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Cefpodoxime proxetil (RU 51 807) is the oral prodrug of cefpodoxime (RU 51 763), a third generation cephalosporin. The antibacterial activity of cefpodoxime was compared with the activities of amoxicillin in combination with clavulanic acid (AUG), cefaclor (CCl), cefuroxime (CXM) and cefotaxime (CTX), against species of Enterobacteriaceae showing a resistance pattern against ampicillin (AMP), ticarcillin (TIC), cefalothin (CFT) and cefotaxime (CTX) respectively. For strains AMP and TIC R, CFT and CTX S, MICs 90% of cefpodoxime were 1 mg/l (E. coli), 0.5 (K. pneumoniae), 0.06 (P. mirabilis), 0.5 (Shigella sp.) and 1 (Salmonella sp.); they were 4 to 16 times as high for AUG -CCL -CXM and 4 to 16 times as low for CTX. For K. pneumoniae AMP and TIC R, CFT I/R and CTX S, similar résults were obsereved for the 5 beta-lactam antibiotics, but with an activity 10 times as low. Among the species AMP R, TIC S, CFT R and CTX S, cefpodoxime was active against P. rettgeri, P. stuartii, C. diversus, E. aerogenes and Y. enterocolitica (MICs 90% ranging from 2 to 4 mg/l; from 0.12 to 1 mg/l for CTX) and less active or inactive against P. vulgaris, E. cloacae, S. marcescens, M. morganii and E. coli (MICs 90% ranged from 16 to 32 mg/l; from 1 to 4 mg/l for CTX).(ABSTRACT TRUNCATED AT 250 WORDS)
In this multicenter, observer-blinded study, 301 patients with signs and symptoms of acute bacterial exacerbation of COPD were randomized (2:1) to receive either cefpodoxime proxetil (200 mg, bid) or cefaclor (250 mg, tid) for 10 days. Clinical and microbiologic evaluations were performed before treatment, during therapy (study days 3 to 5), at the end of therapy (3 to 7 days posttreatment), and at long-term follow-up (4 weeks posttreatment). The most common pretreatment isolates were Haemophilus influenzae, Haemophilus parainfluenzae, and Streptococcus pneumoniae. Significantly (p < 0.001) more bacterial isolates were susceptible in vitro to cefpodoxime (233 of 256, 91 percent) than to cefaclor (215 of 255, 84 percent). There were no statistically significant differences between the two drug regimens in eradication of the initial pathogen (cefpodoxime, 116 of 128, 91 percent; cefaclor, 59 of 64, 92 percent) or end-of-therapy clinical response (cure + proved; cefpodoxime, 99 of 100, 99 percent; cefaclor, 45 of 49, 92 percent) rates for evaluable patients. Both drug treatments were well-tolerated, with a similar incidence of drug-related adverse events (cefpodoxime 11 percent, cefaclor 12 percent). Cefpodoxime (bid) was as safe and effective as cefaclor (tid) in the treatment of acute exacerbation of COPD. The less frequent dosing regimen of cefpodoxime may improve patient compliance compared to those antibiotics that require three or four daily doses.
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The value of MIC90 s cefdinir against these bacterial strains except penicillin non-sensitive pneumococci were 0.031-1 mg/L. Cefpodoxime held similar antibacterial activity with cefdinir, but was less potent against staphylococci. Cefaclor had much higher MIC values than other two drugs. After oral administration of 250 mg cefaclor, the drug concentration quickly reached peak concentration of 4.95 mg/L +/- 2.41 mg/L and the eliminative half time was 0.69 h +/- 0.6 h; the Tmax, Cmax and T1/2beta of cefdinir and cefpodoxime after oral administration of 100 mg were 2.5 h +/- 0.48 h, 0.81 mg/L +/- 0.19 mg/L, 1.73 h +/- 0.3 h and 2.38 h +/- 0.43 h, 1.12 mg/L +/- 0.28 mg/L, 1.92 h +/- 0.55 h, respectively. T > MIC of cefdinir in thrice daily administration were longer than 40% of medication interval against most of the tested isolates; no T > MIC period was found in cefpodoxime against staphylococci and the T > MICs of cefaclor after 250 mg oral administration were shorter than expected values against most bacteria.
