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The study enrolled 851 patients. Comparable clinical cure rates were observed among evaluable patients in the 3 treatment groups at both the posttreatment and followup visits: at the posttreatment visit, cure rates were 90.5% (162/179) for cefditoren 200 mg, 89.7% (148/165) for cefditoren 400 mg, and 92.2% (153/166) for cefpodoxime 200 mg; at the follow-up visit, they were a respective 88.4% (160/181), 87.2% (143/164), and 90.4% (151/167). Of the 171 strains of Streptococcus pneumoniae isolated before treatment, 22 (12.9%) had reduced susceptibility to penicillin, 5 (2.9%) of them penicillin resistant (minimum inhibitory concentration > or = 2 microg/mL). At the posttreatment visit, the overall eradication rates of pathogens isolated from microbiologically evaluable patients were 88.7% (134/151), 89.9% (134/149), and 95.7% (134/140) in the respective treatment groups (P = 0.031, cefditoren 200 mg vs cefpodoxime). Eradication rates of S pneumoniae were 93.8% (45/48), 95.7% (45/47), and 95.6% (43/ 45) in the respective treatment groups; those of Haemophilus influenzae were 90.2% (46/51), 97.7% (43/44), and 97.4% (37/38). The rates of resolution and/or improvement in clinical signs and symptoms were comparable between groups. The study drugs were well tolerated, with 1.7%, 2.5%, and 1.4% of patients in the respective groups discontinuing study drug prematurely due to a treatment-related adverse event, the majority of these associated with the digestive system.
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Cefpodoxime proxetil (CPDX-PR) is an oral cephalosporin antibiotic with poor aqueous solubility and bioavailability. Effect of beta-cyclodextrin on aqueous solubility and dissolution rate of cefpodoxime proxetil was evaluated by the formation of solid inclusion complexes in 1:2 molar ratio of drug: cyclodextrin. Phase solubility study was carried out whereby a typical B's type curve was obtained thus, indicating a 1:2 stoichiometric ratio for optimum complex formation. Solid inclusion complexes in 1:2 molar ratios were prepared by using methods such as physical mixture, solvent evaporation and freeze drying. Prepared complexes were characterized by fourier transform infrared spectroscopy (FT-IR) differential scanning calorimetry (DSC), powder x-ray diffraction (PXRD) and scanning electron microscopy (SEM). Results of in vitro studies appraised of an increased solubility and dissolution rate of cefpodoxime proxetil on complexation with beta- cyclodextrin (P < 0.05) as compared to CPDX-PR alone. Amongst the complexes prepared by different methods, the complex prepared by freeze drying showed the highest dissolution rate (P< 0.01). The in vitro antimicrobial activity of cefpodoxime proxetil and its freeze dried complex (1:2) was studied against both antibiotic-susceptible and antibiotic-resistant clinical isolates of Neisseria gonorrhoeae. The freeze dried complex (1:2) inhibited all penicillin-susceptible strains and penicillinase-producing strains at 0.015 microg/ml concentration. Chromosomally resistant strains which were not responsive to penicillin were inhibited by the complex at 0.125 microg/ml concentration. The study revealed that complexation of cefpodoxime proxetil with beta-cyclodextrin effectively enhanced the aqueous solubility and in vitro antibacterial activity.
The evaluation of seven widely-used antibiotic preparations [five cephem antibiotics; cefaclor (CCL), cefpodoxime proxetil (CPDX-PR), cefdinir (CFDN), cefditoren pivoxil (CDTR-PI), cefcapene pivoxil (CFPN-PI), one macrolide; clarithromycin (CAM) and one penem; faropenem sodium (FRPM)] for children were performed from a standpoint of water-solubilities, both as a preparation and as a component drug. As the results, these preparations showed great differences in the water-solubilities when added 10 ml water to 0.5 g of each preparation. That is, their solubilities differed from about 40% (CFPN-PI) to 100% (FRPM) as a preparation, and from nearly 0% (CAM) to 100% (FRPM, CCL) as a component drug. Additionally, about a half of the insoluble residues were found to be the component drug, in the cases of three preparations (CPDX-PX, CFDN, CDTR-PI) which were solubilized at 80-90%. From these results, it was suggested that the marketed antibiotic preparations for children might be classified into three categories; i.e., [A] preparation for solution and suspension (FRPM, CCL), [B] preparation suitable to suspension (CPDX-PR, CFDN, CDTR-PI), and [C] fine granule preparation for children unsuitable to suspension (CFPN-PI, CAM). Consequently, the names for dosage-forms of these preparations should be standardized.
