Global clinical efficacy was assessed by the physicians to be "very good" and "good" in 96.4% of the cases. With regard to tolerance, the physicians' assessment was "very good" and "good" in 96.3%. In 51 patients (1.9%), 70 adverse drug reactions involving the gastrointestinal tract, CNS and skin occurred.
Pharmacokinetic, bacteriological and clinical studies on S-1108 were performed in children. The results were as follows: 1. A total of 11 patients were treated with S-1108. Each dose was 3 mg/kg, orally administered 3 times daily for 4-14 days. The clinical efficacies of S-1108 in 10 patients with bacterial infections (1 with bacteremia, 4 with pneumonia, 1 with acute maxillary sinusitis, 1 with scarlet fever and 2 with streptococcal pharyngitis) were evaluated as excellent in 8 patients and as good in 2 patients with an efficacy rate of 100%. Only one patient with staphylococcal scalded skin syndrome due to methicillin resistant Staphylococcus aureus (MRSA) who received gamma-globulin was not evaluated. Fourteen causative strains of 5 species were found in 10 patients. Three strains of Streptococcus pneumoniae out of 5, 2 of 3 Branhamella catarrhalis strains, none of Staphylococcus aureus and all 3 strains of Streptococcus pyogenes were eradicated. No adverse reaction was observed in any of the 11 patients. 2. MICs of S-1108 against 5 clinically isolated S. pneumoniae from cases of infections were examined. All of them were relatively highly resistant to penicillins. S-1108 was compared with cefteram pivoxil, cefpodoxime proxetil, cefaclor and cefixime, and it showed better antibacterial activity or than other cephems. 3. Double peaks were obtained in plasma levels of S-1108 orally administered at a dose of 3 mg/kg at 30 minutes after meal and were 1.03 microgram/ml and 0.74 microgram/ml at 1 and 4 hours after administration, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)
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We report a case of acute interstitial nephritis (AIN) and immune hemolytic anemia (IHA) associated with cefpodoxime therapy.
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.
Application of the HPLC hyphenated techniques of LC-MS, LC-NMR and solvent-elimination LC-IR was demonstrated by the identification of the degradation products of a third generation cephalosporin antibiotic, cefpodoxime proxetil, in solid state, drug formulation and solution. Molecular weight and fragment information were obtained by LC-MS, and detailed structural information was confirmed by LC-NMR. Information on the carboxyl functional group obtained by solvent-elimination LC-IR was useful for confirmation of the ester hydrolysis. The degradation products were successfully identified without complicated isolation or purification processes.
Data were evaluated with respect to in vitro activity, study design, clinical and microbiologic outcomes, and adverse drug reactions.
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Immediate antimicrobial therapy with trimethoprim-sulfamethoxazole, nitrofurantoin, or fosfomycin is indicated for acute cystitis in adult women. Increasing resistance rates among uropathogens have complicated treatment of acute cystitis. Individualized assessment of risk factors for resistance and regimen tolerability is needed to choose the optimum empirical regimen.
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The plasma sample was extracted by a mixture of methanol and acetonitrile. A concentration range from 500 to 3500 ng/spot for CEFPO and 1000 to 7000 ng/spot for AMBRO were used for the calibration curve, respectively. This recovery was found to be 74.40 and 94.50 for CEFPO and AMBRO, respectively. The mobile phase used consists of chloroform: methanol (9:1v/v). Densitometric analysis was carried out at a wavelength of 240 nm.
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A high-performance liquid chromatographic method has been developed to determine cefpodoxime levels in chinchilla plasma and middle ear fluid (MEF) to be used in studying otitis media. Cefpodoxime and the internal standard, cefuroxime, were separated on an ODS column (250 x 2.1 mm I.D., 5 microns Hypersil), using a mobile phase of 25 mM acetate buffer (pH 4.3)/15 mM triethylamine-acetonitrile (92.5:7.5, v/v). Following elution of cefpodoxime and the internal standard, at 3.5 and 5.9 min respectively, the acetonitrile concentration was increased to 1:1 (v/v) in a step function to elute endogenous compounds retained on the column. Sample preparation involved protein precipitation with acetonitrile. This fast, efficient protein precipitation procedure together with UV detection allows a quantitation limit of 50 ng/ml with a 50-microliters sample size. Recoveries (mean +/- S.D., n = 3) at 0.1 microgram/ml in MEF were 90.3 +/- 2.9% and 88.6 +/- 1.2% for cefpodoxime and cefuroxime respectively. Recoveries (mean +/- S.D., n = 3) at 0.1 microgram/ml in plasma were 72.1 +/- 7.3% and 81.1 +/- 1.1% for cefpodoxime and cefuroxime respectively. The method was evaluated with biological samples taken from chinchillas with middle ear infections after administering cefpodoxime proxetil.