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The pharmacokinetic, economic and practical aspects of sequential therapy with iv and oral cephalosporins are reviewed. New broad spectrum oral cephalosporins, such as cefixime, cefpodoxime proxetil and cefetamet pivoxil achieve serum concentrations above the MICs for most Enterobacteriaceae for at least as long as for parenteral cefuroxime. Substantial cost reductions are possible with an early switch from iv to oral cephalosporins. The clinical studies that have been performed so far have important shortcomings. Well designed clinical studies are necessary to prove the feasibility of sequential therapy with cephalosporins for serious infections in hospitalized patients.
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We compared the effects of nifedipine and diltiazem on the uptake of cefpodoxime proxetil (CP). The study was aimed at establishing the impact of increased mesenteric blood flow due to calcium channel blockers on passive transport. Twelve volunteers were given CP (200 mg) orally in a crossover design. The absorption, disposition, and elimination parameters of cefpodoxime were compared among the following three treatment groups: CP alone, CP following oral administration of diltiazem (60 mg), or CP following oral administration of nifedipine (20 mg). No statistically significant difference in pharmacokinetic parameters was observed between the three treatment groups.
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A patient with a recent history of cefpodoxime proxetil treatment presented with elevated serum creatinine, oliguria, nausea, vomiting, and dyspnea. Evidence of renal failure, abnormal urinalysis, and renal biopsy with inflammatory infiltrate in the interstitium confirmed a diagnosis of AIN. The patient subsequently developed IHA, which was confirmed by peripheral blood smear results and positive Coombs' test. The patient recovered after dialysis therapy and 2 days of intravenous methylprednisolone (500mg/day) followed by oral prednisolone (60 mg/day), which was rapidly tapered and stopped within 3 weeks.
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A simple, selective and precise thin-layer chromatographic method has been developed for the analysis of eight cephalosporin antibiotics, namely cephadroxil, cephalexin, cefixime, cefaclor, cefpodoxime proxetil, cefuroxime axetil, cefotaxime sodium and ceftriaxone sodium. The hR(F) values of these cephalosporins were investigated on silica gel G-zinc ferrocyanide layers. Mixing of zinc ferrocyanide with silica gel G resulted in a decrease in hR(F) values, removal of tailing and better resolutions. The influence of silica gel G-zinc ferrocyanide ratio and mobile phases on the chromatographic behavior of cephalosporins on thin layers was investigated. Cephalosporins were selectively separated in their binary and ternary synthetic mixtures and pharmaceutical formulations. Quantitative separations of cephalosporins from their synthetic mixtures were also achieved with good recoveries (97.8-100.3%).
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Pharmacist intervention and cefpodoxime step-down therapy were associated with decreased overall antibiotic costs in our intravenous-to-oral program.