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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.
We diagnosed a 41-year-old female patient to be suffering from Chlamydia pneumoniae (C. pneumoniae) by using PCR and culture methods. She had a prolonged dry cough and slight fever. Her chest roentgenogram showed a segmental infiltration in the middle of the right lung field. We treated her with 400 mg of cefpodoxime proxetil (CPDX-PR) per day. On the 4th day after beginning the treatment with CPDX-PR, she still complained of a productive cough. We changed the treatment by using 300 mg of roxithromycin per day and these symptoms disappeared. To diagnose C. pneumoniae early, PCR, MIF and culture methods are very useful diagnostic tools.
The proposed HPTLC method can be applied for identification and quantitative determination of cefpodoxime proxetil in both bulk drug and pharmaceutical formulation.
In 2011, new guidelines on antibiotic prescription for acute otitis media (AOM) were published in France to decrease the use of third generation cephalosporins that promote the carriage of extended-spectrum beta-lactamase producing Escherichia coli. Our objective was to assess the impact of the 2011 French recommendations on the type of antibiotics prescribed for AOM.
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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.
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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 stability-indicating spectrofluorometric method was investigated for the determination of three cephalosporin drugs, namely, cefpodoxime proxetil (CPD), cefixime trihydrate (CFX), and cefepime hydrochloride (CPM), via their acid and alkali degradation products. The three drugs were determined via their acid degradation at 432, 422, and 435 nm using an excitation wavelength of 310, 330, and 307 nm for CPD, CFX, and CPM determination, respectively, and via their alkali degradation at 407, 411, and 405 nm using an excitation wavelength of 310, 305, and 297 nm for CPD, CFX, and CPM determination, respectively. Linearity was achieved in the ranges of 0.35-3.50, 0.4-4.0, and 0.3-3.0 μg/mL for the acid degradation products of CPD, CFX, and CPM, respectively, and in ranges of 0.05-0.5, 0.1-1.0, and 0.08-0.80 μg/mL for the alkali degradation products of CPD, CFX, and CPM, respectively. The method was validated for various parameters according to International Conference on Harmonization guidelines. The method was successfully applied for the determination of these cephalosporin drugs in pharmaceutical dosage forms with good accuracy and precision. The results obtained by the proposed spectrofluorometric method were compared with good agreement to the official HPLC method.
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The pharmacokinetic properties of cefpodoxime, and its prodrug, cefpodoxime proxetil, were evaluated in two separate studies, one following intravenous (i.v.) administration of cefpodoxime sodium and the second after oral (p.o.) administration of cefpodoxime proxetil to healthy dogs. After cefpodoxime administration, serial blood samples were collected and plasma concentrations were determined by high performance liquid chromatography (HPLC). A single i.v. administration of cefpodoxime sodium at a dose of 10 mg cefpodoxime/kg body weight resulted in a cefpodoxime average maximum plasma concentration (Cmax) of 91 (+/-17.7) microg/mL, measured at 0.5 h after drug administration, an average half-life (t1/2) of 4.67 (+/-0.680) h, an average AUC(0-infinity) of 454 (+/-83.1) h.microg/mL, an average V(d(ss)) of 151 (+/-27) mL/kg, an average Cl(B) of 22.7 (+/-4.2) mL/h/kg and an average MRT(0-infinity) of 5.97 (+/-0.573) h. When dose normalized to 10 mg cefpodoxime/kg body weight, cefpodoxime proxetil administered orally resulted in Cmax of 17.8 +/- 11.4 microg/mL for the tablet formulation and 20.1 +/- 6.20 microg/mL for the suspension formulation and an average AUC(0-LOQ) of 156 (+/-76.1) h.microg/mL for the tablet formulation and 162 (+/-48.6) h.microg/mL for the suspension formulation. Relative bioavailability of the two oral formulations was 1.04 (suspension compared with tablet), whereas the absolute bioavailability of both oral formulations was estimated to be approximately 35-36% in the cross-study comparison with the i.v. pharmacokinetics. Combined with previous studies, these results suggest that a single daily oral dose of 5-10 mg cefpodoxime/kg body weight as cefpodoxime proxetil maintains plasma concentrations effective for treatment of specified skin infections in dogs.