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.
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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%).
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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One hundred and fifty female patients with acute uncomplicated cystitis were given 200 mg of CPDX-PR twice daily for 3-7 days to evaluate both its overall clinical efficacy and its adverse effects. In 82 cases (Group I) in which it was administered for 3 days, the overall clinical efficacy, evaluated by the criteria proposed by the Japanese UTI committee, was excellent in 64 cases, moderate in 17 and poor in one, with the effective rate being 98.8%. In 35 cases (Group II) in which it was administered for 4-7 days, the overall clinical efficacy was excellent in 18 cases, moderate in 15 and poor in 2, with the effective rate being 94.3%. The overall clinical evaluation was not performed in another 33 cases because they were given CPDX-PR for more than 8 days or 300 mg/day. Subjective adverse effects such as hoarseness and lingual inflammation were observed in only one of the 150 cases, but they disappeared spontaneously after the cessation of administration of CPDX-PR. These findings suggest that CPDX-PR is one of the most effective and safe antibiotic in the treatment of acute uncomplicated cystitis.
Trial methodological quality was assessed independently by 7 reviewers; outcomes were extracted as the number of treatment failures, relapses, or reinfections.
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This study aims to prove the complexation of cefpodoxime proxetil (CP) by hydroxypropyl-β-cyclodextrin (HP-β-CD) in the presence of sodium carboxymethyl cellulose (Na CMC), and makes a comparison of commercial tablets by dissolution and antimicrobial activity studies. The CP--HP-β-CD complex was prepared by kneading method and characterized by SEM, FTIR and DSC. The solubility method was used to investigate the effect of HP-β-CD and Na CMC on the solubility of CP. The complex tablets were prepared using direct compression method. Dissolution studies were performed with complex tablets and commercial tablets in pH 1.2, 4.5, 6.8 and 7.4 buffer solutions. It was observed that complexation occurred in all formulations, and HP-β-CD is able to increase CP solubility and dissolution rate of CP was improved from complex tablets, when compared with commercial tablets. Furthermore, the antimicrobial activity studies revealed that the CP--HP-β-CD complex and complex tablets were shown to have more effective antimicrobial activity than commercial tablets. It is evident from the results that complexation with HP-β-CD in the presence of Na CMC is feasible way to prepare a more efficient tablet formulation with improved dissolution and antimicrobial activity.
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For the post-marketing surveillance of cefpodoxime proxetil (CPDX-PR, Banan), MICs of oral cephem antibacterials including CPDX against clinical isolates from 15 medical institutions all over Japan are measured yearly and the incidence rates of resistance in various species are also evaluated. In the first surveillance from June 2000 to March 2001, 1,091 isolates of 22 species were tested, 993 isolates of the same 22 species were tested in the second surveillance from April 2001 to March 2002, and 1,115 isolates of the same 22 species were tested in the third surveillance from April 2002 to March 2003. No remarkable changes in the activity of CPDX were observed against most of the species in these surveillances spanning three years and in comparison with that in the studies conducted before Banan was launched. In the study, CPDX as well as other cephem antibacterials showed a gradual decrease in activity against all the strains of Streptococcus pneumoniae and Haemophilus influenzae in proportion to the increase in the incidence rates of penicillin-resistant S. pneumoniae (PRSP) and beta-lactamase-negative ampicillin-resistant H. influenzae (BLNAR). A small percentage of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae, which are high-resistant strains, were isolated. The findings of this surveillance indicate that it is necessary to pay careful attention to the trends of resistant bacteria such as PRSP, BLNAR, and ESBL-producing strains.