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Cefpodoxime proxetil is the orally absorbed ester of cefpodoxime, a new third generation cephalosporin. In the gastrointestinal tract, cefpodoxime proxetil is hydrolysed to cefpodoxime, which has potent antibacterial activity against the major bacterial pathogens involved in lower respiratory tract infections: Haemophilus influenzae, Moraxella (Branhamella) catarrhalis (including beta-lactamase-producing strains), and Streptococcus pneumoniae (including amoxicillin-resistant strains). Six randomised comparative studies in patients with lower respiratory tract infections, 5 of which were large (enrollment of more than 200 patients) and double-blind, examined the efficacy and safety of cefpodoxime proxetil. Cefpodoxime proxetil (at a dosage equivalent to 200mg of cefpodoxime) administered twice daily for 5 to 10 days was similar in clinical and bacteriological efficacy to the following: amoxicillin 500mg 3 times daily in the treatment of community-acquired pneumonia; intramuscular ceftriaxone Ig once daily in the treatment of pulmonary infections in hospitalised patients; and to amoxicillin/clavulanic acid 500/125mg 3 times daily in the treatment of acute exacerbations of chronic bronchitis (AECB). Additionally, a dosage equivalent to 100mg or 200mg of cefpodoxime twice daily was similar in clinical and bacteriological efficacy to amoxicillin 250mg 3 times daily in the treatment of bronchitis (acute or AECB). The adverse events noted with cefpodoxime proxetil administration were similar to those associated with other beta-lactam antibacterials and most commonly involved the gastrointestinal tract and skin or mucous membranes. Thus, cefpodoxime proxetil is a useful addition to the antibacterials available for the treatment of infections of the lower respiratory tract.
The antibacterial activity of cefpodoxime against Branhamella catarrhalis was studied. All of the 65 clinical isolates tested were inhibited at and below 1.56 micrograms/ml, both at 10(7) and at 10(5) CFUs. The following was further studied on B. catarrhalis N-5 which showed average susceptibility to each drug examined. Bactericidal activity was observed at and above the MIC. Scanning and transmission electron microscopy revealed morphological changes, such as cellular swelling, bleb formation, inhibition of septum formation, and lysis, of the cells exposed to cefpodoxime at concentrations around the MIC. Cefpodoxime was poorly hydrolyzed by the beta-lactamase and it showed affinity for two penicillin-binding proteins that had approximate molecular weights of 83 and 74 kilodaltons, with I50 values of 3.7 and 2.1 micrograms/ml, respectively.
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.
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This was a multicenter, prospective, randomized, double-blind study conducted in the United States and South Africa. Ambulatory patients with a diagnosis of CAP were randomized to 14 days of treatment with cefditoren 200 or 400 mg BID or cefpodoxime 200 mg BID. Assessments of clinical cure and pathogen eradication were conducted at 2 visits during treatment, 1 posttreatment visit (s48 hours after completion of treatment), and 1 follow-up visit (7-14 days after completion of treatment). The development of resistant pathogens was assessed at the follow-up visit but not thereafter. The relative cost of treatment was not assessed.
Cefpodoxime proxetil (CFP), a broad-spectrum third-generation cephalosporin, has been used most widely in the treatment of respiratory and urinary tract infections. For bioequivalence study of CFP in rabbit plasma, it was necessary to develop a highly sensitive and selective high-performance liquid chromatographic (HPLC) method with fluorescence (FL) detection. The pre-column labeling of cefpodoxime acid (CFA) (active metabolite) with an efficient benzofurazan type fluorogenic reagent, 4-N,N-dimethyl aminosulfonyl-7-fluoro-2,1,3-benzoxadiazole (DBD-F) was carried out in the present study in 100mM borate buffer (pH=8.5) at 50°C for 15min. The obtained fluorescent products were separated on C18 column with an isocratic elution of the mobile phase, which consists of 10mM phosphate buffer (pH=3.5)/CH3CN (70:30, v/v). The fluorescent product (DBD-CFA) was detected fluorimetrically at 556nm with an excitation wavelength of 430nm. Cefotaxime sodium was used as internal standard. The method was validated according to the requirements of US-FDA guidelines. The correlation coefficient of 0.999 was obtained in the concentration ranges of 10-1000ngmL(-1). The limits of detection and quantification (S/N=3) were 3 and 10ngmL(-1), respectively. Plasma CFA levels were successfully determined in rabbit with satisfactory precision and accuracy. The proposed HPLC-FL method was successfully applied to study bioequivalence in rabbits for two formulations of different brands contained CFP (prodrug) in a randomized, two-way, single-dose, crossover study and all pharmacokinetic parameters for the two formulations were assessed.
