The antibacterial activities of 3 agents against 238 clinical isolates were determined by standard agar dilution test and the pharmacokinetics of these antibiotics in male healthy volunteers were conducted in Latin-square manner. The time over MIC (T > MIC) of serum antibiotic concentrations were calculated with pharmacokinetic equation and MIC.
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Acute bacterial rhinosinusitis (ABRS) is a common reason for healthcare visits, and one of the more common reasons for the use of antibiotics. In an effort to improve the diagnosis and appropriate therapy of ABRS, several guidelines have been developed. Current guidelines recommend extended-spectrum cephalosporins as one of the first-line options for the treatment of this condition. In addition, most cephalosporins recommended by recent guidelines (e.g. cefuroxime axetil, cefpodoxime proxetil and cefdinir) are unlikely to be associated with cross-reactivity with penicillins, and may be considered effective alternatives to amoxicillin in adults who are allergic to penicillin.
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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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Cefpodoxime (CPDX-PR) was evaluated clinically in respiratory tract infections. The results obtained are summarized as follows; 1. The total number of the patients who were treated with CPDX-PR was 61, out of whom 53 cases were evaluated for clinical efficacy and 55 cases were investigated for the safety of the drug. CPDX-PR was given orally twice a day at 100-200 mg for 5-21 days. 2. Clinical efficacies were excellent in 9 patients, good in 36, fair in 4 and poor in 4. The overall clinical efficacy was 84.9%. In particular, CPDX-PR showed satisfactory efficacy for acute respiratory infections and mild chronic respiratory infections, with efficacy rates of 88.6% (31/35) and 100% (8/8), respectively. 3. No adverse reactions was observed, but slight and transient elevation of BUN was noted. In conclusion, it has been confirmed that CPDX-PR is an excellent and safe drug for the treatment of the respiratory tract infections.
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Cefpodoxime, the deesterified part of the orally available cefpodoxime proxetil, is active against most Enterobacteriaceae with MIC50 of 0.06 to 2 mg/l. Only Enterobacter cloacae and Citrobacter freundii strains show MIC50 of 4 mg/l. Coagulase negative staphylococci have a MIC50 of 2, while Staphylococcus aureus strains have a MIC of 4 mg/l. In comparison to other orally available cephalosporins cefpodoxime is slightly less active than cefixime and cefotiam against gram-negative bacteria but more active than cefuroxime, cefaclor, and cephalexin. Against staphylococci the activity of cefpodoxime is comparable to that of cefotiam and cefuroxime and superior to cefaclor and cephalexin, while cefixime does not have sufficient activity against these species. Like all cephalosporins cefpodoxime has no activity against enterococci.
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Although postoperative infections continue to be a major problem in gynecologic surgery, there is still no consensus on the efficacy of antibiotic prophylaxis.
Open-label, unblind, nonrandomized clinical trial.
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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A sensitive and selective electrochemical method for Cefpodoxime Proxetil (CP) determination has been developed by incorporating gold nanoparticles (AuNPs) onto the poly-1,5-diaminonapthalene layer (p-DAN) coated pyrolytic graphite. The modified sensor was characterized by X-ray photoelectron spectroscopy (XPS) and scanning electron microscopy (SEM). The sensor exhibited an effective catalytic response towards oxidation of CP with excellent reproducibility and stability. The peak current of CP was found to be linear in the range of 0.1-12 μM and detection limit and sensitivity of 39 nM (S/N=3) and 4.621 μA μM(-1), respectively, were observed. The method was successfully applied for the determination of CP in pharmaceutical formulations and human urine samples. The common metabolites present in human urine such as uric acid, ascorbic acid, xanthine and hypoxanthine did not interfere in the determination. A comparison of the results obtained by using developed method with high performance liquid chromatography (HPLC) indicated a good agreement. The method is simple, sensitive, rapid and precise and is useful for the routine determination of CP in pharmaceutical dosages and biological samples.
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Cefpodoxime proxetil is a new third generation oral cephalosporin, which shows potent antibacterial activity against both Gram-positive and Gram-negative bacteria, and high stability in the presence of beta-lactamases. Low concentrations of cefpodoxime inhibit most respiratory pathogens, including Haemophilus influenzae, Streptococcus pneumoniae, and Moraxella (Branhamella) catarrhalis. Cefpodoxime reaches concentrations of 0.24 +/- 0.06 mg/kg in tonsils, 0.89 +/- 0.80 mg/kg in lung parenchyma, and 0.91 +/- 0.01 mg/kg in bronchial mucosa; these values exceed by far the minimum inhibitory concentrations (MICs) of cefpodoxime for respiratory pathogens. Preliminary clinical studies were carried out in 181 patients with upper respiratory tract infections: the results indicated an overall clinical response in 88.4% of patients; in 30% the clinical efficacy was excellent and in 58.5% it was good. Further studies showed clinical cure in 90.3% of patients with pharyngotonsillitis, and clinical efficacy (cure plus improvement) in 95% of those with acute sinusitis. Moreover, bacterial eradication was obtained in 78 to 96.7% of cases, most of which involved H. influenzae, streptococci, or M. catarrhalis. Cefpodoxime appears to be an effective new antibacterial that can be recommended as a drug of first choice in the treatment of most upper respiratory tract infections.