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Decreasing the dose frequency of cefpodoxime proxetil increases patient compliance; patients prefer to take the drug once daily. It also improves the rate of bacterial killing and hastens the cure from the indications, and therefore increases compliance. The hydrophilic matrix of HPMC controlled the cefpodoxime proxetil release effectively for 24 hours; hence, the formulation can be considered as a once-daily sustained-release tablet of cefpodoxime proxetil. The formulation showed acceptable pharmacotechnical properties and assay requirements. In vitro dissolution studies indicated a sustained-release pattern throughout 24 hours of the study that was comparable to the theoretical release profile. Drug release kinetics indicated that drug release was best explained by Higuchi's equation, as these plots showed the highest linearity (r (2)=0.9734), but a close relationship was also noted with zero-order kinetics (r (2)=0.9708). Korsmeyer's plots indicated ann value of 0.57, which was indicative of an anomalous diffusion mechanism or diffusion coupled with erosion; hence, the drug release was controlled by more than one process. Hixson-Crowell plots indicated a change in surface area and diameter of the tablets with the progressive dissolution of the matrix as a function of time.
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An open-label, dose-response study of cefpodoxime proxetil (CPD), an expanded-spectrum cephalosporin, was conducted with 58 males with uncomplicated Neisseria gonorrhoeae infections with single doses of 600, 400, 200, 100, or 50 mg of CPD administered orally by tablet. CPD eradicated N. gonorrhoeae in all 50 evaluable patients (10 per group) at all doses studied. Eight of the isolates eradicated were beta-lactamase-producing organisms. Two patients reported three side effects, nausea, vomiting, and diarrhea, which were mild and resolved without intervention or sequelae. There were no clinically remarkable drug-related changes in vital signs or clinical laboratory assays. Results show that single oral doses of CPD are an effective and well-tolerated treatment for uncomplicated N. gonorrhoeae infection in males at doses as low as 50 mg.
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The present study deals with spectrophotometric analysis of cefpodoxime proxetil by utilizing 4 different hydrotropic agents such as ammonium acetate (6 M), sodium citrate (1.25 M), sodium gycinate (1 M), sodium chloride (1 M), and urea (1 M).
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Dry syrup and tablet of newly developed cefpodoxime proxetil (CS-807, CPDX-PR) was investigated in the departments of pediatrics of 17 institutes and their related hospitals. 1. Pharmacokinetics of CPDX-PR in pediatrics were investigated. Peak blood levels of CPDX at dose levels of 3 mg/kg and 6 mg/kg were 2.24 +/- 0.21 and 4.68 +/- 0.54 micrograms/ml, respectively, in fasting and 1.65 +/- 0.07 and 3.71 +/- 0.41 micrograms/ml, respectively, after meal. Urinary recovery rates in 6 hours were 31.2 +/- 2.2% of dose in average. 2. Clinical efficacies of CPDX-PR on various infectious diseases were studied in 748 cases. Clinical efficacy rate in 499 cases with causative bacteria isolated was 94.6%: efficacy rates for individual infections were 96.8% (120/124) for tonsillitis, 96.0% (96/100) for urinary tract infection, 93.5% (58/62) for pneumonia, 92.4% (61/66) for impetigo, 100% (32/32) for scarler fever and 93.2% for pharyngitis or laryngitis. Bacteriological eradication rate for Gram-positive organisms was 91.0% (244/268); and for Gram-negative organisms, 89.7% (210/234). The clinical efficacy rate for cases which were non-responsive to previous antibiotic therapy was 88.1% (74/84). 3. Side effects and clinical laboratory findings were investigated in 779 cases. Two each of vomiting, loose stool and rash, 10 of diarrhea and 1 of diarrhea associated with candidiasis were reported, but no serious side effects were noted. There was no serious laboratory test abnormality except slight elevations of eosinophile, platelet, transaminase or prolongation of prothrombin time, totalling 34 occurrences.
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122 patients with bacterial infections of respiratory tract, ear, nose, and throat, urinary tract and skin and soft tissue were treated with cefpodoxime proxetil. In the treatments of patients with clinical efficacy tates of cefpodoxime proxetil for infections in these four systems were 90.0%, 97.5%, 90.0% and 86.4%, respectively. The bacterial clearance rate of gram-positive bacterial was 96.9%, and that of gram-negative bacteria 96.4%. Adverse drug reaction rate was 18.9%.
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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.
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.