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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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The most common pathogen causing skin infections is Staphylococcus aureus and the incidence of multiply resistant strains of S. aureus has been increasing. The in vitro susceptibility of 130 isolates of S. aureus to 19 antimicrobial agents: ampicillin (ABPC), methicillin, cefaclor, cefpodoxime proxetil, gentamicin, erythromycin, clindamycin, minocycline, vancomycin, fusidic acid, norfloxacin, ofloxacin, enoxacin, ciprofloxacin, lomefloxacin, tosufloxacin, sparfloxacin, nadifloxacin and grepafloxacin, was evaluated by agar dilution tests. The S. aureus isolates were isolated from 130 patients with skin infections in 1994. The proportion of methicillin-resistant S. aureus isolates among the strains isolated was 19.2%. The concentration needed to inhibit 50% of the isolates was 3.13 mg/ml or less for all of the drugs, but the concentration needed to inhibit 90% of isolates was over 12.5 micrograms/ml, except in the cases of minocycline, vancomycin, fusidic acid, tosufloxacin and nadifloxacin. Tosufloxacin and nadifloxacin had the lowest minimum inhibitory concentrations. None of the S. aureus strains was resistant to nadifloxacin.
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We explored the antibacterial prescribing patterns of physicians in ear, nose and throat (ENT) outpatient and inpatient departments (OPD, IPD) of a University Hospital, New Delhi, India.
Cefpodoxime proxetil is a third generation cephalosporin with a broad spectrum of antibacterial activity and a favourable pharmacokinetic profile which allows twice-daily administration. It is generally well tolerated and demonstrates good bacteriological and clinical efficacy in paediatric patients with various infectious diseases, including acute otitis media, tonsillitis and/or pharyngitis. Based on these characteristics, cefpodoxime proxetil is a suitable option for the treatment of paediatric patients with various common bacterial infections.
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This study confirms the disparity in terms of acceptability among the different antibiotics prescribed for children even for the same drug, warranting evaluation for marketing of future generic drugs pediatric oral suspension. The disparity ranges for drugs three times daily asking consequences pharmacokinetics and dosage adjustment for a transition to two doses per day.
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Blood glucose, protein, AST and ALT activities were not significantly altered but the hemoglobin level and total and live sperm count decreased significantly in the study group compared to the control group. Residual level of cefpodoxime was highest in liver followed by kidney and other study organs. Therefore, the drug should be used in human beings judiciously and further study on human subjects is warranted.
Literature was identified by a MEDLINE search from 1986 to January 1995.
The luminal and mucosal deesterification of the prodrug ester cefpodoxime-proxetil was studied in human duodenal washings in vitro. Enzymatic hydrolysis of the ester, releasing the active third generation cephalosporin, was observed in luminal washing in the same way as it had previously been observed in the rabbit. Eserine and PMSF and HgCl(2) were potent inhibitors of cefpodoxime-proxetil hydrolysis in luminal washing, suggesting the participation of a cholinesterase in the hydrolysis of cefpodoxime-proxetil. These results are in agreement with our previous findings performed in the rabbit. Moreover, cefpodoxime-proxetil directly decreases the acetylcholinesterase activity when tested by a specific enzymatic method. These observations support the hypothesis that the partial oral bioavailability of cefpodoxime-proxetil results from hydrolysis by luminal cholinesterases. In vitro experiments run with rabbit duodenal washing with food components were compared with the pharmacokinetics of cefpodoxime-proxetil in humans. Amino acids, trace elements and vitamins were potent inhibitors for cefpodoxime-proxetil hydrolysis in duodenal washings. Otherwise, lipids (LTC and mixed LCT/MCT) did not interact. In the human, cefpodoxime-proxetil bioavailability is significantly enhanced when tablets are administered with food. The correlation found between animal results and human results in vitro for prospective investigation of a new prodrug ester could be very useful. An in vitro hydrolysis in intestinal animal washings could allow the potentially degraded condition and the food effect of the luminal tract to be assessed before absorption.