Pharmacokinetic and clinical evaluation of cefpodoxime proxetil (CPDX-PR, CS-807) were performed in the field of pediatrics. The obtained results are summarized as follows. 1. Peak serum concentrations of CPDX upon single oral doses of 3.0 mg/kg and 4.4 mg/kg of CPDX-PR were 1.26-1.46 micrograms/ml and 1.45 micrograms/ml, respectively, achieved at 4 hours and 1 hour after administration. Urinary excretion rates for CPDX in the first 8 hours ranged between 28.1 and 30.2%. 2. Clinical efficacy rates for pediatric infections obtained at single dose levels ranging 3 to 6 mg/kg were 97.5%, and that at a single dose of 1 mg/kg were 90.9%. 3. Bacteriological effectiveness was determined in 45 strains identified in recent cases. Eradication rates for these bacteria at dose levels of 3 to 6 mg/kg and 1 mg/kg were 91.3% and 95.5%, respectively. 4. No side effect nor abnormal laboratory test data were found in any of the cases examined. From these results, CPDX-PR appeared to be a useful antibiotic agent in the field of pediatrics.
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To determine the effect of protein binding on the pharmacokinetics and distribution from plasma to interstitial fluid (ISF) of cephalexin and cefpodoxime proxetil in dogs.
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The results of this study suggest that cefditoren may have a role in the treatment of CAP in ambulatory patients.
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Fourteen thousand six hundred and sixty-one children, 6 to 24 months of age, presenting with AOM were included in 2 studies, between November 1, 2009 and October 31, 2012. The first one was conducted with the support of 62 private practice pediatricians; the second one was conducted in 7 pediatric emergency departments. Three periods of 1 year each were defined.
Aerobic bacterial examination for sinusitis was conducted using specimens from maxillary sinuses collected by antral puncture in 540 patients--284 men and 256 women aged 6-89 years--between May 1999 and April 2000. We obtained 528 strains of bacteria. Our results were as follows: 1. We obtained 303 pathogens from 540 patients. In acute sinusitis, the most frequently found was Streptococcus pneumoniae (30.4%), followed by Hemophilus influenzae (27.7%). In chronic cases, the most frequently found was Streptococcus pneumoniae (16.0%), followed by Hemophilus influenzae (15.1%) and Staphylococcus epidermidis (12.6%). 2. We found an increase in bacteria resistant to multiple drugs, with 11.1% of the Staphylococcus aureus isolates methicillin-resistant in acute sinusitis and 40% methicillin-resistant in chronic sinusitis, and that 30.6% of Streptococcus pneumoniae isolates were penicillin-resistant. 3. Ciclacillin was effective against 64.7% of all pathogens isolated in this study, cefpodoxime proxetil effective against 6.5%, and cefixime effective against 2.4%. 4. In considering pathogens, we therefore choose antibiotics and make a maxillary aspiration puncture.
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Group A beta-hemolytic streptococcus (GABHS) is the most common bacterial cause of acute pharyngitis. Although children infected with GABHS will recover clinically without antibiotics, treatment is recommended in order to prevent acute rheumatic fever and probably suppurative complications, hasten resolution of clinical signs and symptoms, and prevent transmission to close contacts. Streptococcal pharyngitis usually cannot be reliably distinguished from other etiologies on the basis of epidemiologic or physical findings, and therefore a throat culture or a rapid antigen detection test is generally necessary to confirm the diagnosis. All isolates of GABHS are sensitive to penicillins and cephalosporins, whereas resistance to macrolides has been identified in some geographic regions. The recommended first-line therapy for streptococcal pharyngitis is a 10-day course of penicillin V, usually given 2 or 3 times per day. A number of alternatives to penicillin V are available, including other penicillins, macrolides, and cephalosporins. As a class, the cephalosporins are noteworthy because they may provide somewhat higher bacteriologic eradication rates than penicillin V. Many cephalosporins can be administered twice daily, but they also must be given for 10 days. Two third-generation cephalosporins, cefdinir and cefpodoxime proxetil, are approved for use in a more convenient 5-day dosing schedule, thus possibly increasing the likelihood of adherence to the full course of therapy. Palatability is also an important consideration when prescribing antibiotics to children. In a series of studies, children preferred the pleasant strawberry-cream taste of cefdinir to that of amoxicillin/clavulanate, cefprozil, and azithromycin. Cefdinir may offer an alternative to penicillin V for children with streptococcal pharyngitis, particularly when compliance is a clinical concern.
Clinical evaluations were performed before treatment (study day 1), at an interim visit (study day 3 through 6), at the end of therapy (study day 12 through 15), and at final follow-up (study day 25 through 38). Microbiologic evaluations were performed at enrollment and whenever appropriate thereafter.
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These findings suggest that cefpodoxime proxetil administered once daily is as effective and safe as cefixime given once daily in the treatment of acute suppurative otitis media in pediatric patients.
