The present work explains the development and validation of a simple and reliable isomer specific liquid chromatographic method for the quantitative determination of cefpodoxime proxetil (CP) in rat in situ intestinal perfusate samples. Chromatography was carried out by reversed-phase technique on a C-18 column with a mobile phase composed of 20 mM ammonium acetate buffer (pH 5.0) and acetonitrile in the ratio of 62:38 pumped at a flow-rate of 1 ml/min. The detection was carried out at 235 nm and a column temperature of 30 degrees C. The method was evaluated for the various validation parameters, such as linearity, accuracy, precision, LOD, LOQ, specificity, selectivity, and sample stability. The results of intra- and inter-day validation (n = 3) showed the method to be efficient and the same was applied in an in situ permeability study conducted for CP in rats.
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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.
A simple, selective, precise, and stability-indicating high-performance thin-layer chromatographic (HPTLC) method for analysis of cefpodoxime proxetil both in bulk and in pharmaceutical formulation has been developed and validated.
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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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To determine the disposition of orally administered cefpodoxime proxetil in foals and adult horses and measure the minimum inhibitory concentrations (MICs) of the drug against common bacterial pathogens of horses.
The clinical efficacy of cefditoren pivoxil (CDTR-PI) was evaluated for 43 pediatric patients with acute otitis media or acute sinusitis. The causative organisms were identified and their susceptibilities to 6 oral beta-lactam antibiotics were measured; ampicillin (ABPC), cefaclor (CCL), cefdinir (CFDN), cefditoren pivoxil (CDTR-PI), cefteram pivoxil (CFTM-PI) and cefpodoxime proxetil (CPDX-PR). The ages of 43 patients were distributed from 4 months to 10 years and 7 months, and especially children under 4 years accounted for 72% (31 cases). In 22 cases (51%), Haemophilus influenzae or Streptococcus pneumoniae were identified as the pathogens, but in 18 cases, no causative organisms were defined. Treatment by CDTR-PI was successful in 12 cases out of 15 evaluable cases in which H. influenzae or S. pneumoniae were identified as the main causative organisms. From the susceptibility testing of them, some strains of H. influenzae were found to be ABPC-resistant and some strains of S. pneumoniae were benzylpenicillin (PCG)-resistant. To support above clinical evaluation of CDTR-PI, susceptibility testings on clinically isolated H. influenzae (81 strains) and S. pneumoniae (79 strains) were performed using above mentioned 6 oral beta-lactam antibiotics. The MIC80s against H. influenzae were; CDTR-PI 0.06 microgram/ml, CCL 2 micrograms/ml, CPDX-PR 0.125 microgram/ml, CFTM-PI 0.03 microgram/ml, CFDN 1 microgram/ml and ABPC 1 microgram/ml. Those against S. pneumoniae were; CDTR-PI 0.5 microgram/ml, CCL > 4 micrograms/ml, CPDX-PR 2 micrograms/ml, CFTM-PI 1 microgram/ml, CFDN 2 micrograms/ml and ABPC 1 microgram/ml. From those results, it was concluded that CDTR-PI or CFTM-PI may be preferable for the treatment of acute otitis media and acute sinusitis in children.
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The bioavailability of cefpodoxime proxetil tablets relative to an oral solution of cefpodoxime proxetil in a sucrose/alcohol/citric acid vehicle was studied in 11 healthy volunteers in a randomized, crossover study. Fasted subjects took one cefpodoxime proxetil 100 mg tablet or 50 mL of a 2 mg mL-1 cefpodoxime proxetil oral solution on two separate occasions. In a third study period, all subjects took a 100 mg dose of the oral solution with a high-fat meal to investigate the effect of food on cefpodoxime proxetil absorption from the oral solution. Serial blood samples were obtained over a 24 h period, and urine was collected for 48 h after dosing. Cefpodoxime concentrations in plasma and in urine were determined using HPLC methods. The bioavailability of cefpodoxime proxetil tablets relative to the oral solution was 82%, as determined from AUC ratios. There was no difference in the rate of cefpodoxime absorption between dosage forms. Food had no effect on the extent of drug absorption from the oral solution but did result in delayed absorption. These results suggest that complete dissolution of cefpodoxime proxetil is critical for optimal bioavailability.