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A multicenter study was conducted in which the in vitro activity of cefpodoxime (the active metabolite of the prodrug ester cefpodoxime proxetil) was compared with those of cefixime, cefuroxime, cefaclor, cefadroxil, and clarithromycin against 5556 recent clinical isolates. Cefpodoxime demonstrated potent activity against members of the Enterobacteriaceae, in particular against species generally resistant to the established oral cephalosporins such as Proteus vulgaris [minimum inhibitory concentration (MIC)50, 0.12 microgram/ml], Providencia rettgeri (MIC50, 0.015 microgram/ml), and Serratia marcescens (MIC50, 2 micrograms/ml). Cefpodoxime was very effective against the fastidious organisms most frequently associated with respiratory infections, such as Streptococcus pneumoniae (MIC90, 0.12 microgram/ml), Haemophilus influenzae (MIC90, 0.12 microgram/ml), and Moraxella catarrhalis (MIC90, 1 microgram/ml). In contrast to other orally administrated third-generation cephalosporins (cefixime or ceftibuten), cefpodoxime demonstrated reasonable activity against oxacillin-susceptible staphylococci, with MIC50 ranging from 1 to 2 micrograms/ml. All cephalosporins tested demonstrated poor activity against Pseudomonas spp., Xanthomonas spp., Enterococcus spp., and oxacillin-resistant staphylococci. Cefpodoxime had the widest spectrum of activity of all tested oral cephalosporins.
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Cross-contamination is a critical issue for pharmaceutical manufacturing, especially for beta-lactam antibiotics. Thus, an analytical method for the simultaneous determination of beta-lactam antibiotics cefmetazole (CMZ) and cefpodoxime proxetil (CPDXPR) contaminants in non-beta-lactam pharmaceuticals was developed using high-performance liquid chromatography-tandem mass spectrometry. The developed method was found to be sensitive at the detection limit of 0.002 ppm for both compounds. Mean recoveries of CMZ and CPDXPR from olmesartan medoxomil (OLM) tablets were 96.7 to 102.2% and 88.9 to 94.2%, respectively. The developed method was successfully applied for the verification of CMZ and CPDXPR contamination to actually manufactured OLM tablets.
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Five days of treatment with cefpodoxime is as efficacious in bacteriologic eradication and clinical response (cure plus improvement) as 10 days of cefpodoxime therapy, and both cefpodoxime regimens produced superior bacteriologic efficacy compared with a 10-day regimen of penicillin V in the treatment of group A beta-hemolytic streptococcal tonsillopharyngitis in children.
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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.
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Cefpodoxime proxetil (CP) is a prodrug with poor oral bioavailability because of its metabolism to Cefpodoxime acid (CA) in luminal contents and intestinal epithelial cells. In the present investigation, regional variability in different segments of the gastrointestinal tract vis-à-vis solubility and metabolism were investigated, and the results indicated potential for a gastro retentive (GR) dosage form. Suitability of a GR dosage from for CP and finally in vivo efficacy were investigated. Thereafter, an effervescent floating GR dosage form was developed for CP and evaluated in rats. The GR dosage form improved the oral bioavailability of CP significantly by about 75%, hence providing a proof-of-concept. The Tmax value increased to 1.43+/-0.24 h from 0.91+/-0.23 h of pure drug, while Cmax values of 4735+/-802 ng/ml and 3094+/-567 ng/ml were obtained for the GR dosage form and pure drug respectively.
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It was found that 62.68% were males, 26% patients were in the age group 26-35 years, followed by 22.8% belonging to the age group 26-35 years. Maximum number of patients were diagnosed with ear (37.3%) and throat (36.2%) infections. The most frequently prescribed antibacterials were β-lactams (45.52%) followed by quinolones (26.31%). The most commonly used agent in penicillins was amoxicillin and clavulanic acid (21.74%), in cepahalosporins was cefpodoxime proxetil (5.49%) and in quinolones was gemifloxacin (14.41%). Further, 66.67% of the patients received single antibacterial drug and the average number of antibacterial agents prescribed per patient per course was found to be 1.58. It was also observed that 70.71% of the antibacterials were prescribed by oral route. The most concomitant conditions were found to be diabetes (10.5%), hypertension (6.16%) and coronary heart disease (5.07%). All the drugs were prescribed by their brand names and 48.91% patients showed good adherence with the prescribed therapy.
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The method employed HPTLC aluminum plates precoated with silica gel 60 RP-18 F(254) as the stationary phase. The solvent system consisted of toluene:methanol:chloroform (4:2:4 v/v). The system was found to give compact spot for cefpodoxime proxetil (R(f) value of 0.55 ± 0.02). Densitometric analysis of cefpodoxime proxetil was carried out in the absorbance mode at 289 nm.
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A simple, accurate, rapid and precise reversed-phase high-performance liquid chromatographic method has been developed and validated for simultaneous determination of cefpodoxime proxetil and dicloxacillin sodium in tablet. The chromatographic separation was carried out on kromasil C18 analytical column (250×4.6 mm; 5 μm) with a mixture of acetonitrile:methanol:trifloroacetic acid (0.001%) with pH 6.5 (30:50:20, v/v/v) as mobile phase; at a flow rate of 1.0 ml/min. UV detection was performed at 235 nm. The dicloxacillin sodium and cefpodoxime proxetil were eluted at 1.92 and 3.35 min, respectively. The peaks were eluted with better resolution. Calibration plots were linear over the concentration range 0.5-20 μg/ml for cefpodoxime proxetil (r(2)=0.9996) and 5-50 μg/ml for dicloxacillin sodium (r(2)=0.9987). The method was validated for accuracy, precision, linearity and specificity. The method was very sensitive with limit of detection 0.0726, 0.3685 μg/ml and limit of quantification 0.220, 1.116 μg/ml for cefpodoxime proxetil and dicloxacillin sodium, respectively. The high recovery and low relative standard deviation confirm the suitability of the method for routine determination of cefpodoxime proxetil and dicloxacillin sodium in bulk drug and tablet dosage form.
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).