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A prospective economic evaluation was undertaken as part of a randomised clinical trial conducted in French general practice. Its aim was to compare the costs and therapeutic outcomes of a 5-day course of cefpodoxime proxetil 100 mg twice daily with 10-day courses of phenoxymethylpenicillin (penicillin V) 1 MIU 3 times daily and amoxicillin-clavulanic acid 500/125 mg 3 times daily for the treatment of recurrent pharyngotonsillitis in 575 adults. Over the 6-month study period, the total cost to society per patient treated with cefpodoxime proxetil was 123 French francs (FF; 1993 values) lower than that for patients treated with phenoxymethylpenicillin and FF227 lower than that for patients treated with amoxicillin-clavulanic acid. This cost saving was primarily attributable to a lower initial drug acquisition cost, and a reduction in the cost associated with lost productivity and general practitioner consultations. Furthermore, as a consequence of a lower relapse rate, the cost-saving ratio for cefpodoxime proxetil, expressed as FF per month free of recurrence, was FF50 less than for phenoxymethylpenicillin and FF60 less than for amoxicillin-clavulanic acid. Thus, a 5-day course of cefpodoxime proxetil is likely to be less costly for treatment of pharyngotonsillitis in the general practice setting than standard 10-day courses of phenoxymethylpenicillin and amoxicillin-clavulanic acid.
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.
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Tween 80 and TPGS as surfactants and Capmul MCM as oil phase were found to produce stable nanoemulsions. Five formulations of SNEDDS had globule size of 55-60 nm and zeta potential of -4 to -11 mV. Self-emulsification time was between 221 and 370 s, while viscosity was dependent on composition of SNEDDS. Cloud point was above 70°C which indicated the retention of in vivo self-emulsifying properties. Average flux for cefpodoxime proxetil (CP) and SNEDDS was 0.104 and 0.985 µg/cm(2) min. Permeability was 19.72 and 206 for CP and SNEDDS. Liquid SNEDDS spray coated onto micropellets of microcrystalline cellulose (18-20#) were analysed by scanning electron microscope (SEM), self-emulsification and in vitro dissolution. A 5.36-fold increase in area under curve AUC(0-∞) was observed for CP-SNEDDS than plain drug. Minimum inhibitory concentration (MIC) was lower for SNEDDS. Liquid and SNEDDS micropellets were stable under accelerated conditions.
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Upper respiratory tract infections in children are common and usually self-limiting conditions, which include acute otitis media (AOM), acute rhinosinusitis (ARS), and acute pharyngitis (AP). Management of pediatric AOM considers observation strategy for selected and uncomplicated cases, older than 2 years of age, only when adequate follow-up can be ensured. Otherwise, an antibiotic treatment should be prescribed. Amoxicillin should be preferred as the first-choice therapy. Switch therapy to ceftriaxone is suggested if amoxicillin regimen failure occurs within 48-72 hours. The diagnosis of ARS is established by the persistence of purulent nasal of post-nasal draining lasting at least 10 days especially if accompanied by supporting symptoms and signs. Amoxicillin is the first choice drug for mild ARS in children. When symptoms persist or worsen, amoxicillin/clavulanate or cefpodoxime proxetil, or ceftriaxone are recommended. Clinical criteria alone are not sufficiently accurate in children with AP to distinguish bacterial and viral etiology. Thus microbiological evaluation is needed and positive throat culture or rapid antigen detection test are required to establish the diagnosis of streptococcal pharyngitis and consequently to prescribe antibiotic treatment. The first choice treatment in European countries still remains amoxicillin or amoxicillin/clavulanate.
This paper reviews 3 previously published articles that provided recommendations for antimicrobial therapy of acute otitis media (AOM) and combines them to provide revised recommendations.
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This study was designed to compare cefditoren pivoxil, a new beta-lactam, with cefpodoxime proxetil, a beta-lactam with an established role in the treatment of CAP.
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Administration of cefpodoxime in the presence of food affected the rate but not the extent of absorption. Cefpodoxime proxetil oral suspension can be administered without regard to meals in children 6 months to 12 years of age.
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To determine the oral kinetic ( blood and tissue) after single therapeutic dose of cefpodoxime proxetil (20mg/kg oral bid 7 days) in rats of either sex on tissue half life and certain biochemical parameters such as glucose, hemoglobin, protein, ALT, AST and other parameters like tissue residue, sperm count and spermatozoa motility in male rats.