As one of the biodefense mechanisms, lactoferrin (LFN) in the secreta of female genital organ may be an interesting biological material in view of its antimicrobial activity. In the present study, we investigated antimicrobial activities of LFN and its combination with cefpodoxime proxetil (CPDX-PR), we also as evaluated clinical effect of CPDX-PR. The following results were obtained. 1. Antimicrobial activities of LFN were tested against 15 strains of 10 species of bacteria, and potent activities against Staphylococcus aureus 209P, Escherichia coli, Klebsiella pneumoniae and Proteus spp. were found. 2. In a concomitant use of LFN with CPDX-PR (a checkerboard method), synergistic actions were observed against S. aureus 209P, E. coli STf, K. pneumoniae 602 and Pseudomonas aeruginosa 1046, and additive actions against E. coli NIHJ and Providencia rettgeri 1603. In 3 strains, the MICs of CPDX-PR in the presence of LFN were reduced to < 1/64. 3. In the evaluation of clinical effect of CPDX-PR, efficacy rates were 53/57 (92.9%) in a patient group with infections. The incidence of adverse reaction was 0/57.
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Acute otitis media (AOM) is diagnosed based on visualization of a full or bulging tympanic membrane with middle ear effusion. The distribution of bacteria causing AOM in North America under the influence of pneumococcal conjugate vaccination and antibiotic selection pressure has resulted in a predominance of β-lactamase-producing Haemophilus influenzae followed by penicillin-resistant Streptococcus pneumoniae. Although guidelines continue to endorse amoxicillin as the preferred treatment, amoxicillin/clavulanate in high dosage would be the preferred treatment based on the otopathogen mix currently. Antibiotic prophylaxis has fallen into disfavor as a preventative strategy for AOM recurrences.
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Cefpodoxime proxetil is an orally administered prodrug which is absorbed and de-esterified by the intestinal mucosa to release the third generation cephalosporin, cefpodoxime. Cefpodoxime is stable towards the most commonly found plasmid-mediated beta-lactamases and the drug has a broad spectrum of antibacterial activity encompassing both Gram-negative and Gram-positive bacteria, rendering it a possible option for empirical use in a wide range of community acquired infections in both adult and paediatric patients. The extended plasma half-life of cefpodoxime (1.9 to 3.7 h) permits twice daily administration. In comparative trials, twice daily cefpodoxime proxetil (dose equivalent cefpodoxime 100 to 400 mg) was as effective as a 3- to 4-times daily regimen of phenoxymethylpenicillin in pharyngotonsillitis, as well as thrice daily amoxicillin (with or without clavulanic acid) or cefaclor against infections of the ear, the upper and lower respiratory tract, the urinary tract and those of the skin and soft tissues. The latter reflects the enhanced antistaphylococcal activity of cefpodoxime, which distinguishes it from other orally active third generation cephalosporins such as cefixime. Most notably, an oral regimen of cefpodoxime proxetil was as efficacious as parenterally administered ceftriaxone for the treatment of bronchopneumonia in hospitalised patients at risk due to the presence of underlying diseases, addictions or advancing age. A single oral dose of cefpodoxime was also as efficacious as ceftriaxone in uncomplicated anogenital gonococcal infections. Cefpodoxime proxetil is generally well tolerated, with mild to moderate gastrointestinal disturbances occurring in 4 to 15% of patients treated with therapeutic doses. Thus, a convenient twice daily oral regimen of cefpodoxime proxetil can be prescribed as an effective alternative to established beta-lactam therapies in the empirical outpatient treatment of infections of the respiratory and urinary tracts as well as those of the skin and soft tissues.
Clinical studies of cefpodoxime proxetil (CPDX-PR), a new cephem antibiotic, were carried out in 60 patients in the pediatric field. The overall efficacy rate on 54 patients with various infections was 98.1%, and few side effects, all of them very mild, were developed in 6 of 60 patients (10%). It was concluded that CPDX-PR was one of the most useful antibiotics in the pediatric field because of the high efficacy rate and the safety.
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In a cross-over study on twelve healthy volunteers cefpodoxime proxetil (CAS 87239-81-4) and acetylcysteine (CAS 616-91-1) were evaluated for possible pharmacokinetic interactions. After a standardized breakfast, the subjects received p.o. either 200 mg cefpodoxime administered as cefpodoxime proxetil (reference) or 200 mg cefpodoxime and 200 mg acetylcysteine (test). To determine the pharmacokinetic profile of cefpodoxime the plasma concentrations were determined by HPLC. The plasma concentration-time curve of cefpodoxime was very similar after both regimens, and with respect to cefpodoxime bioequivalence has been proven. The narrow range of 90% confidence intervals for the quotient test/reference for Cmax and AUC indicate reliable bioavailability of cefpodoxime proxetil independent of co-administered acetylcysteine.