% CI [57.6 to 72.4]) than for cefpodoxime 47.1% (95% CI [43.8-50.4]) or cefuroxime axetil 26% (95% [CI 15.9-39.6]). Conversely, cefpodoxime proxetil obtained a better score for compliance 91.8% (95% CI [89.8 to 93.4) as amoxicillin-clavulanic acid 84.6% (95%CI 80.8 to 87.8) because of its mode of administration in two doses per day. There is no difference between the amoxicillin clavulanic acid reference product and its generics as a whole, however a large variability exists between generics. If, for antibiotics prescribed in two doses per day, the two administrations by day are roughly equidistant, it is not the same for those prescribed three times a day: indeed, while the doses taken are identical, only four hours separate the first intake of the morning from the second intake in mid-day and more than 12 hours between the evening dose from the next morning intake.
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The purpose of this research was to assessment of antimicrobial activity and in vitro/in vivo evaluation of cefpodoxime proxetil extended-release (ER) tablet for once daily administration. The tablets were prepared using combination of biodegradable polysaccharides including hydroxypropyl methylcellulose and sodium alginate as matrix material to achieve pH-independent ER release. The tablets were found within the permissible limits for various physicochemical parameters. The in vitro drug release showed that the drug was released over a period of 24h in a sustained release manner. The drug release followed Higuchi kinetics as these plots showed the highest linearity (R(2)=0.9833), but a close relationship was also observed with zero-order kinetics (R(2)=0.9088) and the drug release mechanism was found to be of anomalous or non-Fickian type. Further, in vitro drug release was assessed by antimicrobial assay and it revealed that drug release through 24h periods was above the MIC. In vivo investigation in rabbits showed ER pharmacokinetic profile of cefpodoxime from the matrix tablets. A good correlation of drug absorption in vivo and drug release in vitro (R(2)=0.9785) was observed. These results suggested that the investigated CFP matrix tablets have a potential for extended-release dosage forms.
A new, simple, precise, rapid and accurate RP-HPLC method has been developed for the simultaneous estimation of cefpodoxime proxetil and clavulanic acid from pharmaceutical dosage forms. The method was carried out on a Zorbax Eclipse XDB 5 mu C 18 (150x4.6 mm) column with a mobile phase consisting of acetonitrile:50 mM potassium dihydrogen phosphate buffer (pH 3.0, 70:30 v/v) at a flow rate of 1.0 ml/min. Detection was carried out at 228 nm. Aspirin was used as an internal standard. The retention time of clavulanic acid, cefpodoxime proxetil and aspirin was 4.43, 6.44 and 5.6 min, respectively. The developed method was validated in terms of accuracy, precision, linearity, limit of detection, limit of quantification and solution stability. The proposed method can be used for the estimation of these drugs in combined dosage forms.
Tissue concentration of protein-unbound cefpodoxime was similar to that of the protein-unbound plasma concentration. Cefpodoxime remained in tissues longer than did cephalexin.
Six pediatric patients who had AOM with otorrhea caused by CA-MRSA.
This European, multicentre trial evaluated the efficacy and tolerance of cefpodoxime proxetil in comparison with co-amoxiclav (amoxycillin plus clavulanic acid) in the treatment of acute exacerbations of chronic bronchitis. The study design was double-blind and double-placebo controlled. Doses of either 200 mg bd of cefpodoxime proxetil or 500 mg/125 mg tds amoxycillin plus clavulanic acid were given orally for 9.6 +/- 1.8 days. Two hundred and fifty-one patients were enrolled in 27 centres in West Germany, France, and Italy. The overall clinical efficacy was 97.2% in the cefpodoxime proxetil group compared with 94.7% in the co-amoxiclav group. Fifty-eight adverse events, mainly gastrointestinal, occurred in 42 patients with no significant difference between the groups. A significant difference in the number of resistant pathogens on pre-treatment culture to the advantage of cefpodoxime was noted. In our experience, both drugs were of similar value in the treatment of respiratory tract infections. Thus, cefpodoxime proxetil should be an effective antibiotic for the treatment of acute exacerbations of chronic bronchitis.
To our knowledge, cefpodoxime-induced AIN and IHA are unprecedented. Physicians should be aware that drug-induced AIN and hemolysis can be associated with cefpodoxime proxetil.
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In order to compare the clinical efficacy and safety of cefatrizine (Cefaperos) and cefpodoxime proxetil (Orelox) in the treatment of secondarily infected chronic obstructive pulmonary disease (COPD) in adults, a multicentre, randomized, open study was conducted by 60 general practitioners in two parallel groups of patient suffering from COPD complicated by an acute episode of superinfection (Anthoniesen stages 2 and 3). After verification of the eligibility criteria, written consent and randomization, the patients received, for 10 days, either cefatrizine at the dose of 1 g/day or cefpodoxime proxetil at the dose of 400 mg/day. A self-assessment form was given to the patient. A telephone visit was planned for D3. The final visit on D11 +/- 1 evaluated clinical efficacy (success or failure) and safety. The study population was composed of 250 patients with a mean age of 59.9 +/- 15.9 years (sex ratio M/F = 1.5). The principal etiology of COPD was chronic bronchitis in 67.5% of patients, longstanding asthma in 24.5% and emphysema in 6.8%. The mean history of the disease was 13.0 +/- 10.8 years. The Anthoniesen score was equal to 2 in 73.6% of patients, 3 in 8.8% of patients and 1 in 17.6% of patients. No significant difference concerning these criteria was observed between the two study groups. The clinical success rate was equivalent in the two groups. The time to regression of clinical signs tended to be shorter, up until the sixth day (mainly between D4 and D6) for patients treated with cefatrizine (p = 0.09; NS). The clinical safety was considered to be good and was comparable in the two study groups. This study concluded on the equivalent clinical efficacy of cefatrizine and cefpodoxime proxetil in the treatment of superinfections of COPD in general practice (97.5% and 99%, respectively), with a satisfactory and comparable safety, but with a much lower cost of treatment for cefatrizine. This conclusion is particularly important in the context of opposable medical references, as, although the treatment of superinfections of COPD by second and third generation cephalosporins is frequently proposed, the prescription of a less expensive cephalosporin appears to be more relevant.
Self-nanoemulsifying drug delivery system (SNEDDS) using various surfactant and cosurfactants such as tween 80, tocopheryl polyethylene glycol succinate (TPGS), propylene glycol and Capmul MCM as oil phase were prepared. Ternary phase diagrams were constructed to identify stable microemulsion region. Percent transmittance studies helped to shortlist the surfactant-cosurfactant combination.