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Cefpodoxime proxetil was administered to 36 children undergoing tonsillectomy, adenoidectomy or both. It was very well tolerated. The detectable tissue concentrations of cefpodoxime were moderate but remained constant (approximately 0.05 mg/kg) 3, 6, and 12 h after the last dose of the drug, while the respective plasma concentrations were declining. This suggests the possibility of twice-daily administration. However, 30% of children did not have quantifiable concentrations in the tonsil and more than half the adenoids did not have quantifiable levels. Whether a higher dosage would lead to higher and more satisfactory tissue concentrations is a matter for further investigation.
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The in-vitro activity of cefpodoxime, the active compound of the ester prodrug, cefpodoxime proxetil, was compared with that of other antibiotics. The susceptibility of bacterial isolates from patients with respiratory tract infections was determined by an agar dilution method. The MIC90s of cefpodozime for ampicillin-sensitive and beta-lactamase-producing strains of Haemophilus influenzae were 0.12 and 0.25 mg/l, respectively; the MIC90s for ampicillin-resistant non-beta-lactamase-producing strains was 1 mg/l. Time-kill curves of cefpodoxime against ampicillin-sensitive and ampicillin-resistant beta-lactamase producing strains showed a time-dependent bactericidal activity. The MIC90s for ampicillin-sensitive and ampicillin-resistant Branhamella catarrhalis were 0.50 and 1 mg/l, respectively. The MIC90s for penicillin-sensitive pneumococci, beta-haemolytic streptococci and Streptococcus agalactiae were 0.06, 0.06 and 0.12 mg/l, respectively. The inhibitory activity against penicillin-resistant pneumococci was limited: the MIC90 was 4 mg/l.
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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).
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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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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The rising rate of CA-MRSA as a cause for many pediatric infections is a major concern. It is very important to obtain cultures from patients with nonresponsive or persistent otorrhea with AOM to look for MRSA and determine the sensitivity of the pathogen to antibacterial therapy. Trimethoprim-sulfamethoxazole is a good choice for initial, empirical therapy when combined with a topical agent for AOM with otorrhea if CA-MRSA is suspected. Further studies are needed to determine whether there is a link between the overuse of topical fluoroquinolones in pediatric patients and the recent rising rate of CA-MRSA.
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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.
In this study, a selective and sensitive LC/MS/MS method for the determination of trace amounts of cefmetazole (CMZ) and cefpodoxime proxetil (CPDXPR) contaminants in manufacturing environments was developed. The necessary sensitivity of this method was estimated based on the detection limit for Penicillin G required by the FDA and the total surface area and volume of the manufacturing facility. The detection limits of this method were estimated to be 10 pg/ml for CMZ and 5 pg/ml for CPDXPR from the signal to noise ratio and as a result satisfactory sensitivity was achieved. The method was linear in a concentration range from 0.20 to 3.20 ng/ml. The accuracy and precision were verified by the determination of the amount of CMZ and CPDXPR added to the sampling materials, a glass plate and a silica fiber filter. The mean recoveries of nine replicated determinations from the glass plate were 99.1% with 5.58%R.S.D. for CMZ and 97.1% with 3.80%R.S.D. for CPDXPR, and those from the silica fiber filter were 100.7% with 4.50%R.S.D. for CMZ and 95.4% with 2.85%R.S.D. for CPDXPR. This method has been successfully applied to the determination of CMZ and CPDXPR contaminants in samples collected from an actual manufacturing environment.
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The objective of this paper was to determine the effectiveness of combined steroid-antimicrobial therapy for otitis media with effusion (OME) of sufficient duration to justify tympanostomy tube insertion. A consecutive sample of 122 children with bilateral OME of at least three months duration, or unilateral OME of at least six months duration, despite treatment with one or more beta-lactamase stable antibiotics was studied. The treatment group received prednisolone plus a beta-lactamase stable antibiotic for 10 days, with responders receiving an additional six weeks of chemoprophylaxis. The control group received no medication. The child's caregiver decided which group the child should be in. Resolution of effusion in all affected ears occurred in 32 per cent of steroid-treated children and in 2 per cent of controls (p < 0.001) at three to four weeks post-therapy. Relapse of effusion occurred in over 40 per cent of initial responders within six months, reducing the final resolution rate to 25 per cent (95 per cent CI: 15-36 per cent). It was concluded that treatment with oral steroids should be considered in selected children with chronic OME prior to surgical intervention. One in every four children whose caregiver consents to this therapy may avoid or postpone surgery for at least six months.
Under day-to-day doctor's office conditions, Podomexef 200 film tablets are both effective and well tolerated in the treatment of bacterial infections of the airways and ENT infections.
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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.